JEANNE HAGGERTY

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

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

Capital Formation Incentives ---H.R.2140/S.961: American Innovation Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R. 5376: Build Back Better Act ---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft) ---A bill 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. (Discussion Draft) ---IGNITE American Innovation Act (Discussion Draft) ---Reform of Net Operating Loss Rules Capital Market Enhancements ---Market Liquidity Proposals Short Selling Transparency ---H.R. 4681-Short Sale Transparency and Fairness Act

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

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

CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Digital Trade ---EU Digital Strategy Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---General Drug Pricing ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---International Pricing Index Proposal ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) 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 Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Intellectual Property International Enforcement ---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. ---India The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-UK Trade Agreement ---Ag-Biotech Provisions ---IP Provisions ---Market Access World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole ---State Attorney General Letter 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 ---S.2387: We Protect American Investment in Drugs Act of 2019 Diversity in Patenting ---S.4394: Inventor Diversity for Economic Advancement (IDEA) Act of 2020 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 Inter Partes Review Intellectual Property International Enforcement ---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. ---India Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility 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

Engineering Biology ---H.R.4373 Engineering Biology Research and Development Act ---S.3734: Bioeconomy Research and Development Act of 2020

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) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.7505: American Innovation Act of 2020 ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7555: The More Cures Act of 2020 ---H.R.7556: Start-Ups for Cures Act ---H.R.7917: IGNITE American Innovation Act ---S.1249: American Innovation Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Introduction of IGNITE American Innovation in the Senate ---Proposed amendments under the Exchange Act of 1934 ---Proposed amendments under the Investment Company Act of 1940 ---Proposed amendments under the Securities Act of 1933 ---Reform of Net Operating Loss Rules ---Securities Regulations (13F, Exempt Offerings, Market Liquidity) Coronavirus (COVID-19) Pandemic ---H.R.7661: Coronavirus Emerging Growth Companies (EGC) Extension Act of 2020 ---H.R.7917: IGNITE American Innovation Act ---Introduction of IGNITE American Innovation in the Senate Research & Development Tax Credit Reforms ---H.R.4549: American Innovation and Competitiveness Act (AICA) of 2019 ---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. ---Expensing of R&D Expenditures ---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 ---R&D Payroll Credit Vaccine Injury Compensation Program Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019

Capital Formation Incentives ---H.R.7505: American Innovation Act of 2020 ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7555: The More Cures Act of 2020 ---H.R.7556: Start-Ups for Cures Act ---H.R.7917: IGNITE American Innovation Act ---S.1249: American Innovation Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Introduction of IGNITE American Innovation Act in Senate ---Proposed amendments under the Exchange Act of 1934 ---Proposed amendments under the Investment Company Act of 1940 ---Proposed amendments under the Securities Act of 1933 ---Reform of Net Operating Loss Rules Capital Market Enhancements ---Amended Definition of Smaller Reporting Company Coronavirus (COVID-19) Pandemic ---H.R.7661: Coronavirus Emerging Growth Companies (EGC) Extension Act of 2020 ---H.R.7917: IGNITE American Innovation Act ---Introduction of IGNITE American Innovation Act in Senate Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---Affiliation ---Eligibility ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Implementation of Jumpstart Our Business Startups (JOBS) Act of 2012 Small Business Innovation Research (SBIR) Program

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

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

Engineering Biology ---H.R.4373 Engineering Biology Research and Development Act ---S.3734: Bioeconomy Research and Development Act of 2020

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

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

Engineering Biology ---H.R.4373 Engineering Biology Research and Development Act ---S.3734: Bioeconomy Research and Development 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

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

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

Engineering Biology ---H.R.4373: Engineering Biology Research and Development Act ---Bioeconomy Research and Development Act Discussion Draft

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

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 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 Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia Inter Partes Review ---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 Patent Reform ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 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-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions

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)

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 Proxy Advisory Services ---Corporate Governance Reform and Transparency ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---Reintroduction of the Fostering Innovation Act in the House of Representatives ---S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Short Selling Transparency

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

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 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 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 ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit

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

Antibiotic & Diagnostic Tax Credit Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---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 Capital Formation Investment Incentives ---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 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 ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement 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

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)

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 Proxy Advisory Services ---Corporate Governance Reform and Transparency ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---Reintroduction of the Fostering Innovation Act in the House of Representatives ---S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Short Selling Transparency

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

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 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 Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia Inter Partes Review ---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 Patent Reform ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 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-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions

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)

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 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 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 ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit

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

Antibiotic & Diagnostic Tax Credit Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---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 Capital Formation Investment Incentives ---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 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 ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019

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)

Biofuels (Non-Funding) ---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 ---Advanced and Second Generation Biofuels Tax Extenders Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---Reintroduction of the American Innovation Act in the House ---Introduction of the American Innovation Act in the Senate Orphan Drug Issues ---Tax Credit 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 Qualified Small Business Stock (QSBS) ---Section 1202 Research & Development Tax Credit Reforms ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019

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

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 ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations ---Like-minded Countries Initiatives Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Intellectual Property International Enforcement ---China The United States-Mexico-Canada Agreement ---IP Provisions ---Ag-Biotech Provisions

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)

Biosimilars ---Patient Cost-Sharing ---Medicare Reimbursement 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 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

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

Capital Market Enhancements ---Amended Definition of Smaller Reporting Company Proxy Advisory Services ---Reintroduction of the Corporate Governance Fairness Act in the Senate ---Corporate Governance Reform and Transparency ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---S.452: Fostering Innovation Act of 2019 ---Reintroduction of the Fostering Innovation Act in the House of Representatives ---Small Issuer Exemption Short Selling Transparency

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

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)

Biosimilars ---Patient Cost-Sharing ---Medicare Reimbursement 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 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

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

Capital Market Enhancements ---Amended Definition of Smaller Reporting Company Proxy Advisory Services ---Reintroduction of the Corporate Governance Fairness Act in the Senate ---Corporate Governance Reform and Transparency ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---S.452: Fostering Innovation Act of 2019 ---Reintroduction of the Fostering Innovation Act in the House of Representatives ---Small Issuer Exemption Short Selling Transparency

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: 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) Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products Foreign Drug Data Protection Laws ---China Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Intellectual Property International Enforcement ---China ---Malaysia ---India The United States-Mexico-Canada Agreement ---IP Provisions ---Ag-Biotech Provisions US-Japan Trade Agreement ---IP Provisions

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

Biofuels (Non-Funding) ---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 ---Advanced and Second Generation Biofuels Tax Extenders Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---Reintroduction of the American Innovation Act in the House ---Introduction of the American Innovation Act in the Senate Orphan Drug Issues ---Tax Credit 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 Qualified Small Business Stock (QSBS) Research & Development Tax Credit Reforms ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019

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

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

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 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 Foreign Drug Data Protection Laws ---China Intellectual Property International Enforcement ---Compulsory Licensing ---China ---Malaysia ---India The United States-Mexico-Canada Agreement ---IP Provisions ---Ag-Biotech Provisions Trade and Foreign Drug Price Controls Committee on Foreign Investment in the United States (CFIUS) ---Foreign Investment Risk Review Modernization Act (FIRRMA) Implementation US-UK Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions ---Ag-Biotech Provisions US-Japan Trade Agreement ---IP Provisions World Trade Organization - Special 301 Submissions ---Canada ---China ---India ---Latin America ---Malaysia ---Middle East

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)

Proxy Advisory Services ---Corporate Governance Reform and Transparency ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---Reintroduction of the Fostering Innovation Act in the House of Representatives ---S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Short Selling Transparency

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 Calculation 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

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)

Antibiotic & Diagnostic Tax Credit Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Entenders ---Master Limited Partnership Parity Act (Discussion Draft Senate) Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---Reintroduction of the American Innovation Act in the House ---Introduction of the American Innovation Act in the Senate Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Master Limited Partnership Parity Act (Discussion Draft Senate) Qualified Small Business Stock (QSBS) Research & Development Tax Credit Reforms ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.1973: Vaccine Access Improvement Act of 2019 ---Reintroduction of the Vaccine Access Improvement Act in the 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

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 Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

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

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

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

Bayh-Dole Act/Tech Transfer ---March-In Rights Intellectual Property International Enforcement ---Compulsory Licensing ---Chile ---Malaysia ---India Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 5340/S. 1390: STRONGER Patents Act ---H.R. 6264: Restoring America's Leadership Act ---H.R. 7251: Hatch-Waxman Integrity Act of 2018 The United States-Mexico-Canada Agreement ---IP Provisions Patent Reform ---H.R. 5340/S. 1390: STRONGER Patents Act Compulsory Licensing in Federal Programs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Small Business IP Training ---H.R. 2655/S.791: Small Business Innovation Protection Act of 2017 Drug Patent Settlements Patenting of Biological Inventions ---Section 101 Modernization US-UK Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---H.R. 6756: American Innovation Act of 2018 Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Qualified Small Business Stock (QSBS) Research & Development Tax Credit Reforms ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R. 4993/S.3253: Vaccine Access Improvement Act of 2018

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

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation 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

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

Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act ---S.3614: Corporate Governance Fairness Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption ---H.R. 10: Financial Choice Act ---H.R. 3978: TRID Improvement Act ---S.488: JOBS and Investor Confidence Act Short Selling Transparency Small Business IP Training ---H.R. 2655/S.791: Small Business Innovation Protection Act of 2017

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)

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

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

Capital Market Enhancements ---SEC Small Business Forum ---Amended Definition of Smaller Reporting Company ---S. 488: JOBS and Investor Confidence Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption ---H.R. 10: Financial Choice Act ---H.R. 3978: TRID Improvement Act Short Selling Transparency Small Business IP Training ---H.R. 2655/S.791: Small Business Innovation Protection Act of 2017 XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act

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

Bayh-Dole Act/Tech Transfer ---March-In Rights Foreign Drug Data Protection Laws Intellectual Property International Enforcement ---Compulsory Licensing ---Chile ---Malaysia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 5340/S. 1390: STRONGER Patents Act ---H.R. 6264: Restoring America's Leadership Act ---Biomedical Innovation Protection Act of 2018 (Discussion Draft House/Senate) North American Free Trade Agreement (NAFTA) Renegotiation ---IP Provisions Patent Reform ---H.R. 5340/S. 1390: STRONGER Patents Act Compulsory Licensing ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Patent Fees ---S. 3416: USPTO Fees Act Diversity of Patent Authorship ---H.R. 6390/S.3483: SUCCESS Act Small Business IP Training ---H.R. 2655/S.791: Small Business Innovation Protection Act of 2017

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation 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

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

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Foreign Drug Data Protection Laws Intellectual Property International Enforcement ---Compulsory Licensing ---Chile ---Malaysia North American Free Trade Agreement (NAFTA) Renegotiation ---IP Provisions ---Pricing and Reimbursement Provisions ---Ag-Biotech Provisions Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals

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

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

Bayh-Dole Act/Tech Transfer ---March-In Rights Foreign Drug Data Protection Laws Intellectual Property International Enforcement ---Compulsory Licensing ---India ---Malaysia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 5340/S. 1390: STRONGER Patents Act ---H.R. 6264: Restoring America's Leadership Act ---Biomedical Innovation Protection Act of 2018 (Discussion Draft House/Senate) North American Free Trade Agreement (NAFTA) Renegotiation ---IP Provisions Patenting of Biological Inventions ---PTO Examination Guidelines ---Section 101 Modernization Patent Reform ---H.R. 5340/S. 1390: STRONGER Patents 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

Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption ---Accelerated Filer Definition Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice 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 ------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

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation 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

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

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Foreign Drug Data Protection Laws Funding for the USDA ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act Intellectual Property International Enforcement ---Compulsory Licensing ---India ---Malaysia North American Free Trade Agreement (NAFTA) Renegotiation ---IP Provisions ---Pricing and Reimbursement Provisions Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals

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

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---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 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

Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial 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. 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

Bayh-Dole Act/Tech Transfer ---March-In Rights Intellectual Property International Enforcement ---Compulsory Licensing ---World Trade Organization - Special 301 Submission ---India ---Canada ---Malaysia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 5340/S. 1390: STRONGER Patents Act ---Biomedical Innovation Protection Act of 2018 (Discussion Draft House/Senate) International IP Patent Law Harmonization North American Free Trade Agreement (NAFTA) Renegotiation ---IP Provisions Patent Reform ---H.R. 5340/S. 1390: STRONGER Patents Act Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act UN High Level Commission on Access to Medicines ---IP Proposals

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

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 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives Foreign Drug Data Protection Laws 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 Intellectual Property International Enforcement ---Compulsory Licensing ---World Trade Organization - Special 301 Submission ---India ---Canada ---Malaysia 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

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

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

Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Proxy Advisory Services ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---Small Company Disclosure Simplification Act (House Discussion Draft)

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

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation 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

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

Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Corporate Tax Reform Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149: Renewable Chemicals Act of 2017 ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft) Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations

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

Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---PCAOB Audit Cost Increases ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)

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)

Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications

Asia Pacific Economic Cooperation Forum ---Biologics Regulations Bayh-Dole Act/Tech Transfer ---Commercialization of Federally Funded Research Initiative ---March-In Rights -------National Defense Authorization Act for 2018 (Sen. King Amendment) ---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 Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing ---Saudi Arabia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---S. 1390: STRONGER Patents Act 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

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

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

Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates 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

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

Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Expansion of Master Limited Partnerships to Renewable Chemicals ---HR 3149: Renewable Chemicals Act of 2017 Research & Development Tax Credit Reforms ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Corporate Tax Reform

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

Intellectual Property International Enforcement ---Compulsory Licensing ---India Inter Partes Review ---Implementation of the America Invents Act of 2011 --S. 1390: STRONGER Patents Act Patent Reform ---Patent Litigation Reforms ---S. 1390: STRONGER Patents Act Patenting of Biological Inventions ---Argentina Biotech Patentability Guidelines ---Section 101 Modernization UN High Level Commission on Access to Medicines ---IP Proposals World Health Organization Cancer Resolution ---Pricing and IP Language

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

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.469: Affordable and Safe Prescription Drug Importation Act --S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Opioid Abuse

Bayh-Dole Act/Tech Transfer ---March-In Rights Intellectual Property International Enforcement ---India ---Saudi Arabia Inter Partes Review ---Implementation of the America Invents Act of 2011 Patent Reform ---Implementation of the America Invents Act of 2011 UN High Level Commission on Access to Medicines ---IP Proposals

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 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act

Funding for Renewable Chemicals/Bio-based Products ---USDA BioPreferred Program ---EPA Safer Choice Program ---Farm Bill Reauthorization ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---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 ---Farm Bill Reauthorization ---New Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program

Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications

Food Waste 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 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---FDA Approval ---The One Health Act (Senate Discussion Draft) ---FDA Proposed Guidance on Gene Editing Potential Regulation of New Genetic Modification Technologies ---Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Potential Revisions to Part 340 Regulations

Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017

Longitudinal Study of Chronic Diseases Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017

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 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act

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.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---India ---Saudi Arabia Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 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 ---Continuing Appropriations Act for FY 2017 Funding for Renewable Chemicals/Bio-based Products ---USDA BioPreferred Program ---EPA Safer Choice Program ---Farm Bill Reauthorization ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---Agriculture, Rural Development, FDA, 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 ---Continuing Appropriations Act for FY 2017 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018

Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)

Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---New Production Tax Credit

Food Waste Genetically Engineered (GE) Animals ---FDA Approval ---The One Health Act (Senate Discussion Draft) ---FDA Proposed Guidance on Gene Editing ---Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law

Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Orphan Drug Act Tax Credit No sub-issues Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---S. 2271: The Renewable Chemical Production Tax Credit Act

Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act

Biofuels (Non-Funding) ---Production Tax Credit Extension Cartagena Biosafety Protocol ---Nagoya Protocol on Access and Benefit sharing Funding for Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 Renewable Fuel Standard ---EPA Proposed Rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018 ---H.R. 1736/S. 1239: To amend the Clean Air Act with respect to the ethanol waiver for the Reid vapor pressure limitations under such Act Review of the Federal Coordinated Framework for Biotechnology Products

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Longitudinal Study of Chronic Diseases Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative

Adventitious Presence (Low Level Presence) ---International Low Level Presence Policies Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act 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 ---Potential Revisions to Part 340 Regulations

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Patient Access to Approved Drugs Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications

Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---Reauthorization of USDA Bio-Preferred Program ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---S. 2271: The Renewable Chemical Production Tax Credit Act ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act

Biosimilars ---Brazil Biologics Regulations ---Colombia Biologics Regulations ---India Biologics Regulations ---Mexico Biologics Regulations Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act 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

Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017

Biofuels (Non-Funding) ---Production Tax Credit Extension Cartagena Biosafety Protocol ---Nagoya Protocol on Access and Benefit sharing Funding for Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 Renewable Fuel Standard ---EPA Proposed Rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018 ---H.R. 1736/S. 1239: To amend the Clean Air Act with respect to the ethanol waiver for the Reid vapor pressure limitations under such Act Review of the Federal Coordinated Framework for Biotechnology Products

Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 Funding for the USDA ----H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived From Biotechnology ---S. 764: Senate Biotech Labeling Compromise Bill USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Potential Revisions to Part 340 Regulations

Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika

Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived From Biotechnology ---S. 764: Senate Biotech Labeling Compromise Bill

Adventitious Presence (Low Level Presence) ---International Low Level Presence Policies Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived From Biotechnology ---S. 764: Senate Biotech Labeling Compromise Bill Transatlantic Trade and Investment Partnership ---Ag-Biotech Issues USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Potential Revisions to Part 340 Regulations Potential Regulation of New Genetic Modification Technologies

Biofuels (Non-Funding) ---Production Tax Credit Extension Funding for Biofuels ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Renewable Fuel Standard ---EPA Proposed rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018

Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing Transatlantic Trade and Investment Partnership ---Ag-Biotech Issues ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines ---Intellectual Property Provisions

Biofuels (Non-Funding) ---Production Tax Credit Extension Funding for Biofuels ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Renewable Fuel Standard ---EPA Proposed rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018

Drug Patent Settlements ---S. 2019: Preserve Access to Affordable Generics Act of 2015 ---S.1137: The PATENTS Act of 2015 Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing Inter Partes Review ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 ---Implementation of the America Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 Patent Reform ---H.R. 9: Innovation Act ---Implementation of the America Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 Transatlantic Trade and Investment Partnership ---Intellectual Property Issues TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals World Trade Organization - Special 301 Submissions ---Latin American Issues UN High Level Commission on Access to Medicines ---Intellectual Property Provisions

340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations

Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit

Government Price Reporting ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Patient Access to Approved Drugs

Government Price Reporting ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products -- --CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Patient Access to Approved Drugs

Synthetic Biology Issue ---H.R. 591: Engineering Biology Research and Development Act Review of the Federal Coordinated Framework for Biotechnology Products Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017

Food Waste ---H.R. 4184: The Food Recovery Act Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.505/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S. 2609: The Biotech Labeling Solutions Act

EPA Regulations on Biotechnology ---Efficient Science-Based Review of Biotech Products ---EPA Points to Consider Guidance Document for GE Algae ---Reauthorization of Pesticide Registration Improvement Act (PRIA) Food Waste ---H.R: 4184: The Food Recovery Act Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives ---Asynchronous Approvals Funding for Biomass Crop Assistance Program ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.505/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S. 2609: The Biotech Labeling Solutions Act Review of the Federal Coordinated Framework for Biotechnology Products USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations TransAtlantic Trade and Investment Partnership ---Ag-Biotech Issues Potential Regulation of New Genetic Modification Technologies

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Implementation of the Agricultural Act of 2014 ---Production Tax Credit Extension ---S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----- Franken-Grassley Amendment Energy Basic Research Funding ---DOE Office of Science ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for Biorefineries ---Department of Defense Funding of Advanced Biofuels Renewable Fuel Standard ---H.R.5538-S.3068: Departments of Interior, and Related Agencies Appropriations Act for FY 2017 ---The 2014-2016 Final Rule ---EPA proposed rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018 Review of the Federal Coordinated Framework for Biotechnology Products

TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization ---Ag-Biotech Issues Biosimilars ---Colombia Biologics Regulations ---Mexico Biologics Regulations Drug Importation ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives ---Asynchronous Approvals Intellectual Property International Enforcement ---Compulsory Licensing ---Colombia ---India UN High Level Commission on Access to Medicines

340B Drug Pricing Program ----Implementation of Affordable Care Act ---Program Implementation & Oversight ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Biosimilars ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act Drug Importation ---H.R.5054 - S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325-S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products -- --CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---- S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 1878: Advancing Hope Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act UN High Level Commission on Access to Medicines Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---Senate Chronic Care Working Group Proposals ---Vaccine Injury Compensation Program ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Vaccines and Infectious Diseases - General ---H.R. 3299: Strengthening Public Health Emergency Response Act ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Combating Antibiotic-Resistant Bacteria (CARB) Initiative Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Vial and Dose Size Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Implementation of the Agricultural Act of 2014 ---Production Tax Credit Extension ---S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----- Franken-Grassley Amendment Energy Basic Research Funding ---DOE Office of Science ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for Biorefineries ---Department of Defense Funding of Advanced Biofuels Renewable Fuel Standard ---H.R.5538-S.3068: Departments of Interior, and Related Agencies Appropriations Act for FY 2017 ---The 2014-2016 Final Rule ---EPA proposed rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018 Review of the Federal Coordinated Framework for Biotechnology Products

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---S. 2271: The Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms ---Refundable R&D Credit

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017

Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions

Biosimilars ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Importation ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S.2609: The Biotech Labeling Solutions Act USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

EPA Regulations on Biotechnology ---Efficient Science-Based Review of Biotech Products ---Reauthorization of Pesticide Registration Improvement Act (PRIA) ---EPA Points to Consider Guidance Document for GE Algae Funding for Renewable Chemicals/Bio-based Products ---H.R.5055 - S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) ---Implementation of the Agricultural Act of 2014 ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---Nomenclature Usage ---Pre-market Notification Review ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2576: TSCA Modernization Act ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 696: The Safe Chemicals Act ---S. 697: Frank R. Lautenberg Chemical Safety for 21st Century Act

Funding for Renewable Chemicals/Bio-based Products --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 EPA Regulation of Biotechnology --EPA Points to Consider Guidance Document for GE Algae Energy Basic Research Funding --Advanced Research Projects Agency --DOE Office of Science --Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for Biofuels --Department of Defense Funding of Advanced Biofuels --Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Renewable Fuel Standard --The 2014-2016 Final Rule --Departments of Interior, and Related Agencies Appropriations Act for FY 2017 Review of the Federal Coordinated Framework for Biotechnology Products Renewable Chemicals/Bio-based Products (Non-Funding) --Implementation of the Agricultural Act of 2014 --Investment Tax Credit for Renewable Chemicals and Bio-based Products --Nomenclature Usage --Reauthorization of USDA Bio-Preferred Program --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act --H.R. 2576: TSCA Modernization Act --S.697: Frank R. Lautenberg Chemical Safety for the 21st Century Act Biofuels (Non-Funding) --Production Tax Credit Extension --S. 1239/H.R. 1736: to amend the Clean Air Act with respect to the ethanol waiver for the Reid vapor pressure limitations under that Act --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Funding for Biomass Crop Assistance Program --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017

TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals Patent Reform --H.R. 9: Innovation Act --S.1137: The PATENTS Act of 2015 Bayh-Dole Act/Tech Transfer --Commercialization of Federally Funded Research Initiative --March-In Rights Intellectual Property International Enforcement Pacific Alliance IP Harmonization Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 World Trade Organization - Special 301 Submissions --Middle East Issues --Latin American Issues --Canada Issues UN Commission on Access to Medicines

Funding for Renewable Chemicals/Bio-based Products --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Nomenclature Usage --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act --H.R. 2576: TSCA Modernization Act --S.697: Frank R. Lautenberg Chemical Safety for the 21st Century Act --Implementation of the Agricultural Act of 2014 --Reauthorization of USDA Bio-Preferred Program --Investment Tax Credit for Renewable Chemicals and Bio-based Products EPA Regulations on Biotechnology --Reauthorization of Pesticide Registration Improvement Act (PRIA)

Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines

EPA Regulations on Biotechnology --Reauthorization of Pesticide Registration Improvement Act (PRIA) --EPA Points to Consider Guidance Document for GE Algae Review of the Federal Coordinated Framework for Biotechnology Products USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products --USDA Decision on GE Crops Environmental Impact Statement --Co-existence of Production Systems --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Foreign Agricultural Biotechnology Laws and Regulations --EU Ag-Biotech Policies and Regulations --China Biotechnology Regulations --Asynchrony of International Approvals --Like-minded Countries Initiatives --Korea Biotechnology Regulations Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy --S.2609: The Biotech Labeling Solutions Act Adventitious Presence (Low Level Presence) --International Low Level Presence Policies Funding for the USDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon --Labeling --One Health Legislation (Senate Discussion Draft) --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 --FDA Approval Funding for Biomass Crop Assistance Program --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 TransAtlantic Trade and Investment Partnership --Ag-Biotech Issues

Genetically Engineered (GE) Animals --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon --Labeling --One Health Legislation (Senate Discussion Draft) --FDA Approval --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --S.2609: The Biotech Labeling Solutions Act --U.S. Government Policy USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products --USDA Decision on GE Crops Environmental Impact Statement --Co-existence of Production Systems --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Biosimilars --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Brazil Biologics Regulations Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017

Funding for Renewable Chemicals/Bio-based Products --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 EPA Regulation of Biotechnology --EPA Points to Consider Guidance Document for GE Algae Energy Basic Research Funding --Advanced Research Projects Agency --DOE Office of Science --Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for Biofuels --Department of Defense Funding of Advanced Biofuels --Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Renewable Fuel Standard --The 2014-2016 Final Rule --Departments of Interior, and Related Agencies Appropriations Act for FY 2017 Review of the Federal Coordinated Framework for Biotechnology Products Renewable Chemicals/Bio-based Products (Non-Funding) --Implementation of the Agricultural Act of 2014 --Investment Tax Credit for Renewable Chemicals and Bio-based Products --Nomenclature Usage --Reauthorization of USDA Bio-Preferred Program --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act --H.R. 2576: TSCA Modernization Act --S.697: Frank R. Lautenberg Chemical Safety for the 21st Century Act Biofuels (Non-Funding) --Production Tax Credit Extension --S. 1239/H.R. 1736: to amend the Clean Air Act with respect to the ethanol waiver for the Reid vapor pressure limitations under that Act --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Funding for Biomass Crop Assistance Program --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017

Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues Senate Innovation for Healthier Americans --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Combating Antibiotic-Resistant Bacteria (CARB) Initiative

Biofuels (Non-Funding) --Production Tax Credit Extension --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Tax Reform --Innovation Box / Patent Box Orphan Drug Act Tax Credit Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Inversions --Financial Services and General Government Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Investment Tax Credit for Renewable Chemicals and Bio-based Products --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act  

Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans --Patient Access to Approved Drugs  

Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act

Biodefense Research, Development and Procurement Issues (Nonfunding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017

Genetically Engineered (GE) Animals --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon --Labeling --One Health Legislation (Senate Discussion Draft) --FDA Approval --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017

Genetically Engineered (GE) Animals --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon --Labeling --One Health Legislation (Senate Discussion Draft) --FDA Approval --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy --S.2609: The Biotech Labeling Solutions Act

TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Foreign Agricultural Biotechnology Laws and Regulations --Asynchrony of International Approvals --China Biotechnology Regulations --EU Ag-Biotech Policies and Regulations --Korea Biotechnology Regulations --Like-minded Countries Initiatives Biosimilars --Brazil Biologics Regulations Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Pacific Alliance IP Harmonization Transatlantic Trade and Investment Partnership --Ag-Biotech Issues UN Commission on Access to Medicines

Renewable Chemicals/Bio-based Products (Non-Funding) ---Nomenclature Usage ---Pre-market Notification Review ---S. 697: Chemical Safety for the 21st Century Act ---H.R. 2576: TSCA Modernization Act ---S. 1447: Sustainable Chemistry Research and Development Act ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016

Livestock Cloning/Product Labeling ---Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals ---FDA Approval ---Labeling ---One Health Legislation (Senate Discussion Draft) ---H.R.2029: Consolidated Appropriations Act for FY 2016 -------Amendment to Restrict FDA Approval of GE Salmon -------Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology ---U.S. Government Policy ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---H.R.2029: Consolidated Appropriations Act for FY 2016 Biosimilars ---Colombia Biologics Regulations ---Mexico Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Naming USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Co-existence of Production Systems Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015

Patent Reform ---S.1137: The PATENTS Act of 2015 ---H.R. 9: Innovation Act ---Implementation of the America Invents Act of 2011 ---H.R.2029: Consolidated Appropriations Act for FY 2016 Bayh-Dole Act/Tech Transfer ---Commercialization of Federally Funded Research Initiative Intellectual Property International Enforcement Transpacific Partnership ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues Drug Patent Settlements ---S.1137: The PATENTS Act of 2015 ---S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review ---Implementation of the American Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 ---H.R. 9: Innovation Act ---H.R.2029: Consolidated Appropriations Act for FY 2016

Livestock Cloning/Product Labeling ---Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals ---FDA Approval ---Labeling ---One Health Legislation (Senate Discussion Draft) ---H.R.2029: Consolidated Appropriations Act for FY 2016 -------Amendment to Restrict FDA Approval of GE Salmon -------Amendment on GE Salmon Labeling

Biosimilars ---Biosimilar User Fee Act Implementation ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming Funding for the National Institutes of Health ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.2029: Consolidated Appropriations Act for FY 2016 Vaccine Access/Financing ---Vaccine Injury Compensation Program 340B Drug Pricing Program ---Program Implementation & Oversight ---H.R.2029: Consolidated Appropriations Act for FY 2016 Medicaid Pricing and Rebates ---Implementation of Affordable Care Act ---Average Manufacturer Price Calculations Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2029: Consolidated Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues TransPacific Partnership ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Reimbursement Transparency Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based contracting and communications Drug Evaluation and Review ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Generic Entry Incentives Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016 Government Price Reporting ---H.R.2029: Consolidated Appropriations Act for FY 2016 Gene Editing Technologies ---H.R. 2029: Consolidated Appropriations Act for 2016 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Precision Medicine Initiative

Synthetic Biology Issue ---H.R. 591: Engineering Biology Research and Development Act

Sarbanes Oxley Section 404 (b) ---H.R. 4139: the Fostering Innovation Act Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Reform of SEC Regulation D ---S. 978: the HALOS Act Expansion of Exemption under SEC Regulation A ---H.R. 1839: Reforming Access for Investments in Startup Enterprises (RAISE) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions XBRL Exemption for Small Public Companies ---H.R. 5405: Promoting Job Creation and Reducing Small Business Burdens Act ---H.R. 1965: Small Company Disclosure Simplification Act Capital Market Enhancements ---H.R. 1525: Disclosure Modernization and Simplification Act ---H.R. 1723: Small Company Simple Registration Act ---H.R. 2064: Improving Access to Capital for Emerging Growth Companies Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 3784: Securities & Exchange Commission Small Business Advocate Act -- H.R. 2357: Accelerating Access to Capital Act Proxy Advisory Services ---Impact of Policies on Small Public Companies

Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015 Intellectual Property International Enforcement Foreign Agricultural Biotechnology Laws and Regulations ---Korea Biotechnology Regulations ---Asynchrony of International Approvals ---EU Ag Biotech Policies and Regulations ---China Biotechnology Regulations Biosimilars ---Mexico Biologics Regulations ---Colombia Biologics Regulations TransPacific Partnership ---Sanitary and Phytosanitary Issues ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Reimbursement Transparency

EPA Regulations on Agricultural Biotechnology ---Pesticide Registration Improvement Act Livestock Cloning/Product Labeling ---Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals ---FDA Approval ---Labeling ---One Health Legislation (Senate Discussion Draft) ---H.R.2029: Consolidated Appropriations Act for FY 2016 -------Amendment to Restrict FDA Approval of GE Salmon -------Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology ---U.S. Government Policy ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---H.R.2029: Consolidated Appropriations Act for FY 2016 Transpacific Partnership ---Sanitary and Phytosanitary Issues Adventitious Presence (Low Level Presence) ---International Low Level Presence Policies Funding for the USDA ---H.R.2029: Consolidated Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony of International Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations Potential Regulation of New Genetic Modification Technologies Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Co-existence of Production Systems Review of the Federal Coordinated Framework for Biotechnology Products

Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Climate Change Benefits ---Production Tax Credit Extension ---Implementation of the Agricultural Act of 2014 ---H.R. 2029: Consolidated Appropriations Act of FY 2016 -------Protecting Americans from Tax Hikes (PATH) Act of 2015 Renewable Chemicals/Bio-based Products (Non-Funding) ---Nomenclature Usage ---Pre-market Notification Review ---S. 697: Chemical Safety for the 21st Century Act ---H.R. 2576: TSCA Modernization Act ---S. 1447: Sustainable Chemistry Research and Development Act ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biofuels ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biorefineries --H.R.2029: Consolidated Appropriations Act for FY 2016 EPA Regulation of Biotechnology ---EPA Points to Consider Guidance Document for GE Algae Renewable Fuel Standard ---Proposed Rule Review of the Federal Coordinated Framework for Biotechnology Products

Renewable Chemicals/Bio-based Products ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Production Tax Credit Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---S. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act Tax Reform ---Innovation Box/Patent Box Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Inversions ---H.R.2029: Consolidated Appropriations Act for FY 2016

Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Climate Change Benefits ---Production Tax Credit Extension ---Implementation of the Agricultural Act of 2014 ---H.R. 2029: Consolidated Appropriations Act of FY 2016 -------Protecting Americans from Tax Hikes (PATH) Act of 2015 Renewable Chemicals/Bio-based Products (Non-Funding) ---Nomenclature Usage ---Pre-market Notification Review ---S. 697: Chemical Safety for the 21st Century Act ---H.R. 2576: TSCA Modernization Act ---S. 1447: Sustainable Chemistry Research and Development Act ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biofuels ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biorefineries --H.R.2029: Consolidated Appropriations Act for FY 2016 EPA Regulation of Biotechnology ---EPA Points to Consider Guidance Document for GE Algae Renewable Fuel Standard ---Proposed Rule Review of the Federal Coordinated Framework for Biotechnology Products

Livestock Cloning/Product Labeling ---Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals ---FDA Approval ---Labeling ---One Health Legislation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Amendment to Restrict FDA Approval of GE Salmon ------Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology ---U.S. Government Policy ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---H.R.2029: Consolidated Appropriations Act for FY 2016

Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2029: Consolidated Appropriations Act for FY 2016

Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products House 21st Century Cures Initiative --Patient Access to Approved Drugs Senate Innovation for Healthier Americans Initiative --Patient Access to Approved Drugs Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015

Renewable Chemicals/Bio-based Products --Expansion of Master Limited Partnerships to Renewable Chemicals --New Production Tax Credit --S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension --S.2089: American Energy Innovation Act Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation Box/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995/S.1910: Department of Financial Services and Related Agencies Appropriations Act for FY 2016 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act

EPA Regulations on Agricultural Biotechnology --Pesticide Registration Improvement Act Reauthorization Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations --Asynchrony of International Approvals --China Biotechnology Regulations --EU Ag-Biotech Policies and Regulations Potential Regulation of New Genetic Modification Technologies USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products International Treaty on Plant Genetic Resources Review of the Federal Coordinated Framework for Biotechnology Products

Renewable Chemicals/Bio-based Products (Non-Funding) --S. 697: Chemical Safety for the 21st Century Act ----Nomenclature Usage ----Pre-market Notification Review --S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 --Expansion of Master Limited Partnerships to Renewable Chemicals --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003

Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling

Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Biosimilars --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products

Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act

Synthetic Biology --H.R. 591: Engineering Biology Research and Development Act

NIH Precision Medicine Initiative Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) House 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Senate Innovation for Healthier Americans Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Biofuels (Non-Funding) --Production Tax Credit Extension --S.2089: American Energy Innovation Act Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Renewable Fuel Standard (RFS) --Proposed Rule --S. 1372: American Crude Oil Export Equality Act ----Amendment to Repeal Conventional Biofuel Category of RFS --H.R. 702: A Bill to Adapt to Changing Crude Oil Market Conditions ---- Amendment to Repeal RFS

Biodefense Research, Development and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --PATH Act (Senate Discussion Draft/Innovation for Healthier Americans Initiative) --ADAPT Act (House Discussion Draft/21st Century Cures Initiative)

Patent Reform --H.R. 9: Innovation Act --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --Implementation of the America Invents Act of 2011 TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues Drug Patent Settlements --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 632: STRONG Patents Act --S. 1137: Protecting American Talent and Entrepreneurship Act of 2015 --H.R. 9: Innovation Act Intellectual Property International Enforcement --India

Biofuels (Non-Funding) --Production Tax Credit Extension --S.2089: American Energy Innovation Act Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Renewable Fuel Standard (RFS) --Proposed Rule --S. 1372: American Crude Oil Export Equality Act ----Amendment to Repeal Conventional Biofuel Category of RFS --H.R. 702: A Bill to Adapt to Changing Crude Oil Market Conditions ----Amendment to Repeal RFS

Genetically Engineered (GE) Animals --One Health Legislation (Senate Discussion Draft) --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy Biosimilars --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy

Biofuels (Non-Funding) --Implementation of the Agricultural Act of 2014 --Production Tax Credit Extension --Renewable Fuel Standard Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products and Biorefineries --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Energy Title IX, Section 9003 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016, --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014

Foreign Agricultural Biotechnology Laws and Regulations --China Biotechnology Regulations --EU Ag Biotech Policies and Regulations Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Ag-Biotech Issues --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Trade Promotion Authority --H.R. 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --H.R. 1295: Trade Adjustment Assistance Act of 2015 IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations

Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)

Genetically Engineered (GE) Animals --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling --One Health Legislation (Senate Discussion Draft) Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy Nutrition Policy --Reauthorization of Federal School Nutrition Programs (Senate Discussion Draft)

Renewable Chemicals/Bio-based Products (Non-Funding) --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 --Investment Tax Credit for Renewable Chemicals and Bio-based Products --New Production Tax Credit --S. 1447: Sustainable Chemistry Research and Development Act --S. 697: Chemical Safety for the 21st Century Act Funding for Renewable Chemicals/Bio-based Products and Biorefineries --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Energy Title IX, Section 9003

Biofuels (Non-Funding) --Implementation of the Agricultural Act of 2014 --Production Tax Credit Extension --Renewable Fuel Standard Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products and Biorefineries --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Energy Title IX, Section 9003 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016, --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014

Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations

Genetically Engineered (GE) Animals --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Amendment on GE Salmon Labeling --One Health Legislation (Senate Discussion Draft) Review and Labeling of Food Derived From Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---U.S. Government Policy Funding for the USDA ---H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Potential Regulation of New Genetic Modification Technologies Funding for Biomass Crop Assistance Program ---H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Trade Promotion Authority ---HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 ---HR 1295: Trade Adjustment Assistance Act of 2015 Transatlantic Trade and Investment Partnership ---Ag-Biotech Issues Nutrition Policy ---Reauthorization of Federal School Nutrition Programs (Senate Discussion Draft)

Genetically Engineered (GE) Animals --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling --One Health Legislation (Senate Discussion Draft)

Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016

Sarbanes Oxley Section 404 (b) --Public Company Accounting Oversight Board - Audit Cost Increases Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --H.R. 2179: PARTNER Act --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Expansion of Exemption under SEC Regulation A --H.R. 1839: Reforming Access for Investments in Startup Enterprises (RAISE) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions --Fostering Innovation Act (House Discussion Draft) XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act Capital Market Enhancements --SEC Office of Small Business Policy Responsibilities --H.R. 1525: Disclosure Modernization and Simplification Act --H.R. 1675/S.576: Encouraging Employee Ownership Act --H.R. 1723: Small Company Simple Registration Act --H.R. 2064: Improving Access to Capital for Emerging Growth Companies Act --H.R. 2357: Accelerating Access to Capital Act Proxy Advisory Services --Impact of Policies on Small Public Companies

Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative --Patient Access to Approved Drugs --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculations --Reimbursement for Infusion Drugs under Medicare Part B

Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015

Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)

Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products

Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Independent Payment Advisory Board Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula -HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Patient Access to Approved Drugs -Coding -Coverage with Evidence Development

Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues

Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment to Restrict FDA Approval of GE Salmon --Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations -China Biotechnology Regulations -Asynchrony of International Approvals -EU Ag-Biotech Policies and Regulations Potential Regulation of New Genetic Modification Technologies Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Transatlantic Trade and Investment Partnership -Ag-Biotech Issues USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products Trade Promotion Authority Local GE Crop Cultivation Bans Coordination of Federal Biotechnology Research -H.R. 591: Engineering Biology Research and Development Act of 2015

Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products

Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues

Independent Payment Advisory Board Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula -HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Patient Access to Approved Drugs -Coding -Coverage with Evidence Development

21st Century Cures Initiative Patient Access to Approved DrugsReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes

USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech ProductsGenetically Engineered (GE) Animals H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Biosimilars Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Sunshine Act Implementation

Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations21st Century Cures Initiative Biomarkers and Regulatory Science Improvements Communication with Healthcare Professionals Expanded Access to Investigational Drugs Expedited Pathways FDA Hiring Flexibility FDA Management and Financial Accountability Innovation Incentives Longitudinal Study of Chronic Diseases Patient Access to Approved Drugs Patient-Focused Drug Development Use of Real-World Evidence Vaccine and Anti-Microbial Resistance Product Development and Incentives Combating Antibiotic-Resistant Bacteria (CARB) Initiative Biosimilars Biosimilar User Fee Act Implementation Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Patent Certification Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 340B Drug Pricing Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Implementation of Affordable Care Act Program Implementation & Oversight Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Issues Intellectual Property IssuesReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Sunshine Act Implementation

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Energy Basic Research Funding H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biofuels H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015

Sunshine Act Implementation 21st Century Cures InitiativeGenetically Engineered (GE) Animals FDA Approval H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Drug Evaluation and Review Compassionate Use/Expanded Access Implementation of the FDA Safety and Innovation Act Special Medical Use/Limited Population Drug Biosimilars Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 21st Century Cures Initiative

Intellectual Property International Enforcement Compulsory Licensing IndiaForeign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Like-minded Countries Initiatives TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Reimbursement Transparency Biosimilars Colombia Biologics Regulations Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies

Patenting of Humanitarian Technologies S. 712: Patents for Humanity Program Improvement Act of 2013Patent Reform H.R. 3309: Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) FTC Regulation of Patent Demand Letters (Senate Commerce Committee Discussion Draft) Intellectual Property International Enforcement Compulsory Licensing India Issues TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Patenting of Biological Inventions

21st Century Cures Initiative Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program: CMS Proposed Rule on Protected Classes

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Naming Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Implementation of Affordable Care Act S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees S. 1413: FDA User Fee Protection Act Drug Evaluation and Review Compassionate Use/Expanded Access Special Medical Use/Limited Population Drug Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies Sunshine Act Implementation Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations 21st Century Cures InitiativeTransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Transparency Intellectual Property Issues

EPA Regulations on Agricultural Biotechnology Efficient Science-Based Review of Biotech ProductsGenetically Engineered (GE) Animals FDA Approval H.R. 4800/S. 2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling Act Funding for the USDA H.R. 4800/S. 2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Like-minded Countries Initiatives Funding for Biomass Crop Assistance Program H.R. 4800/S. 2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Transatlantic Trade and Investment Partnership Ag-Biotech Issues USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) (Non-Funding) Program Implementation Sequestration of PDUFA Fees Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade & Investment Partnership Regulatory Harmonization/TransparencyDrug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act

Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Funding for USDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products Funding for Biofuels Department of Defense Funding of Advanced Biofuels Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Department of Defense Appropriations Act for FY 2015 Department of Interior, Environment, and Related Agencies Appropriations for FY 2015 Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biorefineries Department of Defense Funding of Advanced Biofuels Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Energy and Water Development and Related Agencies Appropriations Act for FY 2015

TransPacific Partnership Data and Intellectual Property Protections for PharmaceuticalsPatent Reform H.R. 3309: Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) FTC Regulation of Patent Demand Letters (Senate Commerce Committee Discussion Draft) Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act Intellectual Property International Enforcement Compulsory Licensing India Issues Transatlantic Trade and Investment Partnership Intellectual Property Issues Patenting of Biological Inventions DNA Patenting and Licensing International Trade Commission Reform

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 National Center for Advancing Translational Science (NCATS) (Non-Funding) Program Implementation

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Genetically Engineered (GE) Animals Labeling GE Animal Models of Human Disease FDA Approval Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Amendment to Restrict FDA Approval of GE Salmon Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Review and Labeling of Food Derived From Biotechnology Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Efficient Science-Based Review of Biotech Products Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation

Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform S. 866: Patent Quality Improvement Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 H.R. 3309: The Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 FTC Regulation of Patent Demand Letters (Senator McCaskill Discussion Draft) World Trade Organization Special 301 Submissions Intellectual Property International Enforcement Compulsory Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Drug Repurposing H.R. 4287/2150: Independent Innovator and Repurposing Act

Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Funding for USDA H.R. 3547: Consolidated Appropriations Act for FY 2014 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Biomass Crop Assistance Program Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.R. 3547: Consolidated Appropriations Act for FY 2014 Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biofuels Department of Defense Funding of Advanced Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Department of Defense Appropriations Act for FY 2015 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2642: Agricultural Act of 2014 (Farm Bill) Agriculture, Rural Development, FDA, and Related Agencies Appropriations for FY 2015 Department of the Interior, Environment, and Related Agencies Appropriations for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Biorefineries S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2642: Agricultural Act of 2014 (Farm Bill) Funding for Biotechnology Research and Development Programs and the Agency for International Development and Department of State H.R. 3547: Consolidated Appropriations Act for FY 2014

Trade Promotion Authority H.R. 3830/S. 1900: Bipartisan Congressional Trade Priorities Act of 2014Intellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Korea Biotechnology Regulations Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Ag-Biotech Issues Reimbursement Transparency Biosimilars Colombia Biologics Regulations World Trade Organization Special 301 Submissions Clinical Trial Data Sharing and Disclosure EU Policies

Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Medicare Part B Physician-Administered Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Physician Payment Sustainable Growth Rate Formula HR 4302: Protecting Access to Medicare Act of 2014 S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S. 2000: SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S. 2122: Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014

Vaccine Access/Financing Adult Immunization (Senate Discussion Draft)Biosimilars Colombia Biologics Regulations Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Interchangeability and Pharmacy Substitution Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1284: Department of Labor, HHS, Education, and Related Agencies Appropriations Act of 2014 Expanded Access to Experimental Products FDA Rules Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Harmonization Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Funding Program Implementation Asia Pacific Economic Cooperation Forum Biologics RegulationTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and related agencies Appropriations Act FY 2014 H.R. 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act Orphan Drug Act Issues Tax Credit Clinical Trial Data Sharing

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations for FY 2014 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014

Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 House Judiciary Committee Discussion Draft DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Asia Pacific Economic Cooperation Forum Biologics Regulations Export Registrations for Products With Expired Patents Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Low-Level Presence Foreign Government Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Intellectual Property Issues Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Asia Pacific Economic Cooperation Forum Biologics Regulations Biosimilars Colombia Biologics Regulations Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 National Center for Advancing Translational Science (NCATS) Funding Program Implementation

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Regulatory Harmonization Ag-Biotech Issues Intellectual Property Issues Biosimilars Colombia Biologics Regulations Naming Trade Promotion Authority Clinical Trial Data Sharing and Disclosure EU Policies

Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research

Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and related Agencies Appropriations Act for FY 2014Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues

Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) H.J. Res. 59: The Bipartisan Budget Act of 2013 Amendment on GE Salmon Labeling Labeling of Food Derived From Biotechnology S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 U.S. Government Policy Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act Biosimilars Naming Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Implementation of Affordable Care Act Drug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality and Security Act USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products

Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform House Judiciary Committee Discussion Draft (Rep. Bob Goodlatte) H.R. 3309: The Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Implementation of H.R. 1249: The America Invents Act of 2011 Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for 2014 Amendment on GE Salmon Labeling (Senate) H.J. Res. 59: The Bipartisan Budget Act of 2013 Amendment on GE Salmon Labeling Labeling of Food Derived From Biotechnology S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 U.S. Government Policy

Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform House Judiciary Committee Discussion Draft (Rep. Bob Goodlatte) H.R. 3309: The Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Implementation of H.R. 1249: The America Invents Act of 2011 Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) H.J. Res. 59: The Bipartisan Budget Act of 2013 Amendment on GE Salmon Labeling Labeling of Food Derived From Biotechnology S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 U.S. Government Policy Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act Biosimilars Naming Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Implementation of Affordable Care Act Drug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality and Security Act USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products

Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act FY 2014 HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act Energy Basic Research Funding DOE Office of Science Advanced Research Projects Agency - Energy Energy and Water Development and Related Agencies Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.J. Res. 59: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biofuels Department of Defense Funding of Advanced Biofuels H.J. Res. 59: The Bipartisan Budget Act of 2013 Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for 2014 Amendment on GE Salmon Labeling (Senate) H.J. Res. 59: The Bipartisan Budget Act of 2013 Amendment on GE Salmon Labeling Labeling of Food Derived From Biotechnology S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 U.S. Government Policy

Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013

Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 National Center for Advancing Translational Science (NCATS) Funding Program Implementation

Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Low-Level Presence Foreign Government Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Intellectual Property Issues Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Asia Pacific Economic Cooperation Forum Biologics Regulations Biosimilars Colombia Biologics Regulations Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Vaccine Access/Financing Adult Immunization (Senate Discussion Draft)Biosimilars Colombia Biologics Regulations Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Interchangeability and Pharmacy Substitution Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1284: Department of Labor, HHS, Education, and Related Agencies Appropriations Act of 2014 Expanded Access to Experimental Products FDA Rules Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Harmonization Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Funding Program Implementation Asia Pacific Economic Cooperation Forum Biologics RegulationTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and related agencies Appropriations Act FY 2014 H.R. 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act Orphan Drug Act Issues Tax Credit Clinical Trial Data Sharing

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014

Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 House Judiciary Committee Discussion Draft DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Asia Pacific Economic Cooperation Forum Biologics Regulations Export Registrations for Products With Expired Patents Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Labeling of Genetically Engineered Crops U.S. Government Policy S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements USDA Decision on GE Crops Environmental Impact Statement H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) Amendment on GE Crop Field Trials/Compensation Fund S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act

Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program

Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 House Judiciary Committee Discussion Draft H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Health Regulatory Agency Review of Patents Brazil Colombia Asia Pacific Economic Cooperation Forum Intellectual Property Issues Drug Patent Settlements

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biofuels Department of Defense Funding/Application of Advanced Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for Biomass Crop Assistance Program S. 1244/ H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2014

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations EU Biotechnology Bilateral Discussions, Low-Level Presence Foreign Government Policies TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Asia Pacific Economic Cooperation Forum Intellectual Property Issues Biologics Regulations Biosimilars Colombia Biologics Regulations Mexico Biologics Regulations Naming Health Regulatory Agency Review of Patents Brazil Colombia

Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products Reauthorization/Funding of USDA Bio-Preferred Program S.10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for Biofuels Department of Defense Funding/Application of Advanced Biofuels Department of Defense Appropriations Act for FY 2014 Department of Energy and Water and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 (Toomey Amendment) Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for Biomass Programs H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Reauthorization/Funding of Biomass Crop Assistance Program Reauthorization/Funding of Biomass R&D Program S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biorefineries Reauthorization/Funding of Biorefinery Assistance Program DOE Biomass Program Department of Defense Funding S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 (Toomey Amendment) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. Con. Res. 8: Senate Budget Resolution

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization ActBiodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningWorld Trade Organization Special 301 Submissions Export Registrations for Products with Expired Patents Intellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Low-Level Presence Foreign Government Policies International Biotechnology Agreement Asynchrony of International Approvals EU Biotechnology Bilateral Discussions TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency Sanitary and Phytosanitary Issues U.S./European Union High-Level Dialogue on Regulatory Issues

Funding for National Institutes of Health H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S. 391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Adult Immunization Policies Adult Immunization Senate Discussion Draft 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 U.S./European Union High-Level Dialogue on Regulatory IssuesSequestration of PDUFA Fees H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Implementation of S. 365: Budget Control Act TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement (Non-Funding Issues) S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review

Patent Reform H.R. 6621: To correct and improve certain provisions of the Leahy-Smith America Invents Act Intellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Export Registrations for Products with Expired Patents

Biodefense Research, Development, and Procurement (Non-Funding Issues) HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act

Average Manufacturer Price Calculations Medicaid Rebates Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Asynchrony of International Approvals TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Intellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues

Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biomass Crop Assistance Program S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act of 2012

Biodefense Research, Development, and Procurement HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Rare Pediatric & Tropical Disease Drug Development Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents U.S. Policy on International Science-Based Regulations Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Sanitary and Phytosanitary Issues Regulatory Transparency International Trade Commission Reform Rep. David Nunes Discussion Draft Intellectual Property International Enforcement Biosimilars Colombia Biologics Regulations Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft ) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Australia Compulsory Licensing Parliamentary Inquiry Confirmatory Genetic Diagnostic Testing Intellectual Property International Enforcement Patent Exhaustion Ag-biotech Products International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Patent Reform Implementation of the America Invents Act of 2011

Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Australia Compulsory Licensing Parliamentary Inquiry Confirmatory Genetic Diagnostic Testing Intellectual Property International Enforcement Patent Exhaustion Ag-biotech Products International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Patent Reform Implementation of the America Invents Act of 2011

Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biomass Crop Assistance Program S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act of 2012

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft ) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S.R. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R.3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning World Trade Organization Special 301 Submissions India Issues Export Registrations for Products with Expired Patents International Trade Commission Reform Rep. Devin Nunes Discussion Draft Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies EU Biotechnology Bilateral Discussions China Biotechnology Regulations European Union Low Level Presence Policy International Biotechnology Agreement Asynchrony of International Approvals Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Sanitary and Phytosanitary Issues Regulatory Transparency

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Medicaid Rebates Dual Eligibles S. 365: Budget Control Act of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program

TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act HRSA Implementation of Program Changes Federal Supply Schedule Access During Emergencies Expanded Access to Experimental Products Medicaid Rebates Dual Eligibles S 365: Budget Control Act of 2011 Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products TREAT Act (Senate Discussion Draft) E-Pedigree and Anti-Counterfeiting Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Cures Acceleration Network S. R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 National Center for Advancing Translational Sciences S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Biodefense Research, Development and Procurement HHS Countermeasures Review S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Part D Prescription Drug Program International Biosecurity Policies Biologics and Toxins Weapons Convention

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Federal Supply Schedule Access During Emergencies Biodefense Research, Development and Procurement HHS Countermeasures Review S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization Act of 2011 International Biosecurity Policies Biologics and Toxins Weapons Convention

Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Medicaid Rebates Dual Eligibles S. 365: Budget Control Act of 2011 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 Reimbursement for Innovative Products Medicare Part D Prescription Drug Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Discussions with EU on Animal Cloning APEC Agricultural Biotechnology Discussions EU Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Sanitary and Phytosanitary Issues Data and Intellectual Property Protections for Pharmaceuticals

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products TREAT Act (Senate Discussion Draft) E-Pedigree and Anti-Counterfeiting Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Funding for the USDA (Office of General Counsel , Biotechnologies Regulatory Services (BRS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H..R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Sciences S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Funding for Biofuels H.R. 2219: Department of Defense Appropriations Act for FY 2012 H.R. 2354: The Energy and Water Appropriations Act for 2012 Funding for Bio-based Products H.R. 2219: Department of Defense Appropriations Act for FY 2012 H.R. 2354: The Energy and Water Appropriations Act for 2012 Funding for Biomass Crop Assistance Program H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents U.S. Policy on International Science-Based Regulations Codex Standards Intellectual Property International Enforcement TransPacific Partnership Sanitary and Phytosanitary Issues Data and Intellectual Property for Pharmaceuticals Foreign Agricultural Biotechnology Laws and Regulations International Biotechnology Agreement Discussions with EU on Animal Cloning China Biotechnology Regulations Low-Level Presence Foreign Government Policies European Union Low Level Presence Policy EU Biotechnology Bilateral Discussions Korea Biotechnology Regulations APEC Agricultural Biotechnology Discussions Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Philippines IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations Potential Regulation of New Genetic Modification Technologies EU Workshop

Patent Reform H.R. 1249: The Leahy-Smith America Invents Act of 2011 S. 23: The Patent Reform Act of 2011 Implementation of H.R. 1249: The America Invents Act of 2011 IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations Generic Drug Patent Settlements Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Philippines DNA Patenting and Licensing Rep. Wasserman Schultz Amendment to H.R. 1249: The America Invents Act of 2011 Bayh-Dole Act/Tech Transfer Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Domestic Manufacturing Requirement Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals

Medicaid Rebates Dual Eligibles Medicare Prescription Drug Coverage Transfer of Certain Drugs from Part B to Part D Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Policies and Regulation

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Genetically Engineered (GE) Animals FDA Approval Labeling H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Amendment to Restrict FDA Approval of GE Salmon Generic Drug Patent Settlements Drug Safety and Review S. 1584: Drug Safety and Accountability Act of 2011 Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2012 Drug Shortages H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Cures Acceleration Network S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Funding for National Institutes of Health S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Rare Pediatric & Tropical Disease Drug Development Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Biodefense Research, Development and Procurement (Non-Funding Issues) Pandemic and All-Hazards Preparedness Act Reauthorization HHS Countermeasures Review

Biodefense Research, Development and Procurement HHS Countermeasures Review Pandemic and All-Hazards Preparedness Act Reauthorization Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012

Biodefense Research, Development and Procurement HHS Countermeasures Review Pandemic and All-Hazards Preparedness Act Reauthorization Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 H.J. RES.48: Department of Defense and Further Additional Continuing Appropriations Act for FY 2011 H.R. 1/H.J. RES.92: Continuing Appropriations Act for FY 2011

Reimbursement for Innovative Products Medicare Policies and Regulation Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicaid Rebates Dual Eligibles Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Repeal

Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicaid Rebates Dual Eligibles Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011

Cures Acceleration Network Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Rare Pediatric & Tropical Disease Drug Development Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 H.J. RES. 48: Department of Defense and Further Additional Continuing Appropriations Act for FY 2011 H.R. 1/H.J. RES.92: Continuing Appropriations Act for FY 2011 Biodefense Research, Development and Procurement HHS Countermeasures Review Pandemic and All-Hazards Preparedness Act Reauthorization

Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Vaccine Access/Financing S. 1094: Combating Autism Reauthorization Act Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicaid Rebates Dual Eligibles Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review Regulatory Reforms for Innovative Products Prescription Drug User Fee Act (PDUFA) Reauthorization Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 1/H.J. RES 92: Continuing Appropriations Act for FY 2011 H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Repeal Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 H.J. RES.48: Department of Defense and Further Additional Continuing Appropriations Act for FY 2011 H.R. 1/H.J. RES.92: Continuing Appropriations Act for FY 2011 Cures Acceleration Network Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development and Procurement HHS Countermeasures Review Pandemic and All-Hazards Preparedness Act Reauthorization Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Policies and Regulation

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 H.J. RES. 48: 6th Continuing Resolution for FY 2011 Biodefense Research, Development and Procurement HHS Countermeasures Review

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative Funding for FDA H.J. RES. 48: 6th Continuing Resolution for FY 2011 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 H.J. RES. 48: 6th Continuing Resolution for FY 2011 Pharmaceutical Industry Annual Fee Treasury and IRS Regulations Implementing the Law Biodefense Research, Development and Procurement HHS Countermeasures Review Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Funding for FDA H.J. RES. 48: 6th Continuing Resolution for FY 2011 USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Livestock Cloning/Product Labeling Genetically-Engineered (GE) Animals Labeling FDA Approval Labeling of Genetically-Engineered (GE) Crops U.S. Government Policy Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Funding for National Institutes of Health H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.J. RES.48: 6th Continuing Resolution for FY 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 H.J. RES. 48: 6th Continuing Resolution for FY 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.J. RES. 48: 6th Continuing Resolution for FY 2011 Funding for Bio-based Products H.J. RES. 48: 6th Continuing Resolution for FY 2011 Funding for Biofuels H.J. RES. 48: 6th Continuing Resolution for FY 2011 DOE Loan Guarantees and Grants under the Energy Policy Act of 2005 (Implementation and Funding)

Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Average Manufacturer Price Calculations H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010

Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Drug Importation S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 S.3607: Department of Homeland Security Appropriations Act for FY 2011 S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011

Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Funding for Biomedical Advanced Research & Development Authority (BARDA) S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Bioterrorism and Emergency Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Pandemic Influenza Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for National Institutes of Health H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding: S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Stem Cell Research Federal Funding of Embryonic Stem Cell Research Biodefense Research, Development and Procurement HHS Countermeasures Review Funding: H.R. 3082: 4th Continuing Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010

Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Average Manufacturer Price Calculations H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Genetically Engineered (GE) Animals Labeling FDA Approval Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3607: Department of Homeland Security Appropriations Act for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act of 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs & Closing Tax Loopholes Act Labeling of Genetically Engineered Crops U.S. Government Policy

Funding for Strategic National Stockpile S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Biodefense Research, Development and Procurement S. 3761: A Bill to Restore Funding for Indian Loan Guarantee Program at the Bureau of Indian Affairs HHS Countermeasures Review H.R. 4899: Supplemental Appropriations Act of 2010 H.R. 5297: American Jobs and Closing Tax Loopholes Act of 2010 S. 3693: A Bill to Provide Funding for the Settlement of Lawsuits Against the Federal Government for Discrimination Against Black Farmers Funding for Pandemic Influenza Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Biomedical Advanced Research and Development Authority (BARDA) S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011

Stem Cell Research Federal Funding of Embryonic Stem Cell Research Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 Research & Development Tax Credit Extension H.R. 4213: American Jobs & Closing Tax Loopholes Act

IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations PTO Administrative Reforms Humanitarian Voucher Three Track Examination Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act of 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs & Closing Tax Loopholes Act Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Convention on Biological Diversity DNA Patenting and Licensing Amicus Matters Bayh-Dole Act/Tech Transfer Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Intellectual Property International Enforcement Compulsory Licensing

Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3607: Department of Homeland Security Appropriations Act for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Drug Safety and Review FDA Globalization Act (Discussion Draft) E-Pedigree and Anti-Counterfeiting

Class Action Fairness Act Amendments H.R. 5503: Securing Protections for the Injured from Limitations on Liability Act Ban on Protective Orders H.R. 5503: Securing Protections for the Injured from Limitations on Liability Act Appointment of Registered Agents H.R. 4678: Foreign Manufacturer Legal Accountability Act

S. 3607: Department of Homeland Security Appropriations Act for FY 2011 Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Livestock Cloning/Product Labeling Funding for the USDA (Office of General Counsel , Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agricultural Service) Funding for Biofuels and Bio-based Products Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Drug Importation S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Funding for National Institutes of Health Cures Acceleration Network Funding for Bioterrorism and Emergency Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Funding for Centers for Disease Control and Prevention Vaccine Programs Drug Importation Funding for Strategic National Stockpile S: 3635: Energy and Water Development and Related Agencies Appropriations Act for FY 2011 Title XVII Loan Guarantee Program Funding for Reverse Auction Loan Program under Section 942 of the Energy Policy Act of 2005 Funding for Biofuels and Bio-based Products Funding for Biorefineries S. 3676: Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2011 Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State Funding for the Bureau of Economic, Energy, and Business Affairs (EEB) at the U.S. Department of State Funding for Global Food Security Initiative H.R.1586 / S.A.4575: Supplemental Education, Jobs and Medicaid Assistance Act of 2010 Funding for Biofuels and Bio-based Products Generic Patent Settlements Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) S. 3677: Financial Services and General Government Appropriations Act of 2011 Generic Patent Settlements H.R. 4899: Emergency Supplemental Appropriations Act for 2010 Generic Drug Patent Settlements Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Average Manufacturer Price Calculations Funding for Biomedical Advanced Research and Development Authority (BARDA)

Drug Safety and Review FDA Globalization Act (Discussion Draft) E-Pedigree and Anti-Counterfeiting Biodefense Research, Development and Procurement S. 3761: A Bill to Restore Funding for Indian Loan Guarantee Program at the Bureau of Indian Affairs HHS Countermeasures Review H.R. 4899: Supplemental Appropriations Act of 2010 H.R. 5297: American Jobs and Closing Tax Loopholes Act of 2010 S. 3693: A Bill to Provide Funding for the Settlement of Lawsuits Against the Federal Government for Discrimination Against Black Farmers Pharmaceutical Industry Annual Fee Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Expansion of 340B Drug Pricing Program H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 S. 3793: Job Creation and Tax Cuts Act of 2010 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Federal Supply Schedule Access During Emergencies S.2868: Federal Supply Schedules Usage Act of 2009 Alliance for Healthcare Competitiveness Stem Cell Research Federal Funding of Embryonic Stem Cell Research Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3607: Department of Homeland Security Appropriations Act for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Average Manufacturer Price Calculations H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Diagnostics and Personalized Medicine Regulation and Oversight Draft Legislation Rare Pediatric & Tropical Disease Drug Development S. 3697: Creating Hope Act of 2010 Funding for the Food and Drug Administration S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding: S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Biomedical Advanced Research and Development Authority (BARDA) S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Strategic National Stockpile S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011

Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 Stem Cell Research Research & Development Tax Credit Extension HR 4213: American Jobs and Closing Tax Loopholes Act of 2010

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S.610: The Patent Reform Act of 2009 Patent Reform Cont... Proposed Ban on Tax Preparation Patents: Senate Finance Committee Draft Genetic Resource Patent Disclosure Requirements Convention on Biological Diversity World Intellectual Property Organization DNA Patenting and Licensing Bayh-Dole Act/Tech Transfer Genomic Research and Accessibility Act Discussion Draft (Rep. Becerra) Amicus Matters Possible Legislation by Rep. Wasserman Schultz IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations Generic Drug Patent Settlements H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs & Closing Tax Loopholes Act S.4322: Preserve Access to Affordable Generics Act PTO Administrative Reforms World Trade Organization Special 301 Submissions Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Intellectual Property International Enforcement

Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Average Manufacturer Price Calculations H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010

Alliance for Healthcare Competitiveness Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Cures Acceleration Network Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for Strategic National Stockpile Department of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Stem Cell Research Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Average Manufacturer Price Calculations H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Biodefense Research, Development and Procurement S.1649/H.R 5498: Weapons of Mass Destruction Prevention and Preparedness Act Human Drug Review Program Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative Diagnostics and Personalized Medicine Regulation and Oversight Draft Legislation Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Expanded Access to Experimental Products FDA Rules Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act: GAO Study

Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for Strategic National Stockpile Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Biodefense Research, Development and Procurement S.1649/H.R 5498: Weapons of Mass Destruction Prevention and Preparedness Act Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010

Class Action Fairness Act Amendments H.R. 5503: Securing Protections for the Injured From Limitations on Liability Act Ban on Protective Orders H.R. 5503: Securing Protections for the Injured From Limitations on Liability Act Appointment of Registered Agents H.R. 4678: Foreign Manufacturers Legal Accountability Act

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Cont... Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agricultural Service) Livestock Cloning/Product Labeling Funding for Biofuels and Bio-based Products Budget of the United States for FY 2011 Funding for Biofuels and Bio-based Products Department of Homeland Security Appropriations Act for FY 2011 Drug Importation Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2011 Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State Funding for Global Food Security Initiative Funding for the Bureau of Economic, Energy, and Business Affairs (EEB) at the Department of State Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health Cures Acceleration Network Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Funding for Centers for Disease Control and Prevention Vaccine Programs Funding for Strategic National Stockpile Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2011 Funding for Biofuels and Bio-based Products Funding for Biorefineries Funding for Reverse Auction Loan Program under Section 942 of the Energy Policy Act of 2005 Title XVII Loan Guarantee Program H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Average Manufacturer Price Calculations Generic Drug Patent Settlements Funding for Biofuels and Bio-based Products

Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Bio-based Products Tax Credits Biofuels Production Tax Credit Extension H.R. 5142: Grow Renewable Energy Economy Now- Jumpstart Other Biofuels Act of 2010 Biofuels Production Tax Credit Modification for Algae-based Biofuels H.R. 5142: Grow Renewable Energy Economy Now- Jumpstart Other Biofuels Act of 2010 H.R. 4168: Algae-based Renewable Fuel Promotion Act of 2009 S.1250: Algae-based Renewable Fuel Promotion Act of 2009 Biofuels Investment Tax Credit Option H.R. 5142: Grow Renewable Energy Economy Now- Jumpstart Other Biofuels Act of 2010 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation Senate Substitute to H.R. 5297: Small Business Lending Fund Act of 2010 Modifications to Internal Revenue Code Section 1202 for Qualified Small Business Stock Incentive H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Senate Financial Regulatory Reform Discussion Draft Research & Development Tax Credit Extension HR 4213: American Jobs and Closing Tax Loopholes Act of 2010

Therapeutic Discovery Project Tax Credit S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Therapeutic Discovery Project Tax Credit Cont... H.R. 4872: Health Care and Education Reconciliation Act of 2010 Bio-based Products Tax Credits Pharmaceutical Fee S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Research and Development Tax Credit Extension H.R. 4213: Tax Extenders Act of 2009 Biofuels Production Tax Credit Modification for Algae-based Biofuels S.1250: Algae-based Renewable Fuel Promotion Act of 2009 H.R. 4168: Algae-based Renewable Fuel Promotion Act of 2009 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation Modification to Internal Revenue Code Section 1202 for Qualified Small Business Stock Incentive Biofuels Production Tax Credit Extension Biorefineries Next Generation Tax Credits Modifications to the Advanced Energy Products Tax Credits

Healthcare Reform Comparative Effectiveness Research Program Initiatives Vaccine Access/Financing Health Care Reform Cont... Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Generic Fill Incentives Therapeutic Discovery Project Tax Credit Pharmaceutical Fee Medicaid Rebates Drug Importation Cures Acceleration Network Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S. 1679: Affordable Health Choices Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Drug Importation H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1796: America's Healthy Future Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2011 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 2011 Stem Cell Research Medicaid Rebates S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 4872: Health Care and Education Reconciliation Act of 2010 Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act Follow-on Biologics Reimbursement Issues S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 4872: Health Care and Education Reconciliation Act of 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 S.1213: Patient-Centered Outcomes Research Act of 2009 S.1796: American's Health Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Strategic National Stockpile Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Reporting of Physician Payments S. 310: Physician Payments Sunshine Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1796: American's Health Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 Vaccine Access/Financing S.1796:America's Healthy Future Act of 2009 S.1679: America's Affordable Health Choices Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act S. 2868: Federal Supply Schedules Usage Act of 2009 S.1649: Weapons of Mass Destruction Preparedness Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Expansion of 340B Drug Pricing Program S.1796:America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 4872: Health Care and Education Reconciliation Act of 2010 Expanded Access to Experimental Products FDA Rules Development of Medical Countermeasures in Response to Bio-threats HHS Countermeasures Review Cures Acceleration Network H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Alliance for Healthcare Competitiveness

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S.610: The Patent Reform Act of 2009 World Trade Organization Special 301 Submissions Convention on Biological Diversity Patent Disclosure Requirements Gene Patenting Possible Legislation by Rep. Wasserman Schultz Genomic Research and Accessibility Act (Discussion Draft) Bayh-Dole Act/Tech Transfer HHS Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations PTO Administrative Reforms

Medicaid Rebates S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Medicaid Rebates Cont. H.R. 4872: Health Care and Education Reconciliation Act of 2010 Reimbursement for Follow-on Biologics H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1796: America's Healthy Future Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 S.1679: Affordable Health Choices Act of 2009 Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Genetically Engineered (GE) Animals FDA Approval of First Product From GE Animals Drug Importation H.R. 3590: (Senate) Patient Protection and Affordable Care Act S. 1796: America's Healthy Future Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Reporting of Physician Payments S.310: Physician Payments Sunshine Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act S. 1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 Livestock Cloning/Product Labeling Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Discussion with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient & Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations Mexico Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions APEC Agricultural Biotechnology Discussions Discussions with EU on Animal Cloning Vietnam Biotechnology Regulations Turkish Biotechnology Regulations Low-level Presence Foreign Government Policies North America Biotechnology Initiative World Trade Organization Special 301 Submissions World Trade Organization on EU Biotech Approvals EU Biotechnology Negotiations Drug Importation H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1796: America's Health Future Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Livestock Cloning/Product Labeling Discussion with EU on Animal Cloning Alliance for Healthcare Competitiveness Funding for International Trade Activities at the USDA (Office of the Secretary & Food Safety Inspection Service, Foreign Agricultural Service) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Stem Cell Research Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 S.1213: Patient-Centered Outcomes Research Act of 2009 S.1796: American's Health Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Cures Acceleration Network H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011

Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Development of Medical Countermeasures in Response to Bio-threats HHS Countermeasures Review Funding for Strategic National Stockpile Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011

Healthcare Reform Comparative Effectiveness Research Program Initiatives In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Health Care Reform Cont... Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Generic Fill Incentives Therapeutic Discovery Project Tax Credit Pharmaceutical Excise Tax Medicaid Rebates Dual Eligibles H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 3200: America's Affordable Health Choices Act of 2009 S. 1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 Drug Safety and Review H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 H.R. 2749: Food Safety Enhancement Act of 2009 Critical Path FDA Regulatory Transparency Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for the Food and Drug Administration H.R. 2997?S.1406: Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates S.1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Dual Eligibles Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Comparative Effectiveness Program Initiatives S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Reporting of Physician Payments S. 310: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Vaccine Access/Financing S.1796:America's Healthy Future Act of 2009 S.1679: America's Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S. 2868: Federal Supply Scheduels Usage Act of 2009 S.1649: Weapons of Mass Destruction Preparedness Act of 2009 Expansion of 340B Drug Pricing Program S.1796:America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Federal Supply Schedule Access S.2868: Federal Supply Schedules Usage Act of 2009 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Reimbursement Issues

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations China Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions Canada Biotechnology Bilateral Discussions APEC Agricultural Biotechnology Discussions Discussions with EU on Animal Cloning Vietnam Biotechnology Regulations Turkish Biotechnology Regulations Korea Living Modified Organisms Act Revisions Thailand Biotechnology Regulations Low-level Presence Foreign Government Policies U.S. Policy on International Science-Based Regulations USDA Export Strategy for Agricultural Biotechnology Products World Trade Organization Special 301 Submissions World Trade Organization on EU Biotech Approvals EU Biotechnology Negotiations Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S. 1213: Patient-Centered Outcomes Research Act of 2009 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Livestock Cloning/Product Labeling Discussion with EU on Animal Cloning USTR, USDA & FDA Outreach to European Commission and Parliament

Therapeutic Discovery Project Tax Credit S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Therapeutic Discovery Project Tax Credit Cont... H.R. 3200: America's Affordable Health Choices Act Bio-based Products Tax Credits H.R. 2454: American Clean Energy and Security Act of 2009 S. 1733: Clean Energy Jobs and American Power Act of 2009 Pharmaceutical Excise Tax S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Research and Development Tax Credit Extension H.R. 4213: Tax Extenders Act of 2009 Cellulosic Tax Credit Modification for Algae-based Biofuels S.1250: Algae-based Renewable Fuel Promotion Act of 2009

Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 Medicaid Rebates Cont... H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Dual Eligibles Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S. 1796: America's Healthy Future Act of 2009 S. 1213: Patient-Centered Outcomes Research Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 H.R. 2749: Food Safety Enhancement Act of 2009 Critical Path FDA Regulatory Transparency Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act

Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S. 1769: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Stem Cell Research Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S. 1679: America's Healthy Future Act of 2009 S. 1213: Patient-Centered Outcomes Research Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S.610: The Patent Reform Act of 2009 World Trade Organization Special 301 Submissions Convention on Biological Diversity Patent Disclosure Requirements Gene Patenting Proposed Legislation by Rep. Wasserman Schultz Genomic Research and Accessibility Act Bayh-Dole Act/Tech Transfer HHS Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations

Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 Medicaid Rebates Cont... H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Dual Eligibles Reimbursement for Follow-on Biologics H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S.1796: America's Healthy Future Act of 2009

Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Enhanced Security Regulations at Biodefense Labs S.1649: Weapons of Mass Destruction Prevention and Preparedness Act of 2009 Managing Risks of Misues of the Life Sciences National Strategy for Countering Biological Threats Federal Supply Schedule Access During Emergencies S. 2868: Federal Supply Schedules Usage Act of 2009

Genetically Engineered (GE) Animals FDA Final Guidance on Regulation of GE Animals FDA Approval of First Product From GE Animals Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related agencies Appropriations Act for FY 2010 Reporting of Physician Payments S.310: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Drug Safety and Review H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 H.R. 2749: Food Safety Enhancement Act of 2009 Critical Path FDA Regulatory Transparency Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Livestock Cloning/Product Labeling H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 2007 Farm Bill Implementation Discussion with EU on Animal Cloning USTR, USDA & FDA Outreach to European Commission and Parliament USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7CFR 340 USDA Docket on Corn Amylase Petition (No. APHIS-2007-0016) Efficient Review of Biotech Products Coexistence of Production Systems

Healthcare Reform H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Health Care Reform Cont... Comparative Effectiveness Research Program Initiatives Hospital Acquired Infections Policy In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Medicaid Rebates S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 2502: Comparative Effectiveness and Research Protection Act H.R. 2824 Doctor-Patient Relationship and Research Protection Act Pharmaceutical Excise Tax Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act FTC Report on Follow-on Biologics Marketplace H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 House Judiciary Committee Hearing on Patent Issues Drug Safety and Review E-Pedigree and Anti-counterfeiting H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 The Food and Drug Administration Amendments Act of 2007 Implementation Risk Evaluation Mitigation Strategies Adverse Event Monitoring/Sentinel Network Advisory Committee System Critical Path FDA Regulatory Transparency Measurement Standards for Review and Approval of Biologics House Science Committee Hearing Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Reporting of Physician Payments S. 301: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act Senate Finance Committee's America's Healthy Future Act of 2009 Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 Vaccine Access/Financing H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 FDA Regulatory Processes for First-Time Filers Expansion of 340B Drug Pricing Program H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 S.1239: 340B Program Improvement and Integrity Act of 2009 Outpatient Prospective Payment System CY2010 Proposed Regulations Payment Methodology for Separately Billable Drugs and Biologics

Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Outpatient Prospective Payment System CY2010 Proposed Regulations Payment Methodology for Separately Billable Drugs and Biologics Drug Safety and Review E-Pedigree and Anti-counterfeiting H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 The Food and Drug Administration Amendments Act of 2007 Implementation Risk Evaluation Mitigation Strategies Adverse Event Monitoring/Sentinel Network Advisory Committee System Critical Path FDA Regulatory Transparency Measurement Standards for Review and Approval of Biologics House Science Committee Hearing Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 S.80: Pharmaceutical Market Access Act of 2009

Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Stem Cell Research Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009

Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Outpatient Prospective Payment System CY2010 Proposed Regulations Payment Methodology for Separately Billable Drugs and Biologics

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S. 610: The Patent Reform Act of 2009 World Trade Organization Special 301 Submissions Convention on Biological Diversity Patent Disclosure Requirements Bayh-Dole Act/Tech Transfer Gene Patenting HHS Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations PTO Administrative Reforms

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement and Living Modified Organisms Act Revisions China Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions Canada Biotechnology Bilateral Discussions Japan Biotechnology Bilateral Discussions Argentina Biotechnology Bilateral Discussions Brazil Biotechnology Bilateral Discussions APEC Agricultural Biotechnology Discussions Korean Biosafety Law Discussions with EU on Animal Cloning India Bilateral Biotechnology Discussions Vietnam Biotechnology Regulations U.S. Policy on International Science-Based Regulations USDA Export Strategy for Agricultural Biotechnology Products World Trade Organization Special 301 Submissions World Trade Organization on EU Biotech Approvals EU Biotechnology Negotiations Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 S.80: Pharmaceutical Market Access Act of 2009

Medicaid Rebates House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft

Genetically Engineered (GE) Animals Coordination Between Federal Agencies USDA APHIS Animal Care - Compliance with the Animal Welfare Act USDA APHIS Veterinary Service - Import and Export Issues Genetically Engineered (GE) Animals Cont... H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 FDA Center for Veterinary Medicine - Regulatory Follow-up USDA APHIS Biotechnology Regulatory Services - Regulatory Follow-up NIH, Extramural Programs, Office of Laboratory Animal Welfare - rDNA Regulatory Compliance USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding USDA, Cooperative State Research Education and Extension Service, National Institute of Food and Agriculture, Small Business Innovation Research Program, Funding USDA, Foreign Agricultural Service and USTR International Coordination Upon First Approval of GE Animal Product Funding for the Food and Drug Administration H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related agencies Appropriations Act for FY 2010 Reporting of Physician Payments S.310: Physician Payments Sunshine Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program USDA APHIS Animal Care USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Small Business Innovation Research Program, Funding USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Agriculture Food Research Initiative - Research Funding H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 USDA Foreign Agricultural Service and USTR International Coordination on Adoption of Cloning in Europe, Japan, Canada 2007 Farm Bill Implementation Discussion with EU on Animal Cloning Drug Safety E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (Discussion Draft) H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 S. 525: Pharmaceutical Market Access and Drug Safety Act of 2009 Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act For FY 2010 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 1256: Family Smoking Prevention and Tobacco Control Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7CFR 340 USDA Docket on Corn Amylase Petition (No. APHIS-2007-0016)

Healthcare Reform House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Health Care Reform Cont... Comparative Effectiveness Research Program Initiatives Hospital Acquired Infections Policy In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Medicaid Rebates Drug Safety E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (Discussion Draft) H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 S. 525: Pharmaceutical Market Access and Drug Safety Act of 2009 Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act For FY 2010 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 1256: Family Smoking Prevention and Tobacco Control Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 Funding for the Food and Drug Administration H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act FTC Report on Follow-on Biologics Marketplace Senate HELP Committee Biologics Price Competition and Innovation Act Discussion Draft House Tri-Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1054: Supplemental Appropriations for FY 2009 In Vitro Diagnostics Regulatory Oversight Healthcare Reform Bills Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 Reporting of Physician Payments S. 301: Physician Payments Sunshine Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Vaccine Access/ Financing Senate HELP Committee Affordable Health Choices Act Discussion Draft House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft S.1003: Immunization Improvement Act of 2009 National Vaccine Advisory Committee Draft Recommendations FDA Regulatory Processes for First-Time Filers Expansion of 340B Drug Pricing Program Senate HELP Committee Affordable Health Choices Act Discussion Draft House Tri-Committee Healthcare Reform Discussion Draft

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S. 610: The Patent Reform Act of 2009 World Trade Organization and Convention on Biological Diversity Patent Disclosure Requirements Special 301 Submissions/Meetings Bayh-Dole Act/Gene Patenting Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement and Living Modified Organisms Act Revisions China Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions Taiwan Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions Canada Biotechnology Bilateral Discussions Japan Biotechnology Bilateral Discussions Argentina Biotechnology Bilateral Discussions Brazil Biotechnology Bilateral Discussions Negotiations of Trans Pacific Partnership APEC Agricultural Biotechnology Discussions Korean Biosafety Law Discussions with EU on Animal Cloning India Bilateral Biotechnology Discussions Vietnam Biotechnology Regulations U.S. Policy on International Science-Based Regulations USDA Export Strategy for Agricultural Biotechnology Products World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations Drug Importation S. 1232: Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 1256: Family Smoking Prevention and Tobacco Control Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2010 S: 525: Pharmaceutical Market Access & Drug Safety Act of 2009

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1054: Supplemental Appropriations for FY 2009 Funding for the Food and Drug Administration H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 In Vitro Diagnostics Regulatory Oversight Healthcare Reform Bills Stem Cell Research Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft

Comparative Effectiveness Program Initiatives H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft) Drug Importation S.525: Pharmaceutical Market Access and Drug Safety H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Medicaid Rebates H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

Adventitious Presence (Low Level Presence) U.S. Government Policy for Codex Guidelines on Adventitious Presence European Union Low Level Presence Policy Philippines Low Level Presence Policy Genetically Engineered (GE) Animals Coordination Between Federal Agencies FDA Final Guidance on Regulation of GE Animals FDA CBER Blood Products Advisory Committee Meeting FDA Approval of First Product from GE Animal USDA APHIS Biotechnology Research Service Request for Information USDA APHIS Animal Care USDA APHIS Veterinary Service USDA National Institute of Food & Agriculture, Agriculture Food Research Institute, Research Funding Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft) Drug Importation S.525: Pharmaceutical Market Access and Drug Safety H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Reporting of Physician Payments S:310: Physician Payments Sunshine Act of 2009 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 USDA APHIS Animal Care USDA National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Medicaid Rebates H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for National Institutes of Health H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Biomedical Advanced Research Development Authority (BARDA) H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 1. and S. Amdt. 570: American Recovery and Reinvestment Act of 2009 Stem Cell Research Executive Order Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft)

Health Care Reform H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Goverment for FY 2010 Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft) Drug Importation S.525: Pharmaceutical Market Access and Drug Safety H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Executive Order Medicaid Rebates H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 Funding for National Institutes of Health H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Reporting of Physician Payments S. 301: Physician Payments Sunshine Act of 2009

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S. 610: The Patent Reform Act of 2009 PTO Reform CBD TRIPS Amendment Patent Disclosure Requirements

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Biomedical Advanced Research Development Authority (BARDA) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages Stem Cell Research Barriers and Incentives Related to Personalized Medicine

Plant Protection Act Amendments/Penalties H.R. 6124 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings Taiwan Biotechnology Negotiations EU Trade Negotiations EPA Regulation of Plant Incorporated Protectants Proposed Rule Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Farm Legislation H.R. 2419 & H.R. 6124 USDA Administrative Proposals Livestock Cloning/Product Labeling Plant Protection Act Amendments/Penalties World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H.R. 6432 Biotechnology Crop Stewardship Biotechnology Quality Management Stewardship Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7 CFR 340 U.S. Policy on Sustainable Agriculture Standard American National Standards Institute (ANSI) Bio-based Products Tax Credits EU Tracebility and Labeling Regulations for Ag-Biotech U.S. Policy on Ag-Biotech Benefits for G-8 Meeting Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination Counterfeit Drugs FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 H.R. 4911 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Patient Services S. 3101: Medicare Improvements for Patients and Providers Act of 2008 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) Access to Investigation Drugs for Seriously Ill Patents The Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.1956) Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H. R. 6432 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination Counterfeit Drugs H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 (S.3181) Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642)

False Claims Act Amendment S.2041 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Access to Drug Pricing Data H.R. 5683

Patent Reform H.R. 1908 S. 1145 CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Biologic Deposit Rule: 73-FR-34 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Bayh-Dole Act Evaluation Intellectual Property Enforcement Gene Patenting Intellectual Property Provisions in U.S. Trade Agreements Korean Trade Agreement

Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H. R. 6432 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663

Human Growth Hormone Regulation S.877 H.R. 4911

Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Medicare Reimbursements in Hospital Outpatient Department Setting Medicaid Rebates Medicaid/Medicare Packages Dual Proportionality

Funding for National Institutes of Health S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health cont... H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Biomedical Advanced Research Development Authority (BARDA) S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for the Food and Drug Administration S.3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Bioterrorism and Emergency Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Pandemic Influenza Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Comparative Effectiveness Program Initiatives S. 3101 S.3408 Stem Cell Research Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases

Patent Reform H.R. 1908 S. 1145 S.3600 PTO Reform CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Intellectual Property Enforcement S.3464

S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Cont...) Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Drug Importation Livestock Cloning/Product Labeling S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Drug Importation S: 3258/H.R. 7324: Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels H.R. 7323/S.3260: Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley - Section 404 H.R. 7322/S: 3282: Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) S.3288: Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development H.R. 2642: Supplemental Appropriations Bill Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 7110/S.3604/S.3688: Job Creation and Unemployment Relief Act for 2008 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration Funding for Biomedical Advanced Research & Development Authority (BARDA) S.3181: Department of Homeland Security Appropriations Act for FY 2009 Drug Importation

Genetically Engineered (GE) Animals FDA and USDA Draft Regulation of GE Animals Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Heparin Contamination E-Pedigree and Anti-counterfeiting H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 S.3409: The Drug and Device Accountability Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for Food Safety at the Food and Drug Administration S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009

Comparative Effectiveness Program Initiatives S. 3101 S.3408 Medicaid Rebates Medicaid/Medicare Packages Dual Proportionality Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Medicare Reimbursement in Hospital Outpatient Department Setting Drug Importation S.3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Heparin Contamination FDA Globalization Act of 2008 E-Pedigree and Anti-counterfeiting H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 S.3409: The Drug and Device Accountability Act of 2008 Funding for the Food and Drug Administration S.3289:Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act

False Claims Act Amendment S.2041 H.R. 4854 . Access to Drug Pricing Data H.R. 5683

Funding for Biomedical Advanced Research Development Authority (BARDA) S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Funding for the Food and Drug Administration S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Funding for Bioterrorism and Emergency Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Funding for Pandemic Influenza Preparedness S. 3230: Departments of Labor, health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Stem Cell Research Human Subject Protections in Clinical Trials Barriers and Incentives Related to Personalized Medicine

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 6432 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for FY 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Human Subject Protections in Clinical Trials Human Growth Hormone Regulation S.877

Human Growth Hormone Regulation S.877

Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Medicaid Rebates H.R. 1424 H.R. 6331 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683

Access to Drug Pricing Data H.R. 5683 Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Medicaid Rebates H.R. 1424 H.R. 6331 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008

Patent Reform H.R. 1908 S. 1145 CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Biologic Deposit Rule: 73-FR-34 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Bayh-Dole Act Evaluation Intellectual Property Enforcement Gene Patenting Intellectual Property Provisions in U.S. Trade Agreements Korean Trade Agreement

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Biomedical Advanced Research Development Authority (BARDA) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages Stem Cell Research Barriers and Incentives Related to Personalized Medicine

Human Growth Hormone Regulation S.877 H.R. 4911

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination Counterfeit Drugs FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 H.R. 4911 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Patient Services S. 3101: Medicare Improvements for Patients and Providers Act of 2008 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) Access to Investigation Drugs for Seriously Ill Patents The Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.1956) Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

False Claims Act Amendment S.2041 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Access to Drug Pricing Data H.R. 5683

Plant Protection Act Amendments/Penalties H.R. 6124 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings Taiwan Biotechnology Negotiations EU Trade Negotiations EPA Regulation of Plant Incorporated Protectants Proposed Rule Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Farm Legislation H.R. 2419 & H.R. 6124 USDA Administrative Proposals Livestock Cloning/Product Labeling Plant Protection Act Amendments/Penalties World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H.R. 6432 Biotechnology Crop Stewardship Biotechnology Quality Management Stewardship Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7 CFR 340 U.S. Policy on Sustainable Agriculture Standard American National Standards Institute (ANSI) Bio-based Products Tax Credits EU Tracebility and Labeling Regulations for Ag-Biotech U.S. Policy on Ag-Biotech Benefits for G-8 Meeting Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions

Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H. R. 6432 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination Counterfeit Drugs H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 (S.3181) Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Cont...) Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels S.3260: Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley - Section 404 Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Funding for Biomedical Advanced Research & Development Authority (BARDA) Funding for USDA/APHIS Funding for Biorefinery Construction, Research & Development Department of Homeland Security Appropriations Act for FY 2009 Drug Importation

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Critical Path Initiative Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res. 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Stem Cell Research S.5 In Vitro Diagnostics Regulatory Oversight Barriers and Incentives Related to Personalized Medicine

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Influenza Vaccine Supply and Immunization Recommendations Drug Importation H.R. 3610 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Drug Safety Implementation of Food & Drug Administration Amendments Act Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs

Patent Reform H.R. 1908 S. 1145 CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Alternative Claims Rule: 72-FR-154 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Bayh-Dole Act Evaluation International Intellectual Property Enforcement Anti-counterfeiting

Human Growth Hormone Abuse S. 877 H.R. 4911

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H. R. 2419 S. 2663l Drug Importation H.R. 3610 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Imported Food Safety

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Critical Path Initiative Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res. 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Stem Cell Research S.5 In Vitro Diagnostics Regulatory Oversight Barriers and Incentives Related to Personalized Medicine

Human Growth Hormone Abuse S. 877 H.R. 4911

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Influenza Vaccine Supply and Immunization Recommendations Drug Importation H.R. 3610 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Drug Safety Implementation of Food & Drug Administration Amendments Act Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H. R. 2419 S. 2663l Drug Importation H.R. 3610 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Imported Food Safety

Patent Reform H.R. 1908 S. 1145 CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Alternative Claims Rule: 72-FR-154 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Bayh-Dole Act Evaluation International Intellectual Property Enforcement Anti-counterfeiting

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H. R. 2419 S. 2663l Drug Importation H.R. 3610 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Imported Food Safety

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency

Patent Reform H.R. 1908 S. 1145 CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Alternative Claims Rule: 72-FR-154 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Bayh-Dole Act Evaluation International Intellectual Property Enforcement Anti-counterfeiting

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Drug Importation H.R. 3610 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Stem Cell Research S.5 Medicaid Rebates H.R. 1424 H. Con. Res. 312 S. Con. Res. 70 Senate Medicare Package Human Growth Hormone Abuse S. 877 H.R. 4911 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Biomedical Advanced Research & Development Authority (BARDA) Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Pandemic Influenza Preparedness Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Medicare Hospital Outpatient Drug Reimbursement Policies In Vitro Diagnostics Regulatory Oversight Critical Path Initiative Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res. 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Influenza Vaccine Supply and Immunization Recommendations Drug Importation H.R. 3610 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Drug Safety Implementation of Food & Drug Administration Amendments Act Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies

Drug Safety H.R. 3580; H.R. 2900 S. 1082 Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence

Patent Reform H.R. 1908 S. 1145 Gene Patenting H.R. 977 ITC Exclusion Orders - Impact on Biotechnology Qualcomm Case CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Alternative Claims Rule: 72-FR-154 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Bayh-Dole Act Evaluation International Intellectual Property Enforcement Anti-counterfeiting IP Provisions in Free Trade Agreements

World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Regulations Mexico Biotech Regulations France Regulations of Plant Biotechnology Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Possible U.S. Government Ratification U.S. Government Positions at Biosafety Protocol Meetings International Intellectual Property Enforcement Anti-counterfeiting ITC Exclusion Orders - Impact on Biotechnology Qualcomm Case CBD TRIPS Amendment Patent Disclosure Requirments Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Farm Subsidies in Trade H.R. 2720 Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Restrictions on Importation of Plant Products/Lacey Act Amendments H.R. 1497 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764

Medicaid Rebates H.R. 3162; H.R. 2764 S. 2499 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 Comparative Effectiveness Program Initiatives S. 2499 H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Vaccines and Medicare Part B/Part D H.R. 4992

Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Loan Guarantees H.R. 3221 S. 1321 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biorefinery Solicitation Demonstration Projects for Feedstock Culture and Collection H.R. 2419

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2419 H.R. 2764 Funding for Food and Drug Administration (FDA) (Critical Path Initiative; Human Drug Review) H.R. 3161 S. 1859 H.R. 2764 Funding for State Children's Health Insurance Program S. 2086; S. 1893; S. 2499 H.R. 3162; H.R. 3963; H.R. 976 Funding for the Biomedical Advanced Research & Development Authority (BARDA) H.R. 3043 S. 1710 H.R. 2764 Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 Funding for Department of Agriculture (Biotechnology Regulatory Services) H.R. 3043 S. 1859 H.R. 2764

Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Genetically Engineered (GE) Animals FDA and USDA Regulations of GE Animals

Farm Subsidies in Trade H.R. 2720 Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credit H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Solicitation Biorefinery Loan Guarantees H.R. 3221 S. 1321 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Regulations Mexico Biotech Regulations France Regulations of Plant Biotechnology Restrictions on Importation of Plant Products/Lacey Act Amendments H.R. 2419 2007 Farm Bill (H.R. 2419) USDA Research and Regulatory Requirements for Ag-Biotech Federal Preemption Study Regarding Cloning of Livestock Study of Competitiveness of Ag-Biotech Industry Biobased Procurement -- USDA Program Demonstration Project for Feedstock Culture and Collection Biofuels Funding Importation of Plant Products Funding for Department of Agriculture (Biotechnology Regulatory Services) H.R. 3043 S. 1859 H.R. 2764 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings USDA Agriculture Biotechnology Regulations & Policies Release of Programmatic Environmental Impact Statement (EIS) Biotechnology Crop Stewardship Proposed Legislation Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Possible U.S. Government Ratification U.S. Government Positions at Biosafety Protocol Meetings Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence EPA Regulation of Plant Agricultural Biotechnology Release of Draft Proposed Rule on Reporting Requirements for Plant Agricultural Biotechnology

Infectious Disease Tax Credit S. 2351 R&D Tax Credit (H.R. 2764) Extension Permanence Alternatives Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Carried Interest Tax Treatment Biotech Capital Formation Tax Incentives/Net Operating Losses H.R. 3264: American Life Sciences Competitiveness Act of 2007

Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Revenue Recognition on Collaborative Agreements SEC Guidance Carried Interest Tax Treatment Biotech Capital Formation Tax Incentives/Net Operating Losses H.R. 3264: American Life Sciences Competitiveness Act of 2007 Convertible Debt Accounting FASB Proposed Guidance

Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Biorefinery Loan Guarantees H.R. 3221 S. 1321 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Solicitation Demonstration Projects for Feedstock Culture and Collection H.R. 2419

Drug Safety H.R. 3580; H.R. 2900 S. 1082 Medicaid Rebates H.R. 3162 H.R. 2764 S. 2499 Comparative Effectiveness Program Initiatives H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 S. 2499 Stem Cell Research Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Funding for Food and Drug Administration (Critical Path Initiative; Human Drug Review) H.R. 3161 S. 1859 H.R. 2764 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 FDA Regulatory Processes for First-Time Filers Food & Drug Administration Amendments Act/Food & Drug Administration Revitalization Act (H.R. 3580; H.R. 2900; S. 1082) User Fees/FDA Waivers for Small Businesses Risk Management Plans and Post-market Authorities Clinical Trial Registry and Results Databases Preemption Pharmaceutical Anti-Counterfeiting Priority Review Vouchers for Approved New Tropical Disease Therapies Civil Monetary Penalties FDA Advisory Panels/Conflict of Interest Possible Follow-on Biologics Amendments Follow-on Biologics H.R. 1038 H.R. 1956 S. 1695 S. 623 Presciption Drug User Fees H.R. 3580; H.R. 2900 S. 1082 Vaccines for Children Program H.R. 4990 Vaccines for Uninsured Adults H.R. 4993 National Vaccine Immunization Rates National Vaccine Program Office Working Paper on Adolescent Immunization Influenza Immunization Physician Quality Reporting Inititiative Vaccine Financing National Vaccine Program Office Draft White Paper on Vaccine Financing Vaccines and Medicare Part B/Part D H.R. 4992 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S. 1710; H.R. 2764) Emerging Diseases Regulatory Processes Emergency Use Authorization Genetic Testing Regulatory Oversight Infectious Disease Research Tax Credit S. 2351 Funding for State Children's Health Insurance Program S. 2086; S. 1893; S. 2499 H.R. 3162; H.R. 3963; H.R. 976 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 Erythropiesis Stimulating Agents CMS National Coverage Decision

Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S.1710; H.R. 2764) Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S.1710; H.R. 2764) Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 Critical Path Inititive H.R. 3161 S. 1859 Stem Cell Research Genetic Testing Regulatory Oversight Infectious Disease Reserach Tax Credit S. 2351 Comparative Effectiveness Program Initiatives S. 2499 H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963

Biobased Products Tax Credits H.R. 2419 H.R. 3586

Infectious Disease Tax Credit S. 2351

World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings

Stem Cell Research

Farm Subsidies in Trade H.R. 2720

Drug Safety H.R. 3580; H.R. 2900 S. 1082

Medicaid Rebates H.R. 3162; H.R. 2764 S. 2499

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764

Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859)

Drug Safety H.R. 3580; H.R. 2900 S. 1082

Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764

Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence

Codex Biotechnology Agenda U.S. Government Food Standards Negotiations Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations India Agricultural Biotechnology Regulations China Biotechnology Regulations Mexico Biotech Regulations International Policy Regarding Agricultural Biotechnology U.S. Government Negotiation Positions World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings USDA Agriculture Biotechnology Regulations USDA Biotechnology Policies Federal Preemption Oversight of Industry Exports of Agricultural Biotechnology Products Agricultural Biotechnology Stewardship Cartagena Biosafety Protocol Implementation and Effect on Agricultural Biotechnology CBD TRIPS Amendment Genetic Origin Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Intellectual Property Protections as Part of Panama and Peru Free Trade Agreements International Intellectual Property Enforcement Bill ITC Exclusion Orders - Impact on Biotechnology ITC Remedy Qualcomm Case

Regulation of Transgenic Animals Development of FDA Guidance and Advance Notice of Proposed Rulemaking Livestock Cloning Draft FDA Animal Cloning Risk Assessment Proposed FDA Risk Management Plan Draft FDA Guidance for Industry USDA National Organic Standards Board Cloning Recommendation

Sarbanes-Oxley Section 404 Reform Small Business Innovation Research (SBIR) Funding

Sarbanes-Oxley Section 404 Reform

Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Energy and Water Development and Related Agencies Appropriations Act, FY 2008 S. 1751: Energy and Water Development Appropriations Act, FY 2008 H.J.Res 20: Revised Continuing Appropriations Resolution, 2007 Adventitious Presence Release of USDA's Precursor to APHIS 340 Regs Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations India Agricultural Biotechnology Regulations China Biotechnology Regulations Mexico Biotech Regulations International Policy Regarding Agricultural Biotechnology U.S. Government Negotiation Position World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings Codex Biotechnology Agenda U.S. Government Food Standards Negotiations USDA Agriculture Biotechnology Regulations USDA Biotechnology Policies Federal Preemption Oversight of Industry Exports of Agricultural Biotechnology Products Agricultural Biotechnology Stewardship 2007 Farm Bill Animal Welfare Biofuels/Energy Research Preemption Application of Federal Insecticide Fungicide and Rodenticide Act (FIFRA) regulations to biotech plants Funding for Biotechnology Regulatory Services/USDA FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act Cartagena Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Energy Conservation Tax Act of 2007 Biorefinery Programs H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007

Drug Safety H.R. 2900: FDA Administration Amendments Act of 2007 (FDAAA) S.1082: FDA Revitalization Act (FDARA) Follow-on Biologics H.R. 1956: Patient Protection and Innovative Biologic Medicines Act S. 6237: Access to Life-Saving Medicines Act H.R. 1038: Access to Lifesaving Medicines Act S.1695: Biologics Price Competition and Innovation Act of 2007 Medicaid Expansion/Rebates H.R. 3162: The Children's Health and Medicare Protection Act of 2007 S.1893: The Children's Health Insurance Program Reauthorization Act of 2007 Medicare Clinical Trial Coverage Policy Implementation of Medicare Clinical Research Policy National Coverage Decision Comparative Effectiveness Research Initiatives S.3: Medicare Prescription Drug Price Negotiation Act of 2007 Medicare Part D "Non-Interference" Proposals S.250 and H.R. 4: Medicare Prescription Drug Price Negotiation Act FDA Appropriations Critical Path; Drug Safety; Human Drug Review Funding for Pandemic Influenza FY 2007 Emergency Supplemental Budget FY 2008 Budget H.R. 3043:Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biodefense Advanced R&D (BARDA) FY 2007 Emergency Supplemental Budget FY 2008 Budget S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act, FY 2008 Funding for National Institutes of Health S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 340B of the Public Health Service Act/Drug Prices for Covered Entities Administrative Interpretations of Pricing Calculations Guidance on Calculation of 340B Ceiling Price Genetic Information Nondiscrimination S. 358 H.R. 493 Drug Importation S.1082: FDA Revitalization Act (FDARA) Biodefense Implementation Plan and Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Vaccines for Children Contract Data Availability Request

Biotech Tax Package H.R. 3264: American Life Sciences Competitiveness Act of 2007 Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 R&D Tax Credit H.R. 2138: Investment in America Act of 2007 Cross Licensing Agreement Taxation Treasury Department Proposal

Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 R&D Tax Credit H.R. 2138: Investment in America Act of 2007 Renewable Fuels Standard S. 1297: Advanced Clean Fuels Act S. 1324: National Low-Carbon Fuel Standard Act H.R. 2215: Federal Low Carbon Fuels Act H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Engery and Water Development and Related Agencies Appropriations Act, FY 2008 S. 1751: Energy and Water Development Appropriations Act, FY 2008 H.J. Res 20: Revised Continuing Appropriations Resolution, 2007 Small Business Innovation Research (SBIR) Funding Funding for Stem Cell Research S.5: Stem Cell Research Enhancement Act of 2007

FDA Appropriations Critical Path Drug Safety Human Drug Review Funding for Pandemic Influenza FY 2007 Emergency Supplemental Budget FY 2008 Budget H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biodefense Advanced R&D (BARDA) FY 2007 Emergency Supplemental Budget FY 2008 Budget S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for National Institutes of Health S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biotechnology Regulatory Services/USDA FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Energy and Water Development and Related Agencies Appropriations Act, FY 2008 S.1751: Energy and Water Development Appropriations Act, FY 2008 H.J.Res 20: Revised Continuing Appropriations Resolution, 2007 Funding for Stem Cell Research S.5: Stem Cell Research Enhancement Act of 2007

Adventitious Presence Release of USDA's Precursor to APHIS 340 Regs Livestock Cloning Draft FDA Animal Cloning Risk Assessment Proposed FDA Risk Management Plan Draft FDA Guidance for Industry USDA National Organic Standards Board Cloning Recommendation Regulation of Transgenic Animals Development of FDA Guidance and Advance Notice of Proposed Rulemaking Application of Federal Insecticide Fungicide and Rodenticide Act (FIFRA) regulations to biotech plants Drug Importation S.1082: FDA Revitalization Act (FDARA) Drug Safety H.R. 2900: FDA Administration Amendments Act of 2007 (FDAAA) S.1082: FDA Revitalization Act (FDARA)

Genetic Information Nondiscrimination S. 358 H.R. 493

Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Energy and Water Development and Related Agencies Appropriations Act, FY 2008; S. 1751: Energy and Water Development Appropriations Act, FY 2008; H.J. Res 20: Revised Continuing Appropriations Resolution, 2007 Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 Biorefinery Programs H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Renewable Fuels Standard S. 1297: Advanced Clean Fuels Act S. 1324: National Low-Carbon Fuel Standard Act H.R. 2215: Federal Low Carbon Fuels Act H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007

Biodefense Implementation Plan and Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Funding for Pandemic Influenza FY 2007 Emergency Supplemental Budget FY 2008 Budget H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biodefense Advanced R&D (BARDA) FY 2007 Emergency Supplemental Budget FY 2008 Budget S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008

Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 Renewable Fuels Standard S. 1297: Advanced Clean Fuels Act S. 1324: National Low-Carbon Fuel Standard Act H.R. 2215: Federal Low Carbon Fuels Act H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Biorefinery Programs H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Engery and Water Development and Related Agencies Appropriations Act, FY 2008; S. 1751: Energy and Water Development Appropriations Act, FY 2008; H.J.Res 20: Revised Continuing Appropriations Resolution, 2007

Patent Reform H.R. 1908: Patent Reform Act of 2007 S. 1145: Patent Reform Act of 2007 Bayh-Dole Act PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71 FR 38808 CBD TRIPS Amendment Genetic Origin Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Intellectual Property Protections as Part of Panama and Peru Free Trade Agreements International Intellectual Property Enforcement Bill ITC Exclusion Orders - Impact on Biotechnology ITC Remedy Qualcomm Case Substantive Patent Law Harmonization U.S. Government Negotiation Positions Gene Patenting H.R. 977: A bill to prohibit gene patents

Adventitious Presence Release of USDA's Precursor to APHIS 340 Regs Livestock Cloning Draft FDA Animal Cloning Risk Assessment Proposed FDA Risk Management Plan Draft FDA Guidance for Industry USDA National Organic Standards Board Cloning Recommendation Regulation of Transgenic Animals Development of FDA Guidance and Advance Notice of Proposed Rulemaking Application of Federal Insecticide Fungicide and Rodenticide Act (FIFRA) regulations to biotech plants

World Health Organization Access to Medicines CBD TRIPS Amendment Genetic Origin Disclosure Requirements Patent Courts H.R. 5418 PTO Proposed Regulations Continuation Applications: 37 CFR Part 1 Information Disclosures Rules : 71 FR 38808 Claims Rules Intellectual Property Aspects of US Malaysia Free Trade Agreement Genetic Origin Disclosure Requirements Patenting of Plants and Animals Intellectual Property Aspects of US Korea Free Trade Agreement Data Exclusivity Patent Linkage Patent Reform S. 3818: Patent Reform Act of 2006

Sarbanes-Oxley Reform H.R. 5405 S.2824

Cellulosic Ethanol Funding H.R. 5427: Energy and Water Appropriations Act, 2007 Cellulose Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act

Cellulosic Ethanol Funding H.R. 5427: Energy and Water Appropriations Act, 2007 Adventitious Presence FDA's Adventitious Presence Policy EPA's Adventitious Policy Release of USDA's Precursor to APHIS 340 Regs Change USDA CFR 7 Part 340 Revision of Regulations for Agricultural Biotechnology 7 CFR Part 340 (Draft EIS and Changes to Part 340) Establishment of Reporting Requirements for Agricultural Biotechnology Revision of Regulations in Section 7 FIFRA (Federal Insecticide Fungicide and Rodenticide Act) Cellulose Biomass Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act Funding for Biotechnology Regulatory Services/USDA H.R. 5384 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations Indian Agricultural Biotechnology Regulations Sri Lanka Biotechnology Regulations EU Biotechnology Regulations China Biotechnology Regulations Mexico Biotechnology Regulations Codex Biotechnology Agenda U.S. Government Food Standards Negotiations Cartagena Biosafety Protocol Implementation of the Biosafety Protocol and Effect on Agricultural Biotechnology World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings

Tricare Retail Pharmacy H.R. 5122, S. 2767: Department of Defense Authorization

H.R. 1227, S. 306: Genetic Information Nondiscrimination Act

Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations Indian Agricultural Biotechnology Regulations Sri Lanka Biotechnology Regulations EU Biotechnology Regulations China Biotechnology Regulations Mexico Biotechnology Regulations Cartagena Biosafety Protocol Implementation of the Biosafety Protocol and Effect on Agricultural Biotechnology World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings Pharmaceutical Coverage and Pricing U.S. Korea Free Trade Agreement Intellectual Property Aspects of US Korea Free Trade Agreement Data Exclusivity Patent Linkage Intellectual Property Aspects of US Malaysia Free Trade Agreement Genetic Origin Disclosure Requirements Patenting of Plants and Animals

Orphan Drug Research H.R. 5080: Orphan Drug Tax Credit Funding for Pandemic Preparedness H.R. 5647: Labor/HHS/Education Appropriations H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act S. 3678: Pandemic and All-Hazards Preparedness Act Funding for Critical Path at FDA H.R. 5384: Agriculture and Related Agencies Appropriations Stem Cell Research H.R. 810: Stem Cell Research S. 2504: Fetus Farming Prohibition Act R&D Tax Credits H.R. 5115: U.S. Healthcare Technologies Competitiveness Act of 2006 H.R. 4082/S. 189: Biotechnology Future Investment Act of 2005 FDA Funding H.R. 5384 2008 Budget

Stem Cell Research H.R. 810: Stem Cell Research S. 2504: Fetus Farming Prohibition Act R&D Tax Credit H.R. 5115: U.S. Healthcare Technologies Competitiveness Act of 2006 Small Business Innovation Research (SBIR) Grants H.R. 2943/S 1263: Save Biotechnology Innovative Research Act of 2005 Cellulosic Ethanol Research Funding H.R. 5427: Energy and Water Appropriations Orphan Drug Research H.R. 5080: Orphan Drug Tax Credit Cellulosic Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act

H.R. 5384: Agriculture and Related Agencies Appropriation Funding for Critical Path at FDA Funding for Biotechnology Regulatory Services/USDA H.R. 5647: Labor/HHS/Education Appropriations Funding for Pandemic Preparedness H.R. 5427: Energy and Water Appropriations Funding for Cellulose Ethanol Funding H.R. 5441: FY 2007 Homeland Security Appropriations Drug Importation

Medicaid Program Rebates S.1932: Deficit Reduction Act Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Ryan White Care Act Reauthorization Covered Drugs List/ADAPs Tricare Retail Pharmacy H.R. 5122, S. 2767: Department of Defense Authorization Biodefense and Pandemic Vaccine Tracking S.3678: Pandemic & All-Hazards Preparedness Act Implementation of Deficit Reduction Act 340B Pricing S. 1932: Deficit Reduction Act

Funding for Pandemic Preparedness H.R. 5647: Labor/HHS/Education Appropriation H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense & Pandemic Biodefense Advanced R&D and Procurement Reform H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Biodefense and Pandemic Regulatory Guidance Vaccine Tracking Information Disclosure S. 3678: Pandemic and All-Hazards Preparedness Act Antitrust Exemptions H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense Information Technology to Improve Situational Awareness S.3678: Pandemic & All-Hazards Preparedness Act

Cellulosic Ethanol Funding H.R. 5427: Energy and Water Appropriations Act, 2007 Cellulose Biomass Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act

Drug Safety S:3807: Enhancing Drug Safety and Innovation Act of 2006 Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Adventitious Presence FDA's Adventitious Presence Policy EPA's Adventitious Policy Release of USDA's Precursor to APHIS 340 Regs Change USDA CFR 7 Part 340 Animal Transgenics and Cloning FDA Draft Risk Assessment on Animal Cloning

FDA's Critical Path Initiative Funding Specific Projects Follow-on Biologics H.R. 6237: Access to Lifesaving Medicines Act FDA Funding H.R. 5384 2008 Budget Drug Safety S:3807: Enhancing Drug Safety and Innovation Act of 2006 Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Prescription Drug User Fee Act Reauthorization Critical Path Drug Safety Drug Reviews Biodefense & Pandemic Biodefense Advanced R&D and Procurement Reform H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Biodefense and Pandemic Regulatory Guidance Vaccine Tracking Information Disclosure S. 3678: Pandemic and All-Hazards Preparedness Act Funding H.R. 5647: Labor/HHS/Education Appropriations H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Antitrust Exemptions H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: "Pandemic and All-Hazards Preparedness Act Biodefense Information Technology to Improve Situational Awareness S.3678: Pandemic & All-Hazards Preparedness Act Genetic Information Nondiscrimination H.R. 1227, S. 306 Ryan White Cases Act Reauthorization Covered Drugs List/ADAP Medicaid Program Rebates S. 1932: Deficit Reduction Act Implementation of Deficit Reduction Act 340B Pricing S. 1932: Deficit Reduction Act Tricare Retail Pharmacy H.R. 5122, S. 2767: Department of Defense Authorization

Animal Transgenics and Cloning FDA Draft Risk Assessment on Animal Cloning

Implementation of Deficit Reduction Act 340B Pricing S. 1932: Deficit Reduction Act Coding for Physician-Administered Biologics Ryan White Care Act Reauthorization Covered Drugs List/ADAP Medicaid Program Rebates S.1932: Deficit Reduction Act

R&D Tax Credits H.R. 5115: U.S. Healthcare Technologies Competitiveness Act of 2006 Orphan Drug Research Tax Credit H.R. 5080 Cellulose Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act Net Operating Losses H.R. 4082/S 1893: Biotechnology Future Investment Act of 2005 Biotechnology Investment Incentives H.R. 5115: US Healthcare Technologies Competitiveness Act of 2006