BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Food Industry (safety, labeling, etc.) FOO

Food Waste Genetically Engineered (GE) Animals ---FDA Approval ---The One Health Act (Senate Discussion Draft) ---FDA Proposed Guidance on Gene Editing ---Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law

Contacted: U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); SENATE; American Battle Monuments Commission; Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); White House Office

Health Issues HCR

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

Contacted: HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); American Battle Monuments Commission; Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); SENATE; Food & Drug Administration (FDA); White House Office; Environmental Protection Agency (EPA); Agriculture, Dept of (USDA)

Bills named: H.R. 1628 (115th), S. 469 (115th), S. 637 (115th), H.R. 749 (115th), H.R. 1840 (115th), S. 297 (115th), S. 771 (115th), S. 204 (115th), H.R. 3204 (115th), S.Con.Res. 3 (115th), H.R. 878 (115th)

Budget/Appropriations BUD

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Renewable Chemicals/Bio-based Products ---USDA BioPreferred Program ---EPA Safer Choice Program ---Farm Bill Reauthorization ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018

Contacted: HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); American Battle Monuments Commission; SENATE; Agriculture, Dept of (USDA); Food & Drug Administration (FDA); White House Office; Environmental Protection Agency (EPA); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS)

Bills named: H.R. 4909 (115th), S. 2943 (115th)

Homeland Security HOM

Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017

Contacted: Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); Environmental Protection Agency (EPA); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; White House Office; SENATE; U.S. Trade Representative (USTR); American Battle Monuments Commission; Agriculture, Dept of (USDA)

Medicare/Medicaid MMM

Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications

Contacted: White House Office; Health & Human Services, Dept of (HHS); American Battle Monuments Commission; U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); SENATE; Office of Management & Budget (OMB); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA)

Trade (domestic/foreign) TRD

Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---India ---Saudi Arabia Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines

Contacted: U.S. Trade Representative (USTR); SENATE; White House Office; Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Agriculture, Dept of (USDA); American Battle Monuments Commission; Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA)

Bills named: S.Con.Res. 3 (115th), S. 469 (115th)

Agriculture AGR

Food Waste Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Genetically Engineered (GE) Animals ---FDA Approval ---The One Health Act (Senate Discussion Draft) ---FDA Proposed Guidance on Gene Editing Potential Regulation of New Genetic Modification Technologies ---Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Potential Revisions to Part 340 Regulations

Contacted: American Battle Monuments Commission; Health & Human Services, Dept of (HHS); SENATE; Environmental Protection Agency (EPA); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); White House Office; Food & Drug Administration (FDA)

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 ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---New Production Tax Credit

Contacted: Office of Management & Budget (OMB); Environmental Protection Agency (EPA); Agriculture, Dept of (USDA); White House Office; Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES; American Battle Monuments Commission; Food & Drug Administration (FDA); U.S. Trade Representative (USTR)

Bills named: H.R. 1840 (115th)

Copyright/Patent/Trademark CPT

Bayh-Dole Act/Tech Transfer ---March-In Rights Intellectual Property International Enforcement ---India ---Saudi Arabia Inter Partes Review ---Implementation of the America Invents Act of 2011 Patent Reform ---Implementation of the America Invents Act of 2011 UN High Level Commission on Access to Medicines ---IP Proposals

Contacted: SENATE; Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); White House Office; Food & Drug Administration (FDA); American Battle Monuments Commission; U.S. Trade Representative (USTR)

Small Business SMB

Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)

Contacted: SENATE; American Battle Monuments Commission; Environmental Protection Agency (EPA); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Food & Drug Administration (FDA); White House Office

Bills named: H.R. 1343 (115th), S. 416 (115th), S. 488 (115th), H.R. 79 (115th), S. 588 (115th), H.R. 1645 (115th), H.R. 1312 (115th)

Chemicals/Chemical Industry CHM

Funding for Renewable Chemicals/Bio-based Products ---USDA BioPreferred Program ---EPA Safer Choice Program ---Farm Bill Reauthorization ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---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 ---Farm Bill Reauthorization ---New Production Tax Credit ---Reauthorization of Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program ---Reauthorization of USDA Bio-Preferred Program

Contacted: American Battle Monuments Commission; U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); White House Office; SENATE; Office of Management & Budget (OMB); Food & Drug Administration (FDA)

Bills named: S. 2943 (115th), H.R. 4909 (115th)

Consumer Issues/Safety/Products CSP

Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act --S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Opioid Abuse

Contacted: White House Office; Office of Management & Budget (OMB); American Battle Monuments Commission; U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); Food & Drug Administration (FDA); Agriculture, Dept of (USDA); SENATE

Bills named: S. 469 (115th), S.Con.Res. 3 (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 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act

Contacted: Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); White House Office; U.S. Trade Representative (USTR); SENATE; Environmental Protection Agency (EPA); Food & Drug Administration (FDA); American Battle Monuments Commission; Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES

Bills named: H.R. 1311 (115th), S. 517 (115th)

Animals ANI

Genetically Engineered (GE) Animals ---FDA Approval ---The One Health Act Discussion Draft ---FDA Proposed Guidance on Gene Editing

Contacted: HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); U.S. Trade Representative (USTR); White House Office; Environmental Protection Agency (EPA); SENATE; Agriculture, Dept of (USDA); American Battle Monuments Commission; Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB)

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 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Renewable Fuel Standard ---Changes to the Point of Obligation under the RFS ---H.R. 1311/S.517: Consumer and Fuel Retailer Choice Act

Contacted: HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); White House Office; Agriculture, Dept of (USDA); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); American Battle Monuments Commission; SENATE; Food & Drug Administration (FDA)

Bills named: H.R. 1311 (115th), S. 517 (115th)

Medical/Disease Research/Clinical Labs MED

Longitudinal Study of Chronic Diseases Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017

Contacted: SENATE; Environmental Protection Agency (EPA); Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); White House Office; American Battle Monuments Commission; Office of Management & Budget (OMB)