BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Agriculture AGR

Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis EPA Regulations on Biotechnology ---EPA Plant Biotech Regulatory Policy ---H.R.4373: Engineering Biology Research and Development Act Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---Korea Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the USDA ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling Genetically Engineered (GE) Plants ---EPA Regulatory Approach to Gene Editing ---FDA Proposed Guidance on Gene Editing The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions US-China Trade Negotiations ---Ag Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---USDA Part 340 Revision

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

Bills named: H.R. 4373 (116th), H.R. 1158 (116th), H.R. 3164 (116th), S. 2522 (116th)

Animals ANI

Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling

Contacted: Natl Economic Council (NEC); SENATE; Agriculture, Dept of (USDA); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; White House Office

Bills named: S. 2522 (116th), H.R. 3164 (116th)

Budget/Appropriations BUD

Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for FDA ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Renewable Chemicals/Bio-based Products ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for the USDA ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 2960 (116th), S. 2520 (116th), H.R. 2740 (116th), H.R. 1865 (116th), H.R. 3052 (116th), H.R. 3163 (116th), S. 2522 (116th), S. 2580 (116th), S. 2470 (116th), H.R. 3164 (116th), H.R. 1158 (116th)

Chemicals/Chemical Industry CHM

Climate Change ---RFI from House Select Committee on the Climate Crisis Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Funding for Renewable Chemicals/Bio-based Products ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Bills named: S. 2522 (116th), S. 999 (116th), H.R. 1158 (116th), S. 2470 (116th), H.R. 2960 (116th), H.R. 3164 (116th), S. 1841 (116th), H.R. 3249 (116th), H.R. 2051 (116th)

Copyright/Patent/Trademark CPT

Bayh-Dole Act/Tech Transfer ---Domestic Manufacturing Requirement ---March-In Rights Compulsory Licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia Inter Partes Review ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---S.440: Preserving Access to Cost Effective Drugs Act (PACED) Act of 2019 Patent Reform ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 Patenting of Biological Inventions ---Argentina Biotech Patentability Guidelines ---DNA Patenting and Licensing ---PTO Examination Guidelines ---Section 101 Modernization The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions

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

Bills named: H.R. 1188 (116th), S. 2082 (116th), H.R. 4398 (116th), H.R. 3991 (116th), S. 659 (116th), H.R. 19 (116th), S. 102 (116th), S. 377 (116th), H.R. 3666 (116th), H.R. 1503 (116th), H.R. 1865 (116th), S. 440 (116th), S. 366 (116th), H.R. 3199 (116th), S. 1416 (116th), H.R. 465 (116th), S. 1895 (116th), S. 3129 (116th), S. 1617 (116th), H.R. 1520 (116th), S. 64 (116th), H.R. 1499 (116th), H.R. 1046 (116th)

Consumer Issues/Safety/Products CSP

Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Provisions on GE Salmon Labeling

Contacted: Natl Economic Council (NEC); White House Office; SENATE; HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Agriculture, Dept of (USDA)

Bills named: H.R. 1046 (116th), S. 97 (116th), S. 2522 (116th), S. 844 (116th), S. 377 (116th), S. 771 (116th), H.R. 3164 (116th)

Energy/Nuclear ENG

Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---RFS Reform ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Small Refinery Waivers

Contacted: SENATE; White House Office; HOUSE OF REPRESENTATIVES

Bills named: S. 2470 (116th), H.R. 3301 (116th), H.R. 1865 (116th), H.R. 3249 (116th), H.R. 2960 (116th), H.R. 3006 (116th), H.R. 3052 (116th), S. 2520 (116th), H.R. 3163 (116th), H.R. 3164 (116th), S. 1841 (116th), S. 2580 (116th), S. 1840 (116th), H.R. 1158 (116th), S. 2522 (116th)

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---FDA Proposed Guidance on Gene Editing ---FDA Regulatory Approach to Animal Biotechnology ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020

Contacted: Natl Economic Council (NEC); SENATE; HOUSE OF REPRESENTATIVES; White House Office; Agriculture, Dept of (USDA); Food & Drug Administration (FDA)

Bills named: H.R. 3164 (116th), S. 2522 (116th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 ---Implementation of the Agriculture Improvement Act of 2018 ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Climate Change ---RFI from House Select Committee on the Climate Crisis Farm Bill Energy Programs ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960/S.2470: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3052/S.2580: Department of the Interior, Environment and Related Agencies Appropriations Act for FY 2020 ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biomass Crop Assistance Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Biorefineries ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2960: Energy and Water Development and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Renewable Fuel Standard (RFS) ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.R.3006: Renewable Fuel Standard Integrity Act of 2019 ---RFS Reform ---S.1840: A bill to establish certain requirements for the small refineries exemption of the renewable fuels provisions under the Clean Air Act, and for other purposes. ---Small Refinery Waivers

Contacted: White House Office; HOUSE OF REPRESENTATIVES; SENATE

Bills named: S. 2580 (116th), S. 1841 (116th), S. 2520 (116th), S. 2522 (116th), H.R. 2960 (116th), H.R. 3249 (116th), S. 2470 (116th), H.R. 1865 (116th), H.R. 3052 (116th), H.R. 3006 (116th), S. 1840 (116th), H.R. 1158 (116th), H.R. 3163 (116th), H.R. 3164 (116th), H.R. 3301 (116th)

Health Issues HCR

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Contacted: White House Office; Council of Economic Advisers (CEA); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); SENATE; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); State, Dept of (DOS); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS)

Bills named: H.R. 1158 (116th), S. 1379 (116th), H.R. 2113 (116th), S. 1895 (116th), H.R. 3 (116th), S. 340 (116th), S. 1872 (116th), H.R. 297 (116th), S. 1224 (116th), S. 3129 (116th), H.R. 749 (116th), H.R. 3991 (116th), H.R. 4398 (116th), S.Con.Res. 25 (116th), S. 64 (116th), H.R. 1865 (116th), H.R. 1188 (116th), H.R. 2069 (116th), S. 3013 (116th), H.R. 275 (116th), S. 844 (116th), H.R. 938 (116th), S. 1416 (116th), S. 377 (116th), H.R. 19 (116th), S. 2543 (116th), H.R. 965 (116th), S. 1227 (116th), H.R. 1093 (116th), H.R. 1973 (116th), H.R. 3199 (116th), S. 660 (116th), H.R. 1520 (116th), S. 97 (116th), S. 771 (116th), H.R. 1046 (116th), H.R. 2740 (116th), H.R. 2374 (116th), S. 1654 (116th), S. 474 (116th), H.R. 269 (116th), S. 476 (116th), S. 378 (116th), H.R. 1499 (116th), S. 99 (116th), H.R. 2376 (116th), S. 2522 (116th), H.R. 1503 (116th), H.R. 2387 (116th), S. 659 (116th), H.R. 488 (116th), S. 2911 (116th), H.R. 3164 (116th), S. 62 (116th), S. 366 (116th), S. 1617 (116th)

Homeland Security HOM

Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills)

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

Bills named: H.R. 2740 (116th), H.R. 269 (116th), S. 1379 (116th)

Medical/Disease Research/Clinical Labs MED

Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills)

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

Bills named: H.R. 2740 (116th), H.R. 269 (116th), S. 1379 (116th)

Medicare/Medicaid MMM

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Biosimilars ---Biosimilar Copay Elimination ---Coding ---Reimbursement 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Drug Pricing ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications

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

Bills named: H.R. 2376 (116th), S. 1895 (116th), S. 771 (116th), S. 3129 (116th), H.R. 1093 (116th), S. 1416 (116th), S. 2911 (116th), H.R. 488 (116th), H.R. 4398 (116th), S. 2543 (116th), H.R. 1046 (116th), H.R. 275 (116th), H.R. 19 (116th), S. 64 (116th), H.R. 2740 (116th), S. 99 (116th), S. 62 (116th), S. 377 (116th), S. 378 (116th), H.R. 3 (116th), S. 3013 (116th), S. 1227 (116th)

Small Business SMB

Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum ---Small Business Capital Formation Enhancement Act Proxy Advisory Services ---Corporate Governance Reform and Transparency ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---Reintroduction of the Fostering Innovation Act in the House of Representatives ---S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Short Selling Transparency

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

Bills named: S. 452 (116th)

Taxation/Internal Revenue Code TAX

Antibiotic & Diagnostic Tax Credit Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Extenders ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.3301: The Taxpayer Certainty and Disaster Tax Relief Act of 2019 Capital Formation Investment Incentives ---Introduction of the American Innovation Act in the Senate ---Reform of Net Operating Loss Rules ---Reintroduction of the American Innovation Act in the House Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 1973 (116th), S. 1841 (116th), S. 1654 (116th), H.R. 3249 (116th), H.R. 3301 (116th)

Trade (domestic/foreign) TRD

Committee on Foreign Investment in the United States (CFIUS) ---Foreign Investment Risk Review Modernization Act (FIRRMA) Implementation Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions ---IP Provisions US-China Trade Negotiations ---Ag Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---IP Provisions

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

Bills named: S. 97 (116th), S. 377 (116th), S. 2522 (116th), H.R. 1046 (116th), S. 771 (116th), H.R. 3164 (116th), S. 844 (116th)

Science/Technology SCI

Engineering Biology ---H.R.4373: Engineering Biology Research and Development Act

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 4373 (116th)