BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Agriculture AGR

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

Contacted: HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); SENATE; Agriculture, Dept of (USDA); U.S. Trade Representative (USTR)

Bills named: S. 802 (118th), H.R. 1472 (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 Issues Relating to Non-Human Primate Shortages

Contacted: U.S. Fish & Wildlife Service (USFWS); HOUSE OF REPRESENTATIVES; SENATE

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

Budget/Appropriations BUD

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

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

Bills named: H.R. 2940 (118th), S. 1355 (118th), H.R. 2811 (118th)

Chemicals/Chemical Industry CHM

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

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Copyright/Patent/Trademark CPT

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

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

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

Energy/Nuclear ENG

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)

Contacted: SENATE; HOUSE OF REPRESENTATIVES

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 ---Farm Bill Reauthorization ---Labeling

Contacted: HOUSE OF REPRESENTATIVES; SENATE

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

Fuel/Gas/Oil FUE

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)

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Health Issues HCR

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)

Contacted: U.S. International Trade Commission (ITC); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); State, Dept of (DOS); HOUSE OF REPRESENTATIVES; White House Office; Centers For Medicare and Medicaid Services (CMS); SENATE; U.S. Trade Representative (USTR)

Bills named: H.R. 2630 (118th), S. 1375 (118th), S. 79 (118th), H.R. 3703 (118th), H.R. 3813 (118th), S. 476 (118th), S. 142 (118th), H.R. 3577 (118th), H.R. 3795 (118th), H.R. 3742 (118th), H.R. 2534 (118th), S. 148 (118th), H.R. 3794 (118th), S. 1355 (118th), H.R. 3613 (118th), H.R. 3840 (118th), S. 127 (118th), S. 1128 (118th), S. 1246 (118th), S. 150 (118th), H.R. 3791 (118th), H.R. 133 (118th), H.R. 3631 (118th), H.R. 1717 (118th), S. 113 (118th), H.R. 2408 (118th), H.R. 3837 (118th), S. 775 (118th), H.R. 830 (118th), H.R. 3820 (118th), S. 652 (118th), H.R. 2940 (118th), H.R. 3066 (118th), H.R. 3832 (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.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

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

Bills named: H.R. 3577 (118th), H.R. 2940 (118th), H.R. 3837 (118th), H.R. 3832 (118th), H.R. 3742 (118th), H.R. 3795 (118th), S. 1355 (118th), H.R. 3820 (118th), H.R. 3813 (118th), H.R. 3703 (118th), H.R. 3613 (118th), H.R. 3840 (118th), H.R. 3631 (118th), H.R. 3791 (118th), H.R. 3794 (118th)

Medical/Disease Research/Clinical Labs MED

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

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

Bills named: H.R. 3837 (118th), H.R. 3613 (118th), H.R. 3791 (118th), H.R. 3795 (118th), H.R. 3742 (118th), H.R. 3631 (118th), H.R. 2940 (118th), H.R. 3577 (118th), H.R. 3813 (118th), H.R. 3840 (118th), H.R. 3703 (118th), H.R. 3832 (118th), H.R. 3794 (118th), S. 1355 (118th), H.R. 3820 (118th)

Medicare/Medicaid MMM

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

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

Bills named: S. 150 (118th), H.R. 830 (118th), S. 476 (118th), H.R. 1717 (118th), S. 142 (118th), S. 113 (118th), S. 1067 (118th), H.R. 2408 (118th), H.R. 2630 (118th), S. 79 (118th), H.R. 133 (118th), S. 127 (118th), H.R. 1790 (118th), S. 1375 (118th), S. 652 (118th)

Small Business SMB

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

Contacted: HOUSE OF REPRESENTATIVES; SENATE

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

Taxation/Internal Revenue Code TAX

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)

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 2673 (118th), H.R. 2624 (118th), S. 866 (118th), H.R. 368 (118th), H.R. 2811 (118th), H.R. 2792 (118th), H.R. 1350 (118th)

Trade (domestic/foreign) TRD

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

Contacted: U.S. International Trade Commission (ITC); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); State, Dept of (DOS); SENATE; Agriculture, Dept of (USDA)