ms AIKEN HACKETT

CFIUS and Foreign Investment ---H.R.9102: BINSA Act ---Outbound Investment Security Program Drug Importation Drug Pricing ---CMMI: GLOBE and GUARD Models ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Reference Pricing in Drug Reimbursement ---Tariffs Foreign Drug Data Protection Laws ---Implementation of BIOSECURE Act ---Implementation of COINS Global Supply Chain Resiliency Incentives for Domestic Manufacturing Intellectual Property International Enforcement Synthetic Biotech Tariffs ---General ---Section 232 Tariffs on Pharmaceuticals and Pharmaceutical Ingredients US-China Trade Relations ---H.R.9102: BINSA Act ---Implementation of COINS

Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization

FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.10359: Priority for Pediatric Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---H.R.1414: Cameron's Law ---Expensing of R&D Expenditures Vaccines and Infectious Disease ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Senate Discussion Draft - Vaccine Injury Protection Act ---VICP

FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention (CDC) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---VICP/CICP Antimicrobial Resistance ---H.R.7352/S.4875: PASTEUR Act of 2026 Biodefense Research, Development and Procurement Issues ---Medical Countermeasure Priority Review Voucher Reauthorization CDC Reform Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China

FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---VICP/CICP Biodefense Research, Development and Procurement Issues ---H.R.1980: State Strategic Stockpile Act ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 ---Ebola BDBV Outbreak ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues

FY 2026 Appropriations for Agencies ---Dept of Interior ---Dept of Energy ---Dept of Transportation ---FDA ---USDA Avian Flu ---USDA - APHIS - Foreign Animal Disease Efforts to expand the Bio Economy & Bio Manufacturing ---Farm to Fly Act Farm Bill ---Farm Bill Reauthorization Food & Ag National Security ---China Biotechnology Regulations Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations Genetically Engineered (GE) Plants ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) United States-Mexico-Canada Agreement (USMCA) ---USMCA Review

FY 2026 Appropriations for Agencies ---ASPR ---BARDA --- Centers for Disease Control and Prevention Vaccine Programs --- Health Resources and Services Administration (HRSA) --- HHS Office of Infectious Disease and HIV/AIDS Policy --- National Institute of Health --- BARDA --- ASPR FY 2026 Appropriations for Specific Issues --- Antimicrobial Resistance (General) --- Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --- Funding for Strategic National Stockpile --- MCM PRV Reauthorization --- Reauthorization of PAHPA --- VICP --- Prescription Drug User Fee Act (PDUFA) VII Implementation --- Funding for Women's Health Research --- Pandemic Flu --- Pandemic Preparedness - R&D Funding for Medical Countermeasures Biodefense Research, Development and Procurement Issues (Non-Funding) ---BIOSECURE Act ---Risky Research Review Act ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---WHO Pandemic Preparedness Accord ---Executive Order on Achieving Efficiency Through State and Local Preparedness ---Executive Order on Withdrawing the United States from the World Health Organization ---HHS Reorganization Pandemic Preparedness --- Drug Supply Chain Management --- Monoclonal Antibody Coverage and Utilization --- Restrictions on Intellectual Property Rights --- Supply Chain Issues --- Temporarily Refundable R&D Credit --- TRIPS Waiver --- WHO Pandemic Preparedness Accord --- House GOP RFI on Supply Chain --- Medical Countermeasure Priority Review Voucher Reauthorization

FY 2026 Appropriations for Agencies --- Centers for Disease Control and Prevention --- FDA --- Health Resources and Services Administration (HRSA) --- HHS Office of Infectious Disease and HIV/AIDS Policy --- National Institute of Health --- BARDA --- ASPR FY 2026 Appropriations for Specific Issues --- Antimicrobial Resistance (General) --- Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Creating Hope Reauthorization Act --- Funding for Strategic National Stockpile --- Implementation of the Inflation Reduction Act (IRA) --- MCM PRV Reauthorization --- Reauthorization of PAHPA --- Vaccine Injury Compensation Program (VICP) --- Prescription Drug User Fee Act (PDUFA) VII Implementation --- Funding for Women's Health Research --- Pandemic Flu --- Pandemic Preparedness - R&D Funding for Medical Countermeasures Biodefense Research, Development and Procurement Issues ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---Tropical Disease Priority Review Voucher (PRV) Program ---HHS Reorganization ---Executive Order on Achieving Efficiency Through State and Local Preparedness CDC Reform Pandemic Preparedness ---MCM PRV Reauthorization

Capital Formation Incentives ---American Innovation Act ---Putting Investors First Act ---Fair Investment Opportunities for Professional Experts Act ---Accredited Investor Definition Review Act ---Helping Startups Continue to Grow Act ---American Innovation and R&D Competitiveness Act ---Small Entity Update Act ---Expanding Access to Capital Act ---American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR ---Implementation of the SBIR and STTR Extension Act

FY 2026 Appropriations for Specific Issues --- Vaccines and Infectious Diseases --- VICP Biofuels and SAF ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---Carbo Capture Utilization Parity Capital Formation Incentives ---American Innovation Act ---Helping Startups Continue to Grow Act ---American Innovation and R&D Competitiveness Act ---Small Entity Update Act ---Expanding Access to Capital Act ---Equal Opportunity for All Investors Act ---American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) ---Orphan Drug Tax Credit (Camerons Law) Pandemic Preparedness Renewable Chemicals/Bio-based Products ---Climate Issues & impact on the agriculture and food sectors Research & Development Tax Credit Reforms ---American Innovation and R&D Competitiveness Act ---American Innovation and Jobs Act ---Expensing of R&D Expenditures ---R&D Payroll Credit --- Net Operating Loss Legislation --- HR 1 One Big Beautiful Bill Act Vaccines and Infectious Disease ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Countermeasure Injury Compensation Fund Amendment Act ---VICP ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act ---VICP CICP (Discussion Draft)

CFIUS and Foreign Investment Drug Importation ---Counterfeit Drug Monitoring Drug Pricing ---Reference Pricing in Drug Reimbursement ---H.R.946: ORPHAN Cures Act ---H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act ---Most Favored Nation ---Tariffs Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations Foreign Drug Data Protection Laws ---BIOSECURE Act ---Protecting Americans Data from Foreign Adversaries Act ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain 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 Synthetic Biotech Tariffs Trade Relations --- United Nations - General --- Section 232 --- US-China Ag-Biotech Provisions --- US China IP Provisions --- World Trade Organization (WTO) - General ---Food and Ag Organization (FAO)

Avian Flu ---USDA - APHIS - Foreign Animal Disease Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations

FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---Department of Energy ---Department of Transportation ---EPA - Office of Biopesticides and Pollution Prevention Division ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health ---USDA FY 2026 Appropriations for Specific Issues --- Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement ---Biofuels, Biomass Crop Assistance, and Biorefineries ---Biotechnology and Agriculture Trade Program ---Environment and Energy R&D ---Farm Bill Programs Energy Title IX ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act ---NextGen Aircraft Technology - Fuels & Metrics ---Pandemic Preparedness ---Project Bio Shield ---Reauthorization of PAHPA ---Renewable Materials/BIO-based Products ---Vaccine Access & Compensation

FY 2026 Appropriations for Specific Issues ---Implementation of the Inflation Reduction Act of 2022 ---Renewable Chemicals/Bio-based Products Renewable Chemicals/Bio-based Products ---Biomanufacturing and Jobs Act ---Investment Tax Credit

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing Data Privacy ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes ---American Privacy Rights Act ---Bio COMPETES (Draft) ---BIOSECURE Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity in Patenting --- Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---A bill to address patent thickets ---A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---FTC Orange Book Delisting Initiative ---Interagency Patent Coordination and Improvement Act of 2025 ---Medication Affordability and Patient Integrity Act ---Orange Book Listing ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Stop STALLING Act ---Executive Order 14273: Lowering Drug Prices by Once Again Putting Americans First ---ETHIC Act Foreign Drug Data Protection Law ---Bio COMPETES (Draft) ---BIOSECURE Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Intellectual Property Enforcement ---China Patent Reform ---Interagency Patent Coordination and Improvement Act ---Patent Eligibility Restoration Act (PERA) ---Patent Litigation Reform ---Prohibiting Adversarial Patents Act (PAPA) ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Patenting of Biological Inventions ---Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord

FY 2026 Appropriations for Specific Issues ---Agricultural Biorefinery Innovation and Opportunity Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---AMMTO ---BETA ---Biofuels and SAF ---Biofuels, Biomass Crop Assistance, and Biorefineries ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Biofuels and SAF ---Farm to Fly Act ---Incentives for Sustainable Aviation Fuels ---IRA Tax Credits ---Sustainable Aviation Fuels Tax Credit Biomass Programs ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries ---Agricultural Biorefinery Innovation and Opportunity ---Climate Issues & impact on the agriculture and food sectors

Efforts to expand the Bio Economy & Bio Manufacturing ---Farm to Fly Act Farm Bill ---Farm Bill Reauthorization Food & Ag National Security ---China Biotechnology Regulations Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations Genetically Engineered (GE) Plants ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) Issues Relating to Medical Research and Animal Testing Models United States-Mexico-Canada Agreement (USMCA) ---USMCA Review

FY 2026 Appropriations for Specific Issues ---Agricultural Biorefinery Innovation and Opportunity Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---AMMTO ---BETA ---Biofuels and SAF ---Biofuels, Biomass Crop Assistance, and Biorefineries ---Climate Change ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Biofuels and SAF ---Farm to Fly Act ---Incentives for Sustainable Aviation Fuels ---IRA Tax Credits ---Sustainable Aviation Fuels Tax Credit Biomass Programs ---Climate Issues & impact on the agriculture and food sectors Biorefineries ---Agricultural Biorefinery Innovation and Opportunity Act ---Climate Issues & impact on the agriculture and food sectors

FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health ---BARDA FY 2026 Appropriations for Specific Issues --- Alternative Funding Programs --- Antimicrobial Resistance (General) --- Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --- CICP --- Creating Hope Reauthorization Act --- Drug Pricing --- Funding for Strategic National Stockpile --- Funding for Women's Health Research --- Implementation of the Inflation Reduction Act (IRA) --- Influenza Planning & Response --- MCM PRV Reauthorization --- Pandemic Preparedness - R&D Funding for Medical Countermeasures --- PPRV --- Prescription Drug User Fee Act (PDUFA) VII Implementation --- Project Bioshield --- Reauthorization of PAHPA --- Vaccines and Infectious Diseases --- Vaccine Injury Compensation Program --- Section 317 Immunization Program 340B Drug Discount Program --- 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues ---Bio COMPETES (Draft) ---Biodefense ---BIOSECURE Act ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act ---Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---MCM PRV Program Reauthorization --- NDAA --- Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) --- Risky Research Review Act --- Tropical Disease Priority Review Voucher (PRV) Program --- VICP Loopholes --- WHO Pandemic Preparedness Accord Biosimilars ---Bio COMPETES (Draft) ---Biosimilar Copay ---Biosimilar Red Tape Elimination Act ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act Climate Change Data Privacy ---American Privacy Rights Act ---Bio COMPETES (Draft) ---BIOSECURE Act ---Clinical Trial Data in China ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA ---FDA Reform Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounding & Counterfeit Medicines Drug Patenting ---A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Medication Affordability and Patient Integrity Act ---Patent Thickets ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Restrictions on Intellectual Property Rights ---Stop STALLING Act Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act --- S.2082 Stronger Patents Act --- Access to Innovative Treatments Act --- Affordable Prescriptions for Patients Act --- Biosimilar Red Tape Elimination Act --- CMMI Authority --- COVID-19 Pricing-Related Provisions --- DRUG Act --- Ensuring Timely Access to Generics --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Inflation Reduction Act (IRA) --- Increasing Transparency in Generic Drug Application --- Interagency Patent Coordination and Improvement Act --- Lowering Drug Costs for American Families Act --- Mandating Exclusive Review of Individual Treatments (MERIT) Act --- Medicare Drug Price Negotiation Act --- Medicare Negotiation and Competitive Licensing Act --- Modernizing and Ensuring PBM Accountability (MEPA) Act --- Most Favored Nation --- National Coverage Determination --- Patient Cost-Sharing and Implementation --- PBM Reform --- Pharmacy Benefit Manager Transparency Act --- Prescription Drug Price Relief Act --- Prescription Pricing for the People Act --- Preserve Access to Affordable Generics and Biosimilars Act --- Protecting Patient Access to Cancer and Therapies --- Stop STALLING Act --- Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---BIOSECURE Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Generic Drug Entry --- Stop STALLING Act Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design --- Modernizing and Ensuring PBM Accountability (MEPA) Act ---Pharmacy Benefit Manager Transparency Act of 2025 ---Pricing and Rebates --- The Medicaid VBPs for Patients (MVP) Act ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 National Security ---American Privacy Rights Act ---BIOSECURE Act ---Clinical Trial Data in China --- Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics ---SUPPORT Act Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---H.R.1262: Give Kids a Chance Act ---S. 946 ORPHAN Cures Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Innovation in Pediatric Drugs Act of 2023 ---Pediatric Priority Review Voucher Program ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Rare Disease Pilot Program Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain --- Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Medical Countermeasures PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---Project Bio Shield ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products --- HR 3375 Fair Prescription Drug Prices for Americans Act --- HR 3493 Global Fairness in Drug Pricing Act --- S.1587 Fair Prescription Drug Prices for Americans Act --- S.1818 Prescription Drug Price Relief Act ---CMMI Authority --- End Price Gauging for Medications Act ---HELP Copays Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Lower Costs, More Transparency Act ---Lowering Drug Costs for American Families Act --- Mandating Exclusive Review of Individual Treatments (MERIT) Act --- Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing --- Prescription Drug Price Relief Act ---Protected Classes --- SAFE STEP Act --- SMART Prices Act --- Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations --- The Medicaid VBPs for Patients (MVP) Act ---Value-based Contracting and Communications --- Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases --- Access to Innovative Treatments Act ---Adult Immunization --- Antimicrobial Resistance (General) ---CICP - General --- Countermeasure Injury Compensation Fund Amendment Act --- Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act --- Let Injured Americans Be Legally Empowered (LIABLE) Act --- Maternal Immunization ---MCM Manufacturing & Capacity --- MCM R&D Incentives --- Monoclonal Antibody Coverage and Utilization --- National Coverage Determination --- SAFE STEP Act --- Vaccine Access Improvement Act --- Vaccine and Antimicrobial Resistance Product Development and Incentives --- Vaccine Injury Compensation Modernization Act --- Vaccine Injury Compensation Program --- Vaccine Quality Measure --- Vaccine Safety --- Vaccine Safety Net and Vaccine Infrastructure --- Value of Vaccines and Vaccine Confidence --- VICP CICP (Discussion Draft) ---HR 3701 Family Vaccine Protection Act

Avian Flu Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Climate Issues & impact on the agriculture and food sectors ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products

Biodefense Research, Development and Procurement Issues (Non-Funding) ---To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---Tropical Disease Priority Review Voucher (PRV) Program ---HHS Reorganization ---Executive Order on Achieving Efficiency Through State and Local Preparedness Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---FY 2026 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Womens Health Research Pandemic Preparedness ---R&D Funding for Medical Countermeasures ---MCM PRV

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement ---General Cell & Gene Therapy ---H.R.1672 MINI Act Climate Change ---FY 2025 Appropriations ---FY 2026 Appropriations Clinical Trial Data in China Data Privacy ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Data Privacy ---General Diversity & Inclusion ---Decentralized Clinical Trials ---Clinical Trial Diversity ---General Drug Evaluation and Review ---Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounded Medicines Drug Patenting ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act of 2025 ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---FY 2026 Appropriations ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---H.R.946: ORPHAN Cures Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---PBN Reform ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.526: Prescription Pricing for the People Act of 2025 ---S.527: Pharmacy Benefit Manager Transparency Act of 2025 ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1095: Stop STALLING Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act ---International Reference Pricing Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations International Reference Pricing Issues Relating to Medical Research and Animal Testing Models Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---H.R.1262: Give Kids A Chance Act ---S.705: Innovation and Pediatric Drugs Act of 2025 ---Pediatric Priority Review Voucher Program Reauthorization ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---General Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864: HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2025 Appropriations ---FY 2026 Appropriations ---Adult Immunization ---Countermeasures Injury Compensation Program ---Vaccine Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence ---VICP Loopholes

Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---American Innovation Act ---Putting Investors First Act ---Fair Investment Opportunities for Professional Experts Act ---Accredited Investor Definition Review Act ---To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---Helping Startups Continue to Grow Act ---American Innovation and R&D Competitiveness Act ---Small Entity Update Act ---Equal Opportunity for All Investors Act ---Expanding Access to Capital Act ---Infectious Disease Therapies Research and Innovation Act ---American Innovation and Jobs Act ---Adjusting the well-known seasoned issuers definition to allow for a larger financing round using ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Net Operating Loss Advance Refunds ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---JOBS Act 4.0 ---Market Liquidity Proposals ---Public Float Threshold Update ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Reform of SEC Regulation D ---Accredited Investor Certification Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR ---Implementation of the SBIR and STTR Extension Act of 2022

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---American Innovation Act ---Helping Startups Continue to Grow Act ---American Innovation and R&D Competitiveness Act ---Small Entity Update Act ---Expanding Access to Capital Act ---Equal Opportunity for All Investors Act ---Infectious Disease Therapies Research and Innovation Act ---Adjusting the well-known seasoned issues definition to allow for a larger financing round using ---American Innovation and Jobs Act ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Orphan Drug Issues ---Orphan Drug Tax Credit (Camerons Law) ---General Pandemic Preparedness Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Research & Development Tax Credit Reforms ---American Innovation and R&D Competitiveness Act ---Tax Relief for American Families and Workers Act ---American Innovation and Jobs Act ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2025 Appropriations ---FY 2026 Appropriations ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act ---VICP ---CICP

CFIUS and Foreign Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Foreign Drug Data Protection Laws ---BIOSECURE Act ---Protecting Americans Data from Foreign Adversaries Act ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Global Supply Chain Resiliency ---B5 Coalition on Supply Chain Resiliency ---Issues Relating to Non-Human Primate Shortages Intellectual Property International Enforcement ---China S.2115/H.R.4307 - Medical Supply Chain Resiliency Act Synthetic Biotech Pharmaceutical and Ag Biotech Tariffs US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver

Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---FY 2026 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---FY 2026 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---FY 2026 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Material/Bio-based Products ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---FY 2025 Appropriations ---FY 2026 Appropriations Pandemic Preparedness --- Implementation of the Inflation Reduction Act of 2022 Funding for Department of Energy ---Bioenergy Technology Office ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for Department of Transportation ---Environmental Energy R&D ---NextGen Aircraft Technology - Fuels & Metrics ---FY 2025 Appropriations ---FY 2026 Appropriations

Funding for Renewable Materials/Bio-based Products ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Biomanufacturing and Jobs Act ---Investment Tax Credit

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI-Aided inventions Bayh-Dole Act/Tech Transfer ---Invent Here, Make Here Act of 2023 (Baldwin) ---Bayh-Dole Act ---March-In Rights ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy Issues ---BIOSECURE Act ---American Privacy Rights Act ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity in Patenting --- Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Affordable Prescriptions for Patients Act ---A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Medication Affordability and Patient Integrity Act ---A bill to address patent thickets ---A Bill to Amend the FTC Act to Prohibit Product Hopping ---A Bill to Amend U.S.C. Title 35 to Address Infringements of Patents Claiming Biological Products ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act ---Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---BIOSECURE Act ---Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Intellectual Property Enforcement ---China Patent Reform ---Prohibiting Adversarial Patents Act (PAPA) ---Interagency Patent Coordination and Improvement Act ---Patent Eligibility Restoration Act (PERA) ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform ---The USPTO Request for Comments: Experimental Use Defense 89 Fed. Reg 53963 Patenting of Biological Inventions ---Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization ---RESTORE Patent Rights Act World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver

Biofuels and SAF (Non-Funding) ---FY 2025 Appropriations ---FY 2026 Appropriations ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---IRA Tax Credits ---S.144/H.R.1719 Farm to Fly Act Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Biorefineries (Non-Funding) ---Agricultural Biorefinery Innovation and Opportunity ---Climate Issues & impact on the agriculture and food sectors Climate Change ---FY 2025 Appropriations ---FY 2026 Appropriations ---Climate Issues & impact on the agriculture and food sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agricultural Biorefinery Innovation and Opportunity Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture and food sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products Pharmaceutical and Ag Biotech Tariffs

Biofuels and SAF (Non-Funding) ---FY 2025 Appropriations ---FY 2026 Appropriations ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---IRA Tax Credits ---S.144/H.R.1719 Farm to Fly Act Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Biorefineries (Non-Funding) ---Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture and food sectors Climate Change ---FY 2025 Appropriations ---FY 2026 Appropriations ---Climate Issues & impact on the agriculture and food sectors ---Mitigating Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agricultural Biorefinery Innovation and Opportunity Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture and food sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.854 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---American Pandemic Preparedness Plan (AP3) ---MCM PRV Program Reauthorization ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---CICP ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy ---H.R.1672: MINI Act Climate Change ---FY 2025 Appropriations ---FY 2026 Appropriations Data Privacy ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Data Privacy ---Clinical Trial Data in China Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Clinical Trial Diversity Drug Evaluation and Review ---Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounded Medicines ---House GOP RFI on Supply Chain Drug Patenting ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act of 2025 ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---FY 2026 Appropriations ---ORPHAN Cures Act ---Maintaining Investments and New Innovation (MINI) Act ---Ensuring Pathways to Innovative Cures (EPIC) Act ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act of 2025 ---Pharmacy Benefit Manager Transparency Act of 2025 ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---VICP ---CICP Funding for FDA ---FY 2025 Appropriations ---FY 2026 Appropriations ---User Fees Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---FY 2026 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research International Reference Pricing Medicaid ---Pharmacy Benefit Manager Transparency Act of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1262: Give Kids a Chance Act ---H.R.946: ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord ---Medical Countermeasures PRV Reauthorization Pharmaceutical and Ag Biotech Tariffs Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864: HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2025 Appropriations ---FY 2026 Appropriations ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence ---VICP Loopholes

Biodefense Research, Development and Procurement Issues (Non-Funding) ---State Strategic Stockpile Act ---To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---BIOSECURE Act ---Risky Research Review Act ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord ---Executive Order on Achieving Efficiency Through State and Local Preparedness ---Executive Order on Withdrawing the United States from the World Health Organization ---HHS Reorganization ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patent eligibility for inventions created using AI tools Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy Issues ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability and Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---H.R.5475: Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---H.R.6275: Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Intellectual Property Enforcement ---China ---TRIPS Waiver Patent Reform ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform ---The USPTO Request for Comments: Experimental Use Defense 89 Fed.Reg 53963 Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

CFIUS and Foreign Investment ---Outbound Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Global Supply Chain Resiliency ---B5 Coalition on Supply Chain Resiliency Synthetic Biotech US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act, American Pandemic Preparedness Plan (AP3) ---S.4667: Risky Research Review Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Bio COMPETES (Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---Viral Gain of Function Research Moratorium Act ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for National Institutes of Health ---Advanced Research Projects Agency for Health (ARPA-H) ---Womens Health Research Pandemic Preparedness ---MCM PRV ---R&D Funding for Medical Countermeasures

Biofuels (Non-Funding) ---H.R.10033: Expanding Clean Fuel Production Act of 2024 ---H.R.10104: Second Generation Biofuel Producer Credit Extension Act of 2024 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Orphan Drug Issues Pandemic Preparedness Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures ---NOL ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit

Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022

Avian Flu Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.7085 - BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Gain of Function Research Definition ---Gene Editing ---House GOP RFI on Supply Chain ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Avian Flu Efforts to expand the Bio Economy & Bio Manufacturing Farm Bill ---Farm Bill Reauthorization Food & Ag National Security ---China Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Funding for the USDA ---FY 2025 Appropriations Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products 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 Regulations for Gene Edited Products Interagency Coordination Synthetic Biotech United States-Mexico-Canada Agreement (USMCA) ---H.R.1435: Raising Concern About the Proposed Constitutional Reforms in Mexico ---Implementation of USMCA

Biofuels (Non-Funding) ---H.R.10033: Expanding Clean Fuel Production Act of 2024 ---H.R.10104: Second Generation Biofuel Producer Credit Extension Act of 2024 ---FY 2025 Appropriations ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture and food sectors Climate Change ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture and food sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Biofuels (Non-Funding) ---H.R.10033: Expanding Clean Fuel Production Act of 2024 ---H.R.10104: Second Generation Biofuel Producer Credit Extension Act of 2024 Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture and food sectors Climate Change ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture and food sectors ---Mitigating Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture and food sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S. 4667 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433 - Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---S.2452/H.R.5134: Biomanufacturing and Jobs Act ---Investment Tax Credit

Biofuels (Non-Funding) ---FY 2025 Appropriations ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture and food sectors Climate Change ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture and food sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---S.2987/H.R.6413 - Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture and food sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---S.2780 - Medication Affordability and Patent Integrity Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Creating Hope Reauthorization Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022 Pandemic Preparedness --- Implementation of the Inflation Reduction Act of 2022

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.2780 - Medication Affordability and Patent Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Biodefense Research, Development and Procurement Issues (Non-Funding) --- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate --- H.R.3832: Disease X Act of 2023 --- H.R. 3837: Improving Public Health Preparedness Act --- H.R. 3840: Ensuring Sufficient Supply of Testing Act, American Pandemic Preparedness Plan (AP3) ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Bio COMPETES (Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---SAFE Risky Research Act ---Tropical Disease Priority Review Voucher (PRV) Program ---Viral Gain of Function Research Moratorium Act ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Womens Health Research Pandemic Preparedness ---MCM PRV ---R&D Funding for Medical Countermeasures

Avian Flu Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Climate Issues & impact on the agriculture and food sectors ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---S.1956 Invent Here, Make Here Act of 2023 (Baldwin) ---Bayh-Dole Act ---March-In Rights ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy Issues ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 - Medication Affordability and Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---H.R.5475 Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---H.R. 6275 Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Intellectual Property Enforcement ---China ---TRIPS Waiver Patent Reform ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform ---The USPTO Request for Comments: Experimental Use Defense 89 Fed.Reg 53963 Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3631: State Strategic Stockpile Act of 2023 --- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.7085 - BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Gain of Function Research Definition ---Gene Editing ---House GOP RFI on Supply Chain ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Avian Flu Climate Change ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture and food sectors Efforts to expand the Bio Economy & Bio Manufacturing Farm Bill ---Farm Bill Reauthorization Food & Ag National Security --- S.4420/H.R.8522 - Agriculture and National Security Act Foreign Agricultural Biotechnology Laws and Regulations ---H.R.5790/S.2992: Prioritizing Offensive Agricultural Disputes and Enforcement Act ---China Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Funding for the USDA ---FY 2025 Appropriations Genetically Engineered (GE) Animals ---Climate Issues & impact on the agriculture and food sectors ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products ---USDA Proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture and food sectors ---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 Regulations for Gene Edited Products Interagency Coordination --- H.R.8538/S.4428 - Biotechnology Oversight Coordination Act --- H.R.8613 - The NSF and USDA Interagency Research Act Synthetic Biotech --- S.4413 - Synthetic Biology Advancement Act USDA/APHIS Agricultural Biotechnology Regulations --- H.R.1472/S.802: Plant Biostimulant Act --- H.R.8539/S.4421- Agricultural Biotechnology Coordination Act --- Regulatory Treatment of Gene Edited Products --- USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---H.R. 9562 Adjusting the well-known seasoned issues definition to allow for a larger financing round using ---S.866: American Innovation and Jobs Act ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Orphan Drug Issues Pandemic Preparedness Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures ---NOL ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products ---USDA proposed Regulation of genetically engineered animals

CFIUS and Foreign Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Global Supply Chain Resiliency ---B5 Coalition on Supply Chain Resiliency ---Issues Relating to Non-Human Primate Shortages Intellectual Property International Enforcement ---China Synthetic Biotech US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver

Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022 Pandemic Preparedness --- Implementation of the Inflation Reduction Act of 2022

Avian Flu Climate Change ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture and food sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy Farm Bill ---Farm Bill Reauthorization Food & Ag National Security --- S.4420/H.R.8522 - Agriculture and National Security Act Foreign Agricultural Biotechnology Laws and Regulations ---H.R.5790/S.2992: Prioritizing Offensive Agricultural Disputes and Enforcement Act ---China Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn ---South Korea Living Modified Organisms Funding for the USDA ---FY 2025 Appropriations Genetically Engineered (GE) Animals ---Climate Issues & impact on the agriculture and food sectors ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products ---USDA Proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture and food sectors ---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 Regulations for Gene Edited Products Interagency Coordination --- H.R.8538/S.4428 - Biotechnology Oversight Coordination Act --- H.R.8613 - The NSF and USDA Interagency Research Act Synthetic Biotech --- S.4413 - Synthetic Biology Advancement Act USDA/APHIS Agricultural Biotechnology Regulations --- H.R.1472/S.802: Plant Biostimulant Act --- H.R.8539/S.4421- Agricultural Biotechnology Coordination Act --- Regulatory Treatment of Gene Edited Products --- USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA

Biofuels (Non-Funding) ---FY 2025 Appropriations ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture and food sectors ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture and food sectors Climate Change ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture and food sectors ---Mitigating Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---S.2987/H.R.6413 - Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture and food sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Biofuels (Non-Funding) ---FY 2025 Appropriations ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture and food sectors ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture and food sectors Climate Change ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture and food sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---S.2987/H.R.6413 - Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture and food sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Avian Flu Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Climate Issues & impact on the agriculture and food sectors ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products ---USDA proposed Regulation of genetically engineered animals

CFIUS and Foreign Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Global Supply Chain Resiliency ---B5 Coalition on Supply Chain Resiliency ---Issues Relating to Non-Human Primate Shortages Intellectual Property International Enforcement ---China Synthetic Biotech United Nations ---Intergovernmental Conference on the Law of the Sea and Marine Genetic Biodiversity (BBNJ) US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---13th Ministerial Conference ---TRIPS Waiver

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---S.1956 Invent Here, Make Here Act of 2023 (Baldwin) ---Bayh-Dole Act ---March-In Rights ---Reasonable Pricing Clause ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights Compulsory Licensing Data Privacy Issues ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2024 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 - Medication Affordability and Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---H.R.5475 Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---H.R. 6275 Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Intellectual Property Enforcement ---China ---TRIPS Waiver Patent Reform ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---13th Ministerial Conference ---TRIPS Waiver

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---S.2452/H.R.5134: Biomanufacturing and Jobs Act ---H.R.6532 - Renewable Chemicals Act of 2023 ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Investment Tax Credit

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3631: State Strategic Stockpile Act of 2023 --- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R. 3837: Improving Public Health Preparedness Act ---H.R. 3840: Ensuring Sufficient Supply of Testing Act ---H.R.7085 - BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Gain of Function Research Definition ---Gene Editing --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---H.R.9562 Adjusting the well known seasoned issuers definition to allow for a larger financing round using ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Net Operating Loss Advance Refunds ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---JOBS Act 4.0 ---Market Liquidity Proposals ---Public Float Threshold Update ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Reform of SEC Regulation D ---Accredited Investor Certification Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR ---Implementation of the SBIR and STTR Extension Act of 2022

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---H.R. 9562 Adjusting the well-known seasoned issues definition to allow for a larger financing round using ---S.866: American Innovation and Jobs Act ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Orphan Drug Issues Pandemic Preparedness Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures ---NOL ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Market Liquidity Proposals ---Public Float Threshold Update ---SEC Small Business Forum Reform of SEC Regulation D ---Accredited Investor Certification Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR

Antibiotic Use in Livestock --- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2630/S.652: SAFE STEP Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---S.2452/H.R.5134: Biomanufacturing and Jobs Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Investment Tax Credit ---Production Tax Credit

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---H.R.5790/S.2992: Prioritizing Offensive Agricultural Disputes and Enforcement Act ---China Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---South Korea Living Modified Organisms Funding for the USDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---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 Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Synthetic Biotech USDA/APHIS Agricultural Biotechnology Regulations --- H.R.1472/S.802: Plant Biostimulant Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---Regulatory Treatment of Gene Edited Products

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Coronavirus (COVID-19) Pandemic Orphan Drug Issues Qualified Small Business Stock (QSBS) Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Biofuels (Non-Funding) ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Biofuels (Non-Funding) ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern 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 ---TRIPS Waiver United Nations ---Intergovernmental Conference on the Law of the Sea and Marine Genetic Biodiversity (BBNJ) US-China Trade Agreement ---Ag-Biotech Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Intergovernmental Committee on IP and Genetic Resources World Trade Organization (WTO) ---13th Ministerial Conference ---TRIPS Waiver

Antitrust Legislation Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---Reasonable Pricing Clause ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights Compulsory Licensing ---28 USC 1498 Government Use of Patents ---Prescription Drug Price Relief Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Intellectual Property Enforcement ---TRIPS Waiver Patent Reform ---H.R.3535: Advancing Americas Interest Act ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---S.4417: Patent Trial and Appeal Board Reform Act of 2022 ---Patent Litigation Reform Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization ---PTO Examination Guidelines United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Intergovernmental Committee on IP and Genetic Resources World Trade Organization (WTO) ---13th Ministerial Conference ---TRIPS Waiver

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---FY 2025 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act

Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---S.2452/H.R.5134: Biomanufacturing and Jobs Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Investment Tax Credit ---Production Tax Credit

Biofuels (Non-Funding) ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Antibiotic Use in Livestock --- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---H.R.5790/S.2992: Prioritizing Offensive Agricultural Disputes and Enforcement Act ---China Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---South Korea Living Modified Organisms Funding for the USDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---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 Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Synthetic Biotech USDA/APHIS Agricultural Biotechnology Regulations --- H.R.1472/S.802: Plant Biostimulant Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---Regulatory Treatment of Gene Edited Products

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---FY 2025 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Coronavirus (COVID-19) Pandemic Orphan Drug Issues Qualified Small Business Stock (QSBS) Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act ---S.866: American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Market Liquidity Proposals ---Public Float Threshold Update ---SEC Small Business Forum Reform of SEC Regulation D ---Accredited Investor Certification Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2630/S.652: SAFE STEP Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence

Biofuels (Non-Funding) ---H.R.5235: Farms to Fuselage Act ---H.R.6271/S.3637: Farm to Fly Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2024 Appropriations ---FY 2025 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulation for Gene Edited Products ---Labeling Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0

Antitrust Legislation Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---Reasonable Pricing Clause ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights Compulsory Licensing ---28 USC 1498 Government Use of Patents ---Prescription Drug Price Relief Act (Discussion Draft) Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Intellectual Property Enforcement ---TRIPS Waiver Patent Reform ---H.R.3535: Advancing Americas Interest Act ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---S.4417: Patent Trial and Appeal Board Reform Act of 2022 ---Patent Litigation Reform Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization ---PTO Examination Guidelines United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Intergovernmental Committee on IP and Genetic Resources World Trade Organization (WTO) ---13th Ministerial Conference ---TRIPS Waiver

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---Pandemic Preparedness Plan ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---National Defense Authorization Act for FY 2024 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for National Institutes of Health ---FY 2024 Appropriations

Biofuels (Non-Funding) ---FY 2024 Appropriations ---H.R.5235: Farms to Fuselage Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---S.2452/H.R.5134: Biomanufacturing and Jobs Act 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 2024 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

Antitrust Legislation ---General Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---Reasonable Pricing Clause ---NIST RFI Compulsory Licensing ---General Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---American Data Privacy and Protection Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---Restrictions on Intellectual Property Rights ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights ---Draft Double Patenting bill ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---CLEAR Patents Act ---H.R.6275: Protecting Consumer Access to Generic Drugs Act of 2023 ---S.3583/H.R.6986 - 118th Cong. A bill to address patent thickets Intellectual Property Enforcement ---TRIPS Waiver ---China Inter Partes Review ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (Discussion Draft) Patent Reform ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---Patent Litigation Reform ---Patent Trial and Appeal Board Reform Act Patenting of Biological Inventions ---Section 101 Modernization ---PTO Examination Guidelines United States-Mexico-Canada Agreement (USMCA) US-China Trade Agreement

Antibiotic Use in Livestock Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---FDA Approvals, Guidance, & Regulations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Revised EIS on Genetically Engineered Salmon ---Labeling Issues Relating to Medical Research and Animal Testing Models

Coronavirus (COVID-19) Pandemic ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations --- H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---MCM PRV Extension Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2024 Appropriations Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R. 3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---Gene Editing ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---S.866: American Innovation and Jobs Act ---H.R.2673: American Innovation and R&D Competitiveness 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---JOBS Act 4.0 ---Net Operating Loss Advance Refunds Orphan Drug Issues Qualified Small Business Stock (QSBS) Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures ---House - Section 174 Amortization ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---H.R. 5142: Vaccine Injury Compensation Modernization Act ---H.R. 5143: Vaccine Access Improvement Act ---VICP CICP (Discussion Draft)

Funding for Renewable Chemicals/Bio-based Products ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---S.2452/H.R.5134: Biomanufacturing and Jobs Act

Antibiotic Use in Livestock Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---FDA Approvals, Guidance, & Regulations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Revised EIS on Genetically Engineered Salmon ---Labeling Issues Relating to Medical Research and Animal Testing Models

Biofuels (Non-Funding) ---FY 2024 Appropriations ---H.R.5235: Farms to Fuselage Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---S.2452/H.R.5134: Biomanufacturing and Jobs Act 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 2024 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction At (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Patient Cost-Sharing and Smoothing Data Privacy ---General Drug Pricing ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.1067: Ensuring Timely Access to Generics of 2023 ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Coverage Determination ---H.R.5547/S.476: Maintaining Investments in New Innovation (MINI) Act ---H.R.4531: Support for Patients and Communities Reauthorization Act ---H.R.5539: ORPHAN Cures Act Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Medicaid Drug Rebate Program Rule (MDRP) ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.2630/S.652: Safe Step Act ---H.R.5378: Lower Costs, More Transparency Act ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure

Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Revised NOM-187 to the WTO ---South Korea Living Modified Organisms Funding for the USDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Antibiotic Use in Livestock Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---FDA Approvals, Guidance, & Regulations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---FDA Revised EIS on Genetically Engineered Salmon ---Labeling Issues Relating to Medical Research and Animal Testing Models Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---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 Synthetic Biotech USDA/APHIS Agricultural Biotechnology Regulations --- H.R.1472/S.802: Plant Biostimulant Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---Regulatory Treatment of Gene Edited Products

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.7024: Tax Relief for American Families and Workers Act of 2024 ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---S.866: American Innovation and Jobs Act ---H.R.2673: American Innovation and R&D Competitiveness 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---JOBS Act 4.0 ---Net Operating Loss Advance Refunds Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---JOBS Act 4.0 ---Market Liquidity Proposals ---SEC Small Business Forum Mergers and Acquisitions Proxy Advisory Services Reform of SEC Regulation D Sarbanes Oxley Section 404 (b) Small Business Innovation Research (SBIR) Program ---Implementation of SBIR and STTR Extension Act of 2022

Biofuels (Non-Funding) ---FY 2024 Appropriations ---H.R.5235: Farms to Fuselage Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---S.2452/H.R.5134: Biomanufacturing and Jobs Act 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 2024 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech ---Mexico Revised NOM-187 to the WTO ---South Korea Living Modified Organisms Funding for the USDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering ---Implementation of GE Salmon language in Consolidated Appropriations Act for FY 2021 ---Labeling Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture, food, and forestry sectors ---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 Synthetic Biotech USDA/APHIS Agricultural Biotechnology Regulations --- H.R.1472/S.802: Plant Biostimulant Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---Regulatory Treatment of Gene Edited Products

Antitrust Legislation ---General ---FTC Oversight ---FTC Merger Guidelines ---FTC Hart Scott Rodino revised form Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---Reasonable Pricing Clause Compulsory Licensing ---General Coronavirus (COVID-19) Pandemic --- H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---American Data Privacy and Protection Act ---General ---RFI Drug Patenting ---AI ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---Affordable Prescriptions for Patients Act ---CLEAR Patents Act ---Protecting Consumer Access to Generic Drugs Act ---Restrictions on Intellectual Property Rights ---Draft Double Patenting bill Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---Patent Eligibility Restoration Act of 2023 ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (Discussion Draft) Patent Reform ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 Patenting of Biological Inventions ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) US-China Trade Agreement

CFIUS and Foreign Investment Drug Importation Drug Pricing Foreign Agricultural Biotechnology Laws and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Intellectual Property International Enforcement ---China ---General Patent Reform ---TRIPS Waiver Issues Relating to Non-Human Primate Shortages United Nations US-China Trade Agreement ---Ag-Biotech Provisions World Health Organization (WHO) ---TRIPS Waiver ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Intergovernmental Committee on IP and Genetic Resources World Trade Organization (WTO) ---TRIPS Waiver ---MC-12 Meeting

340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---Patient Cost-Sharing and Smoothing Data Privacy ---General Drug Pricing ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.133:Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.1067: Ensuring Timely Access to Generics of 2023 ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Coverage Determination Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Medicaid Drug Rebate Program Rule (MDRP) ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.2630/S.652: Stage Step Act ---H.R.5378: Lower Costs, More Transparency Act ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.368: American Innovation Act of 2023 ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---S.866: American Innovation and Jobs 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---JOBS Act 4.0 ---Net Operating Loss Advance Refunds Coronavirus (COVID-19) Pandemic Orphan Drug Issues Qualified Small Business Stock (QSBS) Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---S.866: American Innovation and Jobs Act ---Expensing of R&D Expenditures ---House - Section 174 Amortization ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---H.R. 5142: Vaccine Injury Compensation Modernization Act ---H.R. 5143: Vaccine Access Improvement Act ---VICP CICP (Discussion Draft)

Antibiotic Use in Livestock --- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter". Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Labeling ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---FDA Revised EIS on Genetically Engineered Salmon ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Funding for Renewable Chemicals/Bio-based Products ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---S.2452/H.R.5134: Biomanufacturing and Jobs Act

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---Pandemic Preparedness Plan ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---National Defense Authorization Act for FY 2024 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for National Institutes of Health ---FY 2024 Appropriations

Coronavirus (COVID-19) Pandemic ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---MCM PRV Extension Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2024 Appropriations Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX House Budget RFI

Antibiotic Use in Livestock --- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter". Genetically Engineered (GE) Animals ---ADUFA & AGDUFA ---Labeling ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---FDA Revised EIS on Genetically Engineered Salmon ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R. 3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---Gene Editing ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)

Biofuels (Non-Funding) ---FY 2024 Appropriations ---H.R.5235: Farms to Fuselage Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---S.2452/H.R.5134: Biomanufacturing and Jobs Act 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 2024 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight ---340B Accountability Act ---General ---H.R.2534: PROTECT 340B Act of 2023 ---RFI Accelerated Approval --- H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs ---General Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Biosimilars ---S.2305: Biosimilar Red Tape Elimination Act ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Interchangeability and Pharmacy Substitution ---Reimbursement ---Ensuring Access to Lower-Cost Medicines for Seniors Act Coronavirus (COVID-19) Pandemic ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Healthcare Disparities ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---General Drug Importation ---General Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---AI ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---Restrictions on Intellectual Property Rights ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---CLEAR Patents Act ---Protecting Consumer Access to Generic Drugs Act ---Restrictions on Intellectual Property Rights ---Draft Double Patenting bill Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---H.R.5378: Lower Costs, More Transparency Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2024 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for 2020 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---Enhanced Access to Affordable Medicines Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Medicaid Drug Rebate Program Rule ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Coverage and Reimbursement ---Non-Opioid Analgesics ---FDA Reforms ---NIH Research Orphan Drug Issues ---H.R.5539: ORPHAN Cures Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Precision Medicine Initiative Rare Pediatric Disease Priority Review ---General Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5378: Lower Costs, More Transparency Act ---S.2327: Seniors Prescription Drug Relief Act ---S.652/H.R.2630: Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---Lower Costs, More Cures Act ---National Coverage Determination ---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 ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter". Genetically Engineered (GE) Animals ---ADUFA Issues Relating to Non-Human Primate Shortages

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---S.866: American Innovation and Jobs 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Infectious Disease Therapies Research and Innovation Act (Discussion Draft) ---Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act (Discussion Draft) ---JOBS Act 4.0 ---Net Operating Loss Advance Refunds Capital Market Enhancements ---Accredited Investor Definition ---JOBS Act 4.0 ---SEC Small Business Forum Mergers and Acquisitions Pandemic Preparedness ---Temporarily Refundable R&D Credit Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption

H.R. 2811: Limit, Save, Grow Act of 2023 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---National Vaccine Injury Compensation Program (VICP) Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Pandemic Preparedness ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act

Biofuels (Non-Funding) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Biomass Programs (Non-Funding) Biorefineries (Non-Funding) Climate Change Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

Climate Change ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn Funding for the USDA ---FY 2024 Appropriations Genetically Engineered (GE) Animals ---ADUFA ---Farm Bill Reauthorization Genetically Engineered (GE) Plants ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) USDA/APHIS Agricultural Biotechnology Regulations ---H.R.1472/S.802: Plant Biostimulant Act ---Farm Bill Reauthorization

340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Pandemic Preparedness ---COVID-19 Pricing-Related Provisions ---In-Home Administration of Part B Drugs ---Seniors Prescription Drug Relief Act (Discussion Draft) Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---National Coverage Determination ---Prescription Drug Price Relief Act (Discussion Draft) Medicaid ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act (Discussion Draft) ---Medicaid VBPs for Patients (MVP) Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.652/H.R.2630: Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Part B Physician-Administered Products ---Medicare Prescription Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---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 ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---DISARM Act (Discussion Draft) ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure

Funding for Renewable Chemicals/Bio-based Products Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit

Antitrust Legislation Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Discussion Draft on PAHPA Reauthorization Compulsory Licensing ---Prescription Drug Price Relief Act (Discussion Draft) Data Privacy Issues ---American Data Privacy and Protection Act (Discussion Draft) Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---Patent Eligibility Restoration Act of 2023 ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (Discussion Draft) ---Restoring Americas Leadership in Innovation Act (Discussion Draft) Pandemic Preparedness ---H.R.3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Patent Reform ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---Patent Litigation Reform ---Patent Trial and Appeal Board Reform Act (Discussion Draft) Patenting of Biological Inventions ---PTO Examination Guidelines ---Section 101 Modernization

Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn Intellectual Property International Enforcement ---TRIPS Waiver Issues Relating to Non-Human Primate Shortages United Nations World Health Organization (WHO) ---TRIPS Waiver ---WHO Pandemic Preparedness Accord World Trade Organization (WTO) ---TRIPS Waiver

340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 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 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) Biorefineries (Non-Funding) Climate Change Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Gene Editing ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Government's collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Pandemic Preparedness ---FY 2024 Appropriations ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit

340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Pandemic Preparedness ---COVID-19 Pricing-Related Provisions ---In-Home Administration of Part B Drugs ---Seniors Prescription Drug Relief Act (Discussion Draft) Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Drug Price Negotiation Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---National Coverage Determination ---Prescription Drug Price Relief Act (Discussion Draft) Medicaid ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act (Discussion Draft) ---Medicaid VBPs for Patients (MVP) Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.652/H.R.2630: Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Part B Physician-Administered Products ---Medicare Prescription Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---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 ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---DISARM Act (Discussion Draft) ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure

Biofuels (Non-Funding) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Biomass Programs (Non-Funding) Biorefineries (Non-Funding) Climate Change Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.448: Putting Investors First Act of 2023 ---H.R.835: Fair Investment Opportunities for Professional Experts Act ---H.R.1579: Accredited Investor Definition Review Act ---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2792: Small Entity Update Act ---H.R.2797: Equal Opportunity for All Investors Act of 2023 ---H.R.2799: Expanding Access to Capital Act of 2023 ---S.866: American Innovation and Jobs 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Infectious Disease Therapies Research and Innovation Act (Discussion Draft) ---Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act (Discussion Draft) ---JOBS Act 4.0 ---Net Operating Loss Advance Refunds Capital Market Enhancements ---Accredited Investor Definition ---JOBS Act 4.0 ---SEC Small Business Forum Mergers and Acquisitions Pandemic Preparedness ---Temporarily Refundable R&D Credit Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption

Antibiotic Use in Livestock --- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter". Genetically Engineered (GE) Animals ---ADUFA ---Farm Bill Reauthorization ---Labeling

Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn Intellectual Property International Enforcement ---TRIPS Waiver Issues Relating to Non-Human Primate Shortages United Nations World Health Organization (WHO) ---TRIPS Waiver ---WHO Pandemic Preparedness Accord World Trade Organization (WTO) ---TRIPS Waiver

Antitrust Legislation Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Discussion Draft on PAHPA Reauthorization Compulsory Licensing ---Prescription Drug Price Relief Act (Discussion Draft) Data Privacy Issues ---American Data Privacy and Protection Act (Discussion Draft) Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---Patent Eligibility Restoration Act of 2023 ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (Discussion Draft) ---Restoring Americas Leadership in Innovation Act (Discussion Draft) Pandemic Preparedness ---H.R.3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Patent Reform ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---Patent Litigation Reform ---Patent Trial and Appeal Board Reform Act (Discussion Draft) Patenting of Biological Inventions ---PTO Examination Guidelines ---Section 101 Modernization

Funding for Renewable Chemicals/Bio-based Products Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Government's collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Pandemic Preparedness ---FY 2024 Appropriations ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit

Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Gene Editing ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA

Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) Biorefineries (Non-Funding) Climate Change Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS)

Climate Change ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn Funding for the USDA ---FY 2024 Appropriations Genetically Engineered (GE) Animals ---ADUFA ---Farm Bill Reauthorization Genetically Engineered (GE) Plants ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) USDA/APHIS Agricultural Biotechnology Regulations ---H.R.1472/S.802: Plant Biostimulant Act ---Farm Bill Reauthorization

340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 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 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)

H.R.2811: Limit, Save, Grow Act of 2023 Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.368: American Innovation Act of 2023 ---H.R.2624: Helping Startups Continue to Grow Act ---H.R.2673: American Innovation and R&D Competitiveness Act ---H.R.2792: Small Entity Update Act ---S.866: American Innovation and Jobs 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act (Discussion Draft) ---JOBS Act 4.0 ---Net Operating Loss Advance Refunds Orphan Drug Issues ---H.R.1350: Cameron's Law Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.2673: American Innovation and R&D Competitiveness Act ---S.866: American Innovation and Jobs Act ---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) ---Expensing of R&D Expenditures ---House - Section 174 Amortization ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---VICP CICP (Discussion Draft)

Antibiotic Use in Livestock ---H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter". Genetically Engineered (GE) Animals ---ADUFA Issues Relating to Non-Human Primate Shortages

CFIUS and Foreign Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Intellectual Property International Enforcement ---China ---General Patent Reform ---India ---TRIPS Waiver Issues Relating to Non-Human Primate Shortages US-China Trade Agreement ---IP Provisions World Health Organization (WHO) ---TRIPS Waiver ---WHO Pandemic Preparedness Accord World Trade Organization (WTO) ---TRIPS Waiver

Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds Coronavirus (COVID-19) Pandemic Orphan Drug Issues Qualified Small Business Stock (QSBS) ---Draft Legislation to modify and expand the Section 1202 exclusion for gain from QSBS ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Promote expansion of credit and oppose cuts Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---S.866: American Innovation and Jobs Act ---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) ---Expensing of R&D Expenditures ---House - Section 174 Amortization ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2023 Appropriations ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act ---VICP CICP (Discussion Draft)

340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing ---Seniors Prescription Drug Relief Act Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Access to Innovative Treatments Act ---Affordable Prescriptions for Patients Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---Prescription Pricing for the People Act Medicaid ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.2327: Seniors Prescription Drug Relief Act ---Access to Innovative Treatments Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---Medicare Prescription Drug Price Negotiation Act ---National Coverage Determination ---New Opportunities for Value that Extend Lives (NOVEL) Act ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Access to Innovative Treatments Act ---DISARM Act ---National Coverage Determination ---Vaccine Injury Compensation Program ---Value of vaccines and vaccine confidence ---Vaccine safety net and vaccine infrastructure

Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---DISARM Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Implementation of USDA Discretion to Provide Support for Biofuel Producers in Consolidated Appropriations Act for FY 2021 Funding for Biorefineries ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for FDA ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Food and Drug Administration Safety and Landmark Advancements Act ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 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 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Biofuels (Non-Funding) ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---The Growing Climate Solutions Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.2617: Consolidated Appropriations Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Pandemic Preparedness Plan ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---DISARM Act ---National Defense Authorization Act for FY 2023 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA

Funding for Renewable Chemicals/Bio-based Products ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2617: Consolidated Appropriations Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Investment Tax Credit

Genetically Engineered (GE) Animals ---ADUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---FDA Revised EIS on Genetically Engineered Salmon ---International Consistency of Regulation for Gene Edited Products ---Labeling ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Antitrust Legislation Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing ---Prescription Drug Price Relief Act Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---H.R.8152: American Data Privacy and Protection Act Drug Patenting ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---CLEAR Patents Act ---Protecting Consumer Access to Generic Drugs Act ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---TRIPS Waiver Patent Reform ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---Interagency Patent Coordination and Improvement Act ---Patent Litigation Reform ---Patent Trial and Appeal Board Reform Act Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---PTO Examination Guidelines ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA US-China Trade Agreement ---IP Provisions

340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act Accelerated Approval Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Disease X ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Biosimilars ---BIOSIM Act ---BSUFA Negotiations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Interchangeability and Pharmacy Substitution ---Protecting Consumer Access to Generic Drugs Act ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4317: SAFE TO WORK Act ---S.4509: Vaccine And Coverage Certainty (VACC) Act ---Access to Generic Drugs 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 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Access to Innovative Treatments Act ---Affordable Prescriptions for Patients Act ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Cures Act ---National Coverage Determination ---Pharmacy Benefit Manager Transparency Act ---Prescription Pricing for the People Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---National Defense Authorization Act for FY 2023 ---DISARM Act ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 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 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---S.148: Stop STALLING Act ---Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.1730: Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.2327: Seniors Prescription Drug Relief Act ---Access to Innovative Treatments Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Access to Innovative Treatments Act ---Adult Immunization ---DISARM Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Access Improvement Act ---Vaccine Injury Compensation Modernization Act ---VICP CICP (Discussion Draft)

Genetically Engineered (GE) Animals ---ADUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---FDA Revised EIS on Genetically Engineered Salmon ---International Consistency of Regulation for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Issues Relating to Non-Human Primate Shortages

Biofuels (Non-Funding) ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---The Growing Climate Solutions Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.2617: Consolidated Appropriations Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022

Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---DISARM Act ---National Defense Authorization Act for FY 2023 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic

Banking Policy Impacting Emerging Companies Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022 ---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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---JOBS Act 4.0 ---Net Operating Loss Advance Refunds Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---JOBS Act 4.0 ---Market Liquidity Proposals ---SEC Small Business Forum Coronavirus (COVID-19) Pandemic ---Small Business Loans ---Temporarily Refundable R&D Credit Mergers and Acquisitions Proxy Advisory Services ---H.R.448: Putting Investors First Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---H.R.1909: Helping Angels Lead Our Startups (HALOS) Act of 2019 ---Accredited Investor Certification Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Implementation of SBIR and STTR Extension Act of 2022

Genetically Engineered (GE) Animals ---ADUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---FDA Revised EIS on Genetically Engineered Salmon ---International Consistency of Regulation for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---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.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates 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 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---National Coverage Determination

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---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 ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---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.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---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.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 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 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 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 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Biofuels (Non-Funding) ---H.R.2617: Consolidated Appropriations Act of 2023 ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---H.R.2617: Consolidated Appropriations Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022

Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation ---Implementation of the Inflation Reduction Act (IRA) of 2022 Foreign Agricultural Biotechnology Laws and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---ADUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---FDA Revised EIS on Genetically Engineered Salmon ---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 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---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 Synthetic Biotech USDA/APHIS Agricultural Biotechnology Regulations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---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 ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Genetically Engineered (GE) Animals ---ADUFA ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---FDA Revised EIS on Genetically Engineered Salmon ---International Consistency of Regulation for 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.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2617: Consolidated Appropriations Act of 2023 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Investment Tax Credit

Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 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 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA

CFIUS and Foreign Investment ---H.R.6329/S.1854: National Critical Capabilities Defense Act of 2021 Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---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 Indo-Pacific Economic Framework (IPEF) Intellectual Property International Enforcement ---TRIPS Waiver Synthetic Biotech US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Trade Organization ---MC-12 Meeting ---TRIPS Waiver World Health Organization (WHO) ---TRIPS Waiver

Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Reform of New Operating Loss Rules Capital Market Enhancements ---Accredited Investor Definition ---JOBS Act 4.0 ---Market Liquidity Proposals Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Proxy Advisory Services ---Impact of Policies on Small Public Companies Small Business Innovation Research (SBIR) Program ---Implementation of SBIR and STTR Extension Act of 2022

Biofuels (Non-Funding) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation 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) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---Draft Legislation to modify and expand the Section 1202 exclusion for gain from QSBS ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---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) ---Expensing of R&D Expenditures ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---R&D Payroll Credit Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---H.R.8152: American Data Privacy and Protection Act ---S.2499: Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act Diversity in Patenting ---H.R.1723/S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2773: Unleashing American Innovators Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---H.R.5874: Restoring America's Leadership in Innovation Act ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Implementation of the America Invents Act of 2011 ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.4417: Patent Trial and Appeal Board Reform Act of 2022 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Patent Litigation Reform Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization Patenting of Humanitarian Technologies ---H.R.5796: Patents for Humanity Act of 2021 United States-Mexico-Canada Agreement (USMCA) ---Mexico Draft Decree Banning Genetically Modified Corn

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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.2617: Consolidated Appropriations Act of 2023 ---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 Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 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

Climate Change ---FY 2023 Appropriations ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation ---SEC Proposed Rule on Climate Risk Disclosures Foreign Agricultural Biotechnology Laws and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Funding for the USDA ---FY 2023 Appropriations ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations 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 ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---FDA Proposed guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products Synthetic Biotech USDA/APHIS Agricultural Biotechnology Regulations ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Farm Bill Reauthorization ---Regulatory Treatment of Gene Edited Products ---USDA Part 340 Draft Rule ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---FY 2023 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.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---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.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---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 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022

Genetically Engineered (GE) Animals ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations 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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---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 ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: 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. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---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) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---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.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 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.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 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 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

Biofuels (Non-Funding) ---H.R.5376: Inflation Reduction Act of 2022 ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act --- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022 ---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) ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Inflation Reduction Act of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.5376: Inflation Reduction Act of 2022 ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

CFIUS and Foreign Investment ---H.R.6329/S.1854: National Critical Capabilities Defense Act of 2021 ---Executive Order Ensuring Robust Consideration of Evolving National Security Risks by the Committee on Foreign Investment in the United States Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---International Consistency of Regulation for Gene Edited Products ---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 Indo-Pacific Economic Framework (IPEF) Intellectual Property International Enforcement ---TRIPS Waiver ---US-Taiwan 21st Century Trade Initiative Synthetic Biotech US-China Trade Agreement ---Ag-Biotech Provisions World Trade Organization ---MC-12 Meeting ---TRIPS Waiver World Health Organization (WHO) ---TRIPS Waiver

Biofuels (Non-Funding) ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2023 Appropriations ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel

Genetically Engineered (GE) Animals ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations 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

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA

Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act --- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022 ---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) ---Reform of New Operating Loss Rules Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Market Liquidity Proposals ---SEC Small Business Forum Coronavirus (COVID-19) Pandemic --- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---Small Business Loans ---Temporarily Refundable R&D Credit Small Business Innovation Research (SBIR) Program ---S.4900: SBIR and STTR Extension Act of 2022

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic

Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.5376: Inflation Reduction Act of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---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 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2023 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Renewable Chemicals/Bio-based Products ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Funding for the USDA ---FY 2023 Appropriations ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act

Biofuels (Non-Funding) ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Sustainable Aviation Fuels Tax Credit Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2023 Appropriations ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel

Coronavirus (COVID-19) Pandemic ---H.R.5376: Build Back Better Act of 2021 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Build Back Better Act (Discussion Draft Senate) ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---FY 2023 Energy and Water Development and Related Agencies funding bill ---H.R.5376: Build Back Better Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of Consolidated Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---FY 2023 Energy and Water Development and Related Agencies funding bill ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---FY 2023 Energy and Water Development and Related Agencies funding bill Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Funding for the USDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

Digital Trade ---EU Digital Strategy Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---FY 2023 Commerce, Justice, Science, and Related Agencies funding bill ---Asynchronous Approval ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---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 ---China ---TRIPS Waiver US-China Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions World Trade Organization ---TRIPS Waiver World Health Organization (WHO) ---TRIPS Waiver

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of 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 Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---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 Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of 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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1644 Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies ADAPT Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---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 ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: 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. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program 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 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Information Systems ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---FY 2023 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.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates 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 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---S.3018: Improving Seniors Timely Access to Care Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare 2023 IPPS Proposed Rule Comment Letter ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.4127: DISARM Act ---Separate Payment Mechanism for Innovative Antimicrobials Products

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of 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 Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Reauthorization of PAHPA

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of 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 Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Information Systems ---Implementation of Consolidated Appropriations Act for FY 2021 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 ---Proposed FTC/DOJ Merger Guidelines Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver ---Coronavirus Supplemental Appropriations Data Privacy Issues ---S.2499: Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act ---US-EU Privacy Shield Drug Patenting ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.5902: CLEAR Patents Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---H.R.5874: Restoring America's Leadership in Innovation Act ---H.R.5902: CLEAR Patents Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents 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.4417: Patent Trial and Appeal Board Reform Act of 2022 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Patent Litigation Reform

Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7556: 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 ---Build Back Better Act (Discussion Draft Senate) --- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---Reform of New Operating Loss Rules Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---SEC Small Business Forum Coronavirus (COVID-19) Pandemic ---Small Business Loans Small Business Innovation Research (SBIR) Program ---H.R.4521: America COMPETES Act of 2022 ---S.1260: United States Innovation and Competition Act of 2021 ---Reauthorization

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---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 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---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 ---In-Home Administration of Part B Drugs ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals Drug Manufacturing, Quality & Distribution ---H.R.7767: 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. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding 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) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 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 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R. 5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Patient Cost-Sharing and Smoothing ---COVID-19 Pricing-Related Provisions ---Immunization Information Systems Drug Pricing ---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.133: Consolidated Appropriations Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---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: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations

Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Immunization Information Systems ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 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

Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---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 ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Coronavirus Supplemental Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act --- H.R. 4521: COMPETES Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---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 ---Coronavirus Supplemental Appropriations

Capital Formation Incentives ---H.R.5376: Build Back Better Act of 2021 ---H.R 7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R 7556: 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. ---Incentives for Sustainable Aviation Fuels ---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 Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---SEC Small Business Forum Sarbanes Oxley Section 404(b) ---Small Issuer Exemption Short Selling Transparency Small Business Innovation Research (SBIR) Program ---Reauthorization Small Business IP Training ---Implementation of S.791:Small Business Innovation Protection Act of 2017 Proxy Advisory Services ---Impact of Policies on Small Public Companies

Biofuels (Non-Funding) ---H.R.5376: Build Back Better Act of 2021 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.5376: Build Back Better Act of 2021 ---H.R 7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R 7556: 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 ---Incentives for Sustainable Aviation Fuels ---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 Coronavirus (COVID-19) Pandemic ---H.R. 3623: IGNITE American Innovation Act ---Coronavirus Supplemental Appropriations Orphan Drug Issues ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Build Back Better Act of 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R 7767: 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. ---H.R.1304 - American Innovation and R&D Competitiveness Act of 2021 ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

Digital Trade ---EU Digital Strategy ---Indo Pacific Economic Framework Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Pricing ---Drug Pricing Issues in Japan Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Indo-Pacific Economic Framework (IPEF) Intellectual Property International Enforcement ---China ---TRIPS Waiver ---Special 301 Review US-China Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions World Trade Organization ---TRIPS Waiver World Health Organization (WHO) ---TRIPS Waiver

Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---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 ---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.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 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.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---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 ---White House National Biodefense Strategy Biosimilars ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---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 ---In-Home Administration of Part B Drugs ---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 ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity ---Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (Discussion Draft) Drug Evaluation and Review ---S.1644: Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Manufacturing, Quality & Distribution ---H.R.7767: 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. ---Drug Shortages ---Executive Order on Buy American ---Inspections ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---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.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Principles Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 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.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding 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) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding 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.6119: Further Extending Government Funding Act ---Funding for 2022-2023 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 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Generic Drug Entry ---H.R.2883: Stop Stalling Access to Affordable Medications Act Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---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 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---Domestic Manufacturing Requirement ---March-In Rights Compulsory Licensing ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---H.R.1723/S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents 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 Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization Patenting of Humanitarian Technologies ---H.R.5796: Patents for Humanity Act of 2021 US-China Trade Agreement ---IP Provisions

Biofuels (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.5376: Build Back Better Act of 2021 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.5376: Build Back Better Act of 2021 ---H.R.7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities ---H.R. 7556: 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. ---Incentives for Sustainable Aviation Fuels ---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 Coronavirus (COVID-19) Pandemic ---H.R.3623: IGNITE American Innovation Act Orphan Drug Issues ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Build Back Better Act of 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.7767: 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. ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---Patient Cost-Sharing and Smoothing Drug Pricing ---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.133: Consolidated Appropriations Act for FY 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act;H.R.5376 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---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: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021

Capital Formation Incentives ---H.R.5376: Build Back Better Act of 2021 ---H.R.7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R. 7556: 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. ---Incentives for Sustainable Aviation Fuels ---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 Proxy Advisory Services ---Impact of Policies on Small Public Companies

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

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

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Capital Formation Incentives ---H.R.2140/S.961: American Innovation Act ---H.R.3448: Helping Startups Continue to Grow 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) ---Incentives for Sustainable Aviation Fuels ---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 Vaccine Injury Compensation Program ---H.R.3656: Vaccine Access Improvement Act of 2021

Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---FY 2022 Appropriations ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Compulsory Licensing Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights Diversity in Patenting ---35 USC Section 101 on Patent Eligibility ---S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---DNA Patenting and Licensing ---Section 101 Modernization United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA ------IP Provisions US-China Trade Agreement ---IP Provisions

21st Century Cures Act 2.0 ---House Discussion Draft ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---H.R.3203: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Promising Pathway Act (Discussion Draft) ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Manufacturing, Quality & Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Lower Health Care Costs for Patients Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Prescription Drug Pricing Reduction Act (Discussion Draft) ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---Pricing and Rebates ---Senate Finance Committee Drug Pricing Principles ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---New Opportunities for Value that Extend Lives (NOVEL) Act (Discussion Draft) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Senate Finance Committee Drug Pricing Principles ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.550: Immunization Infrastructure Modernization Act ---H.R.951: Maternal Vaccinations Act ---H.R.979: Vaccine Fairness Act ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.1452: A bill to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes. ---H.R.1550: Promoting Resources to Expand Vaccination, Education, and New Treatments for (PREVENT) HPV Cancers Act of 2021 ---H.R.1978: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3013: COVID Vaccine Transportation Access Act ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3742: Vaccine Information for Nursing Facility Operators (INFO) Act ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---H.R.4127: A bill to amend title XVIII of the Social Security Act to encourage the development and use of DISARM antimicrobial drugs, and for other purposes. ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine Injury Compensation Program ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021

Digital Trade ---EU Digital Strategy Drug Pricing --- Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Intellectual Property International Enforcement ---China ---TRIPS Waiver The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ------Ag-Biotech Provisions ------IP Provisions ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions World Trade Organization ---TRIPS Waiver ---United States Withdrawal from the World Trade Organization (WTO) World Health Organization (WHO) ---TRIPS Waiver ---United States Withdrawal from the World Health Organization (WHO)

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.3743: Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic

Capital Formation Incentives ---H.R.2140/S.961: American Innovation Act ---H.R.3448: Helping Startups Continue to Grow 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) ---Incentives for Sustainable Aviation Fuels ---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 Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Market Liquidity Proposals ---SEC Small Business Reform Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Short Selling Transparency

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Biosimilars ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.869/S.289: Research Investment to Spark the Economy (RISE) Act of 2021 ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Temporarily Refundable R&D Credit Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft) Diversity & Inclusion ---H.R.1319: American Rescue Plan Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---COVID-19 Lessons Learned ---Expedited Pathways ---FDA Hiring Flexibility ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. Drug Manufacturing, Quality & Distribution ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Drug Shortages ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---Affordable Prescriptions for Patients Act (Discussion Draft) ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Negotiation and Competitive Licensing Act (Discussion Draft) ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Medicare Prescription Drug Price Negotiation Act (Discussion Drafts) ---Strengthening Innovation in Medicare and Medicaid Act (Discussion Draft) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Reference Pricing in Drug Reimbursement Funding for Antimicrobial Resistance Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2022 Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) - 340B Program Integrity Issues ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Medicaid ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---S.908: A bill to amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. ---S.909: A bill to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. ---Lower Costs, More Cures Act (Discussion Draft) ---Lower Drug Costs Now Act (Discussion Draft) ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Protected Classes ---Reference Pricing in Drug Reimbursement ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---DISARM Act (Discussion Draft) ---Protecting Seniors through Immunizations Act (Discussion Draft) ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Adult Immunization ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Antimicrobial Resistance Product Development and Incentives Vaccine Injury Compensation Program Tax ---FY 2022 Appropriations ---Vaccine Access Improvement Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.1319: American Rescue Plan Act of 2021 ------Funding Allocation from HHS to BARDA for Therapeutics ------Funding for Vaccine Distribution ------Funding for Vaccine Hesitancy ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (Discussion Drafts) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.1319: American Rescue Plan Act of 2021 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

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

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Pricing ---International Pricing Index Proposal Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Foreign Drug Data Protection Laws ---Regulatory Harmonization Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization US-UK Trade Agreement ---Ag-Biotech Provisions ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)

Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Coronavirus (COVID-19) Pandemic ---NOL Monetization ---Pause on Graduating from ECG Status (ECG Pause) ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

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

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

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels Capital Formation Incentives ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Incentives for Sustainable Aviation Fuels ---Infectious Disease Therapies Research and Innovation Act (Discussion Draft) ---Introduction of the American Innovation Act in the Senate ---Reintroduction of the American Innovation Act in the House ---NOL Monetization ---Reform of Net Operating Loss Rules ---Start-ups for Cures Act (Discussion Draft) ---The More Cures Act (Discussion Draft) Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Expensing of R&D Expenditures ---Incentives for Sustainable Aviation Fuels ---R&D Credit Temporary Refundability ---R&D Payroll Credit

Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Coronavirus (COVID-19) Pandemic ---NOL Monetization ---Pause on Graduating from ECG Status (ECG Pause) ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Pricing ---International Pricing Index Proposal Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Foreign Drug Data Protection Laws ---Regulatory Harmonization Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization US-UK Trade Agreement ---Ag-Biotech Provisions ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)

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

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

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

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

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

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

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 ---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

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

Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Coronavirus (COVID-19) Pandemic ---NOL Monetization ---Pause on Graduating from ECG Status (ECG Pause) ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

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

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

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

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

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

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 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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