ANDREW EMMETT

Renewable Chemicals/Bio-based Products --Expansion of Master Limited Partnerships to Renewable Chemicals --New Production Tax Credit --S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension --S.2089: American Energy Innovation Act Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE 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 --H.R. 2179: PARTNER Act Tax Reform --Innovation Box/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995/S.1910: Department of Financial Services and Related Agencies Appropriations Act for FY 2016 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act

Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Biosimilars --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products

Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: 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 Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --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 --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --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 Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act

NIH Precision Medicine Initiative Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) House 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Senate Innovation for Healthier Americans Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Biodefense Research, Development and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --PATH Act (Senate Discussion Draft/Innovation for Healthier Americans Initiative) --ADAPT Act (House Discussion Draft/21st Century Cures Initiative)

Sunshine Act Implementation 21st Century Cures InitiativeGenetically Engineered (GE) Animals FDA Approval H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies 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. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Drug Evaluation and Review Compassionate Use/Expanded Access Implementation of the FDA Safety and Innovation Act Special Medical Use/Limited Population Drug Biosimilars Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 21st Century Cures Initiative

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Naming Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Implementation of Affordable Care Act 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 2015 Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees S. 1413: FDA User Fee Protection Act Drug Evaluation and Review Compassionate Use/Expanded Access Special Medical Use/Limited Population Drug Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies Sunshine Act Implementation Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations 21st Century Cures InitiativeTransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Transparency Intellectual Property Issues

Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Funding for USDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products Funding for Biofuels Department of Defense Funding of Advanced Biofuels Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Department of Defense Appropriations Act for FY 2015 Department of Interior, Environment, and Related Agencies Appropriations for FY 2015 Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biorefineries Department of Defense Funding of Advanced Biofuels Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Energy and Water Development and Related Agencies Appropriations Act for FY 2015

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Genetically Engineered (GE) Animals Labeling GE Animal Models of Human Disease FDA Approval Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Amendment to Restrict FDA Approval of GE Salmon Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Review and Labeling of Food Derived From Biotechnology Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Efficient Science-Based Review of Biotech Products Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation

Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Funding for USDA H.R. 3547: Consolidated Appropriations Act for FY 2014 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Biomass Crop Assistance Program Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.R. 3547: Consolidated Appropriations Act for FY 2014 Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biofuels Department of Defense Funding of Advanced Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Department of Defense Appropriations Act for FY 2015 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2642: Agricultural Act of 2014 (Farm Bill) Agriculture, Rural Development, FDA, and Related Agencies Appropriations for FY 2015 Department of the Interior, Environment, and Related Agencies Appropriations for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Biorefineries S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2642: Agricultural Act of 2014 (Farm Bill) Funding for Biotechnology Research and Development Programs and the Agency for International Development and Department of State H.R. 3547: Consolidated Appropriations Act for FY 2014

Trade Promotion Authority H.R. 3830/S. 1900: Bipartisan Congressional Trade Priorities Act of 2014Intellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Korea Biotechnology Regulations Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Ag-Biotech Issues Reimbursement Transparency Biosimilars Colombia Biologics Regulations World Trade Organization Special 301 Submissions Clinical Trial Data Sharing and Disclosure EU Policies

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations for FY 2014 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014

Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 House Judiciary Committee Discussion Draft DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Asia Pacific Economic Cooperation Forum Biologics Regulations Export Registrations for Products With Expired Patents Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Low-Level Presence Foreign Government Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Intellectual Property Issues Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Asia Pacific Economic Cooperation Forum Biologics Regulations Biosimilars Colombia Biologics Regulations Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Regulatory Harmonization Ag-Biotech Issues Intellectual Property Issues Biosimilars Colombia Biologics Regulations Naming Trade Promotion Authority Clinical Trial Data Sharing and Disclosure EU Policies

Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) H.J. Res. 59: The Bipartisan Budget Act of 2013 Amendment on GE Salmon Labeling Labeling of Food Derived From Biotechnology S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 U.S. Government Policy Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act Biosimilars Naming Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Implementation of Affordable Care Act Drug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality and Security Act USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products

Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act FY 2014 HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act Energy Basic Research Funding DOE Office of Science Advanced Research Projects Agency - Energy Energy and Water Development and Related Agencies Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.J. Res. 59: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biofuels Department of Defense Funding of Advanced Biofuels H.J. Res. 59: The Bipartisan Budget Act of 2013 Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Low-Level Presence Foreign Government Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Intellectual Property Issues Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Asia Pacific Economic Cooperation Forum Biologics Regulations Biosimilars Colombia Biologics Regulations Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Vaccine Access/Financing Adult Immunization (Senate Discussion Draft)Biosimilars Colombia Biologics Regulations Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Interchangeability and Pharmacy Substitution Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1284: Department of Labor, HHS, Education, and Related Agencies Appropriations Act of 2014 Expanded Access to Experimental Products FDA Rules Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Harmonization Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Funding Program Implementation Asia Pacific Economic Cooperation Forum Biologics RegulationTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and related agencies Appropriations Act FY 2014 H.R. 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act Orphan Drug Act Issues Tax Credit Clinical Trial Data Sharing

Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 House Judiciary Committee Discussion Draft DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Asia Pacific Economic Cooperation Forum Biologics Regulations Export Registrations for Products With Expired Patents Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing

Labeling of Genetically Engineered Crops U.S. Government Policy S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements USDA Decision on GE Crops Environmental Impact Statement H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) Amendment on GE Crop Field Trials/Compensation Fund S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningUSDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) Amendment on Weed Resistance Amendment on GE Crop Field Trials/Compensation Fund S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Amendment on Farmer Assurance Genetically Engineered (GE) Animals Labeling S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for 2014 Amendment on GE Salmon Labeling (Senate) S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Labeling of Genetically Engineered Crops U.S. Government Policy H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Amendments on GE Food Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Drug Safety and Review Supply Chain Integrity Pharmacy Compounding HR. 1919: The Safeguarding Americas Pharmaceuticals Act S. 957: Drug Supply Chain Security Act S. 959: Pharmaceutical Compounding Quality Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biofuels Department of Defense Funding/Application of Advanced Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for Biomass Crop Assistance Program S. 1244/ H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2014

Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products Reauthorization/Funding of USDA Bio-Preferred Program S.10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for Biofuels Department of Defense Funding/Application of Advanced Biofuels Department of Defense Appropriations Act for FY 2014 Department of Energy and Water and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 (Toomey Amendment) Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for Biomass Programs H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Reauthorization/Funding of Biomass Crop Assistance Program Reauthorization/Funding of Biomass R&D Program S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biorefineries Reauthorization/Funding of Biorefinery Assistance Program DOE Biomass Program Department of Defense Funding S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 (Toomey Amendment) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. Con. Res. 8: Senate Budget Resolution

Funding for National Institutes of Health H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S. 391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Adult Immunization Policies Adult Immunization Senate Discussion Draft 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 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 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 U.S./European Union High-Level Dialogue on Regulatory IssuesSequestration of PDUFA Fees H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Implementation of S. 365: Budget Control Act TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act

Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biomass Crop Assistance Program S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act of 2012

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft ) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biomass Crop Assistance Program S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act of 2012

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft ) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Funding for USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Funding for Biofuels S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013 Funding for Biorefineries S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013 Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Renewable Chemicals S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biomass Crop Assistance Program S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products

Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Medicaid Rebates Dual Eligibles S. 365: Budget Control Act of 2011 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 Reimbursement for Innovative Products Medicare Part D Prescription Drug Program

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Genetically Engineered (GE) Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products TREAT Act (Senate Discussion Draft) E-Pedigree and Anti-Counterfeiting Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Funding for the USDA (Office of General Counsel , Biotechnologies Regulatory Services (BRS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H..R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Sciences S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Funding for Biofuels H.R. 2219: Department of Defense Appropriations Act for FY 2012 H.R. 2354: The Energy and Water Appropriations Act for 2012 Funding for Bio-based Products H.R. 2219: Department of Defense Appropriations Act for FY 2012 H.R. 2354: The Energy and Water Appropriations Act for 2012 Funding for Biomass Crop Assistance Program H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012

Funding for Biomass Crop Assistance Program (BCAP) H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2012 Funding for Bio-based Products H.R. 2354: The Energy and Water Appropriations Act for FY 2012 H.R. 2219: Department of Defense Appropriations Act for FY 2012 Funding for Biofuels H.R. 2354: The Energy and Water Appropriations Act for FY 2012 H.R. 2219: Department of Defense Appropriations Act for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Funding for National Institutes of Health Cures Acceleration Network S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Genetically Engineered (GE) Animals H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Amendment to Restrict FDA Approval of GE Salmon

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Genetically Engineered (GE) Animals FDA Approval Labeling H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Amendment to Restrict FDA Approval of GE Salmon Generic Drug Patent Settlements Drug Safety and Review S. 1584: Drug Safety and Accountability Act of 2011 Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2012 Drug Shortages H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Biomass Crop Assistance Program (BCAP) Funding H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 H.J. RES.48: Department of Defense and Continuing Appropriations Act for FY 2011 H.R. 1/H.J. RES.92: Continuing Appropriations Act for FY 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 1/H.J. RES 92: Continuing Appropriations Act for FY 2011 H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Funding for Bio-based Products H.R. 2354: The Energy and Water Appropriations Act for FY 2012 Funding for Biofuels H.R. 2354: The Energy and Water Appropriations Act for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Genetically Engineered (GE) Animals H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Amendment to Restrict FDA Approval of GE Salmon

Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Vaccine Access/Financing S. 1094: Combating Autism Reauthorization Act Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicaid Rebates Dual Eligibles Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review Regulatory Reforms for Innovative Products Prescription Drug User Fee Act (PDUFA) Reauthorization Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 1/H.J. RES 92: Continuing Appropriations Act for FY 2011 H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Repeal Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 H.J. RES.48: Department of Defense and Further Additional Continuing Appropriations Act for FY 2011 H.R. 1/H.J. RES.92: Continuing Appropriations Act for FY 2011 Cures Acceleration Network Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development and Procurement HHS Countermeasures Review Pandemic and All-Hazards Preparedness Act Reauthorization Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Policies and Regulation

Funding for FDA H.J. RES. 48: 6th Continuing Resolution for FY 2011 USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Livestock Cloning/Product Labeling Genetically-Engineered (GE) Animals Labeling FDA Approval Labeling of Genetically-Engineered (GE) Crops U.S. Government Policy Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Funding for National Institutes of Health H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.J. RES.48: 6th Continuing Resolution for FY 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 H.J. RES. 48: 6th Continuing Resolution for FY 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.J. RES. 48: 6th Continuing Resolution for FY 2011 Funding for Bio-based Products H.J. RES. 48: 6th Continuing Resolution for FY 2011 Funding for Biofuels H.J. RES. 48: 6th Continuing Resolution for FY 2011 DOE Loan Guarantees and Grants under the Energy Policy Act of 2005 (Implementation and Funding)

USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Genetically Engineered (GE) Animals Labeling FDA Approval S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act for FY 2011 H.R. 3082: 4th Continuing Appropriations Act for FY 2011 S. 4322: Preserve Access to Affordable Generics Act Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Drug Importation S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 S.3607: Department of Homeland Security Appropriations Act for FY 2011 S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011

Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Drug Importation S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 S.3607: Department of Homeland Security Appropriations Act for FY 2011 S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011

Livestock Cloning/Product Labeling S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for USDA (Office of General Counsel , Biotechnology Regulatory Services, Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agricultural Service) S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for Biofuels S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3635: Energy and Water Development and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Biomass Crop Assistance Program Rural Energy for America Program Biomass and Biorefinery Systems R&D Programs DOE Loan Guarantees and Grants under The Energy Policy Act of 2005 (Implementation and Funding) Funding for Bio-based Products S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3635: Energy and Water Development and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Biorefineries S. 3635: Energy and Water Development and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Reverse Auction Loan Program Under Section 942 of the Energy Policy Act of 2005 Drug Importation S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 S.3607: Department of Homeland Security Appropriations Act for FY 2011 S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Cures Acceleration Network S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Pandemic Influenza Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Biomedical Advanced Research & Development Authority (BARDA) S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Bioterrorism and Emergency Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Centers for Disease Control and Prevention Vaccine Programs S.3686: Departs of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Strategic National Stockpile S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Biotechnology Research and Development Programs at the Agency for International Development S. 3676: Department of State, Foreign Operations and Related Programs Appropriations act for FY 2011 Funding for the Bureau of Economic, Energy, and Business Affairs (EEB) at the U.S. Department of State S. 3676: Department of State, Foreign Operations and Related Programs Appropriations act for FY 2011 Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act for FY 2011 Funding for Biodefense Research, Development and Procurement H.R. 3082: 4th Continuing Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Global Food Security Initiative S. 3676: Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2011

Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3607: Department of Homeland Security Appropriations Act for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Drug Safety and Review FDA Globalization Act (Discussion Draft) E-Pedigree and Anti-Counterfeiting

S. 3607: Department of Homeland Security Appropriations Act for FY 2011 Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Livestock Cloning/Product Labeling Funding for the USDA (Office of General Counsel , Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agricultural Service) Funding for Biofuels and Bio-based Products Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Drug Importation S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Funding for National Institutes of Health Cures Acceleration Network Funding for Bioterrorism and Emergency Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Funding for Centers for Disease Control and Prevention Vaccine Programs Drug Importation Funding for Strategic National Stockpile S: 3635: Energy and Water Development and Related Agencies Appropriations Act for FY 2011 Title XVII Loan Guarantee Program Funding for Reverse Auction Loan Program under Section 942 of the Energy Policy Act of 2005 Funding for Biofuels and Bio-based Products Funding for Biorefineries S. 3676: Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2011 Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State Funding for the Bureau of Economic, Energy, and Business Affairs (EEB) at the U.S. Department of State Funding for Global Food Security Initiative H.R.1586 / S.A.4575: Supplemental Education, Jobs and Medicaid Assistance Act of 2010 Funding for Biofuels and Bio-based Products Generic Patent Settlements Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) S. 3677: Financial Services and General Government Appropriations Act of 2011 Generic Patent Settlements H.R. 4899: Emergency Supplemental Appropriations Act for 2010 Generic Drug Patent Settlements Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Average Manufacturer Price Calculations Funding for Biomedical Advanced Research and Development Authority (BARDA)

Drug Safety and Review FDA Globalization Act (Discussion Draft) E-Pedigree and Anti-Counterfeiting Biodefense Research, Development and Procurement S. 3761: A Bill to Restore Funding for Indian Loan Guarantee Program at the Bureau of Indian Affairs HHS Countermeasures Review H.R. 4899: Supplemental Appropriations Act of 2010 H.R. 5297: American Jobs and Closing Tax Loopholes Act of 2010 S. 3693: A Bill to Provide Funding for the Settlement of Lawsuits Against the Federal Government for Discrimination Against Black Farmers Pharmaceutical Industry Annual Fee Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Expansion of 340B Drug Pricing Program H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 S. 3793: Job Creation and Tax Cuts Act of 2010 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Federal Supply Schedule Access During Emergencies S.2868: Federal Supply Schedules Usage Act of 2009 Alliance for Healthcare Competitiveness Stem Cell Research Federal Funding of Embryonic Stem Cell Research Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3607: Department of Homeland Security Appropriations Act for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Average Manufacturer Price Calculations H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Diagnostics and Personalized Medicine Regulation and Oversight Draft Legislation Rare Pediatric & Tropical Disease Drug Development S. 3697: Creating Hope Act of 2010 Funding for the Food and Drug Administration S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding: S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Biomedical Advanced Research and Development Authority (BARDA) S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Strategic National Stockpile S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Cont... Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agricultural Service) Livestock Cloning/Product Labeling Funding for Biofuels and Bio-based Products Budget of the United States for FY 2011 Funding for Biofuels and Bio-based Products Department of Homeland Security Appropriations Act for FY 2011 Drug Importation Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2011 Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State Funding for Global Food Security Initiative Funding for the Bureau of Economic, Energy, and Business Affairs (EEB) at the Department of State Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health Cures Acceleration Network Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Funding for Centers for Disease Control and Prevention Vaccine Programs Funding for Strategic National Stockpile Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2011 Funding for Biofuels and Bio-based Products Funding for Biorefineries Funding for Reverse Auction Loan Program under Section 942 of the Energy Policy Act of 2005 Title XVII Loan Guarantee Program H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Average Manufacturer Price Calculations Generic Drug Patent Settlements Funding for Biofuels and Bio-based Products

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Cont... Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels, Foreign Agricultural Service) Livestock Cloning/Product Labeling Funding for Biofuels and Bio-based Products Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health Cures Acceleration Network Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Funding for Centers for Disease Control and Prevention Vaccine Programs Funding for Strategic National Stockpile Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2011 Funding for Biofuels and Bio-based Products Biorefineries Funding for Reverse Auction Loan Program under Section 942 of the Energy Policy Act of 2005 Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2011 Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State Funding for Global Food Security Initiative Funding for the Bureau of Economic, Energy, and Business Affairs (EEB) at the Department of State Department of Homeland Security Appropriations Act for FY 2011 Drug Importation Budget of the United States for FY 2011 Funding for Biofuels and Bio-based Products

Genetically Engineered (GE) Animals FDA Approval of First Product From GE Animals Drug Importation H.R. 3590: (Senate) Patient Protection and Affordable Care Act S. 1796: America's Healthy Future Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Reporting of Physician Payments S.310: Physician Payments Sunshine Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act S. 1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 Livestock Cloning/Product Labeling Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Discussion with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient & Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Stem Cell Research Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 S.1213: Patient-Centered Outcomes Research Act of 2009 S.1796: American's Health Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Cures Acceleration Network H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011

Healthcare Reform Comparative Effectiveness Research Program Initiatives In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Health Care Reform Cont... Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Generic Fill Incentives Therapeutic Discovery Project Tax Credit Pharmaceutical Excise Tax Medicaid Rebates Dual Eligibles H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 3200: America's Affordable Health Choices Act of 2009 S. 1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 Drug Safety and Review H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 H.R. 2749: Food Safety Enhancement Act of 2009 Critical Path FDA Regulatory Transparency Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for the Food and Drug Administration H.R. 2997?S.1406: Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates S.1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Dual Eligibles Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Comparative Effectiveness Program Initiatives S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Reporting of Physician Payments S. 310: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Vaccine Access/Financing S.1796:America's Healthy Future Act of 2009 S.1679: America's Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S. 2868: Federal Supply Scheduels Usage Act of 2009 S.1649: Weapons of Mass Destruction Preparedness Act of 2009 Expansion of 340B Drug Pricing Program S.1796:America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Federal Supply Schedule Access S.2868: Federal Supply Schedules Usage Act of 2009 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Reimbursement Issues

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations China Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions Canada Biotechnology Bilateral Discussions APEC Agricultural Biotechnology Discussions Discussions with EU on Animal Cloning Vietnam Biotechnology Regulations Turkish Biotechnology Regulations Korea Living Modified Organisms Act Revisions Thailand Biotechnology Regulations Low-level Presence Foreign Government Policies U.S. Policy on International Science-Based Regulations USDA Export Strategy for Agricultural Biotechnology Products World Trade Organization Special 301 Submissions World Trade Organization on EU Biotech Approvals EU Biotechnology Negotiations Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S. 1213: Patient-Centered Outcomes Research Act of 2009 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Livestock Cloning/Product Labeling Discussion with EU on Animal Cloning USTR, USDA & FDA Outreach to European Commission and Parliament

Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 Medicaid Rebates Cont... H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Dual Eligibles Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S. 1796: America's Healthy Future Act of 2009 S. 1213: Patient-Centered Outcomes Research Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 H.R. 2749: Food Safety Enhancement Act of 2009 Critical Path FDA Regulatory Transparency Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act

Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S. 1769: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Stem Cell Research Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S. 1679: America's Healthy Future Act of 2009 S. 1213: Patient-Centered Outcomes Research Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act

Genetically Engineered (GE) Animals FDA Final Guidance on Regulation of GE Animals FDA Approval of First Product From GE Animals Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related agencies Appropriations Act for FY 2010 Reporting of Physician Payments S.310: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Drug Safety and Review H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 H.R. 2749: Food Safety Enhancement Act of 2009 Critical Path FDA Regulatory Transparency Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Livestock Cloning/Product Labeling H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 2007 Farm Bill Implementation Discussion with EU on Animal Cloning USTR, USDA & FDA Outreach to European Commission and Parliament USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7CFR 340 USDA Docket on Corn Amylase Petition (No. APHIS-2007-0016) Efficient Review of Biotech Products Coexistence of Production Systems

Healthcare Reform H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Health Care Reform Cont... Comparative Effectiveness Research Program Initiatives Hospital Acquired Infections Policy In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Medicaid Rebates S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 2502: Comparative Effectiveness and Research Protection Act H.R. 2824 Doctor-Patient Relationship and Research Protection Act Pharmaceutical Excise Tax Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act FTC Report on Follow-on Biologics Marketplace H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 House Judiciary Committee Hearing on Patent Issues Drug Safety and Review E-Pedigree and Anti-counterfeiting H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 The Food and Drug Administration Amendments Act of 2007 Implementation Risk Evaluation Mitigation Strategies Adverse Event Monitoring/Sentinel Network Advisory Committee System Critical Path FDA Regulatory Transparency Measurement Standards for Review and Approval of Biologics House Science Committee Hearing Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Reporting of Physician Payments S. 301: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act Senate Finance Committee's America's Healthy Future Act of 2009 Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 Vaccine Access/Financing H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 FDA Regulatory Processes for First-Time Filers Expansion of 340B Drug Pricing Program H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 S.1239: 340B Program Improvement and Integrity Act of 2009 Outpatient Prospective Payment System CY2010 Proposed Regulations Payment Methodology for Separately Billable Drugs and Biologics

Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Outpatient Prospective Payment System CY2010 Proposed Regulations Payment Methodology for Separately Billable Drugs and Biologics Drug Safety and Review E-Pedigree and Anti-counterfeiting H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 The Food and Drug Administration Amendments Act of 2007 Implementation Risk Evaluation Mitigation Strategies Adverse Event Monitoring/Sentinel Network Advisory Committee System Critical Path FDA Regulatory Transparency Measurement Standards for Review and Approval of Biologics House Science Committee Hearing Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 S.80: Pharmaceutical Market Access Act of 2009

Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Stem Cell Research Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009

H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine) H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Cont... Funding for the USDA: Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Genetically Engineered (GE) Animals Livestock Cloning/Product Labeling Funding for Biofuels and Bio-based Products Drug Importation H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Drug Importation H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010 Funding for Biofuels and Bio-based Products H.R. 3081/S.1434: Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2010 Funding for Biotechnology Research and Development Programs at the Agency for International Development H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010 Funding for Biofuels at the U.S. Forest Service Funding for Bio-based Products Climate Change/Indirect Land Use Department of Homeland Security Appropriations Act for FY 2010 Drug Importation

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement and Living Modified Organisms Act Revisions China Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions Canada Biotechnology Bilateral Discussions Japan Biotechnology Bilateral Discussions Argentina Biotechnology Bilateral Discussions Brazil Biotechnology Bilateral Discussions APEC Agricultural Biotechnology Discussions Korean Biosafety Law Discussions with EU on Animal Cloning India Bilateral Biotechnology Discussions Vietnam Biotechnology Regulations U.S. Policy on International Science-Based Regulations USDA Export Strategy for Agricultural Biotechnology Products World Trade Organization Special 301 Submissions World Trade Organization on EU Biotech Approvals EU Biotechnology Negotiations Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 S.80: Pharmaceutical Market Access Act of 2009

Genetically Engineered (GE) Animals Coordination Between Federal Agencies USDA APHIS Animal Care - Compliance with the Animal Welfare Act USDA APHIS Veterinary Service - Import and Export Issues Genetically Engineered (GE) Animals Cont... H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 FDA Center for Veterinary Medicine - Regulatory Follow-up USDA APHIS Biotechnology Regulatory Services - Regulatory Follow-up NIH, Extramural Programs, Office of Laboratory Animal Welfare - rDNA Regulatory Compliance USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding USDA, Cooperative State Research Education and Extension Service, National Institute of Food and Agriculture, Small Business Innovation Research Program, Funding USDA, Foreign Agricultural Service and USTR International Coordination Upon First Approval of GE Animal Product Funding for the Food and Drug Administration H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related agencies Appropriations Act for FY 2010 Reporting of Physician Payments S.310: Physician Payments Sunshine Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program USDA APHIS Animal Care USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Small Business Innovation Research Program, Funding USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Agriculture Food Research Initiative - Research Funding H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 USDA Foreign Agricultural Service and USTR International Coordination on Adoption of Cloning in Europe, Japan, Canada 2007 Farm Bill Implementation Discussion with EU on Animal Cloning Drug Safety E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (Discussion Draft) H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 S. 525: Pharmaceutical Market Access and Drug Safety Act of 2009 Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act For FY 2010 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 1256: Family Smoking Prevention and Tobacco Control Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7CFR 340 USDA Docket on Corn Amylase Petition (No. APHIS-2007-0016)

Healthcare Reform House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Health Care Reform Cont... Comparative Effectiveness Research Program Initiatives Hospital Acquired Infections Policy In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Medicaid Rebates Drug Safety E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (Discussion Draft) H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 S. 525: Pharmaceutical Market Access and Drug Safety Act of 2009 Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act For FY 2010 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 1256: Family Smoking Prevention and Tobacco Control Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 Funding for the Food and Drug Administration H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act FTC Report on Follow-on Biologics Marketplace Senate HELP Committee Biologics Price Competition and Innovation Act Discussion Draft House Tri-Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1054: Supplemental Appropriations for FY 2009 In Vitro Diagnostics Regulatory Oversight Healthcare Reform Bills Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 Reporting of Physician Payments S. 301: Physician Payments Sunshine Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Vaccine Access/ Financing Senate HELP Committee Affordable Health Choices Act Discussion Draft House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft S.1003: Immunization Improvement Act of 2009 National Vaccine Advisory Committee Draft Recommendations FDA Regulatory Processes for First-Time Filers Expansion of 340B Drug Pricing Program Senate HELP Committee Affordable Health Choices Act Discussion Draft House Tri-Committee Healthcare Reform Discussion Draft

H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine) H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Cont... Funding for the USDA: Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Genetically Engineered (GE) Animals Livestock Cloning/Product Labeling Funding for Biofuels and Bio-based Products Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2010 Funding for Biofuels and Bio-based Products at the Department of Energy Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2010 Funding for Biotechnology Research and Development Programs at the Agency for International Development H.R. 2996: Department of the Interior, Environment, and Related agencies Appropriations Act for FY 2010 Funding for Biofuels at the U.S. Forest Service Funding for Bio-based Products H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research and Development Authority (BARDA) Department of Homeland Security Appropriations Act for FY 2010 Drug Importation

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement and Living Modified Organisms Act Revisions China Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions Taiwan Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions Canada Biotechnology Bilateral Discussions Japan Biotechnology Bilateral Discussions Argentina Biotechnology Bilateral Discussions Brazil Biotechnology Bilateral Discussions Negotiations of Trans Pacific Partnership APEC Agricultural Biotechnology Discussions Korean Biosafety Law Discussions with EU on Animal Cloning India Bilateral Biotechnology Discussions Vietnam Biotechnology Regulations U.S. Policy on International Science-Based Regulations USDA Export Strategy for Agricultural Biotechnology Products World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations Drug Importation S. 1232: Pharmaceutical Market Access and Drug Safety Act of 2009 S. 80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 1256: Family Smoking Prevention and Tobacco Control Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2010 S: 525: Pharmaceutical Market Access & Drug Safety Act of 2009

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1054: Supplemental Appropriations for FY 2009 Funding for the Food and Drug Administration H.R. 2997: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2346/S.1057: Supplemental Appropriations for FY 2009 In Vitro Diagnostics Regulatory Oversight Healthcare Reform Bills Stem Cell Research Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 House Tri-Committee Healthcare Reform Discussion Draft Senate Finance Committee Healthcare Reform Discussion Draft Senate HELP Committee Affordable Health Choices Act Discussion Draft

Comparative Effectiveness Program Initiatives H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft) Drug Importation S.525: Pharmaceutical Market Access and Drug Safety H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Medicaid Rebates H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

Adventitious Presence (Low Level Presence) U.S. Government Policy for Codex Guidelines on Adventitious Presence European Union Low Level Presence Policy Philippines Low Level Presence Policy Genetically Engineered (GE) Animals Coordination Between Federal Agencies FDA Final Guidance on Regulation of GE Animals FDA CBER Blood Products Advisory Committee Meeting FDA Approval of First Product from GE Animal USDA APHIS Biotechnology Research Service Request for Information USDA APHIS Animal Care USDA APHIS Veterinary Service USDA National Institute of Food & Agriculture, Agriculture Food Research Institute, Research Funding Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft) Drug Importation S.525: Pharmaceutical Market Access and Drug Safety H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Reporting of Physician Payments S:310: Physician Payments Sunshine Act of 2009 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 USDA APHIS Animal Care USDA National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions Taiwan Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions Canada Biotechnology Bilateral Discussions Japan Biotechnology Bilateral Discussions Argentina Biotechnology Bilateral Discussions Brazil Biotechnology Bilateral Discussions Colombia Biotechnology Bilateral Discussions Negotiations of Trans Pacific Partnership APEC Agricultural Biotechnology Discussions Korean Biosafety Law Discussions with EU on Animal Cloning Adventitious Presence (Low Level Presence) U.S. Government Policy for Codex Guidelines on Adventitious Presence European Union Low Level Presence Policy Philippines Low Level Presence Policy World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations CBD TRIPS Amendment Patent Disclosure Requirements Drug Importation S.525: Pharmaceutical Market Access and Drug Safety H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for National Institutes of Health H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Biomedical Advanced Research Development Authority (BARDA) H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 1. and S. Amdt. 570: American Recovery and Reinvestment Act of 2009 Stem Cell Research Executive Order Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft)

Health Care Reform H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Goverment for FY 2010 Drug Safety Implementation of Food & Drug Administration Act of 2007 E-Pedigree and Anti-counterfeiting Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft) FDA Globalization Act of 2009 (House Discussion Draft) S.525: Pharmaceutical Market Access and Drug Safety The Drug and Device Accountability Act of 2009 (Senate Discussion Draft) Drug Importation S.525: Pharmaceutical Market Access and Drug Safety H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration H.R. 1105: Omnibus Appropriations for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Executive Order Medicaid Rebates H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 Funding for National Institutes of Health H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 1105: Omnibus Appropriations for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Reporting of Physician Payments S. 301: Physician Payments Sunshine Act of 2009

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination Counterfeit Drugs FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 H.R. 4911 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Patient Services S. 3101: Medicare Improvements for Patients and Providers Act of 2008 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) Access to Investigation Drugs for Seriously Ill Patents The Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.1956) Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H. R. 6432 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination Counterfeit Drugs H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 (S.3181) Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for National Institutes of Health S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health cont... H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Biomedical Advanced Research Development Authority (BARDA) S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for the Food and Drug Administration S.3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Bioterrorism and Emergency Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Funding for Pandemic Influenza Preparedness S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act Comparative Effectiveness Program Initiatives S. 3101 S.3408 Stem Cell Research Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases

Genetically Engineered (GE) Animals FDA and USDA Draft Regulation of GE Animals Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Heparin Contamination E-Pedigree and Anti-counterfeiting H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 S.3409: The Drug and Device Accountability Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for Food Safety at the Food and Drug Administration S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009

Comparative Effectiveness Program Initiatives S. 3101 S.3408 Medicaid Rebates Medicaid/Medicare Packages Dual Proportionality Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Medicare Reimbursement in Hospital Outpatient Department Setting Drug Importation S.3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Heparin Contamination FDA Globalization Act of 2008 E-Pedigree and Anti-counterfeiting H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 S.3409: The Drug and Device Accountability Act of 2008 Funding for the Food and Drug Administration S.3289:Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2642: Supplemental Appropriations Act for FY 2008 H.R. 7110/S.3604/S.3689: Job Creation and Unemployment Relief Act

S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Cont...) Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Drug Importation Livestock Cloning/Product Labeling S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Drug Importation S: 3258: Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels S.3260: Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley - Section 404 S: 3282: Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration H.R. 7110/S.3604: Second Supplemental Appropriations Act Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration Department of Homeland Security Appropriations Act for FY 2009 Drug Importation

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking S: 3289: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 6432 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for FY 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008 Human Subject Protections in Clinical Trials Human Growth Hormone Regulation S.877

Access to Drug Pricing Data H.R. 5683 Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Medicaid Rebates H.R. 1424 H.R. 6331 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Drug Importation S: 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 S. 3181: Department of Homeland Security Appropriations Act for FY 2009 S: 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration S. 3230: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 H.R. 2638: Consolidated Security, Disaster Assistance, and Continuing Appropriations Act for 2009 H.R. 7110/S.3604: Second Supplemental Appropriations Act for FY 2008

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H. R. 6432 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination Counterfeit Drugs H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 (S.3181) Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Cont...) Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels S.3260: Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley - Section 404 Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Funding for Biomedical Advanced Research & Development Authority (BARDA) Funding for USDA/APHIS Funding for Biorefinery Construction, Research & Development Department of Homeland Security Appropriations Act for FY 2009 Drug Importation

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Drug Importation H.R. 3610 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Stem Cell Research S.5 Medicaid Rebates H.R. 1424 H. Con. Res. 312 S. Con. Res. 70 Senate Medicare Package Human Growth Hormone Abuse S. 877 H.R. 4911 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Biomedical Advanced Research & Development Authority (BARDA) Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Pandemic Influenza Preparedness Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Medicare Hospital Outpatient Drug Reimbursement Policies In Vitro Diagnostics Regulatory Oversight Critical Path Initiative Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res. 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

Drug Safety H.R. 3580; H.R. 2900 S. 1082 Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence

Patent Reform H.R. 1908 S. 1145 Gene Patenting H.R. 977 ITC Exclusion Orders - Impact on Biotechnology Qualcomm Case CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Alternative Claims Rule: 72-FR-154 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Bayh-Dole Act Evaluation International Intellectual Property Enforcement Anti-counterfeiting IP Provisions in Free Trade Agreements

World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Regulations Mexico Biotech Regulations France Regulations of Plant Biotechnology Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Possible U.S. Government Ratification U.S. Government Positions at Biosafety Protocol Meetings International Intellectual Property Enforcement Anti-counterfeiting ITC Exclusion Orders - Impact on Biotechnology Qualcomm Case CBD TRIPS Amendment Patent Disclosure Requirments Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Farm Subsidies in Trade H.R. 2720 Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Restrictions on Importation of Plant Products/Lacey Act Amendments H.R. 1497 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764

Medicaid Rebates H.R. 3162; H.R. 2764 S. 2499 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 Comparative Effectiveness Program Initiatives S. 2499 H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Vaccines and Medicare Part B/Part D H.R. 4992

Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Loan Guarantees H.R. 3221 S. 1321 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biorefinery Solicitation Demonstration Projects for Feedstock Culture and Collection H.R. 2419

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2419 H.R. 2764 Funding for Food and Drug Administration (FDA) (Critical Path Initiative; Human Drug Review) H.R. 3161 S. 1859 H.R. 2764 Funding for State Children's Health Insurance Program S. 2086; S. 1893; S. 2499 H.R. 3162; H.R. 3963; H.R. 976 Funding for the Biomedical Advanced Research & Development Authority (BARDA) H.R. 3043 S. 1710 H.R. 2764 Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 Funding for Department of Agriculture (Biotechnology Regulatory Services) H.R. 3043 S. 1859 H.R. 2764

Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Genetically Engineered (GE) Animals FDA and USDA Regulations of GE Animals

Farm Subsidies in Trade H.R. 2720 Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credit H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Solicitation Biorefinery Loan Guarantees H.R. 3221 S. 1321 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Regulations Mexico Biotech Regulations France Regulations of Plant Biotechnology Restrictions on Importation of Plant Products/Lacey Act Amendments H.R. 2419 2007 Farm Bill (H.R. 2419) USDA Research and Regulatory Requirements for Ag-Biotech Federal Preemption Study Regarding Cloning of Livestock Study of Competitiveness of Ag-Biotech Industry Biobased Procurement -- USDA Program Demonstration Project for Feedstock Culture and Collection Biofuels Funding Importation of Plant Products Funding for Department of Agriculture (Biotechnology Regulatory Services) H.R. 3043 S. 1859 H.R. 2764 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings USDA Agriculture Biotechnology Regulations & Policies Release of Programmatic Environmental Impact Statement (EIS) Biotechnology Crop Stewardship Proposed Legislation Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Possible U.S. Government Ratification U.S. Government Positions at Biosafety Protocol Meetings Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence EPA Regulation of Plant Agricultural Biotechnology Release of Draft Proposed Rule on Reporting Requirements for Plant Agricultural Biotechnology

Infectious Disease Tax Credit S. 2351 R&D Tax Credit (H.R. 2764) Extension Permanence Alternatives Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Carried Interest Tax Treatment Biotech Capital Formation Tax Incentives/Net Operating Losses H.R. 3264: American Life Sciences Competitiveness Act of 2007

Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Revenue Recognition on Collaborative Agreements SEC Guidance Carried Interest Tax Treatment Biotech Capital Formation Tax Incentives/Net Operating Losses H.R. 3264: American Life Sciences Competitiveness Act of 2007 Convertible Debt Accounting FASB Proposed Guidance

Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Biorefinery Loan Guarantees H.R. 3221 S. 1321 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Solicitation Demonstration Projects for Feedstock Culture and Collection H.R. 2419

Drug Safety H.R. 3580; H.R. 2900 S. 1082 Medicaid Rebates H.R. 3162 H.R. 2764 S. 2499 Comparative Effectiveness Program Initiatives H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 S. 2499 Stem Cell Research Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Funding for Food and Drug Administration (Critical Path Initiative; Human Drug Review) H.R. 3161 S. 1859 H.R. 2764 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 FDA Regulatory Processes for First-Time Filers Food & Drug Administration Amendments Act/Food & Drug Administration Revitalization Act (H.R. 3580; H.R. 2900; S. 1082) User Fees/FDA Waivers for Small Businesses Risk Management Plans and Post-market Authorities Clinical Trial Registry and Results Databases Preemption Pharmaceutical Anti-Counterfeiting Priority Review Vouchers for Approved New Tropical Disease Therapies Civil Monetary Penalties FDA Advisory Panels/Conflict of Interest Possible Follow-on Biologics Amendments Follow-on Biologics H.R. 1038 H.R. 1956 S. 1695 S. 623 Presciption Drug User Fees H.R. 3580; H.R. 2900 S. 1082 Vaccines for Children Program H.R. 4990 Vaccines for Uninsured Adults H.R. 4993 National Vaccine Immunization Rates National Vaccine Program Office Working Paper on Adolescent Immunization Influenza Immunization Physician Quality Reporting Inititiative Vaccine Financing National Vaccine Program Office Draft White Paper on Vaccine Financing Vaccines and Medicare Part B/Part D H.R. 4992 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S. 1710; H.R. 2764) Emerging Diseases Regulatory Processes Emergency Use Authorization Genetic Testing Regulatory Oversight Infectious Disease Research Tax Credit S. 2351 Funding for State Children's Health Insurance Program S. 2086; S. 1893; S. 2499 H.R. 3162; H.R. 3963; H.R. 976 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 Erythropiesis Stimulating Agents CMS National Coverage Decision

Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S.1710; H.R. 2764) Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S.1710; H.R. 2764) Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 Critical Path Inititive H.R. 3161 S. 1859 Stem Cell Research Genetic Testing Regulatory Oversight Infectious Disease Reserach Tax Credit S. 2351 Comparative Effectiveness Program Initiatives S. 2499 H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963

Biobased Products Tax Credits H.R. 2419 H.R. 3586

Infectious Disease Tax Credit S. 2351

World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings

Stem Cell Research

Farm Subsidies in Trade H.R. 2720

Drug Safety H.R. 3580; H.R. 2900 S. 1082

Medicaid Rebates H.R. 3162; H.R. 2764 S. 2499

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764

Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859)

Drug Safety H.R. 3580; H.R. 2900 S. 1082

Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456

Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764

Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence

Codex Biotechnology Agenda U.S. Government Food Standards Negotiations Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations India Agricultural Biotechnology Regulations China Biotechnology Regulations Mexico Biotech Regulations International Policy Regarding Agricultural Biotechnology U.S. Government Negotiation Positions World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings USDA Agriculture Biotechnology Regulations USDA Biotechnology Policies Federal Preemption Oversight of Industry Exports of Agricultural Biotechnology Products Agricultural Biotechnology Stewardship Cartagena Biosafety Protocol Implementation and Effect on Agricultural Biotechnology CBD TRIPS Amendment Genetic Origin Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Intellectual Property Protections as Part of Panama and Peru Free Trade Agreements International Intellectual Property Enforcement Bill ITC Exclusion Orders - Impact on Biotechnology ITC Remedy Qualcomm Case

Regulation of Transgenic Animals Development of FDA Guidance and Advance Notice of Proposed Rulemaking Livestock Cloning Draft FDA Animal Cloning Risk Assessment Proposed FDA Risk Management Plan Draft FDA Guidance for Industry USDA National Organic Standards Board Cloning Recommendation

Sarbanes-Oxley Section 404 Reform Small Business Innovation Research (SBIR) Funding

Sarbanes-Oxley Section 404 Reform

Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Energy and Water Development and Related Agencies Appropriations Act, FY 2008 S. 1751: Energy and Water Development Appropriations Act, FY 2008 H.J.Res 20: Revised Continuing Appropriations Resolution, 2007 Adventitious Presence Release of USDA's Precursor to APHIS 340 Regs Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations India Agricultural Biotechnology Regulations China Biotechnology Regulations Mexico Biotech Regulations International Policy Regarding Agricultural Biotechnology U.S. Government Negotiation Position World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings Codex Biotechnology Agenda U.S. Government Food Standards Negotiations USDA Agriculture Biotechnology Regulations USDA Biotechnology Policies Federal Preemption Oversight of Industry Exports of Agricultural Biotechnology Products Agricultural Biotechnology Stewardship 2007 Farm Bill Animal Welfare Biofuels/Energy Research Preemption Application of Federal Insecticide Fungicide and Rodenticide Act (FIFRA) regulations to biotech plants Funding for Biotechnology Regulatory Services/USDA FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act Cartagena Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Energy Conservation Tax Act of 2007 Biorefinery Programs H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007

Drug Safety H.R. 2900: FDA Administration Amendments Act of 2007 (FDAAA) S.1082: FDA Revitalization Act (FDARA) Follow-on Biologics H.R. 1956: Patient Protection and Innovative Biologic Medicines Act S. 6237: Access to Life-Saving Medicines Act H.R. 1038: Access to Lifesaving Medicines Act S.1695: Biologics Price Competition and Innovation Act of 2007 Medicaid Expansion/Rebates H.R. 3162: The Children's Health and Medicare Protection Act of 2007 S.1893: The Children's Health Insurance Program Reauthorization Act of 2007 Medicare Clinical Trial Coverage Policy Implementation of Medicare Clinical Research Policy National Coverage Decision Comparative Effectiveness Research Initiatives S.3: Medicare Prescription Drug Price Negotiation Act of 2007 Medicare Part D "Non-Interference" Proposals S.250 and H.R. 4: Medicare Prescription Drug Price Negotiation Act FDA Appropriations Critical Path; Drug Safety; Human Drug Review Funding for Pandemic Influenza FY 2007 Emergency Supplemental Budget FY 2008 Budget H.R. 3043:Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biodefense Advanced R&D (BARDA) FY 2007 Emergency Supplemental Budget FY 2008 Budget S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Approp. Act, FY 2008 Funding for National Institutes of Health S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 340B of the Public Health Service Act/Drug Prices for Covered Entities Administrative Interpretations of Pricing Calculations Guidance on Calculation of 340B Ceiling Price Genetic Information Nondiscrimination S. 358 H.R. 493 Drug Importation S.1082: FDA Revitalization Act (FDARA) Biodefense Implementation Plan and Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Vaccines for Children Contract Data Availability Request

Biotech Tax Package H.R. 3264: American Life Sciences Competitiveness Act of 2007 Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 R&D Tax Credit H.R. 2138: Investment in America Act of 2007 Cross Licensing Agreement Taxation Treasury Department Proposal

Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 R&D Tax Credit H.R. 2138: Investment in America Act of 2007 Renewable Fuels Standard S. 1297: Advanced Clean Fuels Act S. 1324: National Low-Carbon Fuel Standard Act H.R. 2215: Federal Low Carbon Fuels Act H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Engery and Water Development and Related Agencies Appropriations Act, FY 2008 S. 1751: Energy and Water Development Appropriations Act, FY 2008 H.J. Res 20: Revised Continuing Appropriations Resolution, 2007 Small Business Innovation Research (SBIR) Funding Funding for Stem Cell Research S.5: Stem Cell Research Enhancement Act of 2007

FDA Appropriations Critical Path Drug Safety Human Drug Review Funding for Pandemic Influenza FY 2007 Emergency Supplemental Budget FY 2008 Budget H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biodefense Advanced R&D (BARDA) FY 2007 Emergency Supplemental Budget FY 2008 Budget S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for National Institutes of Health S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biotechnology Regulatory Services/USDA FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Energy and Water Development and Related Agencies Appropriations Act, FY 2008 S.1751: Energy and Water Development Appropriations Act, FY 2008 H.J.Res 20: Revised Continuing Appropriations Resolution, 2007 Funding for Stem Cell Research S.5: Stem Cell Research Enhancement Act of 2007

Adventitious Presence Release of USDA's Precursor to APHIS 340 Regs Livestock Cloning Draft FDA Animal Cloning Risk Assessment Proposed FDA Risk Management Plan Draft FDA Guidance for Industry USDA National Organic Standards Board Cloning Recommendation Regulation of Transgenic Animals Development of FDA Guidance and Advance Notice of Proposed Rulemaking Application of Federal Insecticide Fungicide and Rodenticide Act (FIFRA) regulations to biotech plants Drug Importation S.1082: FDA Revitalization Act (FDARA) Drug Safety H.R. 2900: FDA Administration Amendments Act of 2007 (FDAAA) S.1082: FDA Revitalization Act (FDARA)

Genetic Information Nondiscrimination S. 358 H.R. 493

Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Energy and Water Development and Related Agencies Appropriations Act, FY 2008; S. 1751: Energy and Water Development Appropriations Act, FY 2008; H.J. Res 20: Revised Continuing Appropriations Resolution, 2007 Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 Biorefinery Programs H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Renewable Fuels Standard S. 1297: Advanced Clean Fuels Act S. 1324: National Low-Carbon Fuel Standard Act H.R. 2215: Federal Low Carbon Fuels Act H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007

Biodefense Implementation Plan and Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Funding for Pandemic Influenza FY 2007 Emergency Supplemental Budget FY 2008 Budget H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 Funding for Biodefense Advanced R&D (BARDA) FY 2007 Emergency Supplemental Budget FY 2008 Budget S. 1710: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008 H.R. 3043: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY 2008

Cellulosic Ethanol Tax Credit S. 1618: To amend the Internal Revenue Code of 1986 to provide a credit for the production of cellulosic biofuel S.Amdt. 1704: To amend the Internal Revenue Code of 1986 to provide for energy advancement and investment, and for other purposes H..R. 2776: Renewable Energy and Engery Conservation Tax Act of 2007 Renewable Fuels Standard S. 1297: Advanced Clean Fuels Act S. 1324: National Low-Carbon Fuel Standard Act H.R. 2215: Federal Low Carbon Fuels Act H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Biorefinery Programs H.R. 6: Renewable Fuels, Consumer Protection, and Energy Efficiency Act of 2007 Biorefinery Funding/Cellulosic Ethanol Funding H.R. 2641: Engery and Water Development and Related Agencies Appropriations Act, FY 2008; S. 1751: Energy and Water Development Appropriations Act, FY 2008; H.J.Res 20: Revised Continuing Appropriations Resolution, 2007

Patent Reform H.R. 1908: Patent Reform Act of 2007 S. 1145: Patent Reform Act of 2007 Bayh-Dole Act PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71 FR 38808 CBD TRIPS Amendment Genetic Origin Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Intellectual Property Protections as Part of Panama and Peru Free Trade Agreements International Intellectual Property Enforcement Bill ITC Exclusion Orders - Impact on Biotechnology ITC Remedy Qualcomm Case Substantive Patent Law Harmonization U.S. Government Negotiation Positions Gene Patenting H.R. 977: A bill to prohibit gene patents

Adventitious Presence Release of USDA's Precursor to APHIS 340 Regs Livestock Cloning Draft FDA Animal Cloning Risk Assessment Proposed FDA Risk Management Plan Draft FDA Guidance for Industry USDA National Organic Standards Board Cloning Recommendation Regulation of Transgenic Animals Development of FDA Guidance and Advance Notice of Proposed Rulemaking Application of Federal Insecticide Fungicide and Rodenticide Act (FIFRA) regulations to biotech plants

World Health Organization Access to Medicines CBD TRIPS Amendment Genetic Origin Disclosure Requirements Patent Courts H.R. 5418 PTO Proposed Regulations Continuation Applications: 37 CFR Part 1 Information Disclosures Rules : 71 FR 38808 Claims Rules Intellectual Property Aspects of US Malaysia Free Trade Agreement Genetic Origin Disclosure Requirements Patenting of Plants and Animals Intellectual Property Aspects of US Korea Free Trade Agreement Data Exclusivity Patent Linkage Patent Reform S. 3818: Patent Reform Act of 2006

Sarbanes-Oxley Reform H.R. 5405 S.2824

Cellulosic Ethanol Funding H.R. 5427: Energy and Water Appropriations Act, 2007 Cellulose Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act

Cellulosic Ethanol Funding H.R. 5427: Energy and Water Appropriations Act, 2007 Adventitious Presence FDA's Adventitious Presence Policy EPA's Adventitious Policy Release of USDA's Precursor to APHIS 340 Regs Change USDA CFR 7 Part 340 Revision of Regulations for Agricultural Biotechnology 7 CFR Part 340 (Draft EIS and Changes to Part 340) Establishment of Reporting Requirements for Agricultural Biotechnology Revision of Regulations in Section 7 FIFRA (Federal Insecticide Fungicide and Rodenticide Act) Cellulose Biomass Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act Funding for Biotechnology Regulatory Services/USDA H.R. 5384 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations Indian Agricultural Biotechnology Regulations Sri Lanka Biotechnology Regulations EU Biotechnology Regulations China Biotechnology Regulations Mexico Biotechnology Regulations Codex Biotechnology Agenda U.S. Government Food Standards Negotiations Cartagena Biosafety Protocol Implementation of the Biosafety Protocol and Effect on Agricultural Biotechnology World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings

Tricare Retail Pharmacy H.R. 5122, S. 2767: Department of Defense Authorization

H.R. 1227, S. 306: Genetic Information Nondiscrimination Act

Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement U.S. Malaysia Free Trade Agreement U.S. Russia World Trade Organization Accession Negotiations Indian Agricultural Biotechnology Regulations Sri Lanka Biotechnology Regulations EU Biotechnology Regulations China Biotechnology Regulations Mexico Biotechnology Regulations Cartagena Biosafety Protocol Implementation of the Biosafety Protocol and Effect on Agricultural Biotechnology World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings Pharmaceutical Coverage and Pricing U.S. Korea Free Trade Agreement Intellectual Property Aspects of US Korea Free Trade Agreement Data Exclusivity Patent Linkage Intellectual Property Aspects of US Malaysia Free Trade Agreement Genetic Origin Disclosure Requirements Patenting of Plants and Animals

Orphan Drug Research H.R. 5080: Orphan Drug Tax Credit Funding for Pandemic Preparedness H.R. 5647: Labor/HHS/Education Appropriations H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act S. 3678: Pandemic and All-Hazards Preparedness Act Funding for Critical Path at FDA H.R. 5384: Agriculture and Related Agencies Appropriations Stem Cell Research H.R. 810: Stem Cell Research S. 2504: Fetus Farming Prohibition Act R&D Tax Credits H.R. 5115: U.S. Healthcare Technologies Competitiveness Act of 2006 H.R. 4082/S. 189: Biotechnology Future Investment Act of 2005 FDA Funding H.R. 5384 2008 Budget

Stem Cell Research H.R. 810: Stem Cell Research S. 2504: Fetus Farming Prohibition Act R&D Tax Credit H.R. 5115: U.S. Healthcare Technologies Competitiveness Act of 2006 Small Business Innovation Research (SBIR) Grants H.R. 2943/S 1263: Save Biotechnology Innovative Research Act of 2005 Cellulosic Ethanol Research Funding H.R. 5427: Energy and Water Appropriations Orphan Drug Research H.R. 5080: Orphan Drug Tax Credit Cellulosic Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act

H.R. 5384: Agriculture and Related Agencies Appropriation Funding for Critical Path at FDA Funding for Biotechnology Regulatory Services/USDA H.R. 5647: Labor/HHS/Education Appropriations Funding for Pandemic Preparedness H.R. 5427: Energy and Water Appropriations Funding for Cellulose Ethanol Funding H.R. 5441: FY 2007 Homeland Security Appropriations Drug Importation

Medicaid Program Rebates S.1932: Deficit Reduction Act Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Ryan White Care Act Reauthorization Covered Drugs List/ADAPs Tricare Retail Pharmacy H.R. 5122, S. 2767: Department of Defense Authorization Biodefense and Pandemic Vaccine Tracking S.3678: Pandemic & All-Hazards Preparedness Act Implementation of Deficit Reduction Act 340B Pricing S. 1932: Deficit Reduction Act

Funding for Pandemic Preparedness H.R. 5647: Labor/HHS/Education Appropriation H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense & Pandemic Biodefense Advanced R&D and Procurement Reform H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Biodefense and Pandemic Regulatory Guidance Vaccine Tracking Information Disclosure S. 3678: Pandemic and All-Hazards Preparedness Act Antitrust Exemptions H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense Information Technology to Improve Situational Awareness S.3678: Pandemic & All-Hazards Preparedness Act

Cellulosic Ethanol Funding H.R. 5427: Energy and Water Appropriations Act, 2007 Cellulose Biomass Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act

Drug Safety S:3807: Enhancing Drug Safety and Innovation Act of 2006 Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Adventitious Presence FDA's Adventitious Presence Policy EPA's Adventitious Policy Release of USDA's Precursor to APHIS 340 Regs Change USDA CFR 7 Part 340 Animal Transgenics and Cloning FDA Draft Risk Assessment on Animal Cloning

FDA's Critical Path Initiative Funding Specific Projects Follow-on Biologics H.R. 6237: Access to Lifesaving Medicines Act FDA Funding H.R. 5384 2008 Budget Drug Safety S:3807: Enhancing Drug Safety and Innovation Act of 2006 Drug Importation H.R. 5441: FY2007 Homeland Security Appropriations Prescription Drug User Fee Act Reauthorization Critical Path Drug Safety Drug Reviews Biodefense & Pandemic Biodefense Advanced R&D and Procurement Reform H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Biodefense Strategic Plan HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Biodefense and Pandemic Regulatory Guidance Vaccine Tracking Information Disclosure S. 3678: Pandemic and All-Hazards Preparedness Act Funding H.R. 5647: Labor/HHS/Education Appropriations H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: Pandemic and All-Hazards Preparedness Act Antitrust Exemptions H.R. 5533: Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S. 3678: "Pandemic and All-Hazards Preparedness Act Biodefense Information Technology to Improve Situational Awareness S.3678: Pandemic & All-Hazards Preparedness Act Genetic Information Nondiscrimination H.R. 1227, S. 306 Ryan White Cases Act Reauthorization Covered Drugs List/ADAP Medicaid Program Rebates S. 1932: Deficit Reduction Act Implementation of Deficit Reduction Act 340B Pricing S. 1932: Deficit Reduction Act Tricare Retail Pharmacy H.R. 5122, S. 2767: Department of Defense Authorization

Animal Transgenics and Cloning FDA Draft Risk Assessment on Animal Cloning

Implementation of Deficit Reduction Act 340B Pricing S. 1932: Deficit Reduction Act Coding for Physician-Administered Biologics Ryan White Care Act Reauthorization Covered Drugs List/ADAP Medicaid Program Rebates S.1932: Deficit Reduction Act

R&D Tax Credits H.R. 5115: U.S. Healthcare Technologies Competitiveness Act of 2006 Orphan Drug Research Tax Credit H.R. 5080 Cellulose Ethanol Tax Credit H.R. 5890: American Made Energy Freedom Act Net Operating Losses H.R. 4082/S 1893: Biotechnology Future Investment Act of 2005 Biotechnology Investment Incentives H.R. 5115: US Healthcare Technologies Competitiveness Act of 2006