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 ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy Biosimilars ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity ---Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (Discussion Draft) Drug Evaluation and Review ---S.1644: Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---Drug Shortages ---Executive Order on Buy American ---Inspections ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Principles Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Generic Drug Entry ---H.R.2883: Stop Stalling Access to Affordable Medications Act Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

Contacted: Natl Institutes of Health (NIH); Environmental Protection Agency (EPA); U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); Office of Science & Technology Policy (OSTP); SENATE; Food & Drug Administration (FDA); White House Office; HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA)

Bills named: H.R. 2347 (117th), H.R. 5125 (117th), H.R. 3085 (117th), H.R. 2884 (117th), H.R. 3 (117th), H.R. 959 (117th), H.R. 951 (117th), S. 581 (117th), S. 1428 (117th), H.R. 4127 (117th), H.R. 2139 (117th), S. 346 (117th), H.R. 5260 (117th), H.R. 153 (117th), H.R. 7767 (117th), H.R. 5376 (117th), H.R. 2170 (117th), S. 2076 (117th), S. 1644 (117th), S. 3087 (117th), H.R. 2873 (117th), S. 909 (117th), H.R. 19 (117th), H.R. 6000 (117th), H.R. 1978 (117th), H.R. 5237 (117th), H.R. 2148 (117th), S. 908 (117th), H.R. 133 (117th), H.R. 3655 (117th), H.R. 6119 (117th), S. 4509 (117th), H.R. 834 (117th), S. 2164 (117th), H.R. 3656 (117th), H.R. 3932 (117th), H.R. 2815 (117th), S. 2327 (117th), H.R. 4811 (117th), S. 345 (117th), S. 1485 (117th), S. 912 (117th), H.R. 2891 (117th), H.R. 729 (117th), H.R. 1629 (117th), H.R. 2071 (117th), H.R. 2883 (117th), S. 1435 (117th), S. 1388 (117th), S. 2691 (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 ---Patient Cost-Sharing and Smoothing Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act;H.R.5376 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021

Contacted: SENATE; White House Office; U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Centers For Disease Control & Prevention (CDC); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA); Natl Economic Council (NEC); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); Agriculture, Dept of (USDA)

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

Homeland Security HOM

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

Contacted: Office of Management & Budget (OMB); Food & Drug Administration (FDA); Natl Institutes of Health (NIH); Agriculture, Dept of (USDA); Centers For Disease Control & Prevention (CDC); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Office of Science & Technology Policy (OSTP); Health & Human Services, Dept of (HHS); SENATE; Natl Economic Council (NEC); White House Office

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

Agriculture AGR

Climate Change ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---FY 2022 Appropriations ---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 Funding for the USDA ---FY 2022 Appropriations ---H.R.5376: Build Back Better Act of 2021 Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon Language in Sec. 778 ---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 ---Farm Bill Reauthorization ---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) 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 ---Farm Bill Reauthorization ---Regulatory Treatment of Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Contacted: Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); Centers For Disease Control & Prevention (CDC); Patent & Trademark Office (PTO); Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Natl Institutes of Health (NIH); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Office of Science & Technology Policy (OSTP); White House Office; SENATE

Bills named: H.R. 6119 (117th), H.R. 2820 (117th), H.R. 5376 (117th), S. 1251 (117th), H.R. 273 (117th), H.R. 133 (117th)

Budget/Appropriations BUD

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

Contacted: Environmental Protection Agency (EPA); Agriculture, Dept of (USDA); Natl Institutes of Health (NIH); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Centers For Disease Control & Prevention (CDC); SENATE; White House Office; Natl Economic Council (NEC)

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

Animals ANI

Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon Language in Sec. 778 ---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 ---Farm Bill Reauthorization ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Contacted: Centers For Disease Control & Prevention (CDC); Office of Science & Technology Policy (OSTP); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Natl Economic Council (NEC); Office of Management & Budget (OMB); Environmental Protection Agency (EPA); Patent & Trademark Office (PTO); SENATE; HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Food & Drug Administration (FDA); White House Office; Natl Institutes of Health (NIH)

Bills named: H.R. 273 (117th), H.R. 6119 (117th), H.R. 133 (117th)

Energy/Nuclear ENG

Biofuels (Non-Funding) ---FY 2022 Appropriations ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---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 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 2022 Appropriations ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---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 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---FY 2022 Appropriations ---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: Natl Institutes of Health (NIH); Natl Economic Council (NEC); SENATE; Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Office of Science & Technology Policy (OSTP); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); White House Office; Environmental Protection Agency (EPA); Food & Drug Administration (FDA); Office of Management & Budget (OMB)

Bills named: H.R. 2820 (117th), S. 1251 (117th), S. 2263 (117th), H.R. 133 (117th), H.R. 3440 (117th), H.R. 6119 (117th), H.R. 5376 (117th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) ---FY 2022 Appropriations ---H.R.3440/S.2263: Sustainable Skies Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---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 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 2022 Appropriations ---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021 ---H.R.5376: Build Back Better Act of 2021 ---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 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Renewable Fuel Standard (RFS) ---FY 2022 Appropriations ---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: HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); Environmental Protection Agency (EPA); Natl Economic Council (NEC); Agriculture, Dept of (USDA); SENATE; Centers For Medicare and Medicaid Services (CMS); Centers For Disease Control & Prevention (CDC); Food & Drug Administration (FDA); Natl Institutes of Health (NIH); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); White House Office; Office of Science & Technology Policy (OSTP); Health & Human Services, Dept of (HHS)

Bills named: H.R. 133 (117th), H.R. 6119 (117th), H.R. 3440 (117th), S. 1251 (117th), S. 2263 (117th), H.R. 2820 (117th), H.R. 5376 (117th)

Chemicals/Chemical Industry CHM

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

Contacted: Patent & Trademark Office (PTO); Environmental Protection Agency (EPA); Natl Economic Council (NEC); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); Centers For Disease Control & Prevention (CDC); Food & Drug Administration (FDA); White House Office; Office of Science & Technology Policy (OSTP); Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); SENATE; Agriculture, Dept of (USDA)

Bills named: H.R. 5376 (117th)

Trade (domestic/foreign) TRD

Digital Trade ---EU Digital Strategy 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 Intellectual Property International Enforcement ---China ---TRIPS Waiver US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Trade Organization ---TRIPS Waiver World Health Organization (WHO) ---TRIPS Waiver

Contacted: Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); SENATE; Natl Institutes of Health (NIH); Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Office of Science & Technology Policy (OSTP); Centers For Disease Control & Prevention (CDC); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Agriculture, Dept of (USDA); Environmental Protection Agency (EPA); White House Office; Natl Economic Council (NEC)

Bills named: H.R. 4811 (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 Proxy Advisory Services ---Impact of Policies on Small Public Companies

Contacted: HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Office of Science & Technology Policy (OSTP); Natl Economic Council (NEC); Natl Institutes of Health (NIH); SENATE; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); White House Office; Office of Management & Budget (OMB); Food & Drug Administration (FDA); Agriculture, Dept of (USDA); Centers For Disease Control & Prevention (CDC); Environmental Protection Agency (EPA)

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

Taxation/Internal Revenue Code TAX

Biofuels (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.5376: Build Back Better Act of 2021 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.5376: Build Back Better Act of 2021 ---H.R.7555: A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities ---H.R. 7556: A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---Incentives for Sustainable Aviation Fuels ---Proposed amendments under the Exchange Act of 1934 ---Proposed amendments under the Investment Company Act of 1940 ---Proposed amendments under the Securities Act of 1933 Coronavirus (COVID-19) Pandemic ---H.R.3623: IGNITE American Innovation Act Orphan Drug Issues ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Build Back Better Act of 2021 Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020

Contacted: Office of Science & Technology Policy (OSTP); SENATE; Natl Economic Council (NEC); White House Office; Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Office of Management & Budget (OMB); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Environmental Protection Agency (EPA); Agriculture, Dept of (USDA); Centers For Disease Control & Prevention (CDC)

Bills named: H.R. 3249 (117th), S. 1841 (117th), H.R. 7556 (117th), H.R. 7555 (117th), H.R. 7767 (117th), H.R. 3656 (117th), S. 3087 (117th), H.R. 3623 (117th), H.R. 5376 (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 ---Domestic Manufacturing Requirement ---March-In Rights Compulsory Licensing ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Diversity in Patenting ---H.R.1723/S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---China ---General Patent Reform ---TRIPS Waiver Inter Partes Review ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization Patenting of Humanitarian Technologies ---H.R.5796: Patents for Humanity Act of 2021 US-China Trade Agreement ---IP Provisions

Contacted: Environmental Protection Agency (EPA); Centers For Disease Control & Prevention (CDC); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA); White House Office; Agriculture, Dept of (USDA); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); SENATE; Patent & Trademark Office (PTO); Office of Management & Budget (OMB); Natl Institutes of Health (NIH)

Bills named: S. 2891 (117th), S. 1485 (117th), S. 1428 (117th), H.R. 2873 (117th), S. 225 (117th), H.R. 5796 (117th), H.R. 4811 (117th), H.R. 2883 (117th), H.R. 2884 (117th), H.R. 153 (117th), S. 909 (117th), S. 1260 (117th), S. 2774 (117th), H.R. 1723 (117th), H.R. 2891 (117th), H.R. 2148 (117th), S. 1435 (117th), S. 632 (117th)

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals ---H.R.133: Consolidated Appropriations Act for FY 2021 ------GE Salmon Language in Sec. 778 ---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 ---Farm Bill Reauthorization ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Contacted: Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); Patent & Trademark Office (PTO); White House Office; Centers For Disease Control & Prevention (CDC); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); Natl Economic Council (NEC); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH); Centers For Medicare and Medicaid Services (CMS); SENATE; Office of Science & Technology Policy (OSTP)

Bills named: H.R. 133 (117th), H.R. 6119 (117th), H.R. 273 (117th)

Medical/Disease Research/Clinical Labs MED

Biodefense Research, Development and Procurement Issues (Non-Funding) ---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 ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.8080: Health STATISTICS Act of 2020 ---Coronavirus Emerging Growth Companies (EGC) Extension Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020

Contacted: Food & Drug Administration (FDA); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); SENATE; Office of Management & Budget (OMB); Office of Science & Technology Policy (OSTP); Centers For Disease Control & Prevention (CDC); Natl Institutes of Health (NIH); Patent & Trademark Office (PTO); White House Office; Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR)

Bills named: H.R. 5376 (117th), S. 2076 (117th), H.R. 6119 (117th), H.R. 8080 (117th), H.R. 3932 (117th), H.R. 4127 (117th), H.R. 133 (117th)