BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Agriculture AGR

Climate Change ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Indo-Pacific Economic Framework (IPEF) Funding for the USDA ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors Genetically Engineered (GE) Animals ---H.R.273 Prevention of Escapement of Genetically Altered Salmon in the United States Act ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech 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 Regulatory Approach to Gene Editing ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---FDA Proposed guidance on Gene Editing ---International Consistency of Regulation for Gene Edited Products USDA/APHIS Agricultural Biotechnology Regulations ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

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

Bills named: H.R. 2471 (117th), S. 1251 (117th), H.R. 273 (117th), H.R. 5376 (117th), H.R. 6119 (117th), H.R. 2820 (117th)

Animals ANI

Genetically Engineered (GE) Animals --- H.R. 273 Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Contacted: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE; Agriculture, Dept of (USDA)

Bills named: H.R. 273 (117th)

Budget/Appropriations BUD

Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.5376: Build Back Better Act of 2021 --- S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Prescription Drug User Fee Act (PDUFA) VII Discussion Draft Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---S.3799: PREVENT Pandemics Act Funding for Renewable Chemicals/Bio-based Products ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for the USDA ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Farm Bill Programs Energy Title IX

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

Bills named: S. 3799 (117th), S. 2076 (117th), H.R. 133 (117th), H.R. 5585 (117th), H.R. 3932 (117th), H.R. 2471 (117th), H.R. 6119 (117th), H.R. 5376 (117th), H.R. 4127 (117th)

Chemicals/Chemical Industry CHM

Funding for Renewable Chemicals/Bio-based Products ---FY 2023 Appropriations ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act Renewable Chemicals/Bio-based Products (Non-Funding) ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R. 2532: Renewable Chemicals Act of 2021 ---Climate Issues & impact on the agriculture, food, and forestry sectors

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

Bills named: H.R. 5376 (117th), H.R. 6119 (117th), H.R. 2532 (117th), H.R. 2471 (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 Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver ---Coronavirus Supplemental Appropriations Data Privacy Issues ---US-EU Privacy Shield Diversity in Patenting ---H.R.1723/S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) ---Implementation of America Invents Act of 2011 Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reform Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization

Contacted: White House Office; Natl Economic Council (NEC); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Commerce, Dept of (DOC); SENATE

Bills named: H.R. 1723 (117th), S. 1485 (117th), H.R. 2891 (117th), S. 225 (117th), S. 1428 (117th), S. 2891 (117th), H.R. 2873 (117th), H.R. 4811 (117th), H.R. 2883 (117th), H.R. 153 (117th), S. 1435 (117th), S. 1260 (117th), H.R. 2884 (117th), S. 632 (117th), S. 2774 (117th)

Energy/Nuclear ENG

Biofuels (Non-Funding) ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act --- S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act --- S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---Small Refinery Waivers Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act --- S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act --- S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel

Contacted: Environmental Protection Agency (EPA); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 6119 (117th), S. 193 (117th), S. 218 (117th), H.R. 5376 (117th), H.R. 2820 (117th), H.R. 2471 (117th), S. 1251 (117th)

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals --- H.R. 273 Prevention of Escapement of Genetically Altered Salmon in the United States Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Efficient Science-Based Review of Biotech Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Contacted: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); SENATE

Bills named: H.R. 273 (117th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act --- S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act --- S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---Small Refinery Waivers Biomass Programs (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Biorefineries (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors Climate Change ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Fighting Climate Change through Biotechnology Innovation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act --- S.193: Adopt Greenhouse gases, Regulated Emissions, and Energy use in Transportation model (GREET) Act --- S.218: A bill to approve certain advanced biofuel registrations, to require the consideration of certain advanced biofuel pathways, and to reduce greenhouse gas emissions, and for other purposes ---A Clean Fuel Standard or Low Carbon Fuel Standard ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel

Contacted: Environmental Protection Agency (EPA); SENATE; Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES

Bills named: S. 218 (117th), H.R. 6119 (117th), S. 1251 (117th), S. 193 (117th), H.R. 5376 (117th), H.R. 2820 (117th), H.R. 2471 (117th)

Health Issues HCR

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R. 5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021

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

Bills named: H.R. 6888 (117th), H.R. 2815 (117th), S. 908 (117th), H.R. 7008 (117th), H.R. 5260 (117th), H.R. 6584 (117th), H.R. 2873 (117th), H.R. 2891 (117th), S. 2164 (117th), S. 2076 (117th), H.R. 5585 (117th), S. 1435 (117th), S. 3799 (117th), H.R. 1978 (117th), S. 2327 (117th), S. 3087 (117th), H.R. 4472 (117th), H.R. 5125 (117th), H.R. 3 (117th), H.R. 1730 (117th), H.R. 133 (117th), H.R. 7006 (117th), H.R. 2884 (117th), H.R. 5376 (117th), H.R. 4811 (117th), H.R. 5030 (117th), H.R. 3927 (117th), H.R. 3655 (117th), S. 345 (117th), S. 2691 (117th), H.R. 2853 (117th), H.R. 7035 (117th), H.R. 6833 (117th), S. 909 (117th), H.R. 5237 (117th), H.R. 6996 (117th), H.R. 729 (117th), S. 1428 (117th), H.R. 2148 (117th), H.R. 959 (117th), H.R. 2071 (117th), S. 4509 (117th), H.R. 6119 (117th), H.R. 1629 (117th), H.R. 6963 (117th), H.R. 3932 (117th), S. 1644 (117th), H.R. 7767 (117th), S. 920 (117th), H.R. 4511 (117th), H.R. 2883 (117th), S. 581 (117th), H.R. 834 (117th), S. 346 (117th), S. 1485 (117th), H.R. 5566 (117th), H.R. 2471 (117th), H.R. 19 (117th), H.R. 7032 (117th), H.R. 2347 (117th), H.R. 3656 (117th), S. 3700 (117th), H.R. 6000 (117th), H.R. 2170 (117th), S. 912 (117th), H.R. 951 (117th), H.R. 3085 (117th), H.R. 2139 (117th), H.R. 4127 (117th), H.R. 153 (117th), S. 1388 (117th)

Homeland Security HOM

Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Coronavirus Supplemental Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act --- H.R. 4521: COMPETES Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Coronavirus Supplemental Appropriations

Contacted: HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); White House Office; Centers For Disease Control & Prevention (CDC); SENATE

Bills named: H.R. 4521 (117th), H.R. 133 (117th), H.R. 5376 (117th), H.R. 6119 (117th), H.R. 3932 (117th), S. 2076 (117th), H.R. 4127 (117th), S. 3799 (117th), H.R. 2471 (117th)

Medical/Disease Research/Clinical Labs MED

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

Contacted: White House Office; SENATE; HOUSE OF REPRESENTATIVES; Centers For Disease Control & Prevention (CDC); Health & Human Services, Dept of (HHS)

Bills named: S. 2076 (117th), H.R. 5585 (117th), H.R. 6119 (117th), H.R. 2471 (117th), H.R. 3932 (117th), H.R. 133 (117th), H.R. 4127 (117th), H.R. 5376 (117th), S. 3799 (117th)

Medicare/Medicaid MMM

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

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

Bills named: H.R. 133 (117th), H.R. 4811 (117th), H.R. 2071 (117th), S. 3799 (117th), H.R. 4127 (117th), H.R. 2139 (117th), S. 2164 (117th), H.R. 6119 (117th), H.R. 5237 (117th), H.R. 3 (117th), S. 3700 (117th), H.R. 19 (117th), H.R. 5376 (117th), H.R. 2170 (117th), S. 909 (117th), S. 912 (117th), H.R. 1978 (117th), S. 2076 (117th), H.R. 6833 (117th), H.R. 2471 (117th), H.R. 6000 (117th), H.R. 5125 (117th), S. 2327 (117th), S. 581 (117th), H.R. 2148 (117th), S. 908 (117th), H.R. 5260 (117th), H.R. 3932 (117th)

Small Business SMB

Capital Formation Incentives ---H.R.5376: Build Back Better Act of 2021 ---H.R 7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R 7556: A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---Incentives for Sustainable Aviation Fuels ---Proposed amendments under the Exchange Act of 1934 ---Proposed amendments under the Investment Company Act of 1940 ---Proposed amendments under the Securities Act of 1933 Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---SEC Small Business Forum Sarbanes Oxley Section 404(b) ---Small Issuer Exemption Short Selling Transparency Small Business Innovation Research (SBIR) Program ---Reauthorization Small Business IP Training ---Implementation of S.791:Small Business Innovation Protection Act of 2017 Proxy Advisory Services ---Impact of Policies on Small Public Companies

Contacted: HOUSE OF REPRESENTATIVES; Small Business Administration (SBA); SENATE; Securities & Exchange Commission (SEC)

Bills named: H.R. 5376 (117th), H.R. 7555 (117th), S. 791 (117th), H.R. 7556 (117th)

Taxation/Internal Revenue Code TAX

Biofuels (Non-Funding) ---H.R.5376: Build Back Better Act of 2021 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.5376: Build Back Better Act of 2021 ---H.R 7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R 7556: A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research ---Incentives for Sustainable Aviation Fuels ---Proposed amendments under the Exchange Act of 1934 ---Proposed amendments under the Investment Company Act of 1940 ---Proposed amendments under the Securities Act of 1933 Coronavirus (COVID-19) Pandemic ---H.R. 3623: IGNITE American Innovation Act ---Coronavirus Supplemental Appropriations Orphan Drug Issues ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Build Back Better Act of 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R 7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---H.R.1304 - American Innovation and R&D Competitiveness Act of 2021 ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 5376 (117th), H.R. 7767 (117th), H.R. 7555 (117th), H.R. 6119 (117th), H.R. 1304 (117th), H.R. 7556 (117th), H.R. 3623 (117th), S. 3087 (117th), H.R. 3656 (117th), H.R. 2471 (117th)

Trade (domestic/foreign) TRD

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

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

Bills named: H.R. 4811 (117th)