BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Medicare/Medicaid MMM

21st Century Cures Initiative Patient Access to Approved DrugsReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes

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

Bills named: H.R. 1416 (113th)

Food Industry (safety, labeling, etc.) FOO

Review and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling ActGenetically Engineered (GE) Animals H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Amendment on GE Salmon Labeling

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

Bills named: H.R. 83 (113th), H.R. 4432 (113th)

Trade (domestic/foreign) TRD

Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International ApprovalsWorld Trade Organization Special 301 Submissions 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 Colombia Biologics Regulations Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Trade Promotion Authority H.R. 3830/S. 1900: Bipartisan Congressional Trade Priorities Act of 2014

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

Bills named: S. 1900 (113th), H.R. 3830 (113th)

Agriculture AGR

Genetically Engineered (GE) Animals H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Amendment on GE Salmon LabelingReview and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling Act Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals Funding for Biomass Crop Assistance Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Transatlantic Trade and Investment Partnership Ag-Biotech Issues USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products

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

Bills named: H.R. 83 (113th), H.R. 4432 (113th)

Taxation/Internal Revenue Code TAX

Renewable Chemicals/Bio-based Products S. 2260: EXPIRE Act of 2014Biofuels Accelerated Depreciation Extension Production Tax Credit Extension S. 2260: EXPIRE Act of 2014 Research & Development Tax Credit Reforms Extension Permanency H.R. 4438: American Research & Competitiveness Act of 2014 H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities S. 2260: EXPIRE Act of 2014 S. 2715: The COMPETE Act S. 193: The Start-up Innovation Credit Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 2260: EXPIRE Act of 2014 H.R. 4855, the PARTNER Act S. 1658: The Start-up Jobs and Innovation Act HR 4855: To amend the Internal Revenue Code of 1986 to provide an exception from the passive loss rules for investments in high technology research small business pass-thru entities Tax Reform Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension S. 2260: EXPIRE Act of 2014 Inversions H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015

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

Bills named: H.R. 83 (113th), S. 1658 (113th), S. 2715 (113th), S. 193 (113th), H.R. 119 (113th), H.R. 4438 (113th), H.R. 4855 (113th), S. 2260 (113th)

Copyright/Patent/Trademark CPT

Clinical Trial Data Sharing and Disclosure Canadian Policies European PoliciesPatent Reform H.R. 2024: End Anonymous Patents Act H.R. 3309: Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) Implementation of H.R. 1249: The America Invents Act of 2011 FTC Regulation of Patent Demand Letters (Senator Commerce Committee Discussion Draft) World Trade Organization Special 301 Submissions TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Trade Promotion Authority H.R. 3830/S. 1900: Bipartisan Congressional Trade Priorities Act of 2014 Patenting of Biological Inventions PTO Examination Guidelines DNA Patenting and Licensing

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

Bills named: H.R. 2024 (113th), S. 1900 (113th), S. 1720 (113th), H.R. 845 (113th), H.R. 3309 (113th), H.R. 1249 (113th), S. 1013 (113th), H.R. 3830 (113th)

Health Issues HCR

Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations21st 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative Biosimilars Biosimilar User Fee Act Implementation Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Patent Certification Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 340B Drug Pricing Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Implementation of Affordable Care Act Program Implementation & Oversight Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Issues Intellectual Property IssuesReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Sunshine Act Implementation

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

Bills named: H.R. 1416 (113th), H.R. 2725 (113th), H.R. 83 (113th)

Small Business SMB

Sarbanes Oxley Section 404 (b) H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 1658: The Start-up Jobs and Innovation Act S. 2260: EXPIRE Act of 2014 H.R. 4855, the PARTNER Act Expansion of Exemption under SEC Regulation A Proposed SEC Rule on Reg A+ H.R. 4565: Startup Capital Modernization Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies H.R. 5405: The Promoting Job Creation and Reducing Small Business Burdens Act H.R. 4164: Small Company Disclosure Simplification Act Stock Exchange Tick Size H.R. 5405: Promoting Job Creation and Reducing Small Business Burdens Act H.R. 3448: The Small Cap Liquidity Reform Act Capital Market Enhancements H.R. 4568: Small Business Freedom to Grow Act H.R. 3623: Improving Access to Capital for Emerging Growth Companies Act H.R. 4697: To require the SEC to revise the definition of a WKSI to reduce the worldwide market value threshold under the definition H.R. 4569: Disclosure Modernization and Simplification Act H.R. 4571: To direct the SEC to revise its rules so as to increase the threshold amount for requiring issuers to provide certain disclosures relating to compensatory benefits plans

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

Bills named: H.R. 4571 (113th), H.R. 5405 (113th), S. 1658 (113th), H.R. 4164 (113th), H.R. 4697 (113th), S. 1526 (113th), H.R. 4565 (113th), H.R. 3623 (113th), H.R. 4855 (113th), H.R. 1564 (113th), S. 2260 (113th), H.R. 3448 (113th), H.R. 4568 (113th), H.R. 4569 (113th), H.R. 2629 (113th)

Budget/Appropriations BUD

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Energy Basic Research Funding H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biofuels H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015

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

Bills named: H.R. 2725 (113th), H.R. 83 (113th)

Environment/Superfund ENV

EPA Regulation of Biotechnology

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

Consumer Issues/Safety/Products CSP

USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech ProductsGenetically Engineered (GE) Animals H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Biosimilars Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Sunshine Act Implementation

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

Bills named: H.R. 4432 (113th), H.R. 83 (113th)

Energy/Nuclear ENG

Funding for Biofuels H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Biofuels Accelerated Depreciation Extension Implementation of the Agricultural Act of 2014 Production Tax Credit Extension Renewable Fuel Standard S. 2260: EXPIRE Act of 2014 Renewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals Implementation of the Agricultural Act of 2014 H.R. 1696/S. 795: Master Limited Partnerships Parity Act H.R. 2421: Renewable Chemicals Parity Act S. 2260: EXPIRE Act of 2014 Funding for Biomass Crop Assistance Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Energy Basic Research Funding H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015

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

Bills named: H.R. 83 (113th), H.R. 2421 (113th), S. 2260 (113th), S. 795 (113th), H.R. 1696 (113th)

Animals ANI

Genetically Engineered (GE) Animals H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Amendment on GE Salmon Labeling

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

Bills named: H.R. 83 (113th)

Fuel/Gas/Oil FUE

Funding for Biofuels H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Biofuels Accelerated Depreciation Extension Implementation of the Agricultural Act of 2014 Production Tax Credit Extension Renewable Fuel Standard S. 2260: EXPIRE Act of 2014 Renewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals Implementation of the Agricultural Act of 2014 H.R. 1696/S. 795: Master Limited Partnerships Parity Act H.R. 2421: Renewable Chemicals Parity Act S. 2260: EXPIRE Act of 2014 Funding for Biomass Crop Assistance Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Energy Basic Research Funding H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015

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

Bills named: S. 2260 (113th), H.R. 2421 (113th), S. 795 (113th), H.R. 83 (113th), H.R. 1696 (113th)

Medical/Disease Research/Clinical Labs MED

Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 21st Century Cures Initiative Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative

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

Bills named: H.R. 83 (113th)