BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Budget/Appropriations BUD

Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biofuels ---Department of Defense Application and Funding of Advanced 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 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biorefineries ---Department of Defense Application and Funding of Advanced Biofuels ---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 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State ---S.1780/H.R.3362: Department of State, Foreign Operations, and Related Programs Appropriations Act for FY 2018

Contacted: Health Resources & Services Administration (HRSA); White House Office; Natl Security Council (NSC); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Defense, Dept of (DOD); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Office of the Vice President of the United States; U.S. Trade Representative (USTR); Natl Economic Council (NEC); Health & Human Services, Dept of (HHS); Centers For Disease Control & Prevention (CDC); SENATE; Commerce, Dept of (DOC); Natl Institutes of Health (NIH)

Bills named: S. 1609 (115th), H.R. 3266 (115th), S. 1771 (115th), H.R. 3268 (115th), H.R. 3358 (115th), H.R. 3362 (115th), S. 1603 (115th), H.R. 3419 (115th), H.R. 3219 (115th), S. 1780 (115th), H.R. 3354 (115th), H.R. 2810 (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. 3419: The Farewell to Unnecessary Energy Lifelines Act Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biofuels ---Department of Defense Application and Funding of Advanced 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 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biorefineries ---Department of Defense Application and Funding of Advanced Biofuels ---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 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---Notice of Data Availability (NODA) Related to 2018 RFS Volumes ---Proposed Rule for 2018 Volumes ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R. 3268/S. 1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018

Contacted: HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); Natl Security Council (NSC); Office of the Vice President of the United States; Commerce, Dept of (DOC); Natl Economic Council (NEC); SENATE; Agriculture, Dept of (USDA); Health & Human Services, Dept of (HHS); Health Resources & Services Administration (HRSA); Natl Institutes of Health (NIH); Food & Drug Administration (FDA); White House Office; U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); Defense, Dept of (DOD)

Bills named: S. 1609 (115th), S. 517 (115th), H.R. 3266 (115th), H.R. 2810 (115th), S. 1603 (115th), H.R. 1311 (115th), H.R. 3419 (115th), H.R. 3268 (115th), H.R. 3354 (115th)

Health Issues HCR

340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations 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 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability 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 ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS Act of 2017 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 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

Contacted: Natl Security Council (NSC); Commerce, Dept of (DOC); Health Resources & Services Administration (HRSA); Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); Natl Economic Council (NEC); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; White House Office; U.S. Trade Representative (USTR); Office of the Vice President of the United States; Health & Human Services, Dept of (HHS); Defense, Dept of (DOD); Natl Institutes of Health (NIH); Food & Drug Administration (FDA); SENATE; Centers For Disease Control & Prevention (CDC)

Bills named: S. 469 (115th), S. 1603 (115th), S. 934 (115th), H.R. 1840 (115th), S. 204 (115th), H.R. 3921 (115th), S. 1348 (115th), S. 260 (115th), S. 637 (115th), H.R. 2212 (115th), S. 1369 (115th), H.R. 3354 (115th), H.R. 878 (115th), H.R. 3268 (115th), H.R. 2430 (115th), H.R. 3358 (115th), S. 771 (115th), H.R. 297 (115th), H.R. 1231 (115th), S. 1681 (115th), S. 1688 (115th), H.R. 749 (115th), S. 1771 (115th), H.R. 3219 (115th), S. 974 (115th), H.R. 2974 (115th), S. 456 (115th)

Animals ANI

Genetically Engineered (GE) ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling

Contacted: Health Resources & Services Administration (HRSA); Centers For Disease Control & Prevention (CDC); Office of the Vice President of the United States; U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Defense, Dept of (DOD); White House Office; Natl Institutes of Health (NIH); HOUSE OF REPRESENTATIVES; Natl Security Council (NSC); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); SENATE; Agriculture, Dept of (USDA)

Bills named: H.R. 3268 (115th), H.R. 3354 (115th), S. 1603 (115th)

Trade (domestic/foreign) TRD

Biosimilars ---Brazil Biologics Regulations ---India Biologics Regulations ---Mexico Biologics Regulations Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing ---Saudi Arabia North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals

Contacted: Food & Drug Administration (FDA); Centers For Disease Control & Prevention (CDC); Natl Institutes of Health (NIH); SENATE; U.S. Trade Representative (USTR); Office of Management & Budget (OMB); White House Office; Agriculture, Dept of (USDA); Natl Security Council (NSC); Health Resources & Services Administration (HRSA); Office of the Vice President of the United States; Commerce, Dept of (DOC); Defense, Dept of (DOD); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES

Bills named: S. 771 (115th), S. 934 (115th), H.R. 3268 (115th), S. 1771 (115th), H.R. 3354 (115th), S. 1603 (115th), S. 469 (115th), H.R. 3358 (115th), H.R. 2430 (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 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act EPA Regulations on Biotechnology ---Efficient Science-Based Review of Biotech Products ---H.R. 1029: Pesticide Registration Improvement Extension Act of 2017 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for the USDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling North American Free Trade Agreement (NAFTA) Renegotiation ---Ag-Biotech Provisions One Health ---The One Health Act (Sen. Franken Discussion Draft) Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law Review of the Federal Coordinated Framework for Biotechnology Products USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Farm Bill Reauthorization ---Potential Revisions to Part 340 Regulations

Contacted: Defense, Dept of (DOD); White House Office; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Office of the Vice President of the United States; Natl Institutes of Health (NIH); U.S. Trade Representative (USTR); SENATE; Commerce, Dept of (DOC); Office of Management & Budget (OMB); Natl Economic Council (NEC); Natl Security Council (NSC); Centers For Disease Control & Prevention (CDC); Health Resources & Services Administration (HRSA); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 3419 (115th), H.R. 1029 (115th), H.R. 3354 (115th), H.R. 3268 (115th), S. 1603 (115th)

Taxation/Internal Revenue Code TAX

Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension 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 Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149: Renewable Chemicals Act of 2017 ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft) Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations

Contacted: SENATE; Food & Drug Administration (FDA); Natl Security Council (NSC); Natl Economic Council (NEC); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Office of the Vice President of the United States; Natl Institutes of Health (NIH); Office of Management & Budget (OMB); Health Resources & Services Administration (HRSA); White House Office; Defense, Dept of (DOD); Agriculture, Dept of (USDA); Centers For Disease Control & Prevention (CDC); Commerce, Dept of (DOC)

Bills named: H.R. 2297 (115th), H.R. 1840 (115th), H.R. 3149 (115th)

Copyright/Patent/Trademark CPT

Asia Pacific Economic Cooperation Forum ---Biologics Regulations Bayh-Dole Act/Tech Transfer ---Commercialization of Federally Funded Research Initiative ---March-In Rights -------National Defense Authorization Act for 2018 (Sen. King Amendment) ---S.1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing ---Saudi Arabia Inter Partes Review ---Implementation of the America Invents Act of 2011 ---S. 1390: STRONGER Patents Act Patent Reform ---Patent Litigation Reforms ---S. 1390: STRONGER Patents Act Patenting of Biological Inventions ---Section 101 Modernization UN High Level Commission on Access to Medicines ---IP Proposals

Contacted: SENATE; Health & Human Services, Dept of (HHS); Health Resources & Services Administration (HRSA); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; White House Office; Natl Economic Council (NEC); Office of Management & Budget (OMB); Agriculture, Dept of (USDA); Office of the Vice President of the United States; U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); Natl Institutes of Health (NIH); Defense, Dept of (DOD); Natl Security Council (NSC); Commerce, Dept of (DOC); Centers For Medicare and Medicaid Services (CMS)

Bills named: S. 1681 (115th), S. 1390 (115th)

Small Business SMB

Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---PCAOB Audit Cost Increases ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)

Contacted: Commerce, Dept of (DOC); Food & Drug Administration (FDA); Office of Management & Budget (OMB); White House Office; Natl Institutes of Health (NIH); Natl Economic Council (NEC); Office of the Vice President of the United States; Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Natl Security Council (NSC); HOUSE OF REPRESENTATIVES; SENATE; Health Resources & Services Administration (HRSA); Defense, Dept of (DOD); Centers For Disease Control & Prevention (CDC); Agriculture, Dept of (USDA)

Bills named: H.R. 1645 (115th), S. 416 (115th), H.R. 10 (115th), H.R. 1343 (115th), H.R. 1312 (115th), S. 488 (115th)

Medicare/Medicaid MMM

Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers 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

Contacted: U.S. Trade Representative (USTR); Office of the Vice President of the United States; Commerce, Dept of (DOC); Defense, Dept of (DOD); Agriculture, Dept of (USDA); Health & Human Services, Dept of (HHS); Natl Economic Council (NEC); Natl Institutes of Health (NIH); Health Resources & Services Administration (HRSA); Food & Drug Administration (FDA); SENATE; HOUSE OF REPRESENTATIVES; Centers For Disease Control & Prevention (CDC); White House Office; Natl Security Council (NSC); Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS)

Bills named: S. 1688 (115th), S. 771 (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. 3419: The Farewell to Unnecessary Energy Lifelines Act Biomass Programs (Non-Funding) ---Farm Bill Reauthorization ---Reauthorization of Biomass Crop Assistance Program ---Reauthorization of Biomass R&D Program ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Energy Basic Research Funding ---Advanced Research Projects Agency - Energy ---DOE Office of Science ---H.R. 3266/S.1609: Energy and Water Development and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biofuels ---Department of Defense Application and Funding of Advanced 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 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Funding for Biorefineries ---Department of Defense Application and Funding of Advanced Biofuels ---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 ---H.R.2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---Notice of Data Availability (NODA) Related to 2018 RFS Volumes ---Proposed Rule for 2018 Volumes ---RFS Reform ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act ---H.R. 3268/S. 1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018

Contacted: Health & Human Services, Dept of (HHS); Office of the Vice President of the United States; Centers For Disease Control & Prevention (CDC); Natl Security Council (NSC); Agriculture, Dept of (USDA); SENATE; U.S. Trade Representative (USTR); Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); White House Office; Natl Institutes of Health (NIH); Food & Drug Administration (FDA); Health Resources & Services Administration (HRSA); Defense, Dept of (DOD)

Bills named: H.R. 3266 (115th), H.R. 3419 (115th), H.R. 3354 (115th), H.R. 1311 (115th), H.R. 3268 (115th), S. 517 (115th), H.R. 2810 (115th), S. 1603 (115th), S. 1609 (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 ---H.R. 2810: National Defense Authorization Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act 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 ---Farm Bill Reauthorization ---HR 3149: Renewable Chemicals Act of 2017 ---H.R. 3419: The Farewell to Unnecessary Energy Lifelines Act ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft)

Contacted: White House Office; Natl Institutes of Health (NIH); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Office of the Vice President of the United States; Centers For Disease Control & Prevention (CDC); Health Resources & Services Administration (HRSA); Natl Security Council (NSC); Natl Economic Council (NEC); Agriculture, Dept of (USDA); Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Defense, Dept of (DOD); SENATE; Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES

Bills named: H.R. 3354 (115th), H.R. 3149 (115th), H.R. 3419 (115th), S. 1603 (115th), H.R. 3268 (115th), H.R. 2810 (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 ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ------Amendment on GE Salmon Labeling Opioid Crisis Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Contacted: Centers For Medicare and Medicaid Services (CMS); Natl Security Council (NSC); White House Office; Centers For Disease Control & Prevention (CDC); SENATE; Health Resources & Services Administration (HRSA); Commerce, Dept of (DOC); Natl Institutes of Health (NIH); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Office of the Vice President of the United States; Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Defense, Dept of (DOD)

Bills named: S. 1771 (115th), S. 469 (115th), H.R. 3358 (115th), H.R. 3354 (115th), S. 934 (115th), S. 771 (115th), H.R. 2430 (115th), H.R. 3268 (115th), S. 1603 (115th)

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---The One Health Act (Sen. Franken Discussion Draft) ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 --------Amendment on GE Salmon Labeling ---H.R. 3354: Omnibus Appropriations Act for FY 2018 --------Amendment on GE Salmon Labeling Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Contacted: Commerce, Dept of (DOC); Health Resources & Services Administration (HRSA); SENATE; Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Office of the Vice President of the United States; Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); Natl Institutes of Health (NIH); Centers For Disease Control & Prevention (CDC); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Natl Security Council (NSC); Agriculture, Dept of (USDA); Natl Economic Council (NEC); White House Office; Defense, Dept of (DOD)

Bills named: S. 1603 (115th), H.R. 3354 (115th), H.R. 3268 (115th)

Homeland Security HOM

Biodefense Research, Development and Procurement Issues (Non-funding) ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---H.R. 3358/S:1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018

Contacted: White House Office; Food & Drug Administration (FDA); Natl Economic Council (NEC); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Defense, Dept of (DOD); Office of the Vice President of the United States; Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); Agriculture, Dept of (USDA); Natl Security Council (NSC); SENATE; Centers For Disease Control & Prevention (CDC); Natl Institutes of Health (NIH); Health Resources & Services Administration (HRSA)

Bills named: S. 1771 (115th), H.R. 3358 (115th), H.R. 3354 (115th), H.R. 2430 (115th), S. 934 (115th), H.R. 3219 (115th)

Medical/Disease Research/Clinical Labs MED

Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R. 3358/S:1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---Tropical Disease Priority Review Voucher (PRV) Program ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus 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 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018

Contacted: Natl Institutes of Health (NIH); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Defense, Dept of (DOD); U.S. Trade Representative (USTR); SENATE; Centers For Medicare and Medicaid Services (CMS); Office of the Vice President of the United States; Centers For Disease Control & Prevention (CDC); Natl Economic Council (NEC); White House Office; Natl Security Council (NSC); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Health Resources & Services Administration (HRSA)

Bills named: H.R. 2430 (115th), S. 1771 (115th), H.R. 3358 (115th), H.R. 3354 (115th), H.R. 3219 (115th), S. 1603 (115th), S. 934 (115th), H.R. 3268 (115th)