BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Animals ANI

Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon

Contacted: White House Office; U.S. Trade Representative (USTR); Natl Institutes of Health (NIH); Securities & Exchange Commission (SEC); Treasury, Dept of; Patent & Trademark Office (PTO); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); Health Resources & Services Administration (HRSA); SENATE; Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES

Trade (domestic/foreign) TRD

World Trade Organization Special 301 Submissions Foreign Agricultural Biotechnology Laws and Regulations -China Biotechnology Regulations -Asynchrony of International Approvals -EU Ag-Biotech Policies and Regulations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Ag-Biotech Issues -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Biosimilars -Mexico Biologics Regulations -Colombia Biologics Regulations Trade Promotion Authority Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues

Contacted: White House Office; SENATE; Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); Centers For Medicare and Medicaid Services (CMS); Health Resources & Services Administration (HRSA); U.S. Trade Representative (USTR); Treasury, Dept of; Patent & Trademark Office (PTO); Agriculture, Dept of (USDA)

Agriculture AGR

Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment to Restrict FDA Approval of GE Salmon --Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations -China Biotechnology Regulations -Asynchrony of International Approvals -EU Ag-Biotech Policies and Regulations Potential Regulation of New Genetic Modification Technologies Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Transatlantic Trade and Investment Partnership -Ag-Biotech Issues USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products Trade Promotion Authority Local GE Crop Cultivation Bans Coordination of Federal Biotechnology Research -H.R. 591: Engineering Biology Research and Development Act of 2015

Contacted: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Treasury, Dept of; White House Office; Centers For Medicare and Medicaid Services (CMS); Agriculture, Dept of (USDA); Health Resources & Services Administration (HRSA); Securities & Exchange Commission (SEC); Natl Institutes of Health (NIH); SENATE

Bills named: H.R. 591 (114th), H.R. 1599 (114th)

Taxation/Internal Revenue Code TAX

Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit

Contacted: Treasury, Dept of; Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Securities & Exchange Commission (SEC); Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); SENATE; Health Resources & Services Administration (HRSA); White House Office; Natl Institutes of Health (NIH); Agriculture, Dept of (USDA); U.S. Trade Representative (USTR)

Bills named: S. 537 (114th), S. 341 (114th)

Copyright/Patent/Trademark CPT

Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues

Contacted: U.S. Trade Representative (USTR); SENATE; Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Health Resources & Services Administration (HRSA); White House Office; Natl Institutes of Health (NIH); Securities & Exchange Commission (SEC); Agriculture, Dept of (USDA)

Bills named: H.R. 9 (114th), S. 632 (114th)

Health Issues HCR

Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues

Contacted: Agriculture, Dept of (USDA); SENATE; Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Natl Institutes of Health (NIH); Health Resources & Services Administration (HRSA); White House Office; Food & Drug Administration (FDA); Treasury, Dept of; Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 1078 (114th), H.R. 2 (114th), S.Con.Res. 11 (114th), S. 2694 (114th)

Small Business SMB

Sarbanes Oxley Section 404 (b) -Public Company Accounting Oversight Board Audit Cost Increases Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -PARTNER Act (House Discussion Draft) -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act Expansion of Exemption under SEC Regulation A - Proposed Legislation -Proposed SEC Rule on Reg A+ Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions -Fostering Innovation Act (House Discussion Draft) XBRL Exemption for Small Public Companies -H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act -Small Company Disclosure Simplification Act (House Discussion Draft) Stock Exchange Tick Size -H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act Capital Market Enhancements -H.R. 1525: Disclosure Modernization and Simplification Act -H.R. 1723: Small Company Simple Registration Act -S. 576: Encouraging Employee Ownership Act -SEC Office of Small Business Policy Responsibilities -Small Business Freedom to Grow Act (House Discussion Draft) -Improving Access to Capital for Emerging Growth Companies Act (House Discussion Draft)

Contacted: White House Office; Health Resources & Services Administration (HRSA); Natl Institutes of Health (NIH); SENATE; Food & Drug Administration (FDA); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Securities & Exchange Commission (SEC)

Bills named: H.R. 1525 (114th), S. 537 (114th), H.R. 1723 (114th), H.R. 37 (114th), S. 576 (114th), S. 341 (114th)

Medicare/Medicaid MMM

Independent Payment Advisory Board Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula -HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Patient Access to Approved Drugs -Coding -Coverage with Evidence Development

Contacted: Patent & Trademark Office (PTO); SENATE; Natl Institutes of Health (NIH); HOUSE OF REPRESENTATIVES; Treasury, Dept of; U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); White House Office; Agriculture, Dept of (USDA); Food & Drug Administration (FDA); Health Resources & Services Administration (HRSA); Securities & Exchange Commission (SEC)

Bills named: H.R. 2 (114th)

Budget/Appropriations BUD

Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); Securities & Exchange Commission (SEC); Food & Drug Administration (FDA); White House Office; U.S. Trade Representative (USTR); SENATE; Treasury, Dept of; Health Resources & Services Administration (HRSA); Natl Institutes of Health (NIH); Agriculture, Dept of (USDA)

Bills named: S.Con.Res. 11 (114th), H.R. 1078 (114th)

Environment/Superfund ENV

EPA Regulation of Biotechnology -Interior, Environment, and Related Agencies Appropriations Act for FY 2016 -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Contacted: SENATE; U.S. Trade Representative (USTR); Health Resources & Services Administration (HRSA); Natl Institutes of Health (NIH); White House Office; Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Patent & Trademark Office (PTO); Treasury, Dept of; Centers For Medicare and Medicaid Services (CMS)

Consumer Issues/Safety/Products CSP

Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products

Contacted: Food & Drug Administration (FDA); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); U.S. Trade Representative (USTR); Securities & Exchange Commission (SEC); SENATE; Centers For Medicare and Medicaid Services (CMS); Health Resources & Services Administration (HRSA); Treasury, Dept of; White House Office; Agriculture, Dept of (USDA)

Bills named: H.R. 1599 (114th)

Energy/Nuclear ENG

Biofuels (Non-Funding) -Department of Defense Application of Advanced Biofuels -Implementation of the Agricultural Act of 2014 -Production Tax Credit Extension -Renewable Fuel Standard Renewable Chemicals/Bio-based Products (Non-Funding) -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 EPA Regulation of Biotechnology -Interior, Environment, and Related Agencies Appropriations Act for FY 2016

Contacted: SENATE; Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Natl Institutes of Health (NIH); Food & Drug Administration (FDA); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; Securities & Exchange Commission (SEC); Health Resources & Services Administration (HRSA); HOUSE OF REPRESENTATIVES; White House Office

Food Industry (safety, labeling, etc.) FOO

Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy

Contacted: Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; Food & Drug Administration (FDA); Securities & Exchange Commission (SEC); Patent & Trademark Office (PTO); Health Resources & Services Administration (HRSA); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Natl Institutes of Health (NIH); SENATE; White House Office

Bills named: H.R. 1599 (114th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) -Department of Defense Application of Advanced Biofuels -Implementation of the Agricultural Act of 2014 -Production Tax Credit Extension -Renewable Fuel Standard Renewable Chemicals/Bio-based Products (Non-Funding) -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 EPA Regulation of Biotechnology -Interior, Environment, and Related Agencies Appropriations Act for FY 2016

Contacted: U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); White House Office; SENATE; Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Health Resources & Services Administration (HRSA); Treasury, Dept of; Natl Institutes of Health (NIH); Securities & Exchange Commission (SEC)

Homeland Security HOM

Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Contacted: Securities & Exchange Commission (SEC); Centers For Medicare and Medicaid Services (CMS); Agriculture, Dept of (USDA); Health Resources & Services Administration (HRSA); SENATE; Natl Institutes of Health (NIH); Treasury, Dept of; White House Office; HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Food & Drug Administration (FDA)

Medical/Disease Research/Clinical Labs MED

Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Contacted: Health Resources & Services Administration (HRSA); Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Securities & Exchange Commission (SEC); SENATE; White House Office; Patent & Trademark Office (PTO); Natl Institutes of Health (NIH); Treasury, Dept of; HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Agriculture, Dept of (USDA)