BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Health Issues HCR

340B Drug Discount Program ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples for Testing ---Columbia Biologics Regulation ---Coding ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---H.R. 2871: Preserving Patient Access to Compound Medications Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 International Biosecurity Policies Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Discussion Drafts House/Senate Orphan Drug Issues ---Technical Amendments ---Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act

Contacted: Natl Institutes of Health (NIH); SENATE; Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); Office of Management & Budget (OMB); Natl Security Council (NSC); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; White House Office; Securities & Exchange Commission (SEC); Health Resources & Services Administration (HRSA); Natl Economic Council (NEC); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS)

Bills named: H.R. 1840 (115th), H.R. 4710 (115th), S. 1603 (115th), H.R. 297 (115th), H.R. 3358 (115th), H.R. 2974 (115th), S. 260 (115th), S. 1771 (115th), H.R. 1892 (115th), H.R. 2212 (115th), S. 1688 (115th), H.R. 849 (115th), H.R. 4993 (115th), S. 1348 (115th), S. 1369 (115th), S. 974 (115th), H.R. 2026 (115th), H.R. 3219 (115th), H.R. 242 (115th), H.R. 1703 (115th), H.R. 3268 (115th), H.R. 4138 (115th), S. 204 (115th), S. 771 (115th), H.R. 1625 (115th), H.R. 2871 (115th), S. 2453 (115th), H.R. 878 (115th), S. 469 (115th), H.R. 749 (115th), S. 637 (115th)

Agriculture AGR

Agricultural Education Policy Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program EPA Regulations on Biotechnology ---H.R. 1029 Pesticide Registration Act Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded countries initiatives Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---Potential Revisions to Part 340 Regulations

Contacted: Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); SENATE; U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Natl Security Council (NSC); Food & Drug Administration (FDA); White House Office; Securities & Exchange Commission (SEC); Office of Management & Budget (OMB); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); Health Resources & Services Administration (HRSA); Natl Institutes of Health (NIH)

Bills named: H.R. 1029 (115th), H.R. 5379 (115th), H.R. 3268 (115th), S. 1603 (115th), S. 2615 (115th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---H.R. 3266: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act Review of the Federal Coordinated Framework for Biotechnology Products

Contacted: Securities & Exchange Commission (SEC); Health & Human Services, Dept of (HHS); White House Office; Health Resources & Services Administration (HRSA); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Food & Drug Administration (FDA); Natl Institutes of Health (NIH); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); SENATE; Natl Security Council (NSC); Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); Natl Economic Council (NEC)

Bills named: S. 1603 (115th), S. 1609 (115th), H.R. 3268 (115th), S. 2005 (115th), H.R. 4118 (115th), H.R. 3266 (115th), S. 517 (115th), H.R. 1892 (115th), H.R. 1311 (115th)

Homeland Security HOM

Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018

Contacted: Securities & Exchange Commission (SEC); Health & Human Services, Dept of (HHS); White House Office; Natl Institutes of Health (NIH); Centers For Medicare and Medicaid Services (CMS); SENATE; Agriculture, Dept of (USDA); Environmental Protection Agency (EPA); Office of Management & Budget (OMB); Food & Drug Administration (FDA); Natl Economic Council (NEC); Health Resources & Services Administration (HRSA); Natl Security Council (NSC); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES

Bills named: S. 1771 (115th), H.R. 3358 (115th)

Trade (domestic/foreign) TRD

Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives Foreign Drug Data Protection Laws Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act Intellectual Property International Enforcement ---Compulsory Licensing ---World Trade Organization - Special 301 Submission ---India ---Canada ---Malaysia International IP Patent Law Harmonization North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions ---IP Provisions ---Pricing and Reimbursement Provisions Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals

Contacted: U.S. Trade Representative (USTR); Natl Security Council (NSC); White House Office; SENATE; HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Securities & Exchange Commission (SEC); Environmental Protection Agency (EPA); Natl Institutes of Health (NIH); Agriculture, Dept of (USDA); Health Resources & Services Administration (HRSA); Natl Economic Council (NEC); Food & Drug Administration (FDA); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS)

Bills named: H.R. 5379 (115th), S. 469 (115th), S. 1771 (115th), H.R. 3358 (115th), S. 1603 (115th), H.R. 3268 (115th), S. 771 (115th)

Energy/Nuclear ENG

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Farm Bill Reauthorization ---Production Tax Credit Extension ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program Biorefineries (non-funding) ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---H.R. 3266: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard (RFS) ---Changes to the Point of Obligation under the RFS ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act Review of the Federal Coordinated Framework for Biotechnology Products

Contacted: Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Natl Security Council (NSC); SENATE; Natl Institutes of Health (NIH); Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); Environmental Protection Agency (EPA); Centers For Medicare and Medicaid Services (CMS); White House Office; Natl Economic Council (NEC); Health Resources & Services Administration (HRSA)

Bills named: S. 1609 (115th), H.R. 3266 (115th), S. 2005 (115th), S. 1603 (115th), H.R. 4118 (115th), H.R. 3268 (115th), H.R. 1311 (115th), S. 517 (115th), H.R. 1892 (115th)

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 --------Amendment on GE Salmon Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Contacted: Food & Drug Administration (FDA); Natl Security Council (NSC); Environmental Protection Agency (EPA); Health Resources & Services Administration (HRSA); Natl Economic Council (NEC); SENATE; Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); White House Office

Bills named: H.R. 3268 (115th), S. 1603 (115th)

Taxation/Internal Revenue Code TAX

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act

Contacted: SENATE; White House Office; Natl Economic Council (NEC); Health Resources & Services Administration (HRSA); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Environmental Protection Agency (EPA); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); Securities & Exchange Commission (SEC); Food & Drug Administration (FDA); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR)

Bills named: H.R. 4993 (115th), H.R. 4118 (115th), H.R. 1892 (115th), S. 1980 (115th), H.R. 3149 (115th), H.R. 2297 (115th), S. 2005 (115th)

Copyright/Patent/Trademark CPT

Bayh-Dole Act/Tech Transfer ---March-In Rights Intellectual Property International Enforcement ---Compulsory Licensing ---World Trade Organization - Special 301 Submission ---India ---Canada ---Malaysia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 5340/S. 1390: STRONGER Patents Act ---Biomedical Innovation Protection Act of 2018 (Discussion Draft House/Senate) International IP Patent Law Harmonization North American Free Trade Agreement (NAFTA) Renegotiation ---IP Provisions Patent Reform ---H.R. 5340/S. 1390: STRONGER Patents Act Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act UN High Level Commission on Access to Medicines ---IP Proposals

Contacted: Securities & Exchange Commission (SEC); Food & Drug Administration (FDA); Health Resources & Services Administration (HRSA); Agriculture, Dept of (USDA); White House Office; SENATE; Natl Security Council (NSC); Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); Office of Management & Budget (OMB); Natl Economic Council (NEC); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH)

Bills named: H.R. 2655 (115th), H.R. 5340 (115th), S. 1390 (115th)

Small Business SMB

Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act

Contacted: Health & Human Services, Dept of (HHS); Health Resources & Services Administration (HRSA); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Securities & Exchange Commission (SEC); Natl Security Council (NSC); White House Office; Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); Natl Institutes of Health (NIH); Natl Economic Council (NEC); Office of Management & Budget (OMB); SENATE; Environmental Protection Agency (EPA); HOUSE OF REPRESENTATIVES

Bills named: H.R. 10 (115th), H.R. 2655 (115th), S. 2126 (115th), H.R. 5054 (115th), H.R. 1645 (115th), H.R. 4015 (115th)

Medicare/Medicaid MMM

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations for FY 2018

Contacted: U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); Office of Management & Budget (OMB); Natl Institutes of Health (NIH); Health Resources & Services Administration (HRSA); Food & Drug Administration (FDA); Natl Security Council (NSC); SENATE; Securities & Exchange Commission (SEC); White House Office; Centers For Medicare and Medicaid Services (CMS); Natl Economic Council (NEC)

Bills named: H.R. 1625 (115th), H.R. 1892 (115th), S. 771 (115th), S. 1688 (115th), H.R. 4138 (115th), H.R. 242 (115th)

Budget/Appropriations BUD

Energy Basic Research Funding ---Advanced Research Projects Agency-Energy ---H.R.3266: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biofuels ---Farm Bill Reauthorization ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Foreign Agriculture Service Funding and Authority ------H.R. 5379: Growing American Food Exports Act

Contacted: Natl Institutes of Health (NIH); SENATE; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); White House Office; Environmental Protection Agency (EPA); Natl Security Council (NSC); Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); Securities & Exchange Commission (SEC); Health Resources & Services Administration (HRSA); Food & Drug Administration (FDA)

Bills named: S. 1603 (115th), H.R. 3266 (115th), H.R. 3268 (115th), S. 1609 (115th), S. 1771 (115th), H.R. 3358 (115th), H.R. 5379 (115th)

Animals ANI

Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling One Health ---S. 2615: Advancing Emergency Preparedness Through One Health Act

Contacted: Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); Agriculture, Dept of (USDA); White House Office; Centers For Medicare and Medicaid Services (CMS); SENATE; U.S. Trade Representative (USTR); Natl Economic Council (NEC); Health Resources & Services Administration (HRSA); Environmental Protection Agency (EPA)

Bills named: H.R. 3268 (115th), S. 2615 (115th), S. 1603 (115th)

Chemicals/Chemical Industry CHM

Funding for Renewable Chemicals/Bio-based Products ---Farm Bill Reauthorization ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program ---Nomenclature Usage ---Farm Bill Reauthorization ---H.R. 3149/S.1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S.2005: Master Limited Partnership Parity Act

Contacted: U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Natl Security Council (NSC); Securities & Exchange Commission (SEC); Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); Health Resources & Services Administration (HRSA); HOUSE OF REPRESENTATIVES; White House Office; Environmental Protection Agency (EPA); SENATE; Natl Economic Council (NEC); Natl Institutes of Health (NIH); Food & Drug Administration (FDA)

Bills named: H.R. 4118 (115th), S. 2005 (115th), S. 1603 (115th), H.R. 3268 (115th), S. 1980 (115th), H.R. 3149 (115th)

Consumer Issues/Safety/Products CSP

Drug Importation ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Discussion Drafts House/Senate Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Contacted: Natl Security Council (NSC); Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); White House Office; Securities & Exchange Commission (SEC); Health Resources & Services Administration (HRSA); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); Natl Economic Council (NEC); SENATE; Agriculture, Dept of (USDA); Office of Management & Budget (OMB); Food & Drug Administration (FDA)

Bills named: H.R. 3268 (115th), S. 1603 (115th), S. 771 (115th), S. 469 (115th), S. 1771 (115th), H.R. 3358 (115th)

Medical/Disease Research/Clinical Labs MED

Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018

Contacted: SENATE; Centers For Medicare and Medicaid Services (CMS); Securities & Exchange Commission (SEC); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); Food & Drug Administration (FDA); Environmental Protection Agency (EPA); White House Office; Natl Security Council (NSC); Health & Human Services, Dept of (HHS); Natl Economic Council (NEC); Health Resources & Services Administration (HRSA); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH)

Bills named: S. 1603 (115th), H.R. 3268 (115th), S. 1771 (115th), H.R. 3358 (115th)