BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Health Issues HCR

340B Drug Discount Program ---Program Implementation & Oversight ---340B Pause Act (Discussion Draft House/Senate) ---340B Optimization Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of the 21st Century Cures Act of 2016 ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Reauthorization of the Pandemic and All Hazards Preparedness Act ---H.R.269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---National Biodefense Strategy ---Gene Editing Biosimilars ---Access to Samples for Testing ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Brazil Biologics Regulations ---Coding ---Naming ---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 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---S.659: Biologic Patent Transparency Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 Drug Evaluation and Review ---H.R.1503: Orange Book Transparency Act of 2019 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S. 97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S. 844: Short on Competition Act of 2019 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---S.551: REFUND Act of 2019 ---Supply Chain Integrity and Traceability Drug Pricing ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Pricing Transparency ---H.R.965/S.340: CREATES 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.2113: Prescription Drug STAR Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.99: Medicare Drug Price Negotiation Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.844: Short on Competition Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act Foreign Drug Data Protection Laws ---China Funding for Antimicrobial Resistance Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for National Institutes of Health ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Drug Entry ---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 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 Medicare Expansion ---H.R.1384: Medicare for All Act of 2019 ---S.1129: A bill to establish a Medicare-for-all national health insurance program of 2019 Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions Opioid Crisis ---NIH Research ---Coverage and Reimbursement ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Protected Classes ---Step Therapy ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Administration Rebate Rule ---Surprise Billing ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.99: Medicare Drug Price Negotiation Act of 2019 Trade and Foreign Drug Price Controls Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Vaccine Injury Compensation Tax ---H.R.1973: Vaccine Access Improvement Act of 2019 ---Reintroduction of the Vaccine Access Improvement Act in the Senate

Contacted: State, Dept of (DOS); Natl Institutes of Health (NIH); Treasury, Dept of; Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); Food & Drug Administration (FDA); SENATE; HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); White House Office; Securities & Exchange Commission (SEC); Office of Management & Budget (OMB); Commerce, Dept of (DOC); Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO)

Bills named: H.R. 1093 (116th), H.R. 1503 (116th), H.J.Res. 31 (116th), H.R. 2069 (116th), S. 62 (116th), S. 659 (116th), S. 476 (116th), H.R. 1499 (116th), S. 340 (116th), H.R. 1188 (116th), H.R. 1520 (116th), S. 1129 (116th), S. 99 (116th), H.R. 1046 (116th), H.R. 275 (116th), H.R. 2113 (116th), S. 474 (116th), H.R. 269 (116th), S. 551 (116th), H.R. 938 (116th), H.R. 965 (116th), S. 64 (116th), H.R. 1384 (116th), S. 97 (116th), S. 377 (116th), H.R. 1973 (116th), H.R. 1959 (116th), S. 844 (116th), S. 378 (116th), S. 366 (116th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Entenders ---Implementation of the Agriculture Improvement Act of 2018 ---Master Limited Partnership Parity Act (Discussion Draft Senate) ---Clean Energy for America Act (Discussion Draft Senate) Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (non-funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biorefineries ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Renewable Fuel Standard (RFS) ---RFS Reform ---Small Refinery Waivers ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.J.Res.31: Consolidated Appropriations Act for FY 2019

Contacted: Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); Environmental Protection Agency (EPA); Food & Drug Administration (FDA); SENATE; Agriculture, Dept of (USDA); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); White House Office; U.S. Trade Representative (USTR); State, Dept of (DOS); Treasury, Dept of; Securities & Exchange Commission (SEC); Natl Institutes of Health (NIH); Commerce, Dept of (DOC)

Bills named: H.J.Res. 31 (116th)

Animals ANI

Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labeling

Contacted: White House Office; U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Agriculture, Dept of (USDA); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); SENATE; Health & Human Services, Dept of (HHS); Commerce, Dept of (DOC); Environmental Protection Agency (EPA); Natl Institutes of Health (NIH); Securities & Exchange Commission (SEC); Treasury, Dept of; State, Dept of (DOS)

Bills named: H.J.Res. 31 (116th)

Agriculture AGR

Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 EPA Regulations on Biotechnology ---Efficient Science-Based Reviews of Biotech Products ---Regulatory Treatment of Gene Edited Products ---S.483: Pesticide Registration Improvement Extension Act of 2018 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations ---Like-minded Countries Initiatives Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labeling Genetically Engineered (GE) Plants ---FDA Proposed Guidance on Gene Editing Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations ---Regulatory Treatment of Gene Edited Products The United States-Mexico-Canada Agreement ---Ag-Biotech Provisions US-EU Trade Agreement ---Ag-Biotech Provisions

Contacted: Environmental Protection Agency (EPA); SENATE; HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Natl Institutes of Health (NIH); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); State, Dept of (DOS); Securities & Exchange Commission (SEC); Patent & Trademark Office (PTO); Agriculture, Dept of (USDA); Treasury, Dept of; White House Office; Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS)

Bills named: S. 483 (116th), H.J.Res. 31 (116th)

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Contacted: Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Securities & Exchange Commission (SEC); Environmental Protection Agency (EPA); White House Office; Treasury, Dept of; Commerce, Dept of (DOC); State, Dept of (DOS); Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); Office of Management & Budget (OMB); Natl Institutes of Health (NIH); Centers For Medicare and Medicaid Services (CMS); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.J.Res. 31 (116th)

Trade (domestic/foreign) TRD

Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S. 97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S. 844: Short on Competition Act of 2019 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Japan Biotechnology Regulations ---Korea Biotechnology Regulations ---Like-minded Countries Initiatives Foreign Drug Data Protection Laws ---China Intellectual Property International Enforcement ---Compulsory Licensing ---China ---Malaysia ---India The United States-Mexico-Canada Agreement ---IP Provisions ---Ag-Biotech Provisions Trade and Foreign Drug Price Controls Committee on Foreign Investment in the United States (CFIUS) ---Foreign Investment Risk Review Modernization Act (FIRRMA) Implementation US-UK Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions ---Ag-Biotech Provisions US-Japan Trade Agreement ---IP Provisions World Trade Organization - Special 301 Submissions ---Canada ---China ---India ---Latin America ---Malaysia ---Middle East

Contacted: White House Office; Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Agriculture, Dept of (USDA); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; State, Dept of (DOS); Treasury, Dept of; Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); Natl Institutes of Health (NIH); Securities & Exchange Commission (SEC); SENATE; U.S. Trade Representative (USTR); Food & Drug Administration (FDA)

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

Taxation/Internal Revenue Code TAX

Antibiotic & Diagnostic Tax Credit Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Entenders ---Master Limited Partnership Parity Act (Discussion Draft Senate) Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---Reintroduction of the American Innovation Act in the House ---Introduction of the American Innovation Act in the Senate Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Master Limited Partnership Parity Act (Discussion Draft Senate) Qualified Small Business Stock (QSBS) Research & Development Tax Credit Reforms ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Tax ---H.R.1973: Vaccine Access Improvement Act of 2019 ---Reintroduction of the Vaccine Access Improvement Act in the Senate

Contacted: Treasury, Dept of; U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); State, Dept of (DOS); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); Commerce, Dept of (DOC); Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH); Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Agriculture, Dept of (USDA); SENATE; White House Office

Bills named: H.R. 1973 (116th)

Copyright/Patent/Trademark CPT

Bayh-Dole Act/Tech Transfer ---March-In Rights Compulsory Licensing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 Intellectual Property International Enforcement ---Compulsory Licensing ---China ---India ---Malaysia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 990/S.344 Hatch-Waxman Integrity Act of 2019 ---STRONGER Patents Act (Discussion Draft House/Senate) Diversity in Patenting Drug Patent Settlements ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act Foreign Drug Data Protection Laws ---China Patenting of Biological Inventions ---Argentina Biotech Patentability Guidelines ---DNA Patenting and Licensing ---PTO Examination Guidelines ---Section 101 Modernization Patent Reform ---Patent Litigation Reform ---STRONGER Patents Act (Discussion Draft House/Senate) The United States-Mexico-Canada Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions World Trade Organization - Special 301 Submissions ---Canada ---China ---India ---Latin America ---Malaysia ---Middle East

Contacted: Food & Drug Administration (FDA); Natl Institutes of Health (NIH); Environmental Protection Agency (EPA); Securities & Exchange Commission (SEC); Treasury, Dept of; Health & Human Services, Dept of (HHS); White House Office; State, Dept of (DOS); SENATE; Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Agriculture, Dept of (USDA); Office of Management & Budget (OMB)

Bills named: H.R. 1499 (116th), S. 64 (116th), H.R. 1188 (116th), S. 344 (116th), S. 366 (116th), H.R. 990 (116th), S. 377 (116th), H.R. 465 (116th), S. 102 (116th), H.R. 1046 (116th)

Small Business SMB

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: Securities & Exchange Commission (SEC); U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); State, Dept of (DOS); Food & Drug Administration (FDA); Office of Management & Budget (OMB); SENATE; Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); White House Office; Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; Patent & Trademark Office (PTO); Natl Institutes of Health (NIH)

Bills named: S. 452 (116th)

Medicare/Medicaid MMM

Medicare Expansion ---H.R.1384: Medicare for All Act of 2019 ---S.1129: A bill to establish a Medicare-for-all national health insurance program of 2019 Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement and Coverage of Innovative Products ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Protected Classes ---Step Therapy ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Administration Rebate Rule ---Surprise Billing ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.99: Medicare Drug Price Negotiation Act of 2019

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); SENATE; Agriculture, Dept of (USDA); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); White House Office; State, Dept of (DOS); Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Treasury, Dept of; Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); Commerce, Dept of (DOC)

Bills named: S. 99 (116th), S. 1129 (116th), H.R. 1384 (116th), S. 62 (116th), H.R. 275 (116th)

Budget/Appropriations BUD

Funding for Antimicrobial Resistance Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biofuels ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biorefineries ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for National Institutes of Health ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Renewable Chemicals/Bio-based Products ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate)

Contacted: Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); White House Office; Centers For Medicare and Medicaid Services (CMS); State, Dept of (DOS); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); Securities & Exchange Commission (SEC); Treasury, Dept of; U.S. Trade Representative (USTR); SENATE; Food & Drug Administration (FDA); Commerce, Dept of (DOC); Natl Institutes of Health (NIH); Patent & Trademark Office (PTO)

Bills named: H.J.Res. 31 (116th)

Chemicals/Chemical Industry CHM

Funding for Renewable Chemicals/Bio-based Products ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Renewable Chemicals/Bio-based Products (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 ---Investment Tax Credit ---Master Limited Partnership Parity Act (Discussion Draft Senate) ---Production Tax Credit ---H.R.2051/S.999: Sustainable Chemistry Research and Development Act of 2019

Contacted: Patent & Trademark Office (PTO); Natl Institutes of Health (NIH); SENATE; Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Securities & Exchange Commission (SEC); U.S. Trade Representative (USTR); White House Office; Treasury, Dept of; Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); Office of Management & Budget (OMB); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); State, Dept of (DOS); Food & Drug Administration (FDA)

Bills named: H.J.Res. 31 (116th), H.R. 2051 (116th), S. 999 (116th)

Consumer Issues/Safety/Products CSP

Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.844: Short on Competition Act of 2019 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to restrict FDA Approval of GE Salmon ---Efficient Science-Based Review of Biotech Products ---FDA Approval ---FDA Proposed Guidance on Gene Editing ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labeling Opioid Crisis ---NIH Research ---Coverage and Reimbursement ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Contacted: Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); Natl Institutes of Health (NIH); Commerce, Dept of (DOC); Agriculture, Dept of (USDA); Treasury, Dept of; U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); Environmental Protection Agency (EPA); State, Dept of (DOS); Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); White House Office

Bills named: S. 844 (116th), H.R. 1046 (116th), S. 377 (116th), H.J.Res. 31 (116th), S. 97 (116th)

Energy/Nuclear ENG

Biofuels (Non-Funding) ---Advanced and Second Generation Biofuels Tax Entenders ---Implementation of the Agriculture Improvement Act of 2018 ---Master Limited Partnership Parity Act (Discussion Draft Senate) ---Clean Energy for America Act (Discussion Draft Senate) Biomass Programs (Non-Funding) ---Implementation of the Agriculture Improvement Act of 2018 Biorefineries (non-funding) ---Implementation of the Agriculture Improvement Act of 2018 Funding for Biofuels ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Energy and Water Development and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biomass Crop Assistance Program ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biorefineries ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) ---Interior, Environment and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Renewable Fuel Standard (RFS) ---RFS Reform ---Small Refinery Waivers ---Cellulosic Registration Applications for Corn Kernel Fiber ---E 15 EPA Implementation of RVP Waiver ---H.J.Res.31: Consolidated Appropriations Act for FY 2019

Contacted: Natl Institutes of Health (NIH); State, Dept of (DOS); Treasury, Dept of; Patent & Trademark Office (PTO); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Securities & Exchange Commission (SEC); Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); White House Office; SENATE; Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); Commerce, Dept of (DOC)

Bills named: H.J.Res. 31 (116th)

Homeland Security HOM

Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of the 21st Century Cures Act of 2016 ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Reauthorization of the Pandemic and All Hazards Preparedness Act ---H.R.269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---National Biodefense Strategy ---Gene Editing Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate)

Contacted: State, Dept of (DOS); Patent & Trademark Office (PTO); Commerce, Dept of (DOC); SENATE; HOUSE OF REPRESENTATIVES; Securities & Exchange Commission (SEC); Centers For Medicare and Medicaid Services (CMS); Agriculture, Dept of (USDA); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); White House Office; Natl Institutes of Health (NIH); U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); Treasury, Dept of

Bills named: H.R. 269 (116th), H.J.Res. 31 (116th)

Medical/Disease Research/Clinical Labs MED

Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of the 21st Century Cures Act of 2016 ---Tropical Disease Priority Review Voucher (PRV) Program ---Reauthorization of the Pandemic and All Hazards Preparedness Act ---Implementation of Medical Countermeasures Innovation Act ---H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---National Biodefense Strategy ---Gene Editing Funding for Antimicrobial Resistance Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate) Funding for National Institutes of Health ---H.J.Res.31: Consolidated Appropriations Act for FY 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft House/Senate)

Contacted: Treasury, Dept of; Office of Management & Budget (OMB); Environmental Protection Agency (EPA); Health & Human Services, Dept of (HHS); Commerce, Dept of (DOC); Natl Institutes of Health (NIH); Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; White House Office; SENATE; State, Dept of (DOS); Agriculture, Dept of (USDA)

Bills named: H.R. 269 (116th), H.J.Res. 31 (116th)