BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Agriculture AGR

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

Contacted: Food & Drug Administration (FDA); SENATE; Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR)

Bills named: S. 802 (118th), H.R. 1472 (118th)

Chemicals/Chemical Industry CHM

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

Contacted: Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; SENATE

Bills named: S. 2452 (118th), H.R. 5134 (118th)

Animals ANI

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

Contacted: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 4012 (118th)

Budget/Appropriations BUD

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

Contacted: SENATE; Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Treasury, Dept of

Bills named: S. 1355 (118th), H.R. 2940 (118th), H.R. 8239 (118th)

Copyright/Patent/Trademark CPT

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

Contacted: Patent & Trademark Office (PTO); SENATE; U.S. Trade Representative (USTR); Federal Trade Commission (FTC); HOUSE OF REPRESENTATIVES

Bills named: S. 148 (118th), S. 113 (118th), S. 142 (118th), S. 150 (118th), H.R. 2883 (118th), S. 1128 (118th), H.R. 3858 (118th), H.R. 2891 (118th), H.R. 1717 (118th), S. 1428 (118th), S. 1834 (118th), S. 79 (118th), S. 1485 (118th)

Energy/Nuclear ENG

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)

Contacted: SENATE; HOUSE OF REPRESENTATIVES; Treasury, Dept of

Bills named: H.R. 5134 (118th), H.R. 5235 (118th), S. 2452 (118th), H.R. 8239 (118th)

Food Industry (safety, labeling, etc.) FOO

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

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 4012 (118th)

Fuel/Gas/Oil FUE

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)

Contacted: HOUSE OF REPRESENTATIVES; Treasury, Dept of; SENATE

Bills named: H.R. 5235 (118th), H.R. 8239 (118th), H.R. 5134 (118th), S. 2452 (118th)

Health Issues HCR

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)

Contacted: White House Office; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE; Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 3742 (118th), S. 909 (118th), H.R. 2534 (118th), H.R. 2139 (118th), S. 1355 (118th), H.R. 1790 (118th), S. 2305 (118th), S. 1485 (118th), H.R. 5142 (118th), S. 127 (118th), S. 1067 (118th), H.R. 5378 (118th), H.R. 3795 (118th), S. 113 (118th), S. 150 (118th), H.R. 1717 (118th), H.R. 2891 (118th), H.R. 830 (118th), H.R. 2148 (118th), S. 1375 (118th), S. 148 (118th), S. 908 (118th), H.R. 3832 (118th), H.R. 5143 (118th), S. 3810 (118th), H.R. 2617 (118th), S. 775 (118th), H.R. 2630 (118th), S. 79 (118th), H.R. 3066 (118th), S. 142 (118th), H.R. 3290 (118th), S. 2327 (118th), S. 1428 (118th), H.R. 4531 (118th), H.R. 2883 (118th), H.R. 5539 (118th), H.R. 2940 (118th), S. 652 (118th), S. 1128 (118th), H.R. 2408 (118th)

Homeland Security HOM

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)

Contacted: SENATE; HOUSE OF REPRESENTATIVES; White House Office

Bills named: H.R. 3613 (118th), H.R. 3832 (118th), H.R. 3795 (118th), H.R. 3577 (118th), H.R. 3703 (118th), H.R. 3631 (118th), H.R. 2940 (118th), H.R. 3794 (118th), S. 1355 (118th), H.R. 3791 (118th), H.R. 3742 (118th)

Medical/Disease Research/Clinical Labs MED

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

Contacted: Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 2940 (118th), H.R. 3832 (118th), S. 1355 (118th)

Medicare/Medicaid MMM

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

Contacted: SENATE; Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES

Bills named: H.R. 2630 (118th), H.R. 4811 (118th), S. 909 (118th), H.R. 3290 (118th), H.R. 2148 (118th), S. 775 (118th), S. 1375 (118th), H.R. 133 (118th), H.R. 830 (118th), H.R. 5125 (118th), S. 1067 (118th), H.R. 2408 (118th), H.R. 5378 (118th), S. 142 (118th), H.R. 5237 (118th), S. 127 (118th), S. 652 (118th), H.R. 2139 (118th), S. 150 (118th), H.R. 5260 (118th), S. 113 (118th), S. 908 (118th)

Trade (domestic/foreign) TRD

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

Contacted: HOUSE OF REPRESENTATIVES; State, Dept of (DOS); Patent & Trademark Office (PTO); SENATE; U.S. Trade Representative (USTR)

Small Business SMB

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.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 ---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 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

Contacted: SENATE; U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES

Bills named: H.R. 2608 (118th), H.R. 368 (118th), H.R. 2624 (118th), S. 2529 (118th), H.R. 2673 (118th), H.R. 2792 (118th), H.R. 2799 (118th), S. 866 (118th), H.R. 3623 (118th), H.R. 835 (118th), H.R. 1579 (118th), H.R. 448 (118th), H.R. 2610 (118th), H.R. 2797 (118th)

Taxation/Internal Revenue Code TAX

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)

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 2673 (118th), H.R. 5142 (118th), S. 866 (118th), S. 2529 (118th), H.R. 368 (118th), H.R. 2792 (118th), H.R. 5143 (118th), H.R. 3623 (118th)