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Reported covered position: Professional Staff Member, Senate Committee on Appropriations, 10-1-14 to 3-26-17 Scheduler and Press Assistant, Congressman Justin Amash, 12-17-12 to 9-31-14 Special Assistant for Constituent Services, Congressman Gregg Harper, 1-1-12 to 7-6-12
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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Renewable Fuel Standard Integrity Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2021 · third_quarter · Q3
Genetically Engineered (GE) Animals ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 273: Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Source: Senate LDA
Renewable Fuel Standard Integrity Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
Renewable Fuel Standard Integrity Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
Renewable Fuel Standard Integrity Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
Renewable Fuel Standard Integrity Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Renewable Fuel Standard Integrity Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Pandemic Preparedness Planning Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Immunization Information Systems ---Defense Production Act ---Supply Chain Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Biosimilars ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Temporarily Refundable R&D Credit Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft) Diversity & Inclusion ---H.R.1319: American Rescue Plan Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Expedited Pathways ---FDA Hiring Flexibility ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. Drug Manufacturing, Quality & Distribution ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Drug Shortages ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---Affordable Prescriptions for Patients Act (Discussion Draft) ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Medicare Prescription Drug Price Negotiation Act (Discussion Drafts) ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Reference Pricing in Drug Reimbursement Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Medicaid ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---Protecting Seniors through Immunizations Act (Discussion Draft) ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program Tax ---FY 2022 Appropriations ---Vaccine Access Improvement Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ------Ensuring Equity for Farmers of Color Amid the Pandemic ---S.278: Emergency Relief for Farmers of Color Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---EPA Regulatory Approach to Gene Editing ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Coronavirus (COVID-19) Pandemic ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Ensuring Equity for Farmers of Color Amid the Pandemic ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Funding for the USDA ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ------Ensuring Equity for Farmers of Color Amid the Pandemic ---S.278: Emergency Relief for Farmers of Color Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Coronavirus (COVID-19) Pandemic ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Biotechnology and Agriculture Trade Program
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
American Rescue Plan Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for FDA ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) Funding for National Institutes of Health ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1319: American Rescue Plan Act of 2021 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the USDA --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Biotechnology and Agriculture Trade Program ---FY 2022 Budget Resolution --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Coronavirus (COVID-19) Pandemic ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Biotechnology and Agriculture Trade Program
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Biosimilars ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Temporarily Refundable R&D Credit Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft) Diversity & Inclusion ---H.R.1319: American Rescue Plan Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Expedited Pathways ---FDA Hiring Flexibility ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. Drug Manufacturing, Quality & Distribution ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Drug Shortages ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---Affordable Prescriptions for Patients Act (Discussion Draft) ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Medicare Prescription Drug Price Negotiation Act (Discussion Drafts) ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Reference Pricing in Drug Reimbursement Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Medicaid ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---Protecting Seniors through Immunizations Act (Discussion Draft) ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program Tax ---FY 2022 Appropriations ---Vaccine Access Improvement Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Coronavirus (COVID-19) Pandemic ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Ensuring Equity for Farmers of Color Amid the Pandemic ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Funding for the USDA ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ------Ensuring Equity for Farmers of Color Amid the Pandemic ---S.278: Emergency Relief for Farmers of Color Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for FDA ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) Funding for National Institutes of Health ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1319: American Rescue Plan Act of 2021 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the USDA --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Biotechnology and Agriculture Trade Program ---FY 2022 Budget Resolution --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Pandemic Preparedness Planning Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Immunization Information Systems ---Defense Production Act ---Supply Chain Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
David’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ------Ensuring Equity for Farmers of Color Amid the Pandemic ---S.278: Emergency Relief for Farmers of Color Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---EPA Regulatory Approach to Gene Editing ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
To direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
To direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.2532: Renewable Chemicals Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
CLEAN Future Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act --- H.R. 5376: Build Back Better Act --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R.2532: Renewable Chemicals Act of 2021 ---FY 2022 Budget Resolution --- Investment Tax Credit --- Production Tax Credit ---Climate Issues & impact on the agriculture, food, and forestry sectors ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Protecting Consumer Access to Generic Drugs Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Protecting Consumer Access to Generic Drugs Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole 40th Anniversary ---Follow Up Discussions about State Attorney General Letter ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing ---Prescription Drug Price Relief Act (Discussion Drafts) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Bringing Back American Jobs Through Intellectual Property Repatriation Act (Discussion Draft House) ---Restrictions on Intellectual Property Rights Diversity in Patenting ---Implementation of Study of Underrepresented Classes Chasing Engineering and Science Success (SUCCESS) Act of 2018 ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---Affordable Prescriptions for Patients Act (Discussion Draft) ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---India ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
Protecting Consumer Access to Generic Drugs Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Biosimilars ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Temporarily Refundable R&D Credit Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft) Diversity & Inclusion ---H.R.1319: American Rescue Plan Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Expedited Pathways ---FDA Hiring Flexibility ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. Drug Manufacturing, Quality & Distribution ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Drug Shortages ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---Affordable Prescriptions for Patients Act (Discussion Draft) ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Medicare Prescription Drug Price Negotiation Act (Discussion Drafts) ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Reference Pricing in Drug Reimbursement Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Medicaid ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---Protecting Seniors through Immunizations Act (Discussion Draft) ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program Tax ---FY 2022 Appropriations ---Vaccine Access Improvement Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020
Protecting Consumer Access to Generic Drugs Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---DNA Patenting and Licensing ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA ------IP Provisions US-China Trade Agreement ---IP Provisions
Protecting Consumer Access to Generic Drugs Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Protecting Consumer Access to Generic Drugs Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---General Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing --- H.R.4811 - Medicare Negotiation and Competitive Licensing Act of 2021 --- Medicare Negotiation and Competitive Licensing Act (Discussion Draft) --- Prescription Drug Price Relief Act (Discussion Draft) --- We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---TRIPS Waiver Inter Partes Review --- S.2891 Restoring the America Invents Act --- S.2774 Pride in Patent Ownership Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents --- S.2774 Pride in Patent Ownership Act ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
PREVENT HPV Cancers Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
PREVENT HPV Cancers Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
RETAIN Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Lower Costs, More Cures Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes.
Lower Costs, More Cures Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Lower Costs, More Cures Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---DNA Patenting and Licensing ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA ------IP Provisions US-China Trade Agreement ---IP Provisions
Lower Costs, More Cures Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Lower Costs, More Cures Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---General Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing --- H.R.4811 - Medicare Negotiation and Competitive Licensing Act of 2021 --- Medicare Negotiation and Competitive Licensing Act (Discussion Draft) --- Prescription Drug Price Relief Act (Discussion Draft) --- We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---TRIPS Waiver Inter Partes Review --- S.2891 Restoring the America Invents Act --- S.2774 Pride in Patent Ownership Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents --- S.2774 Pride in Patent Ownership Act ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
Protecting Seniors Through Immunization Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes.
Protecting Seniors Through Immunization Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Protecting Seniors Through Immunization Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
HAPI Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
HAPI Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes.
HAPI Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Strengthening the Vaccines for Children Program Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Strengthening the Vaccines for Children Program Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes.
Strengthening the Vaccines for Children Program Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Renewable Chemicals Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.2532: Renewable Chemicals Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018
Renewable Chemicals Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act --- H.R. 5376: Build Back Better Act --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R.2532: Renewable Chemicals Act of 2021 ---FY 2022 Budget Resolution --- Investment Tax Credit --- Production Tax Credit ---Climate Issues & impact on the agriculture, food, and forestry sectors ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Prevention of Escapement of Genetically Altered Salmon in the United States Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 273: Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Prevention of Escapement of Genetically Altered Salmon in the United States Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Climate Change ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---FY 2022 Appropriations ---Climate Risk Disclosures ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Genetically Engineered (GE) Animals ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 273: Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors USDA/APHIS Agricultural Biotechnology Regulations ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Prevention of Escapement of Genetically Altered Salmon in the United States Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 273: Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Growing Climate Solutions Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
Growing Climate Solutions Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---General Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing --- H.R.4811 - Medicare Negotiation and Competitive Licensing Act of 2021 --- Medicare Negotiation and Competitive Licensing Act (Discussion Draft) --- Prescription Drug Price Relief Act (Discussion Draft) --- We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---TRIPS Waiver Inter Partes Review --- S.2891 Restoring the America Invents Act --- S.2774 Pride in Patent Ownership Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents --- S.2774 Pride in Patent Ownership Act ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---DNA Patenting and Licensing ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA ------IP Provisions US-China Trade Agreement ---IP Provisions
Stop Stalling Access to Affordable Medications
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---General Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing --- H.R.4811 - Medicare Negotiation and Competitive Licensing Act of 2021 --- Medicare Negotiation and Competitive Licensing Act (Discussion Draft) --- Prescription Drug Price Relief Act (Discussion Draft) --- We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---TRIPS Waiver Inter Partes Review --- S.2891 Restoring the America Invents Act --- S.2774 Pride in Patent Ownership Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents --- S.2774 Pride in Patent Ownership Act ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---DNA Patenting and Licensing ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA ------IP Provisions US-China Trade Agreement ---IP Provisions
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---General Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing --- H.R.4811 - Medicare Negotiation and Competitive Licensing Act of 2021 --- Medicare Negotiation and Competitive Licensing Act (Discussion Draft) --- Prescription Drug Price Relief Act (Discussion Draft) --- We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---TRIPS Waiver Inter Partes Review --- S.2891 Restoring the America Invents Act --- S.2774 Pride in Patent Ownership Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents --- S.2774 Pride in Patent Ownership Act ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
Elijah E. Cummings Lower Drug Costs Now Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Elijah E. Cummings Lower Drug Costs Now Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes.
Elijah E. Cummings Lower Drug Costs Now Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
COVID Vaccine Transportation Access Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
COVID Vaccine Transportation Access Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes.
To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Sustainable Skies Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Sustainable Skies Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Sustainable Skies Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
Sustainable Skies Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
Vaccine Injury Compensation Modernization Act of 2021
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Climate Change ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---FY 2022 Appropriations ---Climate Risk Disclosures ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Genetically Engineered (GE) Animals ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 273: Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors USDA/APHIS Agricultural Biotechnology Regulations ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Digital Trade ---EU Digital Strategy Drug Pricing ---Drug pricing and reimbursement policy in Taiwan ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Intellectual Property International Enforcement ---China ---TRIPS Waiver The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ------Ag-Biotech Provisions ------IP Provisions ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions World Trade Organization ---TRIPS Waiver World Health Organization (WHO) ---TRIPS Waiver
21st Century Cures Act 2.0 ---House Energy and Commerce Discussion Draft ---RFI from House Energy and Commerce Committee Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines --- Implementation of 21st Century Cures Act of 2016 --- Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Reimbursement --- H.R. 2891/S.1428, the Preserve Access to Affordable Generics and Biosimilars Act; Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020, ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver ---Temporarily Refundable R&D Credit ---NOL Monetization Diagnostics and Personalized Medicine Regulation and Oversight --- VALID Act (Discussion Draft) Diversity & Inclusion ---Clinical Trial Diversity ---ENACT Act ---DEPICT Act ---DIVERSE Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---Advisory Committee Enhancements Drug Importation ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Inspections Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R. 2883/S.1425: the Stop Stalling Access to Affordable Medications; ---H.R. 2891/S.1428: the Preserve Access to Affordable Generics and Biosimilars Act; ---H.R. 2873: the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; ---H.R. 2884: the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; ---H.R. 3684 - Infrastructure Investment and Jobs Act? ---S.1435, Affordable Prescriptions for Patients Act of 2021 ---S.632/H.R. 1732, IDEA Act ---HR 5125 Strengthening Innovation in Medicare/Medicaid ---EO 14036 on Competition in American Economy Under importation ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 4127, the DISARM Act ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R. 5376: Build Back Better Act ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administrative Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Step Therapy ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Budget Resolution ---S. 1251/H.R. 2820: The Growing Climate Solutions Act of 2020 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R. 5376: Build Back Better Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---FY 2022 Budget Resolution ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing Related Provisions ---Immunization Information Systems Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.5260: Reduced Costs and Continued Cures Act ---S.2327 - Seniors Prescription Drug Relief Act ---H.R. 5376: Build Back Better Act ---H.R.3684: Infrastructure Investment and Jobs Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 --- Alternative payment arrangements for gene therapies ---Drug Benefit Design ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Step Therapy ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes.
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Pandemic Preparedness Planning Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Immunization Information Systems ---Defense Production Act ---Supply Chain Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 --- H.R. 2891 Preserve Access to Affordable Generics and Biosimilars ---General Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing --- H.R.4811 - Medicare Negotiation and Competitive Licensing Act of 2021 --- Medicare Negotiation and Competitive Licensing Act (Discussion Draft) --- Prescription Drug Price Relief Act (Discussion Draft) --- We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---TRIPS Waiver Inter Partes Review --- S.2891 Restoring the America Invents Act --- S.2774 Pride in Patent Ownership Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents --- S.2774 Pride in Patent Ownership Act ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
Biodefense Research, Development and Procurement Issues (Non-Funding) ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Genetically Engineered (GE) Animals ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 273: Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for FDA ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) Funding for National Institutes of Health ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1319: American Rescue Plan Act of 2021 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the USDA --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Biotechnology and Agriculture Trade Program ---FY 2022 Budget Resolution --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act --- H.R. 5376: Build Back Better Act --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act; ---H.R.2532: Renewable Chemicals Act of 2021 ---FY 2022 Budget Resolution --- Investment Tax Credit --- Production Tax Credit ---Climate Issues & impact on the agriculture, food, and forestry sectors ---USDA Climate-Smart Agriculture and Forestry Partnership Initiative
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2021 · second_quarter · Q2
Coronavirus (COVID-19) Pandemic ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Biotechnology and Agriculture Trade Program
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
Genetically Engineered (GE) Animals ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---DNA Patenting and Licensing ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA ------IP Provisions US-China Trade Agreement ---IP Provisions
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.2118: Clean Energy for America Act of 2021 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for FY 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---FY 2022 Appropriations ---S.1251/H.R.2820: Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---S.1260: United States Innovation and Competition Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---RFS Reform ---Small Refinery Waivers
21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---H.R.2532: Renewable Chemicals Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Agriculture Improvement Act of 2018
Digital Trade ---EU Digital Strategy Drug Pricing --- Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Intellectual Property International Enforcement ---China ---TRIPS Waiver The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ------Ag-Biotech Provisions ------IP Provisions ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions World Trade Organization ---TRIPS Waiver ---United States Withdrawal from the World Trade Organization (WTO) World Health Organization (WHO) ---TRIPS Waiver ---United States Withdrawal from the World Health Organization (WHO)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---FY 2022 Appropriations ---Climate Risk Disclosures ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---RFI from House Select Committee on the Climate Crisis Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) Genetically Engineered (GE) Animals ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---EPA Regulatory Approach to Gene Editing Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Genetically Engineered (GE) Animals ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approvals, Guidance, & Regulations ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2021 · first_quarter · Q1
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Biosimilars ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Temporarily Refundable R&D Credit Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft) Diversity & Inclusion ---H.R.1319: American Rescue Plan Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Expedited Pathways ---FDA Hiring Flexibility ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. Drug Manufacturing, Quality & Distribution ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Drug Shortages ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---Affordable Prescriptions for Patients Act (Discussion Draft) ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Medicare Prescription Drug Price Negotiation Act (Discussion Drafts) ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Reference Pricing in Drug Reimbursement Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Medicaid ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---Protecting Seniors through Immunizations Act (Discussion Draft) ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program Tax ---FY 2022 Appropriations ---Vaccine Access Improvement Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020
Biofuels (Non-Funding) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Renewable Fuel Standard (RFS) ---H.R.1113: Renewable Fuel Standard Integrity Act of 2021 ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act ---S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes. ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---RFS Reform ---Small Refinery Waivers
Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.1512: The Climate Leadership and Environmental Action for Our Nations (CLEAN) Future Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit
Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole 40th Anniversary ---Follow Up Discussions about State Attorney General Letter ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing ---Prescription Drug Price Relief Act (Discussion Drafts) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---We Protect American Investment in Drugs Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Bringing Back American Jobs Through Intellectual Property Repatriation Act (Discussion Draft House) ---Restrictions on Intellectual Property Rights Diversity in Patenting ---Implementation of Study of Underrepresented Classes Chasing Engineering and Science Success (SUCCESS) Act of 2018 ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---Affordable Prescriptions for Patients Act (Discussion Draft) ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---India ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions
Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law
Climate Change ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ------Ensuring Equity for Farmers of Color Amid the Pandemic ---S.278: Emergency Relief for Farmers of Color Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------Feed Additives ------GE Salmon ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---EPA Regulatory Approach to Gene Editing ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Review and Labeling of Food Derived from Biotechnology ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------GE Salmon ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Coronavirus (COVID-19) Pandemic ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Ensuring Equity for Farmers of Color Amid the Pandemic ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biofuels ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---S.Con.Res.5: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2021 and setting forth the appropriate budgetary levels for fiscal years 2022 through 2030 ------Cruz Amdt. #871 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biomass Crop Assistance Program ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for Biorefineries ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Funding for the USDA ---H.R.1319: American Rescue Plan Act of 2021 ------Funding the monitoring of COVID-19 in animals ------Supporting Farmers and Strengthening the Food Supply Chain ------Ensuring Equity for Farmers of Color Amid the Pandemic ---S.278: Emergency Relief for Farmers of Color Act of 2021 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2022 (Discussion Draft House) ------USDA Energy Program Funding
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2020 · second_quarter · 2A
Biofuels (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions US-China Trade Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Regulatory Treatment of Gene Edited Products ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---USDA Part 340 Draft Rule
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels Capital Formation Incentives ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Incentives for Sustainable Aviation Fuels ---Infectious Disease Therapies Research and Innovation Act (Discussion Draft) ---Introduction of the American Innovation Act in the Senate ---Reintroduction of the American Innovation Act in the House ---NOL Monetization ---Reform of Net Operating Loss Rules ---Start-ups for Cures Act (Discussion Draft) ---The More Cures Act (Discussion Draft) Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Expensing of R&D Expenditures ---Incentives for Sustainable Aviation Fuels ---R&D Credit Temporary Refundability ---R&D Payroll Credit
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act of 2020 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Pricing ---International Pricing Index Proposal Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Foreign Drug Data Protection Laws ---Regulatory Harmonization Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization US-UK Trade Agreement ---Ag-Biotech Provisions ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)
Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Coronavirus (COVID-19) Pandemic ---NOL Monetization ---Pause on Graduating from ECG Status (ECG Pause) ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program
Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6395: William M. (Mac) Thornberry National Defense Authorization Act for FY 2021 ---S.4049: National Defense Authorization Act for FY 2021 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit ---Sustainable Chemistry Research and Development
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2020 · second_quarter · 2A
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020
Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act of 2020 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
Biofuels (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels Capital Formation Incentives ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Incentives for Sustainable Aviation Fuels ---Infectious Disease Therapies Research and Innovation Act (Discussion Draft) ---Introduction of the American Innovation Act in the Senate ---Reintroduction of the American Innovation Act in the House ---NOL Monetization ---Reform of Net Operating Loss Rules ---Start-ups for Cures Act (Discussion Draft) ---The More Cures Act (Discussion Draft) Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Expensing of R&D Expenditures ---Incentives for Sustainable Aviation Fuels ---R&D Credit Temporary Refundability ---R&D Payroll Credit
Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Coronavirus (COVID-19) Pandemic ---NOL Monetization ---Pause on Graduating from ECG Status (ECG Pause) ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions
CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Pricing ---International Pricing Index Proposal Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Foreign Drug Data Protection Laws ---Regulatory Harmonization Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization US-UK Trade Agreement ---Ag-Biotech Provisions ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6395: William M. (Mac) Thornberry National Defense Authorization Act for FY 2021 ---S.4049: National Defense Authorization Act for FY 2021 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit ---Sustainable Chemistry Research and Development
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions US-China Trade Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Regulatory Treatment of Gene Edited Products ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---USDA Part 340 Draft Rule
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2020 · fourth_quarter · Q4
Biofuels (Non-Funding) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act of 2020 ---H.R.8759: Streamlining Advanced Biofuels Registration Act of 2020 ---H.R.8769: The Sustainable Aviation Fuel Act ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Incentives for Sustainable Aviation Fuels ---One-year extension of the Second-generation Biofuel Producer Tax Credit and Two-year Extension of the Section 45Q Credit for Carbon Dioxide Sequestration in H.R. 133: Consolidated Appropriations Act for FY 2021 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Incentives for Sustainable Aviation Fuels ---USDA Discretion to Provide Support for Biofuel Producers in H.R.133: Consolidated Appropriations Act for FY 2021 Funding for Biomass Crop Assistance Program ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for Biorefineries ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---USDA Discretion to Provide Support for Biofuel Producers in H.R.133: Consolidated Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.8759: Streamlining Advanced Biofuels Registration Act of 2020 ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFS Reform ---Small Refinery Waivers
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2020 · third_quarter · Q3
Asia Pacific Economic Cooperation Forum - - - Biologics Regulations - - - Intellectual Property Issues Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2020 · second_quarter · Q2
Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2020 · first_quarter · Q1
Genetically Engineered (GE) Animals ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology ---Priority Zoonotic Animal Drugs ---USDA Authority to Review Animal Biotechnology
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Patient Cost-Sharing and Smoothing ---Reasonable Pricing Provisions Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Reasonable Pricing Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---Alternative payment arrangements for gene therapies ---Pricing and Rebates Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2019 · fourth_quarter · 4A
Committee on Foreign Investment in the United States (CFIUS) ---Foreign Investment Risk Review Modernization Act (FIRRMA) Implementation Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions ---IP Provisions US-China Trade Negotiations ---Ag Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---IP Provisions
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2019 · fourth_quarter · Q4
Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling
Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---RFS Reform ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Small Refinery Waivers
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2019 · third_quarter · Q3
340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---340B Optimization Act (Discussion Draft House/Senate) ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Program Implementation & Oversight Access to Medicines/World Health Organization Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Biosimilars ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---Access to Samples for Testing ---Patient Cost-Sharing ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Interchangeability and Pharmacy Substitution ---Medicare Reimbursement ---Naming ---Biosimilar Copay Elimination Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Drug Manufacturing, Quality & Distribution ---S.551 REFUND Act of 2019 ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight Drug Patenting ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs Act of 2019 Drug Pricing ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416/H.R. 4398 : Affordable Prescriptions for Patients Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---International Reference Pricing ---Administration International Pricing Index Proposal ---Direct Government Negotiation/Price Setting/Arbitration/Compulsory Licensing ---Medicare Part D Prescription Drug Program ---Medicare Part B Prescription Drug Program ---Value-based Contracting ---Rebate reform Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for FDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing Funding for Health Resources and Services Administration (HRSA) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---340B Program Integrity Issues ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the National Vaccine Program Office (NVPO) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Generic Drug Entry ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---Access to Samples for Testing ---Incentives for Generic Drug Entry Medicaid ---H.R.3: Lower Drug Costs Now Act of 2019 ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Arrangements Medicare Expansion ---S.1129: A bill to establish a Medicare-for-all national health insurance program of 2019 Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---NIH Research ---H.R.5590: Opioid Addiction Action Plan Act ---Transparency Orphan Drug Issues ---Tax Credit Precision Medicine Initiative ---Genome Editing Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing ---Protected Classes ---Step Therapy ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Adult Immunization Education ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2019 · second_quarter · Q2
Bayh-Dole Act/Tech Transfer ---Domestic Manufacturing Requirement ---March-In Rights Compulsory Licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Diversity in Patenting ---H.R.6390/S.3483: SUCCESS Act Drug Patenting ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.440: Preserving Access to Cost Effective Drugs Act (PACED) Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs Act of 2019 Foreign Drug Data Protection Laws ---China ---Saudi Arabia Intellectual Property International Enforcement ---China ---India ---Malaysia Inter Partes Review ---H.R.990/S.344 Hatch-Waxman Integrity Act of 2019 ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---S.440: Preserving Access to Cost Effective Drugs Act (PACED) Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---Implementation of the America Invents Act of 2011 Patent Reform ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---Patent Litigation Reform Patenting of Biological Inventions ---Argentina Biotech Patentability Guidelines ---DNA Patenting and Licensing ---PTO Examination Guidelines ---Section 101 Modernization The United States-Mexico-Canada Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2019 · first_quarter · Q1
Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Entenders ---Implementation of the Agriculture Improvement Act of 2018 ---Master Limited Partnership Parity Act (Discussion Draft Senate) ---Clean Energy for America Act (Discussion Draft Senate) Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (non-funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biorefineries ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Renewable Fuel Standard (RFS) ---RFS Reform ---Small Refinery Waivers ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.J.Res.31: Consolidated Appropriations Act for FY 2019
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2018 · fourth_quarter · Q4
Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S. 771: Improving Access to Affordable Prescription Drugs ---General Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---DOE Office of Science ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Renewable Chemicals/Bio-based Products ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---EPA Safer Choice Program Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2018 · third_quarter · Q3
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Transfer of Authority for National Strategic Stockpile ------S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) ---National Biodefense Strategy Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019
Agricultural Education Policy Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act EPA Regulations on Biotechnology ---H.R. 1029 Pesticide Registration Act ---Efficient Science-Based Reviews of Biotech Products Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act Potential Regulation of New Genetic Editing/Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2018 · second_quarter · Q2
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Energy Basic Research Funding ---DOE Office of Science ---Advanced Research Projects Agency-Energy ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act Review of the Federal Coordinated Framework for Biotechnology Products
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2018 · first_quarter · Q1
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---H.R. 3266: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act Review of the Federal Coordinated Framework for Biotechnology Products
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · fourth_quarter · Q4
Bayh-Dole Act/Tech Transfer ---March-In Rights -------H.R. 2810: National Defense Authorization Act of 2018 Intellectual Property International Enforcement ---Compulsory Licensing ---India Inter Partes Review ---Implementation of the America Invents Act of 2011 ---S. 1390: STRONGER Patents Act ---Sovereign Immunity International IP Patent Law Harmonization North American Free Trade Agreement (NAFTA) Renegotiation ---IP Provisions Nomination of Under Secretary of Commerce for Intellectual Property Patent Reform ---Patent Litigation Reforms ---S. 1390: STRONGER Patents Act Patenting of Biological Inventions ---Section 101 Modernization UN High Level Commission on Access to Medicines ---IP Proposals
Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 2810: National Defense Authorization Act of 2018 Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---Farm Bill Reauthorization ---H.R. 3149/S.1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S.2005: Master Limited Partnership Parity Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · third_quarter · Q3
Genetically Engineered (GE) ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling
Drug Importation ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling Opioid Crisis Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · second_quarter · Q2
Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program EPA Regulations on Biotechnology ---Efficient Science-Based Review of Biotech Products ---H.R. 1029: Pesticide Registration Improvement Extension Act of 2017 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Labeling ---The One Health Act (Sen. Franken Discussion Draft) North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions One Health ---The One Health Act (Sen. Franken Discussion Draft) Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law Review of the Federal Coordinated Framework for Biotechnology Products USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---Potential Revisions to Part 340 Regulations
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---COVID-19 Pricing-Related Provisions ---Immunization information systems ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Preventive Monoclonal Antibody Coverage Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---General ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---International Pricing Index Proposal ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019
Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biofuels ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Incentives for Sustainable Aviation Fuels ---USDA Discretion to Provide Support for Biofuel Producers in H.R.133: Consolidated Appropriations Act for FY 2021 Funding for Biomass Crop Assistance Program ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for Biorefineries ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---USDA Discretion to Provide Support for Biofuel Producers in H.R.133: Consolidated Appropriations Act for FY 2021 Funding for FDA ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for National Institutes of Health ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Renewable Chemicals/Bio-based Products ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for the USDA ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.7661: Coronavirus Emerging Growth Companies (EGC) Extension Act of 2020 ---H.R.8080: Health STATISTICS Act of 2020 ---S.4317: SAFE TO WORK Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Immunization information systems ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Operation Warp Speed ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 declaration coverage for private sector procurement ---Preventive Monoclonal Antibody Coverage Diversity & Inclusion Drug Evaluation and Review ---COVID-19 Lessons Learned ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---General Drug Manufacturing, Quality & Distribution ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.7767: To amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment ---Drug Shortages ---Executive Order on Buy American Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---General ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---International Pricing Index Proposal ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) Funding for Antimicrobial Resistance Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.4760:Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for National Institutes of Health ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Orphan Drug Issues ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Rare Pediatric Disease Priority Review ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, MFN EO) ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccine Injury Compensation Program Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 Vaccines and Infectious Diseases ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Adult Immunization Education ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---Operation Warp Speed ---Preventive Monoclonal Antibody Coverage ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety
Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---General Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---GE Salmon language in Sec. 778 in H.R.133: Consolidated Appropriations Act for FY 2021 ---International Consistency of Regulation for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Fighting Climate Change through Biotechnology Innovation Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Foreign Agricultural Biotechnology Laws and Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---GE Salmon language in Sec. 778 in H.R.133: Consolidated Appropriations Act for FY 2021 ---International Consistency of Regulation for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---EPA Regulatory Approach to Gene Editing ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions US-China Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Regulatory Treatment of Gene Edited Products ---Implementation of the SECURE Rule under the Plant Protection Act ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Biodefense Research, Development and Procurement Issues (Nonfunding) ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.7661: Coronavirus Emerging Growth Companies (EGC) Extension Act of 2020 ---H.R.8080: Health STATISTICS Act of 2020 ---COVID-19 Pricing-Related Provisions ---Drug Supply Chain Management ---Immunization information systems ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Preventive Monoclonal Antibody Coverage Funding for Antimicrobial Resistance Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Biodefense Research, Development and Procurement Issues (Nonfunding) ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---GE Salmon language in Sec. 778 in H.R.133: Consolidated Appropriations Act for FY 2021 ---International Consistency of Regulation for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---GE Salmon language in Sec. 778 in H.R.133: Consolidated Appropriations Act for FY 2021 ---International Consistency of Regulation for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Funding for Renewable Chemicals/Bio-based Products ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.8879: Renewable Chemicals Act of 2020
Biofuels (Non-Funding) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act of 2020 ---H.R.8759: Streamlining Advanced Biofuels Registration Act of 2020 ---H.R.8769: The Sustainable Aviation Fuel Act ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Incentives for Sustainable Aviation Fuels ---One-year extension of the Second-generation Biofuel Producer Tax Credit and Two-year Extension of the Section 45Q Credit for Carbon Dioxide Sequestration in H.R. 133: Consolidated Appropriations Act for FY 2021 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Incentives for Sustainable Aviation Fuels ---USDA Discretion to Provide Support for Biofuel Producers in H.R.133: Consolidated Appropriations Act for FY 2021 Funding for Biomass Crop Assistance Program ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for Biorefineries ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---USDA Discretion to Provide Support for Biofuel Producers in H.R.133: Consolidated Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.8759: Streamlining Advanced Biofuels Registration Act of 2020 ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFS Reform ---Small Refinery Waivers
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology ---USDA Agriculture Innovation Agenda ---FDA Proposed Guidance on Gene Editing
H.R.34: 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Affordable Life-saving Medications ---H.R. 7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Reimbursement and Coverage of Innovative Products ---Executive order on Lowering Drug Prices by Putting America First Drug Importation ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients Antibiotic & Diagnostic Tax Credit Asia Pacific Economic Cooperation Forum ---Biologics Regulations ---Intellectual Property Issues Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---H.R. 748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---S.4231: Preparing for the Next Pandemic Act of 2020 ---Strategic National Stockpile ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Executive Order on Buy American ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Biodefense Strategy ---Senate HELP Pandemic Preparedness White Paper ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Biosimilar Copay ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7917: IGNITE American Innovation Act ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.4775: The Delivering Immediate Relief to America's Families, Schools and Small Business Act ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Coverage for Covid Tx ---Drug Supply Chain Management ---Funding for Countermeasure Injury Compensation Program ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.7269/S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management ---Executive Order on Buy American Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---CMMI Authority ---Executive Order on Buy American ---Executive Order on Access to Affordable Life-saving Medications ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---General ---International Pricing Index Proposal ---Most Favored Nation Executive Order ---Proposed Federal Price Caps on COVID-19 Therapeutics and Vaccines Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---S.4760:Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---Health Defense Operations Funding Designation ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act Funding for FDA ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Lowering Drug Prices by Putting America First ---Executive Order on Access to Affordable Life-Saving Medications ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S.4509: Vaccine And Coverage Certainty (VACC) Act ---Adult Immunization Education ---Countermeasure Injury Compensation Program ---Implementation of the Families First Coronavirus Response Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Maternal Immunization ---Operation Warp Speed/ACTIV ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Anti-Microbial Resistance Product Development and Incentives
Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---H.R.8337:Continuing Appropriations Act, 2021 and Other Extensions Act Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---H.R.7614:Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7612: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613: Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---H.R.7616: Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613:Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Funding for FDA ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Renewable Chemicals/Bio-based Products ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613: Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology Drug Importation ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---International Pricing Index Proposal ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020
Capital Formation Incentives ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Incentives for Sustainable Aviation Fuels ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. H.R.7537: Infectious Disease Therapies Research and Innovation Act H.R.7505: American Innovation Act Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Coronavirus (COVID-19) Pandemic ---H.R.7917 IGNITE American Innovation Act ---H.R.7661: Covid ECG Extension Act ---H.R. 7917 IGNITE American Innovation Act ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---S.4775: The Delivering Immediate Relief to America's Families, Schools and Small Business Act ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program
Funding for Renewable Chemicals/Bio-based Products ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613: Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6395: William M. (Mac) Thornberry National Defense Authorization Act for FY 2021 ---S.4049: National Defense Authorization Act for FY 2021 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit ---Sustainable Chemistry Research and Development
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act of 2020 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7612: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613: Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---H.R.7616: Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613: Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Funding for Biomass Crop Assistance Program ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---H.R.7610:Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology ---FDA Proposed Guidance on Gene Editing Genetically Engineered (GE) Plants ---EPA Regulation of Plant Incorporated Protectants (PIPs) ---EPA Regulatory Approach to Gene Editing ---FDA Proposed Guidance on Gene Editing The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions US-China Trade Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Regulatory Treatment of Gene Edited Products ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---USDA Part 340 Draft Rule
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Executive Order on Buy American ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7614:Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7614:Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Health Defense Operations Funding Designation Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7614:Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7614:Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic
CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Importation ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients Drug Pricing ---Executive Order on Buy American ---Executive Order on Access to Affordable Life-saving Medications ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---International Pricing Index Proposal ---Most Favored Nation Executive Order Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations ---Mexico Biologics Regulations Foreign Drug Data Protection Laws ---Regulatory Harmonization Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization US-UK Trade Agreement ---Ag-Biotech Provisions ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act 2020 ---H.R.6201: Families First Coronavirus Response Act 2020 ---S.4231: Preparing for the Next Pandemic Act of 2020 ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---Executive Order on Modernizing Influenza Vaccines ---Executive Order on Lowering Drug Prices by Putting America First ---Executive Order on Access to Affordable Life-Saving Medications ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Biodefense Strategy ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Strategic National Stockpile ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act of 2020 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7612: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613: Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---H.R.7616: Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7613: Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels Capital Formation Incentives ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Incentives for Sustainable Aviation Fuels ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7505: American Innovation Act ---Reform of Net Operating Loss Rules Coronavirus (COVID-19) Pandemic ---H.R.7917: IGNITE American Innovation Act Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Expensing of R&D Expenditures ---Incentives for Sustainable Aviation Fuels ---R&D Credit Temporary Refundability ---R&D Payroll Credit ---H.R.4549: American Innovation and Competitiveness Act (AICA) of 2019
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7610:Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology ---FDA Proposed Guidance on Gene Editing ---USDA Agriculture Innovation Agenda
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6395: William M. (Mac) Thornberry National Defense Authorization Act for FY 2021 ---S.4049: National Defense Authorization Act for FY 2021 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit ---Sustainable Chemistry Research and Development
CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Pricing ---International Pricing Index Proposal Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Foreign Drug Data Protection Laws ---Regulatory Harmonization Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization US-UK Trade Agreement ---Ag-Biotech Provisions ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)
Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions US-China Trade Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Regulatory Treatment of Gene Edited Products ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---USDA Part 340 Draft Rule
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels Capital Formation Incentives ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Incentives for Sustainable Aviation Fuels ---Infectious Disease Therapies Research and Innovation Act (Discussion Draft) ---Introduction of the American Innovation Act in the Senate ---Reintroduction of the American Innovation Act in the House ---NOL Monetization ---Reform of Net Operating Loss Rules ---Start-ups for Cures Act (Discussion Draft) ---The More Cures Act (Discussion Draft) Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Expensing of R&D Expenditures ---Incentives for Sustainable Aviation Fuels ---R&D Credit Temporary Refundability ---R&D Payroll Credit
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Biofuels (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Coronavirus (COVID-19) Pandemic ---NOL Monetization ---Pause on Graduating from ECG Status (ECG Pause) ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program
Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology
Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act of 2020 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---S.3986: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Coronavirus (COVID-19) Pandemic ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) ---Priority Zoonotic Animal Drugs Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations Funding for Biomass Crop Assistance Program ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Farm Bill Programs Energy Title IX ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) Genetically Engineered (GE) Animals ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology ---Priority Zoonotic Animal Drugs ---USDA Authority to Review Animal Biotechnology Genetically Engineered (GE) Plants ---EPA Regulatory Approach to Gene Editing The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions US-China Trade Negotiations ---Ag Biotech Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Regulatory Treatment of Gene Edited Products
Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy Funding for Antimicrobial Resistance Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
Genetically Engineered (GE) Animals ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology ---Priority Zoonotic Animal Drugs ---USDA Authority to Review Animal Biotechnology
Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---March-In Rights Compulsory Licensing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Intellectual Property International Enforcement ---China ---India Inter Partes Review ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.440 PACED Act of 2019 ---Implementation of the America Invents Act of 2011 Patent Reform ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---Patent Litigation Reforms Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions
Committee on Foreign Investment in the United States (CFIUS) ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---General Drug Pricing ---International Pricing Index Proposal Foreign Agricultural Biotechnology Laws and Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations Intellectual Property International Enforcement ---China ---India The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions ---IP Provisions US-China Trade Negotiations ---Ag Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Trade Organization - Special 301 Submissions ---China ---India
Biofuels (Non-Funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels ---RFI from House Select Committee on the Climate Crisis ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Funding for Biofuels ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) Renewable Fuel Standard (RFS) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Cellulosic Registration Applications for Corn Kernel Fiber ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Coronavirus (COVID-19) Pandemic ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biofuels ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) Funding for Coronavirus (COVID-19) Small Business Loans ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Renewable Chemicals/Bio-based Products ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Farm Bill Programs Energy Title IX ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC)
Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Affiliation ---Eligibility Funding for Coronavirus (COVID-19) Small Business Loans ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Proxy Advisory Services ---H.R.4015: Corporate Governance Reform and Transparency Act of 2017 ---S.3614: Corporate Governance Fairness Act of 2018 ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Short Selling Transparency Small Business Innovation Research (SBIR) Program
Biofuels (Non-Funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels ---RFI from House Select Committee on the Climate Crisis ---Small Refinery Waivers ---Sustainable Aviation Fuels Tax Credit Funding for Biofuels ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) Renewable Fuel Standard (RFS) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Cellulosic Registration Applications for Corn Kernel Fiber ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers
Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---General Genetically Engineered (GE) Animals ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology ---Priority Zoonotic Animal Drugs ---USDA Authority to Review Animal Biotechnology Opioid Crisis ---General ---Implementation of the SUPPORT for Patients and Communities Act of 2018
Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy Funding for Antimicrobial Resistance Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021
Biofuels (Non-Funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Investment Incentives ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Introduction of the American Innovation Act in the Senate ---Reform of Net Operating Loss Rules ---Reintroduction of the American Innovation Act in the House Orphan Drug Issues ---Tax Credit Qualified Small Business Stock (QSBS) Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Expensing of R&D Expenditures ---Incentives for Sustainable Aviation Fuels ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020
Funding for Renewable Chemicals/Bio-based Products ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Increased Borrowing Authority for the Commodity Credit Corporation (CCC) Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Bioeconomy Research and Development Act of 2020 (Discussion Draft House) ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Investment Tax Credit ---Production Tax Credit
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Drug Supply Chain Management ---Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Reasonable Pricing Provisions Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.6102/S3404: VALID Act of 2020 Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---Patient-Focused Drug Development ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---General Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Reasonable Pricing Provisions Funding for Antimicrobial Resistance Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Pricing and Rebates Opioid Crisis ---General ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439: Creating Hope Reathorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccine Injury Compensation Program Tax ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 202 ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 Vaccines and Infectious Diseases ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives
Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for FDA ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Renewable Chemicals/Bio-based Products ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for the USDA ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020
Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills)
Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020
340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Biosimilars ---Biosimilar Copay Elimination ---Coding ---Reimbursement 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Drug Pricing ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications
Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---RFS Reform ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Small Refinery Waivers
Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills)
Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling
Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling
Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis EPA Regulations on Biotechnology ---EPA Plant Biotech Regulatory Policy ---H.R.4373: Engineering Biology Research and Development Act Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---Korea Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the USDA ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling Genetically Engineered (GE) Plants ---EPA Regulatory Approach to Gene Editing ---FDA Proposed Guidance on Gene Editing The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions US-China Trade Negotiations ---Ag Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---USDA Part 340 Revision
Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---RFS Reform ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Small Refinery Waivers
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling
Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills)
Committee on Foreign Investment in the United States (CFIUS) ---Foreign Investment Risk Review Modernization Act (FIRRMA) Implementation Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions ---IP Provisions US-China Trade Negotiations ---Ag Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---IP Provisions
Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis EPA Regulations on Biotechnology ---EPA Plant Biotech Regulatory Policy ---H.R.4373: Engineering Biology Research and Development Act Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---Korea Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the USDA ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling Genetically Engineered (GE) Plants ---EPA Regulatory Approach to Gene Editing ---FDA Proposed Guidance on Gene Editing The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions US-China Trade Negotiations ---Ag Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---USDA Part 340 Revision
Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020
Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for FDA ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Renewable Chemicals/Bio-based Products ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for the USDA ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020
Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---RFS Reform ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Small Refinery Waivers
340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Biosimilars ---Biosimilar Copay Elimination ---Coding ---Reimbursement 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Drug Pricing ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications
Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills)
340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Genetically Engineered (GE) Animals ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Amendment to Restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---H.R.4373: Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products
Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate)
Genetically Engineered (GE) Animals ---H.R.3164/S. 2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 -----Amendment to Restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---H.R.4373: Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Review and Labeling of Food Derived from Biotechnology
Biofuels (Non-Funding) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---S.617: Tax Extender and Disaster Relief Act of 2019 ---S.1288: Clean Energy for America Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.4373: Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 Biomass Programs (Non-Funding) ---H.R.4373: Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Rep. Craig Amendment #50 ------Rep. Perry Amendment #56 ---S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.4373: Engineering Biology Research and Development Act ---RFS Reform ---Small Refinery Waivers
Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Genetically Engineered (GE) Animals ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Efficient Science-Based Review of Biotech Products ---H.R.4373: Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---NIH Research ---H.R.5590: Opioid Addiction Action Plan Act ---Transparency Review and Labeling of Food Derived from Biotechnology
Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate)
Funding for Renewable Chemicals/Bio-based Products ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.4373: Engineering Biology Research and Development Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit
Bayh-Dole Act/Tech Transfer ---Domestic Manufacturing Requirement ---March-In Rights Compulsory Licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Diversity in Patenting ---H.R.6390/S.3483: SUCCESS Act Drug Patenting ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.440: Preserving Access to Cost Effective Drugs Act (PACED) Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs Act of 2019 Intellectual Property International Enforcement ---China Inter Partes Review ---H.R.990/S.344 Hatch-Waxman Integrity Act of 2019 ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---S.440: Preserving Access to Cost Effective Drugs Act (PACED) Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---Implementation of the America Invents Act of 2011 Patent Reform ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---Patent Litigation Reforms Patenting of Biological Inventions ---Section 101 Modernization (Senate Discussion Draft- Sens. Coon/Tillis) The United States-Mexico-Canada Agreement ---IP Provisions
Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biofuels ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Rep. Craig Amendment #50 ------Rep. Perry Amendment #56 ---S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for FDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing ---S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---340B Program Integrity Issues ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Renewable Chemicals/Bio-based Products ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the National Vaccine Program Office (NVPO) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the USDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 -----Biotechnology and Agriculture Trade Program
Biomass Programs (Non-Funding) ---H.R.4373: Engineering Biology Research and Development Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 EPA Regulations on Biotechnology ---Efficient Science-Based Reviews of Biotech Products ---H.R.4373: Engineering Biology Research and Development Act ---Regulatory Treatment of Gene Edited Products FDA Regulations on Biotechnology ---H.R.4373: Engineering Biology Research and Development Act ---Regulatory Treatment of Gene Edited Products Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the USDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Genetically Engineered (GE) Animals ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Amendment to Restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---H.R.4373:Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---H.R.4373: Engineering Biology Research and Development Act ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products ---EPA Regulatory Approach to Gene Editing Review and Labeling of Food Derived from Biotechnology The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---H.R.4373: Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 ---Regulatory Treatment of Gene Edited Products ---USDA Part 340 Draft Rule
Biofuels (Non-Funding) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---S.617: Tax Extender and Disaster Relief Act of 2019 ---S.1288: Clean Energy for America Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.4373: Engineering Biology Research and Development Act ---Implementation of the Agriculture Improvement Act of 2018 Biomass Programs (Non-Funding) ---H.R.4373: Engineering Biology Research and Development Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Rep. Craig Amendment #50 ------Rep. Perry Amendment #56 ---S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.4373: Engineering Biology Research and Development Act ---RFS Reform ---Small Refinery Waivers
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biofuels ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Craig Amendment #50 ------Perry Amendment #56 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biorefineries ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for FDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Health Resources and Services Administration (HRSA) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---340B Program Integrity Issues ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Renewable Chemicals/Bio-based Products ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the National Vaccine Program Office (NVPO) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the USDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate)
340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---340B Optimization Act (Discussion Draft House/Senate) ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Program Implementation & Oversight Access to Medicines/World Health Organization Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Biosimilars ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---Access to Samples for Testing ---Patient Cost-Sharing ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Interchangeability and Pharmacy Substitution ---Medicare Reimbursement ---Naming Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Drug Manufacturing, Quality & Distribution ---S.551 REFUND Act of 2019 ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight Drug Patenting ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs Act of 2019 Drug Pricing ---General ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency Foreign Drug Data Protection Laws ---China ---Saudi Arabia Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for FDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Health Resources and Services Administration (HRSA) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---340B Program Integrity Issues ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the National Vaccine Program Office (NVPO) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Generic Drug Entry ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---Access to Samples for Testing ---Incentives for Generic Drug Entry Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Arrangements Medicare Expansion ---S.1129: A bill to establish a Medicare-for-all national health insurance program of 2019 Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---NIH Research Orphan Drug Issues ---Tax Credit Precision Medicine Initiative ---Genome Editing Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing ---Protected Classes ---Step Therapy ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Adult Immunization Education ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program
Genetically Engineered (GE) Animals ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Efficient Science-Based Review of Biotech Products ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products
Biofuels (Non-Funding) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---S.617: Tax Extender and Disaster Relief Act of 2019 ---S.1288: Clean Energy for America Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Advanced and Second Generation Biofuels Tax Extenders ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 Biomass Programs (Non-Funding) ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Craig Amendment #50 ------Perry Amendment #56 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biorefineries ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---Engineering Biology Research and Development Act (Discussion Draft House) ---RFS Reform ---Small Refinery Waivers
Biomass Programs (Non-Funding) ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 EPA Regulations on Biotechnology ---Efficient Science-Based Reviews of Biotech Products ---Engineering Biology Research and Development Act (Discussion Draft House) ---Regulatory Treatment of Gene Edited Products FDA Regulations on Biotechnology ---Engineering Biology Research and Development Act (Discussion Draft House) ---Regulatory Treatment of Gene Edited Products Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the USDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Genetically Engineered (GE) Animals ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Efficient Science-Based Review of Biotech Products ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---Engineering Biology Research and Development Act (Discussion Draft House) ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Review and Labeling of Food Derived from Biotechnology The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---Potential Revisions to Part 340 Regulations ---Regulatory Treatment of Gene Edited Products
Funding for Renewable Chemicals/Bio-based Products ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit
Genetically Engineered (GE) Animals ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Efficient Science-Based Review of Biotech Products ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Review and Labeling of Food Derived from Biotechnology
Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate)
Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate)
Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Genetically Engineered (GE) Animals ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Efficient Science-Based Review of Biotech Products ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---FDA Proposed Guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---NIH Research Review and Labeling of Food Derived from Biotechnology
Biofuels (Non-Funding) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---S.617: Tax Extender and Disaster Relief Act of 2019 ---S.1288: Clean Energy for America Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Advanced and Second Generation Biofuels Tax Extenders ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 Biomass Programs (Non-Funding) ---Engineering Biology Research and Development Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Craig Amendment #50 ------Perry Amendment #56 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biomass Crop Assistance Program ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biorefineries ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---Engineering Biology Research and Development Act (Discussion Draft House) ---RFS Reform ---Small Refinery Waivers
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for Renewable Chemicals/Bio-based Products ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Renewable Chemicals/Bio-based Products (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Master Limited Partnership Parity Act (Discussion Draft Senate) ---Production Tax Credit ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019
Funding for Antimicrobial Resistance Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biofuels ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biorefineries ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for National Institutes of Health ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Renewable Chemicals/Bio-based Products ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate)
Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.844: Short on Competition Act of 2019 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labeling Opioid Crisis ---NIH Research ---Coverage and Reimbursement ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of the 21st Century Cures Act of 2016 ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Reauthorization of the Pandemic and All Hazards Preparedness Act ---H.R.269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---National Biodefense Strategy ---Gene Editing Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate)
Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of the 21st Century Cures Act of 2016 ---Tropical Disease Priority Review Voucher (PRV) Program ---Reauthorization of the Pandemic and All Hazards Preparedness Act ---Implementation of Medical Countermeasures Innovation Act ---H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---National Biodefense Strategy ---Gene Editing Funding for Antimicrobial Resistance Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for National Institutes of Health ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate)
Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labeling
Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 EPA Regulations on Biotechnology ---Efficient Science-Based Reviews of Biotech Products ---Regulatory Treatment of Gene Edited Products ---S.483: Pesticide Registration Improvement Extension Act of 2018 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations ---Like-minded Countries Initiatives Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labeling Genetically Engineered (GE) Plants ---FDA Proposed Guidance on Gene Editing Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations ---Regulatory Treatment of Gene Edited Products The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions
Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Entenders ---Implementation of the Agriculture Improvement Act of 2018 ---Master Limited Partnership Parity Act (Discussion Draft Senate) ---Clean Energy for America Act (Discussion Draft Senate) Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (non-funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biorefineries ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Renewable Fuel Standard (RFS) ---RFS Reform ---Small Refinery Waivers ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.J.Res.31: Consolidated Appropriations Act for FY 2019
340B Drug Discount Program ---Program Implementation & Oversight ---340B Pause Act (Discussion Draft House/Senate) ---340B Optimization Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of the 21st Century Cures Act of 2016 ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Reauthorization of the Pandemic and All Hazards Preparedness Act ---H.R.269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---National Biodefense Strategy ---Gene Editing Biosimilars ---Access to Samples for Testing ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Brazil Biologics Regulations ---Coding ---Naming ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---S.659: Biologic Patent Transparency Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 Drug Evaluation and Review ---H.R.1503: Orange Book Transparency Act of 2019 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S. 97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S. 844: Short on Competition Act of 2019 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---S.551: REFUND Act of 2019 ---Supply Chain Integrity and Traceability Drug Pricing ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Pricing Transparency ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.99: Medicare Drug Price Negotiation Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.844: Short on Competition Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act Foreign Drug Data Protection Laws ---China Funding for Antimicrobial Resistance Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for National Institutes of Health ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Drug Entry ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 Medicare Expansion ---H.R.1384: Medicare for All Act of 2019 ---S.1129: A bill to establish a Medicare-for-all national health insurance program of 2019 Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions Opioid Crisis ---NIH Research ---Coverage and Reimbursement ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Protected Classes ---Step Therapy ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Administration Rebate Rule ---Surprise Billing ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.99: Medicare Drug Price Negotiation Act of 2019 Trade and Foreign Drug Price Controls Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Vaccine Injury Compensation Tax ---H.R.1973: Vaccine Access Improvement Act of 2019 ---Reintroduction of the Vaccine Access Improvement Act in the Senate
Bayh-Dole Act/Tech Transfer ---March-In Rights Compulsory Licensing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 Intellectual Property International Enforcement ---Compulsory Licensing ---China ---India ---Malaysia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 990/S.344 Hatch-Waxman Integrity Act of 2019 ---STRONGER Patents Act (Discussion Draft House/Senate) Diversity in Patenting Drug Patent Settlements ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act Foreign Drug Data Protection Laws ---China Patenting of Biological Inventions ---Argentina Biotech Patentability Guidelines ---DNA Patenting and Licensing ---PTO Examination Guidelines ---Section 101 Modernization Patent Reform ---Patent Litigation Reform ---STRONGER Patents Act (Discussion Draft House/Senate) The United States-Mexico-Canada Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions World Trade Organization - Special 301 Submissions ---Canada ---China ---India ---Latin America ---Malaysia ---Middle East
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.771: Improving Access to Affordable Prescription Drugs ---General Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act ---Incentives for Generic Drug Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---Pricing and Reimbursement Provisions ---IP Provisions ---Regulatory Harmonization US-UK Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-EU Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-Japan Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Diagnostic and Personalized Medicine Regulation and Oversight Precision Medicine Initiative
Agricultural Education Policy Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act EPA Regulations on Biotechnology ---Regulatory Treatment of Gene Edited Products ---Efficient Science-Based Reviews of Biotech Products Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Like-minded Countries Initiatives Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act Potential Regulation of New Genetic Editing/Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---Regulatory Treatment of Gene Editing Products The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---Toomey Amendment to H.R.6147 - Interior, Environment, Financial Services and General Government, Agriculture, Rural Development, Food and Drug Administration, and Transportation, Housing and Urban Development Appropriations Act for FY 2019 Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Energy Basic Research Funding ---DOE Office of Science ---Advanced Research Projects Agency-Energy ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---EPA's Issuance of Small Refinery Waivers ---Administratively Extend Reid Vapor Pressure (RVP) relief to E15 ---New Cellulosic Registration Applications Impacting Corn Kernel Fiber ---Proposal to attach RINs to Ethanol Exports ---Renewable Fuel Standard Program: Proposed Standards for 2019 and Biomass-Based Diesel Volume for 2020 ---Shimkus, Flores Draft 21st Century Transportation Fuels Act
Funding for Renewable Chemicals/Bio-based Products ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---EPA Safer Choice Program Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R. 3149/S.1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S.2005: Master Limited Partnership Parity Act ---S.3296: Sustainable Chemistry Research and Development Act of 208
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Funding for Antimicrobial Resistance Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---Toomey Amendment to H.R.6147 - Interior, Environment, Financial Services and General Government, Agriculture, Rural Development, Food and Drug Administration, and Transportation, Housing and Urban Development Appropriations Act for FY 2019 Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Energy Basic Research Funding ---DOE Office of Science ---Advanced Research Projects Agency-Energy ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---EPA's Issuance of Small Refinery Waivers ---Administratively Extend Reid Vapor Pressure (RVP) relief to E15 ---New Cellulosic Registration Applications Impacting Corn Kernel Fiber ---Proposal to attach RINs to Ethanol Exports ---Renewable Fuel Standard Program: Proposed Standards for 2019 and Biomass-Based Diesel Volume for 2020 ---Shimkus, Flores Draft 21st Century Transportation Fuels Act
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---Toomey Amendment to H.R.6147 - Interior, Environment, Financial Services and General Government, Agriculture, Rural Development, Food and Drug Administration, and Transportation, Housing and Urban Development Appropriations Act for FY 2019 Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Energy Basic Research Funding ---DOE Office of Science ---Advanced Research Projects Agency-Energy ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R. 5212/S.2519: Greener Fuels Act ---EPA's Issuance of Small Refinery Waivers ---Administratively Extend Reid Vapor Pressure (RVP) relief to E15
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act
Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Transfer of Authority for National Strategic Stockpile ------S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---National Biodefense Strategy Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Drug Product Communications ---H.R. 1703: The Medical Products Communications Act of 2017 ---S. 2157: Drug-Price Transparency in Communications Act ---Direct to Consumer Advertising Disclosures ------H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---Toomey Amendment to H.R.6147 - Interior, Environment, Financial Services and General Government, Agriculture, Rural Development, Food and Drug Administration, and Transportation, Housing and Urban Development Appropriations Act for FY 2019 Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Energy Basic Research Funding ---DOE Office of Science ---Advanced Research Projects Agency-Energy ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R. 5212/S.2519: Greener Fuels Act ---EPA's Issuance of Small Refinery Waivers ---Administratively Extend Reid Vapor Pressure (RVP) relief to E15
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing --------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ------Transfer of Authority for National Strategic Stockpile ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) ---National Biodefense Strategy Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019
Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---DOE Office of Science ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Renewable Chemicals/Bio-based Products ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---EPA Safer Choice Program Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019
Funding for Renewable Chemicals/Bio-based Products ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---EPA Safer Choice Program Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R. 3149/S.1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S.2005: Master Limited Partnership Parity Act ---S.3296: Sustainable Chemistry Research and Development Act of 208 Chemical Weapons Convention ---Coverage of Unscheduled Biomediated Chemicals
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---DOE Office of Science ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Renewable Chemicals/Bio-based Products ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---EPA Safer Choice Program Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the USDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) ---S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019
Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Agricultural Education Policy Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act EPA Regulations on Biotechnology ---H.R. 1029 Pesticide Registration Act ---Efficient Science-Based Reviews of Biotech Products Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for the USDA ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Review of the Coordinated Framework for Biotechnology Products
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Biomass Programs (Non-Funding) ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act Energy Basic Research Funding ---DOE Office of Science ---Advanced Research Projects Agency-Energy ---H.R.5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 Funding for Biofuels ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5895/S.2975: Energy and Water Development and Related Agencies Appropriations Act for FY 2019 ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biomass Crop Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for Biorefineries ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 2: Agriculture and Nutrition Act ---S. 3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act Review of the Federal Coordinated Framework for Biotechnology Products
340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) ---S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) Biosimilars ---Access to Samples for Testing ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---S. 974/H.R. 2212: CREATES Act of 2017 Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6142/S. 2042: Reducing Drug Waste Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act
Funding for Renewable Chemicals/Bio-based Products ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ------Klobuchar Amendment #1 to Agriculture Improvement Act (Mandatory Funding of Energy Title) ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---Nomenclature Usage ---H.R. 2: Agriculture and Nutrition Act ---S.3042: Agriculture Improvement Act ---H.R. 3149/S.1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S.2005: Master Limited Partnership Parity Act
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing --------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) ---S.2852: Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 --------Amendment on GE Salmon Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Drug Importation ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Discussion Drafts House/Senate Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---Nomenclature Usage ---Farm Bill Reauthorization ---H.R. 3149/S.1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S.2005: Master Limited Partnership Parity Act
340B Drug Discount Program ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples for Testing ---Columbia Biologics Regulation ---Coding ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---H.R. 2871: Preserving Patient Access to Compound Medications Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 International Biosecurity Policies Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Discussion Drafts House/Senate Orphan Drug Issues ---Technical Amendments ---Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018
Agricultural Education Policy Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program EPA Regulations on Biotechnology ---H.R. 1029 Pesticide Registration Act Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded countries initiatives Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---Potential Revisions to Part 340 Regulations
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---H.R. 3266: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act Review of the Federal Coordinated Framework for Biotechnology Products
Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---H.R.3266: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act
Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---Compulsory Licensing ---India International IP Patent Law Harmonization North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions ---IP Provisions ---Pricing and Reimbursement Provisions Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals
Agricultural Education Policy Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions One Health ---The One Health Act (Sen. Franken Discussion Draft) Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---Potential Revisions to Part 340 Regulations
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Job Act Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---Notice of Data Availability (NODA) Related to 2018 RFS Volumes ---Proposed Rule for 2018 Volumes ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018
Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Drug Importation ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling Opioid Crisis Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 --------Amendment on GE Salmon Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Job Act Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---Notice of Data Availability (NODA) Related to 2018 RFS Volumes ---Proposed Rule for 2018 Volumes ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act
Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act of 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018
Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biofuels ---Department of Defense Application and Funding of Advanced Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biorefineries ---Department of Defense Application and Funding of Advanced Biofuels ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---Notice of Data Availability (NODA) Related to 2018 RFS Volumes ---Proposed Rule for 2018 Volumes ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R. 3268/S. 1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018
Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biofuels ---Department of Defense Application and Funding of Advanced Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biorefineries ---Department of Defense Application and Funding of Advanced Biofuels ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State ---S.1780/H.R.3362: Department of State, Foreign Operations, and Related Programs Appropriations Act for FY 2018
Biosimilars ---Brazil Biologics Regulations ---India Biologics Regulations ---Mexico Biologics Regulations Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing ---Saudi Arabia North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals
Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---H.R. 3358/S:1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018
Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 --------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 --------Amendment on GE Salmon Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biofuels ---Department of Defense Application and Funding of Advanced Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biorefineries ---Department of Defense Application and Funding of Advanced Biofuels ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---Notice of Data Availability (NODA) Related to 2018 RFS Volumes ---Proposed Rule for 2018 Volumes ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R. 3268/S. 1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018
Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R. 3358/S:1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---Tropical Disease Priority Review Voucher (PRV) Program ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018
Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---Farm Bill Reauthorization ---HR 3149: Renewable Chemicals Act of 2017 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft)
Agricultural Education Policy Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act EPA Regulations on Biotechnology ---Efficient Science-Based Review of Biotech Products ---H.R. 1029: Pesticide Registration Improvement Extension Act of 2017 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions One Health ---The One Health Act (Sen. Franken Discussion Draft) Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law Review of the Federal Coordinated Framework for Biotechnology Products USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---Potential Revisions to Part 340 Regulations
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R.2430: FDA Reauthorization Act of 2017 Genetically Engineered (GE) Animals ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Labeling ---The One Health Act (Sen. Franken Discussion Draft) Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law
Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance ---Program Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Department of Defense Appropriations Act for FY 2018 ---Department of Defense Funding of Advanced Biofuels ---Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization ---H.R.2810: National Defense Authorization Act for 2018 ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Renewable Fuel Standard ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Changes to the Point of Obligation under the RFS ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---RFS Reform ---Proposed Rule for 2018 Volumes
Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018
Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Department of Defense Appropriations Act for FY 2018 ---Department of Defense Funding of Advanced Biofuels ---Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Farm Bill Reauthorization ---H.R.2810: National Defense Authorization Act for 2018 ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---EPA Safer Choice Program ---Farm Bill Reauthorization ---H.R.2810: National Defense Authorization Act for 2018 ---Reauthorization of USDA Bio-Preferred Program ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance ---Program Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance ---Program Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Department of Defense Appropriations Act for FY 2018 ---Department of Defense Funding of Advanced Biofuels ---Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization ---H.R.2810: National Defense Authorization Act for 2018 ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Renewable Fuel Standard ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Changes to the Point of Obligation under the RFS ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---RFS Reform ---Proposed Rule for 2018 Volumes
Genetically Engineered (GE) Animals ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Labeling ---The One Health Act (Sen. Franken Discussion Draft)
Genetically Engineered (GE) Animals ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---Labeling ---The One Health Act (Sen. Franken Discussion Draft) Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law
Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---EPA Safer Choice Program ---Farm Bill Reauthorization ---H.R.2810: National Defense Authorization Act for 2018 ---Reauthorization of USDA Bio-Preferred Program ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Farm Bill Reauthorization ---HR 3149: Renewable Chemicals Act of 2017 ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program
Biosimilars ---Brazil Biologics Regulations ---India Biologics Regulations ---Mexico Biologics Regulations Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---Compulsory Licensing ---India North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization UN High Level Commission on Access to Medicines ---IP Proposals World Health Organization (WHO) Cancer Resolution ---Pricing and IP Language Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office