BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Agriculture AGR

Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions US-China Trade Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions US-UK Trade Agreement ---Ag-Biotech Provisions USDA/APHIS Agricultural Biotechnology Regulations ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Regulatory Treatment of Gene Edited Products ---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act ---USDA Part 340 Draft Rule

Contacted: SENATE; U.S. Trade Representative (USTR); Natl Economic Council (NEC); Food & Drug Administration (FDA); State, Dept of (DOS); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES

Bills named: S. 1903 (116th), S. 3894 (116th), H.R. 3771 (116th), H.R. 7393 (116th), H.R. 6800 (116th)

Animals ANI

Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology

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

Bills named: S. 1903 (116th), H.R. 3771 (116th), H.R. 6800 (116th)

Budget/Appropriations BUD

Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX

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

Bills named: H.R. 6379 (116th), H.R. 2 (116th), H.R. 6800 (116th), H.R. 266 (116th)

Chemicals/Chemical Industry CHM

Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Renewable Chemicals/Bio-based Products ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 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 ---H.R.6395: William M. (Mac) Thornberry National Defense Authorization Act for FY 2021 ---S.4049: National Defense Authorization Act for FY 2021 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Production Tax Credit ---Sustainable Chemistry Research and Development

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 2051 (116th), S. 999 (116th), S. 3894 (116th), H.R. 6395 (116th), H.R. 3249 (116th), H.R. 7393 (116th), S. 4049 (116th), S. 1841 (116th)

Copyright/Patent/Trademark CPT

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Contacted: HOUSE OF REPRESENTATIVES; SENATE; Patent & Trademark Office (PTO); Health & Human Services, Dept of (HHS); State, Dept of (DOS); U.S. Trade Representative (USTR); Commerce, Dept of (DOC); Office of the Vice President of the United States

Bills named: S. 2814 (116th), H.R. 4398 (116th), S. 3952 (116th), H.R. 1499 (116th), H.R. 5133 (116th), H.R. 3991 (116th), H.R. 6800 (116th), H.R. 7259 (116th), S. 1416 (116th), S. 2387 (116th)

Consumer Issues/Safety/Products CSP

Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology

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

Bills named: H.R. 3771 (116th), H.R. 6800 (116th), S. 1903 (116th)

Energy/Nuclear ENG

Biofuels (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---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. ---S.3986: 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 ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers

Contacted: SENATE; Environmental Protection Agency (EPA); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Office of Management & Budget (OMB)

Bills named: S. 1840 (116th), S. 1841 (116th), H.R. 7393 (116th), H.R. 2 (116th), H.R. 7330 (116th), S. 3894 (116th), H.R. 6379 (116th), S. 1288 (116th), S. 3986 (116th), H.R. 3249 (116th), H.R. 6800 (116th), H.R. 4385 (116th), S. 3938 (116th), H.R. 3006 (116th)

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals ---H.R.3771/S.1903: Advancing Emergency Preparedness Through One Health Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ------Amendment on GE Salmon Labeling ---FDA Regulatory Approach to Animal Biotechnology

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

Bills named: S. 1903 (116th), H.R. 3771 (116th), H.R. 6800 (116th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act of 2020 ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.7330: Growing Renewable Energy and Efficiency Now (GREEN) Act ---S.1288: Clean Energy for America Act of 2019 ---S.3938: A bill to extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. ---RFI from House Select Committee on the Climate Crisis ---Sustainable Aviation Fuels Tax Credit Climate Change ---H.R.7393/S.3894: The Growing Climate Solutions Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---RFI from House Select Committee on the Climate Crisis Funding for Biofuels ---H.R.2: The Moving Forward Act of 2020 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels ---Transportation, and Housing and Urban Development, and Related Agencies Act for FY 2021 Funding for Biomass Crop Assistance Program ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Biorefineries ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2021 RFS (Renewable Fuel Standard) ---H.R.3006: Support RFS Integrity Act of 2019 ---H.R.4385: Small Refinery Exemption Fairness Act of 2019 ---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. ---S.3986: 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 ---Cellulosic Registration Applications for Corn Kernel Fiber ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Economic Hardship Waiver of the Renewable Volume Obligations (RVO) for 2020 ---Implementation of the Agriculture Improvement Act of 2018 ---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel ---RFI from House Select Committee on the Climate Crisis ---RFS Reform ---Small Refinery Waivers

Contacted: Office of Management & Budget (OMB); Environmental Protection Agency (EPA); Natl Economic Council (NEC); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 6800 (116th), S. 1840 (116th), S. 1841 (116th), S. 3894 (116th), H.R. 2 (116th), S. 3938 (116th), H.R. 7393 (116th), H.R. 7330 (116th), S. 3986 (116th), H.R. 6379 (116th), S. 1288 (116th), H.R. 3006 (116th), H.R. 3249 (116th), H.R. 4385 (116th)

Health Issues HCR

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---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.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---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.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Contacted: Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); Natl Security Council (NSC); Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); U.S. Trade Representative (USTR); SENATE; Office of the Vice President of the United States; White House Office

Bills named: H.R. 2376 (116th), H.R. 5741 (116th), S. 378 (116th), H.R. 4398 (116th), H.R. 6260 (116th), S. 474 (116th), S. 1872 (116th), S. 1712 (116th), H.R. 2113 (116th), S. 1619 (116th), S. 3872 (116th), H.R. 6206 (116th), S. 2326 (116th), H.R. 4439 (116th), H.R. 5133 (116th), S. 377 (116th), H.R. 4712 (116th), H.R. 4100 (116th), H.R. 6800 (116th), H.R. 5122 (116th), H.R. 7288 (116th), S. 1227 (116th), H.R. 3991 (116th), H.R. 1046 (116th), S. 2543 (116th), S. 3545 (116th), H.R. 1425 (116th), H.R. 2862 (116th), H.R. 5076 (116th), S. 1617 (116th), S. 1416 (116th), S. 4010 (116th), H.R. 2069 (116th), H.R. 1093 (116th), H.R. 1499 (116th), H.R. 275 (116th)

Homeland Security HOM

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 6800 (116th)

Medical/Disease Research/Clinical Labs MED

Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021

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

Bills named: H.R. 7288 (116th), H.R. 6800 (116th)

Medicare/Medicaid MMM

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---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.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020

Contacted: Office of the Vice President of the United States; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); White House Office; Health & Human Services, Dept of (HHS); SENATE; Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES

Bills named: H.R. 4398 (116th), H.R. 5133 (116th), S. 1712 (116th), S. 377 (116th), S. 2543 (116th), S. 378 (116th), H.R. 3991 (116th), H.R. 7288 (116th), H.R. 5741 (116th), S. 1872 (116th), H.R. 5122 (116th), S. 2326 (116th), H.R. 2376 (116th), H.R. 1046 (116th), S. 1227 (116th), H.R. 4100 (116th), H.R. 6800 (116th), S. 1416 (116th), H.R. 5076 (116th), H.R. 1093 (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 Coronavirus (COVID-19) Pandemic ---NOL Monetization ---Pause on Graduating from ECG Status (ECG Pause) ---Small Business Loans ---R&D Credit Temporary Refundability Coronavirus (COVID-19) Small Business Loans (Non-Funding) ---H.R.266: Paycheck Protection Program and Health Care Enhancement Act of 2020 ---Affiliation ---CARES Act Payroll Protection Loan Program Implementation ---Eligibility ---Payroll Tax Deferral Funding for Coronavirus (COVID-19) Small Business Loans --- H.R.266: Paycheck Protection Program and Health Care Enhancement Act Proxy Advisory Services ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R.3886/S.452: Fostering Innovation Act of 2019 ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program

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

Bills named: H.R. 266 (116th), H.R. 3886 (116th), S. 452 (116th)

Taxation/Internal Revenue Code TAX

Biofuels (Non-Funding) ---H.R.2: The Moving Forward Act ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---H.R.6379: Take Responsibility for Workers and Families Act of 2020 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Incentives for Sustainable Aviation Fuels Capital Formation Incentives ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Incentives for Sustainable Aviation Fuels ---Infectious Disease Therapies Research and Innovation Act (Discussion Draft) ---Introduction of the American Innovation Act in the Senate ---Reintroduction of the American Innovation Act in the House ---NOL Monetization ---Reform of Net Operating Loss Rules ---Start-ups for Cures Act (Discussion Draft) ---The More Cures Act (Discussion Draft) Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R.3249/S.1841: Financing Our Energy Future Act of 2019 ---Climate Leadership and Environmental Action for our Nations (CLEAN) Future Act (Discussion Draft House) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Expensing of R&D Expenditures ---Incentives for Sustainable Aviation Fuels ---R&D Credit Temporary Refundability ---R&D Payroll Credit

Contacted: HOUSE OF REPRESENTATIVES; Small Business Administration (SBA); SENATE; Treasury, Dept of

Bills named: H.R. 2 (116th), H.R. 6379 (116th), H.R. 3249 (116th), S. 1841 (116th), H.R. 6800 (116th)

Trade (domestic/foreign) TRD

CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Drug Pricing ---International Pricing Index Proposal Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations Foreign Drug Data Protection Laws ---Regulatory Harmonization Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-EU Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Japan Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-Kenya Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization US-UK Trade Agreement ---Ag-Biotech Provisions ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)

Contacted: Agriculture, Dept of (USDA); State, Dept of (DOS); Natl Security Council (NSC); U.S. Trade Representative (USTR); Natl Economic Council (NEC); SENATE; Treasury, Dept of; HOUSE OF REPRESENTATIVES

Bills named: S. 3952 (116th)

Science/Technology SCI

Engineering Biology ---H.R.4373 Engineering Biology Research and Development Act ---S.3734: Bioeconomy Research and Development Act of 2020

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 4373 (116th), S. 3734 (116th)