BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Health Issues HCR

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)

Contacted: Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); Natl Security Council (NSC); HOUSE OF REPRESENTATIVES; White House Office; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Office of Science & Technology Policy (OSTP); State, Dept of (DOS); Natl Economic Council (NEC); U.S. Trade Representative (USTR); SENATE; Centers For Disease Control & Prevention (CDC); Patent & Trademark Office (PTO)

Bills named: S. 908 (117th), H.R. 2884 (117th), H.R. 2617 (117th), S. 4430 (117th), H.R. 4127 (117th), S. 1388 (117th), S. 2209 (117th), S. 4351 (117th), S. 2076 (117th), S. 1428 (117th), H.R. 4128 (117th), H.R. 6000 (117th), H.R. 2891 (117th), S. 4509 (117th), H.R. 3 (117th), H.R. 5566 (117th), S. 1645 (117th), H.R. 6988 (117th), S. 4185 (117th), H.R. 6973 (117th), S. 920 (117th), H.R. 3656 (117th), H.R. 6888 (117th), H.R. 153 (117th), S. 1485 (117th), H.R. 6996 (117th), S. 1435 (117th), H.R. 951 (117th), H.R. 2347 (117th), S. 2082 (117th), H.R. 5030 (117th), H.R. 2170 (117th), H.R. 19 (117th), S. 4543 (117th), S. 1644 (117th), H.R. 7006 (117th), H.R. 3932 (117th), S. 909 (117th), H.R. 8152 (117th), S. 4348 (117th), S. 4293 (117th), H.R. 6963 (117th), S. 4071 (117th), S. 4338 (117th), H.R. 5125 (117th), S. 2691 (117th), H.R. 7032 (117th), H.R. 3927 (117th), H.R. 7389 (117th), H.R. 6972 (117th), S. 912 (117th), S. 2416 (117th), H.R. 5585 (117th), H.R. 2148 (117th), H.R. 1978 (117th), H.R. 834 (117th), S. 3087 (117th), H.R. 2853 (117th), H.R. 8239 (117th), S. 3013 (117th), H.R. 9127 (117th), S. 345 (117th), H.R. 3655 (117th), S. 4215 (117th), H.R. 7900 (117th), S. 581 (117th), S. 3810 (117th), H.R. 9358 (117th), S. 346 (117th), S. 2164 (117th), H.R. 3085 (117th), H.R. 2139 (117th), H.R. 2873 (117th), H.R. 7008 (117th), H.R. 6584 (117th), H.R. 2071 (117th), H.R. 959 (117th), H.R. 2883 (117th), S. 3799 (117th), S. 2327 (117th), H.R. 7667 (117th)

Homeland Security HOM

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

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

Bills named: S. 4543 (117th), H.R. 7900 (117th), H.R. 3932 (117th), H.R. 2617 (117th), S. 2076 (117th), H.R. 4127 (117th)

Medical/Disease Research/Clinical Labs MED

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

Contacted: Natl Institutes of Health (NIH); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES; White House Office; Centers For Disease Control & Prevention (CDC)

Bills named: S. 2076 (117th), S. 4543 (117th), H.R. 4127 (117th), H.R. 5585 (117th), H.R. 7900 (117th), H.R. 3932 (117th), H.R. 2617 (117th)

Agriculture AGR

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

Contacted: HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); White House Office; U.S. Trade Representative (USTR); SENATE; Agriculture, Dept of (USDA); Food & Drug Administration (FDA)

Bills named: S. 1251 (117th), H.R. 2617 (117th), H.R. 8239 (117th), H.R. 2820 (117th)

Animals ANI

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

Contacted: HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); SENATE; Agriculture, Dept of (USDA); Food & Drug Administration (FDA); White House Office

Budget/Appropriations BUD

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

Contacted: Natl Institutes of Health (NIH); SENATE; Centers For Disease Control & Prevention (CDC); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Bills named: S. 3799 (117th), H.R. 2617 (117th), H.R. 4127 (117th), H.R. 3932 (117th), H.R. 7667 (117th), S. 4348 (117th), H.R. 8239 (117th), S. 4543 (117th), S. 2076 (117th), H.R. 7900 (117th), H.R. 5585 (117th)

Chemicals/Chemical Industry CHM

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

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

Bills named: H.R. 2617 (117th)

Copyright/Patent/Trademark CPT

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

Contacted: State, Dept of (DOS); White House Office; SENATE; Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO); Natl Security Council (NSC); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Commerce, Dept of (DOC); U.S. Trade Representative (USTR)

Bills named: H.R. 2873 (117th), H.R. 2884 (117th), S. 2891 (117th), S. 2499 (117th), H.R. 5874 (117th), H.R. 5796 (117th), S. 632 (117th), H.R. 8152 (117th), S. 909 (117th), H.R. 4811 (117th), H.R. 1723 (117th), S. 4417 (117th), H.R. 2891 (117th), S. 2773 (117th), S. 4430 (117th), H.R. 2148 (117th), S. 1485 (117th), S. 1428 (117th), H.R. 2883 (117th), S. 2774 (117th), S. 1435 (117th), S. 225 (117th)

Energy/Nuclear ENG

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

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

Bills named: S. 1251 (117th), H.R. 2820 (117th), H.R. 2617 (117th), H.R. 8239 (117th)

Food Industry (safety, labeling, etc.) FOO

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

Contacted: Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Environmental Protection Agency (EPA); White House Office; SENATE

Fuel/Gas/Oil FUE

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

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

Bills named: S. 1251 (117th), H.R. 2617 (117th), H.R. 8239 (117th), H.R. 2820 (117th)

Medicare/Medicaid MMM

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

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

Bills named: H.R. 9358 (117th), H.R. 3 (117th), H.R. 2170 (117th), H.R. 7389 (117th), S. 1388 (117th), H.R. 2148 (117th), S. 3013 (117th), H.R. 7667 (117th), S. 4348 (117th), S. 2164 (117th), S. 912 (117th), S. 2327 (117th), H.R. 2617 (117th), H.R. 8152 (117th), S. 1435 (117th), S. 4293 (117th), H.R. 5125 (117th), S. 909 (117th), S. 581 (117th), H.R. 2071 (117th), H.R. 4127 (117th), H.R. 19 (117th), H.R. 9127 (117th), H.R. 6000 (117th), S. 908 (117th), S. 2416 (117th), H.R. 1978 (117th), H.R. 2139 (117th)

Small Business SMB

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

Contacted: SENATE; Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES

Bills named: H.R. 1304 (117th), H.R. 3448 (117th), S. 749 (117th), H.R. 3623 (117th), S. 2529 (117th)

Taxation/Internal Revenue Code TAX

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)

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 3448 (117th), S. 4185 (117th), H.R. 3623 (117th), S. 3087 (117th), H.R. 3655 (117th), S. 749 (117th), H.R. 3656 (117th), S. 3810 (117th), H.R. 1304 (117th), S. 2529 (117th), H.R. 2617 (117th)

Trade (domestic/foreign) TRD

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

Contacted: Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); SENATE; State, Dept of (DOS); U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); Commerce, Dept of (DOC); White House Office; Patent & Trademark Office (PTO); Natl Economic Council (NEC)

Bills named: H.R. 6329 (117th), S. 1854 (117th)