TOM DILENGE

Biofuels (Non-Funding) ---Production Tax Credit Extension 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 ---H.R. 2179: PARTNER Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Orphan Drug Act Tax Credit No sub-issues Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---S. 2271: The Renewable Chemical Production Tax Credit Act

Adventitious Presence (Low Level Presence) ---International Low Level Presence Policies Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Potential Regulation of New Genetic Modification Technologies Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law Review of the Federal Coordinated Framework for Biotechnology Products USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Patient Access to Approved Drugs Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications

Biosimilars ---Brazil Biologics Regulations ---Colombia Biologics Regulations ---India Biologics Regulations ---Mexico Biologics Regulations Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Renewable Chemicals/Bio-based Products (Non-Funding) ---Nomenclature Usage ---Pre-market Notification Review ---S. 697: Chemical Safety for the 21st Century Act ---H.R. 2576: TSCA Modernization Act ---S. 1447: Sustainable Chemistry Research and Development Act ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016

Livestock Cloning/Product Labeling ---Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals ---FDA Approval ---Labeling ---One Health Legislation (Senate Discussion Draft) ---H.R.2029: Consolidated Appropriations Act for FY 2016 -------Amendment to Restrict FDA Approval of GE Salmon -------Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology ---U.S. Government Policy ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---H.R.2029: Consolidated Appropriations Act for FY 2016 Biosimilars ---Colombia Biologics Regulations ---Mexico Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Naming USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Co-existence of Production Systems Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015

Patent Reform ---S.1137: The PATENTS Act of 2015 ---H.R. 9: Innovation Act ---Implementation of the America Invents Act of 2011 ---H.R.2029: Consolidated Appropriations Act for FY 2016 Bayh-Dole Act/Tech Transfer ---Commercialization of Federally Funded Research Initiative Intellectual Property International Enforcement Transpacific Partnership ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues Drug Patent Settlements ---S.1137: The PATENTS Act of 2015 ---S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review ---Implementation of the American Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 ---H.R. 9: Innovation Act ---H.R.2029: Consolidated Appropriations Act for FY 2016

Biosimilars ---Biosimilar User Fee Act Implementation ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming Funding for the National Institutes of Health ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.2029: Consolidated Appropriations Act for FY 2016 Vaccine Access/Financing ---Vaccine Injury Compensation Program 340B Drug Pricing Program ---Program Implementation & Oversight ---H.R.2029: Consolidated Appropriations Act for FY 2016 Medicaid Pricing and Rebates ---Implementation of Affordable Care Act ---Average Manufacturer Price Calculations Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2029: Consolidated Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues TransPacific Partnership ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Reimbursement Transparency Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based contracting and communications Drug Evaluation and Review ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---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 ---Generic Entry Incentives Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016 Government Price Reporting ---H.R.2029: Consolidated Appropriations Act for FY 2016 Gene Editing Technologies ---H.R. 2029: Consolidated Appropriations Act for 2016 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Precision Medicine Initiative

Synthetic Biology Issue ---H.R. 591: Engineering Biology Research and Development Act

Sarbanes Oxley Section 404 (b) ---H.R. 4139: the Fostering Innovation Act Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Reform of SEC Regulation D ---S. 978: the HALOS Act Expansion of Exemption under SEC Regulation A ---H.R. 1839: Reforming Access for Investments in Startup Enterprises (RAISE) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions XBRL Exemption for Small Public Companies ---H.R. 5405: Promoting Job Creation and Reducing Small Business Burdens Act ---H.R. 1965: Small Company Disclosure Simplification Act Capital Market Enhancements ---H.R. 1525: Disclosure Modernization and Simplification Act ---H.R. 1723: Small Company Simple Registration Act ---H.R. 2064: Improving Access to Capital for Emerging Growth Companies Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 3784: Securities & Exchange Commission Small Business Advocate Act -- H.R. 2357: Accelerating Access to Capital Act Proxy Advisory Services ---Impact of Policies on Small Public Companies

Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015 Intellectual Property International Enforcement Foreign Agricultural Biotechnology Laws and Regulations ---Korea Biotechnology Regulations ---Asynchrony of International Approvals ---EU Ag Biotech Policies and Regulations ---China Biotechnology Regulations Biosimilars ---Mexico Biologics Regulations ---Colombia Biologics Regulations TransPacific Partnership ---Sanitary and Phytosanitary Issues ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Reimbursement Transparency

EPA Regulations on Agricultural Biotechnology ---Pesticide Registration Improvement Act Livestock Cloning/Product Labeling ---Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals ---FDA Approval ---Labeling ---One Health Legislation (Senate Discussion Draft) ---H.R.2029: Consolidated Appropriations Act for FY 2016 -------Amendment to Restrict FDA Approval of GE Salmon -------Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology ---U.S. Government Policy ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---H.R.2029: Consolidated Appropriations Act for FY 2016 Transpacific Partnership ---Sanitary and Phytosanitary Issues Adventitious Presence (Low Level Presence) ---International Low Level Presence Policies Funding for the USDA ---H.R.2029: Consolidated Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony of International Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations Potential Regulation of New Genetic Modification Technologies Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Co-existence of Production Systems Review of the Federal Coordinated Framework for Biotechnology Products

Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Climate Change Benefits ---Production Tax Credit Extension ---Implementation of the Agricultural Act of 2014 ---H.R. 2029: Consolidated Appropriations Act of FY 2016 -------Protecting Americans from Tax Hikes (PATH) Act of 2015 Renewable Chemicals/Bio-based Products (Non-Funding) ---Nomenclature Usage ---Pre-market Notification Review ---S. 697: Chemical Safety for the 21st Century Act ---H.R. 2576: TSCA Modernization Act ---S. 1447: Sustainable Chemistry Research and Development Act ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biofuels ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biorefineries --H.R.2029: Consolidated Appropriations Act for FY 2016 EPA Regulation of Biotechnology ---EPA Points to Consider Guidance Document for GE Algae Renewable Fuel Standard ---Proposed Rule Review of the Federal Coordinated Framework for Biotechnology Products

Renewable Chemicals/Bio-based Products ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Production Tax Credit Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 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. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act Tax Reform ---Innovation Box/Patent Box Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Inversions ---H.R.2029: Consolidated Appropriations Act for FY 2016

Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Climate Change Benefits ---Production Tax Credit Extension ---Implementation of the Agricultural Act of 2014 ---H.R. 2029: Consolidated Appropriations Act of FY 2016 -------Protecting Americans from Tax Hikes (PATH) Act of 2015 Renewable Chemicals/Bio-based Products (Non-Funding) ---Nomenclature Usage ---Pre-market Notification Review ---S. 697: Chemical Safety for the 21st Century Act ---H.R. 2576: TSCA Modernization Act ---S. 1447: Sustainable Chemistry Research and Development Act ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biofuels ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biorefineries --H.R.2029: Consolidated Appropriations Act for FY 2016 EPA Regulation of Biotechnology ---EPA Points to Consider Guidance Document for GE Algae Renewable Fuel Standard ---Proposed Rule Review of the Federal Coordinated Framework for Biotechnology Products

Livestock Cloning/Product Labeling ---Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals ---FDA Approval ---Labeling ---One Health Legislation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Amendment to Restrict FDA Approval of GE Salmon ------Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology ---U.S. Government Policy ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---H.R.2029: Consolidated Appropriations Act for FY 2016

EPA Regulations on Agricultural Biotechnology --Pesticide Registration Improvement Act Reauthorization 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 Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations --Asynchrony of International Approvals --China Biotechnology Regulations --EU Ag-Biotech Policies and Regulations Potential Regulation of New Genetic Modification Technologies USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products International Treaty on Plant Genetic Resources Review of the Federal Coordinated Framework for Biotechnology Products

Renewable Chemicals/Bio-based Products (Non-Funding) --S. 697: Chemical Safety for the 21st Century Act ----Nomenclature Usage ----Pre-market Notification Review --S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 --Expansion of Master Limited Partnerships to Renewable Chemicals --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003

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

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

Synthetic Biology --H.R. 591: Engineering Biology Research and Development 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

Biofuels (Non-Funding) --Production Tax Credit Extension --S.2089: American Energy Innovation Act Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Renewable Fuel Standard (RFS) --Proposed Rule --S. 1372: American Crude Oil Export Equality Act ----Amendment to Repeal Conventional Biofuel Category of RFS --H.R. 702: A Bill to Adapt to Changing Crude Oil Market Conditions ---- Amendment to Repeal RFS

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)

Patent Reform --H.R. 9: Innovation Act --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --Implementation of the America Invents Act of 2011 TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues Drug Patent Settlements --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 632: STRONG Patents Act --S. 1137: Protecting American Talent and Entrepreneurship Act of 2015 --H.R. 9: Innovation Act Intellectual Property International Enforcement --India

Biofuels (Non-Funding) --Production Tax Credit Extension --S.2089: American Energy Innovation Act Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Renewable Fuel Standard (RFS) --Proposed Rule --S. 1372: American Crude Oil Export Equality Act ----Amendment to Repeal Conventional Biofuel Category of RFS --H.R. 702: A Bill to Adapt to Changing Crude Oil Market Conditions ----Amendment to Repeal RFS

Foreign Agricultural Biotechnology Laws and Regulations --China Biotechnology Regulations --EU Ag Biotech Policies and Regulations Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Ag-Biotech Issues --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Trade Promotion Authority --H.R. 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --H.R. 1295: Trade Adjustment Assistance Act of 2015 IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations

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 --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)

Genetically Engineered (GE) Animals --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling --One Health Legislation (Senate Discussion Draft) Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy Nutrition Policy --Reauthorization of Federal School Nutrition Programs (Senate Discussion Draft)

Renewable Chemicals/Bio-based Products (Non-Funding) --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 --Investment Tax Credit for Renewable Chemicals and Bio-based Products --New Production Tax Credit --S. 1447: Sustainable Chemistry Research and Development Act --S. 697: Chemical Safety for the 21st Century Act Funding for Renewable Chemicals/Bio-based Products and Biorefineries --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Energy Title IX, Section 9003

Biofuels (Non-Funding) --Implementation of the Agricultural Act of 2014 --Production Tax Credit Extension --Renewable Fuel Standard Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products and Biorefineries --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Energy Title IX, Section 9003 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016, --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014

Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations

Genetically Engineered (GE) Animals --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Amendment on GE Salmon Labeling --One Health Legislation (Senate Discussion Draft) Review and Labeling of Food Derived From Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---U.S. Government Policy Funding for the USDA ---H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Potential Regulation of New Genetic Modification Technologies Funding for Biomass Crop Assistance Program ---H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Trade Promotion Authority ---HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 ---HR 1295: Trade Adjustment Assistance Act of 2015 Transatlantic Trade and Investment Partnership ---Ag-Biotech Issues Nutrition Policy ---Reauthorization of Federal School Nutrition Programs (Senate Discussion Draft)

Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --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/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016

Sarbanes Oxley Section 404 (b) --Public Company Accounting Oversight Board - Audit Cost Increases Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --H.R. 2179: PARTNER Act --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Expansion of Exemption under SEC Regulation A --H.R. 1839: Reforming Access for Investments in Startup Enterprises (RAISE) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions --Fostering Innovation Act (House Discussion Draft) XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act Capital Market Enhancements --SEC Office of Small Business Policy Responsibilities --H.R. 1525: Disclosure Modernization and Simplification Act --H.R. 1675/S.576: Encouraging Employee Ownership Act --H.R. 1723: Small Company Simple Registration Act --H.R. 2064: Improving Access to Capital for Emerging Growth Companies Act --H.R. 2357: Accelerating Access to Capital Act Proxy Advisory Services --Impact of Policies on Small Public Companies

Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative --Patient Access to Approved Drugs --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculations --Reimbursement for Infusion Drugs under Medicare Part B

Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy 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 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 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 --Implementation of Affordable Care Act 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 Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues 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 --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015

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 21st Century Cures 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)

IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations21st Century Cures Initiative Biomarkers and Regulatory Science Improvements Communication with Healthcare Professionals Expanded Access to Investigational Drugs Expedited Pathways FDA Hiring Flexibility FDA Management and Financial Accountability Innovation Incentives Longitudinal Study of Chronic Diseases Patient Access to Approved Drugs Patient-Focused Drug Development Use of Real-World Evidence Vaccine and Anti-Microbial Resistance Product Development and Incentives Combating Antibiotic-Resistant Bacteria (CARB) Initiative Biosimilars Biosimilar User Fee Act Implementation Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Patent Certification Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 340B Drug Pricing Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Implementation of Affordable Care Act Program Implementation & Oversight Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Issues Intellectual Property IssuesReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Sunshine Act Implementation

Bonus Depreciation S. 2260: EXPIRE Act of 2014Tax Reform Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products Bonus Depreciation for Renewable Chemical Facilities S. 2260: EXPIRE Act of 2014 Biofuels Accelerated Depreciation Extension Production Tax Credit Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 2260: EXPIRE Act of 2014 Research & Development Tax Credit Reforms Extension Permanency H.R. 4438: American Research & Competitiveness Act of 2014 S. 2260: EXPIRE Act of 2014 S. 2715: The COMPETE Act S.193: The Start-up Innovation Credit Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 4855: The PARTNER Act S. 1658: The Start-up Jobs and Innovation Act S. 2715: The COMPETE Act Controlled Foreign Corporation Look-Through Rule Extension S. 2260: EXPIRE Act of 2014 Inversions H.R.4870: Department of Defense Appropriations Act for FY 2015 H.R.5016: Financial Services and General Government Appropriations Act for FY 2015

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 Biofuels H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Biofuels (Non-Funding) Accelerated Depreciation Extension Climate Change Benefits Production Tax Credit Extension Renewable Fuel Standard H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 2260: EXPIRE Act of 2014 Renewable Chemicals/Bio-based Products (Non-Funding) Implementation of the Agriculture Act of 2014 Bonus Depreciation for Renewable Chemical Facilities S. 2260: EXPIRE Act of 2014 Funding for Biomass Crop Assistance Program H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biorefineries Implementation of the Agricultural Act of 2014 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015

Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 1658: The Start-up Jobs and Innovation Act H.R. 4855: The PARTNER Act S.2715: The COMPETE Act Expansion of Exemption under SEC Regulation A H.R. 4565: Startup Capital Modernization Act Proposed SEC Rule on Reg A+ Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies H.R. 4164: Small Company Disclosure Simplification Act H.R. 5405: The Promoting Job Creation and Reducing Small Business Burdens Act Stock Exchange Tick Size H.R. 3448: The Small Cap Liquidity Reform Act H.R. 1952: The Spread Pricing Liquidity Act Capital Market Enhancements H.R. 3623: Improving Access to Capital for Emerging Growth Companies Act H.R. 4568: Small Business Freedom to Grow Act H.R. 4569: Disclosure Modernization and Simplification Act H.R. 4571: To direct the SEC to revise its rules so as to increase the threshold amount for requiring issuers to provide certain disclosures relating to compensatory benefits plans H.R. 4697: To require the SEC to revise the definition of a WKSI to reduce the worldwide market value threshold under the definition

Intellectual Property International Enforcement Compulsory Licensing IndiaForeign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Like-minded Countries Initiatives TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Reimbursement Transparency Biosimilars Colombia Biologics Regulations Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies

Patenting of Humanitarian Technologies S. 712: Patents for Humanity Program Improvement Act of 2013Patent Reform H.R. 3309: Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) FTC Regulation of Patent Demand Letters (Senate Commerce Committee Discussion Draft) Intellectual Property International Enforcement Compulsory Licensing India Issues TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Patenting of Biological Inventions

21st Century Cures Initiative Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program: CMS Proposed Rule on Protected Classes

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 Biofuels H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Biofuels (Non-Funding) Accelerated Depreciation Extension Climate Change Benefits Production Tax Credit Extension Renewable Fuel Standard H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 2260: EXPIRE Act of 2014 Renewable Chemicals/Bio-based Products (Non-Funding) Implementation of the Agriculture Act of 2014 Bonus Depreciation for Renewable Chemical Facilities S. 2260: EXPIRE Act of 2014 Funding for Biomass Crop Assistance Program H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biorefineries Implementation of the Agricultural Act of 2014 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015

Trade Promotion Authority S.1900/H.R. 3830: Bipartisan Congressional Trade Priorities Act of 2014Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Intellectual Property International Enforcement Compulsory Licensing India Issues Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Sanitary and Phytosantiary Issues International Trade Commission Reform Transatlantic Trade and Investment Partnership Intellectual Property Issues Ag-Biotech Issues Regulatory Harmonization/Transparency Biosimilars Colombia Biologics Regulations Clinical Trial Data Sharing and Disclosure EU Policies

Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Colombia Biologics Regulations Naming 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 Adult Immunization (Senate Discussion Draft) 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 Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) (Non-Funding) Program Implementation Sequestration of PDUFA Fees Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade & Investment Partnership Regulatory Harmonization/TransparencyDrug 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 Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act

TransPacific Partnership Data and Intellectual Property Protections for PharmaceuticalsPatent Reform H.R. 3309: Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) FTC Regulation of Patent Demand Letters (Senate Commerce Committee Discussion Draft) Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act Intellectual Property International Enforcement Compulsory Licensing India Issues Transatlantic Trade and Investment Partnership Intellectual Property Issues Patenting of Biological Inventions DNA Patenting and Licensing International Trade Commission Reform

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

Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform S. 866: Patent Quality Improvement Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 H.R. 3309: The Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 FTC Regulation of Patent Demand Letters (Senator McCaskill Discussion Draft) World Trade Organization Special 301 Submissions Intellectual Property International Enforcement Compulsory Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Drug Repurposing H.R. 4287/2150: Independent Innovator and Repurposing Act

Review and Labeling of Food Derived From Biotechnology House Energy and Commerce Discussion Draft U.S. Government PolicyEPA Regulations on Agricultural Biotechnology Efficient Science-Based Review of Biotech Products Herbicide Label Changes Insect Resistance Management Department of Interior, Environment, and Related Agencies Appropriations Act for FY 2015 Genetically Engineered (GE) Animals Labeling Agriculture, Rural Development, FDA, and Related Appropriations Act for 2015 FDA Approval H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for USDA H.R. 3547: Consolidated Appropriations Act for FY 2014 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Korea Biotechnology Regulations Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State H.R. 3547: Consolidated Appropriations Act for FY 2014 Biomass Programs Reauthorization of Biomass Crop Assistance Program Reauthorization of Biomass R&D Program 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 Act for FY 2015 USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement Coexistence of Production Systems Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Trans Pacific Partnership Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Ag-Biotech Issues

Biofuels Accelerated Depreciation Extension Production Tax Credit ExtensionRenewable Chemicals/Bio-based Products New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Bonus Depreciation for Renewable Chemical Facilities Research & Development Tax Credit Reforms Extension Permanency The Start-up Innovation Credit Act (Senator Coons Discussion Draft) The Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act House Ways and Means Committee Discussion Draft (Rep. Camp) Tax Reform House Ways and Means Committee Discussion Draft (Rep. Camp) Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension

Review and Labeling of Food Derived From Biotechnology House Energy and Commerce Discussion Draft U.S. Government PolicyGenetically Engineered (GE) Animals Labeling Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2015 FDA Approval 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

Capital Market Enhancements H.R. 3623: Improving Access to Capital for Emerging Growth Companies ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies H.R. 4164: Small Company Disclosure Simplification Act Stock Exchange Tick Size H.R. 3488: The Small Cap Liquidity Reform Act

Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionRenewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act H.R. 1696/S. 795: Master Limited Partnerships Parity Act Research & Development Tax Credit Reforms Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Tax Reform Orphan Drug Act Issues Tax Credit

Stock Exchange Tick Size Tick Size Flexibility Act (Rep. Duffy Discussion Draft) H.R. 1952: The Spread Pricing Liquidity ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Rep. McHenry Discussion Draft Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: Fostering Innovation Act Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies

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

Biofuels Production Tax Credit Extension Renewable Fuel Standard Accelerated Depreciation ExtensionBiofuels Cont... Department of Defense Application of Advanced Biofuels H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 1960/S. 1034: National Defense Authorization Act H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biorefineries Reauthorization of Biorefinery Assistance Program H.R. 1960/S. 1034: National Defense Authorization Act HR 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Reauthorization of USDA Bio-Preferred Program Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2421: Renewable Chemicals Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biomass Programs Reauthorization of Biomass R&D Program Reauthorization of Biomass Crop Assistance Program 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) 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.R. Res. 59: 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: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)Funding for Biorefineries Cont... H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Coordination of Federal Biotechnology Research

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

Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform House Judiciary Committee Discussion Draft (Rep. Bob Goodlatte) H.R. 3309: The Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Implementation of H.R. 1249: The America Invents Act of 2011 Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues

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 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

EPA Regulations on Agricultural Biotechnology Herbicide Label Changes Efficient Science-Based Review of Biotech ProductsLivestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically 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 TransPacific Partnership Sanitary and Phytosanitary Issues Adventitious Presence International Low Level Presence Policies Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals Biomass Programs Reauthorization of Biomass Crop Assistance Program Reauthorization of Biomass R&D Program 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) Transatlantic Trade and Investment Partnership Ag-Biotech Issues USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products Coordination of Federal Biotechnology Research

Biofuels Production Tax Credit Extension Renewable Fuel Standard Accelerated Depreciation ExtensionBiofuels Cont... Department of Defense Application of Advanced Biofuels H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 1960/S. 1034: National Defense Authorization Act H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biorefineries Reauthorization of Biorefinery Assistance Program H.R. 1960/S. 1034: National Defense Authorization Act HR 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Reauthorization of USDA Bio-Preferred Program Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2421: Renewable Chemicals Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biomass Programs Reauthorization of Biomass R&D Program Reauthorization of Biomass Crop Assistance Program 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) 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.R. Res. 59: 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: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)Funding for Biorefineries Cont... H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Coordination of Federal Biotechnology Research

Biofuels Production Tax Credit Extension Accelerated Depreciation Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms Extension Permanency H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities H.R.3757: The Igniting American Research Act The Innovative Research and Competitiveness Act (Senator Carper Discussion Draft), The Start-up Innovation Credit Act (Senator Coons Discussion Draft) Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Tax Reform Orphan Drug Act Tax Credit

Biofuels Production Tax Credit Extension Renewable Fuel Standard Accelerated Depreciation ExtensionBiofuels Cont... Department of Defense Application of Advanced Biofuels H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 1960/S. 1034: National Defense Authorization Act H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biorefineries Reauthorization of Biorefinery Assistance Program H.R. 1960/S. 1034: National Defense Authorization Act HR 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Reauthorization of USDA Bio-Preferred Program Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2421: Renewable Chemicals Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biomass Programs Reauthorization of Biomass R&D Program Reauthorization of Biomass Crop Assistance Program 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) 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.R. Res. 59: 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: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)Funding for Biorefineries Cont... H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Coordination of Federal Biotechnology Research

Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform House Judiciary Committee Discussion Draft (Rep. Bob Goodlatte) H.R. 3309: The Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Implementation of H.R. 1249: The America Invents Act of 2011 Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues

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

Biofuels Production Tax Credit Extension Renewable Fuel Standard Accelerated Depreciation ExtensionBiofuels Cont... Department of Defense Application of Advanced Biofuels H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 1960/S. 1034: National Defense Authorization Act H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biorefineries Reauthorization of Biorefinery Assistance Program H.R. 1960/S. 1034: National Defense Authorization Act HR 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Reauthorization of USDA Bio-Preferred Program Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2421: Renewable Chemicals Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Biomass Programs Reauthorization of Biomass R&D Program Reauthorization of Biomass Crop Assistance Program 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) 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.R. Res. 59: 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: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)Funding for Biorefineries Cont... H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Coordination of Federal Biotechnology Research

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 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

Stock Exchange Tick Size Tick Size Flexibility Act (Rep. Duffy Discussion Draft) H.R. 1952: The Spread Pricing Liquidity ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Rep. McHenry Discussion Draft Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: Fostering Innovation Act Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies

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

Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionRenewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act H.R. 1696/S. 795: Master Limited Partnerships Parity Act Research & Development Tax Credit Reforms Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Tax Reform Orphan Drug Act Issues Tax Credit

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

Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program

Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 House Judiciary Committee Discussion Draft 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 DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Health Regulatory Agency Review of Patents Brazil Colombia Asia Pacific Economic Cooperation Forum Intellectual Property Issues Drug Patent Settlements

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

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 EU Biotechnology Bilateral Discussions, Low-Level Presence Foreign Government Policies TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Asia Pacific Economic Cooperation Forum Intellectual Property Issues Biologics Regulations Biosimilars Colombia Biologics Regulations Mexico Biologics Regulations Naming Health Regulatory Agency Review of Patents Brazil Colombia

Reform of SEC Regulation D Implementation of H.R. 3606: Jumpstart Our Business Start-ups (JOBS) ActCapital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action. Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Fostering Innovation Act (Rep. Fitzpatrick Discussion Draft) Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act Stock Exchange Tick Size H.R. 1952: The Spread Pricing Liquidity Act Tick Size Flexibility Act (Rep. Duffy Discussion Draft)

USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Reviews of Biotech ProductsLivestock Cloning/Product Labeling Discussions with EU on Animal Cloning EPA Regulations on Agricultural Biotechnology Genetically Engineered (GE) Animals FDA Approval Amendment to Restrict FDA Approval of GE Salmon Labeling Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 S. Con. Res. 8: Senate Budget Resolution Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy S. 10: Agriculture Reform, Food, and Jobs Act of 2013 S (Farm Bill) Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations International Biotechnology Agreement EU Biotechnology Bilateral Discussions Low-Level Presence Foreign Government Policies Agricultural Biotechnology Regulatory Reform and Modernization S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Benefits of Ag-Biotech Research and Innovation Regulatory Review of Animal Pharmaceuticals S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 TransPacific Partnership Sanitary and Phytosanitary Issues

Patent Reform LitigationTransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl World Trade Organization Special 301 Submissions Generic Drug Patent Settlements S. Con. Res. 8: Senate Budget Resolution Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Intellectual Property International Enforcement Compulsory Licensing International Patent Law Harmonization Patent Exhaustion

Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionResearch & Development Tax Credit Extension Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Capital Formation Investment Incentives High Technology Small Business Research Incentives Act (Discussion Draft) 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 Tax Reform Renewable Chemicals/Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Advanced Manufacturing Investment Tax Credit to Renewable Chemicals and Bio-Based Products Expansion of Master Limited Partnerships to Renewable Chemicals

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningWorld Trade Organization Special 301 Submissions Export Registrations for Products with Expired Patents Intellectual Property International Enforcement Compulsory Licensing Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Low-Level Presence Foreign Government Policies International Biotechnology Agreement Asynchrony of International Approvals EU Biotechnology Bilateral Discussions TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency Sanitary and Phytosanitary Issues U.S./European Union High-Level Dialogue on Regulatory Issues

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

Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation (Rep. Hurt Discussion Draft) Tax ReformCapital Formation Investment Incentives High Technology Small Business Research Incentives Act (Discussion Draft) Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a eadline for such action Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Small Business Innovation Research (SBIR) Program Implementation of Final Rulemaking

Patent Reform H.R. 6621: To correct and improve certain provisions of the Leahy-Smith America Invents ActIntellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Export Registrations for Products with Expired Patents

Biorefineries 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)Renewable Fuels Standard Regulatory Oversight Implementation of P.L. No: 112-140: Energy Independence and Security Act Super Storm Sandy Emergency Supplemental Appropriations (Discussion Draft) Biofuels Funding Department of Defense Applications of Advanced Biofuels Production Tax Credit Extension Production Tax Credit Modification for Algae-based Biofuels Investment Tax Credit Options Next Generation Incentives Economic Growth Impact/Potential of Advanced Biofuels 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) S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S. 3521: Family and Business Tax Cut Certainty Act of 2012 H.R. 5856: Department of Defense Appropriations Act for FY 2013 H.R. 4310/S.3254: National Defense Authorization Act for FY 2013 American Taxpayer Relief Act (Discussion Draft) Bio-based Products Tax Credit 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) H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012 American Taxpayer Relief Act (Discussion Draft) Renewable Chemicals 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) H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012 American Taxpayer Relief Act (Discussion Draft)

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningUSDA/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

EPA Regulations on Agricultural Biotechnology EPA Notice on PIP Data RequirementsUSDA/APHIS Agricultural Biotechnology Regulations 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) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning 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 Export Registrations for Products with Expired Patents Labeling of Genetically Engineered (GE) Crops U.S. Government Policy 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 Agricultural Biotechnology Regulatory Reform and Modernization 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) Potential Regulation of New Genetic Modification Technologies Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Asynchrony of International Approvals Adventitious Presence (Low Level Presence)

Renewable Fuels Standard Regulatory Oversight Implementation of P.L. No: 112-140: Energy Independence and Security Act Super Storm Sandy Emergency Supplemental Appropriations (Discussion Draft)Biofuels Funding Department of Defense Applications of Advanced Biofuels Production Tax Credit Extension Production Tax Credit Modification for Algae-based Biofuels Investment Tax Credit Options Next Generation Incentives Economic Growth Impact/Potential of Advanced Biofuels 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) S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S. 3521: Family and Business Tax Cut Certainty Act of 2012 H.R. 5856: Department of Defense Appropriations Act for FY 2013 H.R. 4310/S.3254: National Defense Authorization Act for FY 2013 American Taxpayer Relief Act (Discussion Draft) Biorefineries 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) Bio-based Products Tax Credit 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) H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012 American Taxpayer Relief Act (Discussion Draft) Renewable Chemicals 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) H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012 American Taxpayer Relief Act (Discussion Draft)

Bio-based Products Tax Credit H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines Tax Reform Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012 Research & Development Tax Credit Extension Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Startup Innovation Credit Act (Senator Coons Discussion Draft) American Taxpayer Relief Act (Discussion Draft) S.3521: Family and Business Tax Cut Certainty Act of 2012 Biofuels Production Tax Credit Modification for Algae-based Biofuels Production Tax Credit Extension Investment Tax Credit Options S. 3521: Family and Business Tax Cut Certainty Act of 2012 American Taxpayer Relief Act (Discussion Draft) Renewable Chemicals H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012

Livestock Cloning/Product Labeling Discussions with EU on Animal CloningExport Registrations for Products with Expired Patents World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Asynchrony of International Approvals TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Intellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues

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 2013Vaccine Access/Financing Federal Response to the Rising Rates of Autism Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program 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 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 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 Biodefense Research, Development, and Procurement S 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act Medicaid Rebates

Average Manufacturer Price Calculations Medicaid RebatesReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program

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 2013Biodefense Research, Development, and Procurement (Non-Funding Issues) S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review

Patent Reform H.R. 6621: To correct and improve certain provisions of the Leahy-Smith America Invents Act Intellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Export Registrations for Products with Expired Patents

EPA Regulations on Agricultural Biotechnology EPA Notice on PIP Data Requirements USDA/APHIS Agricultural Biotechnology Regulations 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) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning 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 Export Registrations for Products with Expired Patents Labeling of Genetically Engineered (GE) Crops U.S. Government Policy 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 Agricultural Biotechnology Regulatory Reform and Modernization 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) Potential Regulation of New Genetic Modification Technologies Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Asynchrony of International Approvals Adventitious Presence (Low Level Presence)

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

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Asynchrony of International Approvals TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Intellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues

Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) Tax Reform Bio-based Products Tax Credit S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012 Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biofuels Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension S. 3521: Family and Business Tax Cut Certainty Act of 2012 Research & Development Tax Credit Extension Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Startup Innovation Credit (Senator Coons Discussion Draft) Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012 Renewable Chemicals S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012 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) S. 1764: Make It in America Tax Credit Act of 2011

EPA Regulations on Agricultural Biotechnology Reauthorization and Implementation of Pesticide Registration Improvement Act H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) USDA/APHIS Agricultural Biotechnology Regulations 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) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Biomass Crop Assistance Program Funding 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) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning 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 Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops U.S. Government Policy U.S. Policy on International Science-Based Regulations TransPacific Partnership Sanitary and Phytosanitary Issues 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 Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Agricultural Biotechnology Regulatory Reform and Modernization 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) Benefits of Ag-Biotech Research and Innovation 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) Potential Regulation of New Genetic Modification Technologies Patent Exhaustion Ag-biotech Products Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents U.S. Policy on International Science-Based Regulations Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Sanitary and Phytosanitary Issues Regulatory Transparency International Trade Commission Reform Rep. David Nunes Discussion Draft Intellectual Property International Enforcement Biosimilars Colombia Biologics Regulations Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals

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

Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Australia Compulsory Licensing Parliamentary Inquiry Confirmatory Genetic Diagnostic Testing Intellectual Property International Enforcement Patent Exhaustion Ag-biotech Products International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Patent Reform Implementation of the America Invents Act of 2011

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents U.S. Policy on International Science-Based Regulations Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Sanitary and Phytosanitary Issues Regulatory Transparency International Trade Commission Reform Rep. David Nunes Discussion Draft Intellectual Property International Enforcement Biosimilars Colombia Biologics Regulations Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals

Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Australia Compulsory Licensing Parliamentary Inquiry Confirmatory Genetic Diagnostic Testing Intellectual Property International Enforcement Patent Exhaustion Ag-biotech Products International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Patent Reform Implementation of the America Invents Act of 2011

Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 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 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development 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 FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 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 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control 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 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

EPA Regulations on Agricultural Biotechnology Reauthorization and Implementation of Pesticide Registration Improvement Act H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) USDA/APHIS Agricultural Biotechnology Regulations 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) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Biomass Crop Assistance Program Funding 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) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning 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 Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops U.S. Government Policy U.S. Policy on International Science-Based Regulations TransPacific Partnership Sanitary and Phytosanitary Issues 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 Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Agricultural Biotechnology Regulatory Reform and Modernization 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) Benefits of Ag-Biotech Research and Innovation 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) Potential Regulation of New Genetic Modification Technologies Patent Exhaustion Ag-biotech Products Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning World Trade Organization Special 301 Submissions India Issues Export Registrations for Products with Expired Patents International Trade Commission Reform Rep. Devin Nunes Discussion Draft Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies EU Biotechnology Bilateral Discussions China Biotechnology Regulations European Union Low Level Presence Policy International Biotechnology Agreement Asynchrony of International Approvals Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Sanitary and Phytosanitary Issues Regulatory Transparency

EPA Regulations on Agricultural Biotechnology Departments of the Interior, Environment, and Related Agencies Appropriations Act for FY 2013 Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) 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) Biotechnology Stewardship Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning 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 Export Registrations for Products with Expired Patents 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 TransPacific Partnership Sanitary and Phytosanitary Issues Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) 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 Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies EU Biotechnology Bilateral Discussions China Biotechnology Regulations European Union Low Level Presence Policy International Biotechnology Agreement Asynchrony of International Approvals Agricultural Biotechnology Regulatory Reform and Modernization 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) Benefits of Ag-Biotech Research and Innovation 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) Patent Exhaustion Ag-biotech Products Potential Regulation of New Genetic Modification Technologies Biomass Crop Assistance Program Funding Renewal 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

Expansion of Exemption under SEC Regulation A H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act Sarbanes Oxley Section 404 (b) H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act S.1933: Reopening American Capital Markets to Emerging Growth Companies Act of 2011 H.R. 3213: Small Company Job Growth and Regulatory Relief Act of 2011 Small Business Early-Stage Investment H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act Therapeutic Discovery Project Tax Credit Extension Capital Formation Investment Incentives Reform of SEC Regulation D H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act S. 1831/H.R. 2940: Access to Capital for Job Creators Act of 2011 Shareholder Reporting Threshold S. 1824/H.R. 2167: Private Company Flexibility and Growth Act of 2011

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

TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 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 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act HRSA Implementation of Program Changes Federal Supply Schedule Access During Emergencies Expanded Access to Experimental Products Medicaid Rebates Dual Eligibles S 365: Budget Control Act of 2011 Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development 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 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 Cures Acceleration Network S. R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 National Center for Advancing Translational Sciences S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Biodefense Research, Development and Procurement HHS Countermeasures Review S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization 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 Part B Physician-Administered Products Medicare Part D Prescription Drug Program International Biosecurity Policies Biologics and Toxins Weapons Convention

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 Federal Supply Schedule Access During Emergencies Biodefense Research, Development and Procurement HHS Countermeasures Review S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization Act of 2011 International Biosecurity Policies Biologics and Toxins Weapons Convention

USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Biomass Crop Assistance Program Funding H.R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Farm Bill Reauthorization EPA Regulations on Agricultural Biotechnology EPA Notice on PIP Data Requirements Reauthorization and Implementation of Pesticide Registration Improvement Act Biotechnology Stewardship International Regulatory Synchronization Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2011 H.R.2112: Consolidated and Further Continuing Appropriations Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops U.S. Government Policy TransPacific Partnership Sanitary and Phytosanitary Issues Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy 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 Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Discussions with EU on Animal Cloning APEC Agricultural Biotechnology Discussions EU Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Discussions with EU on Animal Cloning APEC Agricultural Biotechnology Discussions EU Biotechnology Bilateral Discussions Mexico Biotechnology Bilateral Discussions Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Sanitary and Phytosanitary Issues Data and Intellectual Property Protections for Pharmaceuticals

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

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents U.S. Policy on International Science-Based Regulations Codex Standards Intellectual Property International Enforcement TransPacific Partnership Sanitary and Phytosanitary Issues Data and Intellectual Property for Pharmaceuticals Foreign Agricultural Biotechnology Laws and Regulations International Biotechnology Agreement Discussions with EU on Animal Cloning China Biotechnology Regulations Low-Level Presence Foreign Government Policies European Union Low Level Presence Policy EU Biotechnology Bilateral Discussions Korea Biotechnology Regulations APEC Agricultural Biotechnology Discussions Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Philippines IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations Potential Regulation of New Genetic Modification Technologies EU Workshop

Patent Reform H.R. 1249: The Leahy-Smith America Invents Act of 2011 S. 23: The Patent Reform Act of 2011 Implementation of H.R. 1249: The America Invents Act of 2011 IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations Generic Drug Patent Settlements Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Philippines DNA Patenting and Licensing Rep. Wasserman Schultz Amendment to H.R. 1249: The America Invents Act of 2011 Bayh-Dole Act/Tech Transfer Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Domestic Manufacturing Requirement Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals

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

Cures Acceleration Network S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Funding for National Institutes of Health S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Rare Pediatric & Tropical Disease Drug Development Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Biodefense Research, Development and Procurement (Non-Funding Issues) Pandemic and All-Hazards Preparedness Act Reauthorization HHS Countermeasures Review

Biodefense Research, Development and Procurement HHS Countermeasures Review Pandemic and All-Hazards Preparedness Act Reauthorization Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012

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

Biosimilars 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 Funding for National Institutes of Health H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative Funding for FDA H.J. RES. 48: 6th Continuing Resolution for FY 2011 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 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 Pharmaceutical Industry Annual Fee Treasury and IRS Regulations Implementing the Law Biodefense Research, Development and Procurement HHS Countermeasures Review Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011

Stem Cell Research Federal Funding of Embryonic Stem Cell Research Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 S. 4053: SBIR/STTR Reauthorization Act of 2010 Research & Development Tax Credit Extension H.R. 4853: Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning U.S. Policy on International Science-Based Regulations 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 Foreign Agricultural Biotechnology Laws and Regulations International Biotechnology Agreement EU Biotechnology Bilateral Discussions China Biotechnology Regulations Genetic Resource Patent Disclosure Requirement Convention on Biological Diversity

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

Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 S. 4053: SBIR/STTR Reauthorization Act of 2010 Sarbanes Oxley Section 404 (b) Exemption H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

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

IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations PTO Administrative Reforms Humanitarian Voucher Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act for 2011 H.R. 3082: 4th Continuing Appropriations Act for FY 2011 S. 4322: Preserve Access to Affordable Generics Act Patent Reform S. 515: The Patent Reform Act of 2009 Genetic Resource Patent Disclosure Requirement Convention on Biological Diversity DNA Patenting and Licensing Genomic Research and Accessibility Act Discussion Draft (Rep. Becerra) Amicus Matters Possible Legislation by Rep. Wasserman Schultz Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Patent Presumption of Validity Amicus Matters

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations Discussions with EU on Animal Cloning China Biotechnology Regulations APEC Agricultural Biotechnology Discussions Low-Level Presence Foreign Government Policies Korea Biotechnology Regulations EU Biotechnology Bilateral Discussions Turkish Biotechnology Regulations Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning 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 Export Registrations for Products with Expired Patents Alliance for Healthcare Competitiveness U.S. Policy on International Science-Based Regulations Intellectual Property International Enforcement Compulsory Licensing Transpacific Partnership Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Convention on Biological Diversity

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 Discussions with EU on Animal Cloning S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Genetically Engineered (GE) Animals Labeling FDA Approval 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 Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act of 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs & Closing Tax Loopholes Act Labeling of Genetically Engineered Crops U.S. Government Policy

IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations PTO Administrative Reforms Humanitarian Voucher Three Track Examination Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act of 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs & Closing Tax Loopholes Act Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Convention on Biological Diversity DNA Patenting and Licensing Amicus Matters Bayh-Dole Act/Tech Transfer Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Intellectual Property International Enforcement Compulsory Licensing

Class Action Fairness Act Amendments H.R. 5503: Securing Protections for the Injured from Limitations on Liability Act Ban on Protective Orders H.R. 5503: Securing Protections for the Injured from Limitations on Liability Act Appointment of Registered Agents H.R. 4678: Foreign Manufacturer Legal Accountability Act

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

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S.610: The Patent Reform Act of 2009 Patent Reform Cont... Proposed Ban on Tax Preparation Patents: Senate Finance Committee Draft Genetic Resource Patent Disclosure Requirements Convention on Biological Diversity World Intellectual Property Organization DNA Patenting and Licensing Bayh-Dole Act/Tech Transfer Genomic Research and Accessibility Act Discussion Draft (Rep. Becerra) Amicus Matters Possible Legislation by Rep. Wasserman Schultz IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations Generic Drug Patent Settlements H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs & Closing Tax Loopholes Act S.4322: Preserve Access to Affordable Generics Act PTO Administrative Reforms World Trade Organization Special 301 Submissions Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Intellectual Property International Enforcement

Genetically Engineered (GE) Animals FDA Approval Labeling Drug Importation 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 Livestock Cloning/Product Labeling Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 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 Generic Drug Patent Settlements H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs & Closing Tax Loopholes Act S.4322: Preserve Access to Affordable Generics Act Labeling of Genetically Engineered Crops U.S. Government Policy U.S. Government Position in Codex Alimentarius Commission

Alliance for Healthcare Competitiveness Biosimilars 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 Cures Acceleration Network Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 4213: American Jobs and Closing Tax Loopholes Act of 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 2011 Funding for Bioterrorism and Emergency Preparedness 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 Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, 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 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for Strategic National Stockpile Department 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 Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Stem Cell Research Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 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 Biodefense Research, Development and Procurement S.1649/H.R 5498: Weapons of Mass Destruction Prevention and Preparedness Act Human Drug Review Program Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative Diagnostics and Personalized Medicine Regulation and Oversight Draft Legislation 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 2011 Expanded Access to Experimental Products FDA Rules Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act: GAO Study

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 Bioterrorism and Emergency Preparedness 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 Funding for Strategic National Stockpile Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Biodefense Research, Development and Procurement S.1649/H.R 5498: Weapons of Mass Destruction Prevention and Preparedness Act Funding for Pandemic Influenza Preparedness 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

Class Action Fairness Act Amendments H.R. 5503: Securing Protections for the Injured From Limitations on Liability Act Ban on Protective Orders H.R. 5503: Securing Protections for the Injured From Limitations on Liability Act Appointment of Registered Agents H.R. 4678: Foreign Manufacturers Legal Accountability Act

Alliance for Healthcare Competitiveness Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Drug Importation Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Foreign Agriculture Biotechnology Laws and Regulations Discussions with EU on Animal Cloning EU Biotechnology Bilateral Discussions Japan Biotechnology Regulations Low-Level Presence Foreign Government Policies Turkish Biotechnology Regulations Vietnam Biotechnology Regulations Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning World Trade Organization on EU Biotech Approvals EU Biotechnology Negotiations Export Registrations for Products With Expired Patents U.S. Policy on International Science-Based Regulations Intellectual Property International Enforcement Genetic Resource Patent Disclosure Requirements Convention on Biological Diversity World Intellectual Property Organization World Trade Organization Special 301 Submissions Labeling of Genetically Engineered Crops U.S. Government Policy U.S. Government Position in Codex Alimentarius Commission

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

Healthcare Reform Comparative Effectiveness Research Program Initiatives 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 Fee Medicaid Rebates Drug Importation Cures Acceleration Network Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S. 1679: Affordable Health Choices Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 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 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 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 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 2011 Stem Cell Research Medicaid Rebates 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 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act Follow-on Biologics Reimbursement Issues 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 H.R. 4872: Health Care and Education Reconciliation Act of 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 2011 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 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 Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, 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 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 2011 Funding for Strategic National Stockpile Departments of Labor, Health and Human Services and Education, 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: American's Health Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 Vaccine Access/Financing S.1796:America's Healthy Future Act of 2009 S.1679: America's Affordable Health Choices Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act S. 2868: Federal Supply Schedules Usage Act of 2009 S.1649: Weapons of Mass Destruction Preparedness Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Expansion of 340B Drug Pricing Program 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 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Expanded Access to Experimental Products FDA Rules Development of Medical Countermeasures in Response to Bio-threats HHS Countermeasures Review 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 Alliance for Healthcare Competitiveness

Climate Change Benefits of Biofuels and Bio-based Products H.R. 2454: American Clean Energy and Security Act of 2009 Bio-based Product Tax Credit Senate Climate Change Discussion Draft (Sen. Kerry, Graham & Lieberman) IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S.610: The Patent Reform Act of 2009 World Trade Organization Special 301 Submissions Convention on Biological Diversity Patent Disclosure Requirements Gene Patenting Possible Legislation by Rep. Wasserman Schultz Genomic Research and Accessibility Act (Discussion Draft) Bayh-Dole Act/Tech Transfer HHS Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations PTO Administrative Reforms

Medicaid Rebates 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 Medicaid Rebates Cont. H.R. 4872: Health Care and Education Reconciliation Act of 2010 Reimbursement for Follow-on Biologics 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 2010 S.1679: Affordable Health Choices Act of 2009 Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agriculture Biotechnology Laws and Regulations Mexico Biotechnology Bilateral Discussions EU Biotechnology Bilateral Discussions APEC Agricultural Biotechnology Discussions Discussions with EU on Animal Cloning Vietnam Biotechnology Regulations Turkish Biotechnology Regulations Low-level Presence Foreign Government Policies North America Biotechnology Initiative World Trade Organization Special 301 Submissions World Trade Organization on EU Biotech Approvals EU Biotechnology Negotiations Drug Importation H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1796: America's Health Future Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 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 Livestock Cloning/Product Labeling Discussion with EU on Animal Cloning Alliance for Healthcare Competitiveness Funding for International Trade Activities at the USDA (Office of the Secretary & Food Safety Inspection Service, Foreign Agricultural Service) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011

Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 SBA Grant Proposal for Early Stage Investment H.R. 3738: Small Business Early-Stage Investment Act of 2009 H.R. 3854: Small Business Financing and Investment Act of 2009 Therapeutic Discovery Project Tax Credit S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3200: America's Affordable Health Choices Act of 2009 H.R. 3962: Affordable Health Care for America Act Small Business Definition in SEC Rule 12b-2 H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Sarbanes Oxley Section 404 (b) Exemption H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009

Therapeutic Discovery Project Tax Credit 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 Therapeutic Discovery Project Tax Credit Cont... H.R. 3200: America's Affordable Health Choices Act Bio-based Products Tax Credits H.R. 2454: American Clean Energy and Security Act of 2009 S. 1733: Clean Energy Jobs and American Power Act of 2009 Pharmaceutical Excise Tax S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Research and Development Tax Credit Extension H.R. 4213: Tax Extenders Act of 2009 Cellulosic Tax Credit Modification for Algae-based Biofuels S.1250: Algae-based Renewable Fuel Promotion Act of 2009

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

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S.610: The Patent Reform Act of 2009 World Trade Organization Special 301 Submissions Convention on Biological Diversity Patent Disclosure Requirements Gene Patenting Proposed Legislation by Rep. Wasserman Schultz Genomic Research and Accessibility Act Bayh-Dole Act/Tech Transfer HHS Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations

Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 Biotech Innovation/R&D Initiatives Research & Development Tax Credit Extension H.R. 4213: Tax Extenders Act of 2009 Stem Cell Research

Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's 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 Reimbursement for Follow-on Biologics H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S.1796: America's Healthy Future Act of 2009

Renewable Fuels Standard EPA Rulemaking on Life-cycle Greenhouse Gas Emissions Requirements Implementation of Energy Independence and Security Act of 2007 Algae-based Renewable Fuel/Carbon Capture and Conversion S.1013: Department of Energy Carbon Capture and Sequestration Program Amendments Act of 2009 S.1250: Algae-based Renewable Fuel Promotion Act of 2009 Biofuels H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010 Loan Guarantees and Grants under S.1: American Recovery and Reinvestment Act Bio-based Products H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010 H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Biopreferred Program Implementation under 2007 Farm Bill Tax Credit Climate Change Benefits of Biofuels and Bio-based Products H.R. 2454: American Clean Energy and Security Act of 2009 Clean Energy Jobs and American Power Act of 2009 Senate Discussion Draft U.S. Government Position for U.N. Convention on Climate Change Negotiations

Renewable Fuels Standard EPA Rulemaking on Life-cycle Greenhouse Gas Emissions Requirements Implementation of Energy Independence and Security Act of 2007 Algae-based Renewable Fuel/Carbon Capture and Conversion S.1013: Department of Energy Carbon Capture and Sequestration Program Amendments Act of 2009 S.1250: Algae-based Renewable Fuel Promotion Act of 2009 Biofuels H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010 Loan Guarantees and Grants under S.1: American Recovery and Reinvestment Act Bio-based Products H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010 H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Biopreferred Program Implementation under 2007 Farm Bill Tax Credit Climate Change Benefits of Biofuels and Bio-based Products H.R. 2454: American Clean Energy and Security Act of 2009 Clean Energy Jobs and American Power Act of 2009 Senate Discussion Draft U.S. Government Position for U.N. Convention on Climate Change Negotiations

Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production Livestock Cloning/Product Labeling Cont... USDA APHIS Animal Care USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Agriculture Food Research Initiative - Research Funding H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of FY 2010 2007 Farm Bill Implementation Discussion with EU on Animal Cloning 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 on EU Biotech Approvals EU Biotechnology Negotiations Genetically Engineered (GE) Animals USDA APHIS Animal Care - Compliance with the Animal Welfare Act USDA APHIS Veterinary Service - Import and Export Issues H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of FY 2010 USDA APHIS Biotechnology Regulatory Services - Regulatory Follow-up USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding FDA Final Guidance on Regulation of GE Animals FDA Approval of First Product From GE Animals Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings 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 U.S. Policy on Sustainable Agriculture Standard American National Standards Institute Sustainable Agriculture Standards (ANSI) International Standards Organization Standard (ISO) Funding for the USDA H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for FY 2010 Biomass Crop Assistance Program (BCAP) BCAP Rulemaking and Environmental Impact Statement 2007 Farm Bill Implementation H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for FY 2010 U.S. Government Agriculture Research Funding H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for FY 2010 Agriculture Federal Research Initiative for FY 2009 Global Food Security Initiative U.S. Government Strategy for Global Food Security Codex Alimentarius Commission Proposed Draft Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance UN Climate Change Convention US Government Position on Ag-biotech and Intellectual Property Rights

Therapeutic Development Investment Tax Credit Senate Finance Committee's America's Healthy Future Act of 2009 Tax Legislation Bio-based Products Tax Credits Pharmaceutical Excise Tax Senate Finance Committee's America's Healthy Future Act of 2009 R&D Tax Credit Extension

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S. 610: The Patent Reform Act of 2009 World Trade Organization Special 301 Submissions Convention on Biological Diversity Patent Disclosure Requirements Bayh-Dole Act/Tech Transfer Gene Patenting HHS Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations PTO Administrative Reforms

Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 SBA Grant Proposal for Early Stage Investment SBA Early Stage Investment Act of 2009 Discussion Draft FDA Regulatory Processes for First-Time Filers Listing Requirements on Exchanges SEC Proposed Rules Therapeutic Development Investment Tax Credit Tax Legislation Senate Finance Committee's America's Healthy Future Act of 2009 Small Business Definition Amendment Investor Protection Act of 2009 House Discussion Draft SEC Rule 12b-2

Climate Change Benefits of Biofuels and Bio-based Products H.R. 2454: American Clean Energy and Security Act of 2009 Clean Energy Jobs and American Power Act of 2009 Senate Discussion Draft U.S. Government Position for U.N. Convention on Climate Change Negotiations IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations Climate Change/Indirect Land Use H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for 2010

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

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S. 610: The Patent Reform Act of 2009 World Trade Organization and Convention on Biological Diversity Patent Disclosure Requirements Special 301 Submissions/Meetings Bayh-Dole Act/Gene Patenting Secretary's Advisory Committee Report IP Rights for Environmental Technologies U.S. Government Position for U.N. Convention on Climate Change Negotiations

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

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

Patent Reform H.R. 1260: The Patent Reform Act of 2009 S. 515. The Patent Reform Act of 2009 S. 610: The Patent Reform Act of 2009 PTO Reform CBD TRIPS Amendment Patent Disclosure Requirements

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 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 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) 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) In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages Stem Cell Research Barriers and Incentives Related to Personalized Medicine

Plant Protection Act Amendments/Penalties H.R. 6124 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 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings Taiwan Biotechnology Negotiations EU Trade Negotiations EPA Regulation of Plant Incorporated Protectants Proposed Rule Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Farm Legislation H.R. 2419 & H.R. 6124 USDA Administrative Proposals Livestock Cloning/Product Labeling Plant Protection Act Amendments/Penalties World Trade Organization on EU Biotech Approvals Review of EU Biotechnology 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 Biotechnology Crop Stewardship Biotechnology Quality Management Stewardship Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7 CFR 340 U.S. Policy on Sustainable Agriculture Standard American National Standards Institute (ANSI) Bio-based Products Tax Credits EU Tracebility and Labeling Regulations for Ag-Biotech U.S. Policy on Ag-Biotech Benefits for G-8 Meeting Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions

Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act R&D Tax Credit H.R. 6049 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Technology Transfer Policies Technology Innovation Program (TIP) Proposed Rules by National Institutes for Standards & Technology Funding --Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

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)

False Claims Act Amendment S.2041 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Access to Drug Pricing Data H.R. 5683

Patent Reform H.R. 1908 S. 1145 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 Biologic Deposit Rule: 73-FR-34 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Bayh-Dole Act Evaluation Intellectual Property Enforcement Gene Patenting Intellectual Property Provisions in U.S. Trade Agreements Korean Trade Agreement

Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 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 Access to Drug Pricing Data H.R. 5683

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings Taiwan Biotechnology Negotiations EU Trade Negotiations Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness 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 Intellectual Property Provisions in U.S. Trade Agreements Korean Trade Agreement

Human Growth Hormone Regulation S.877 H.R. 4911

Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 Sarbanes-Oxley Reform Section 404 H.R. 7323/S.3260:Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers Modification/Extension of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 7327: Worker, Retiree, and Employer Recovery Act of 2008 S.1: American Recovery & Reinvestment Act of 2009 Net Operating Losses Monetization Tax Proposal S.1: American Recovery & Reinvestment Act of 2009

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

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural 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 Peru Biotechnology Bilateral Discussions Argentina Biotechnology Bilateral Discussions Brazil Biotechnology Bilateral Discussions Paraguay Biotechnology Bilateral Discussions Transpacific Economic Partnership Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Policy World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Policies Impacting Global Trade of Ag-Biotech Products Asia Pacific Economic Cooperation Forum Participation U.S. Government Positions International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness Intellectual Property Enforcement S.3464 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

Patent Reform H.R. 1908 S. 1145 S.3600 PTO Reform CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Intellectual Property Enforcement S.3464

Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 Modification/Extension of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 7327: Worker, Retiree, and Employer Recovery Act of 2008 S.1. American Recovery & Reinvestment Act of 2009 Technology Innovation Program (TIP) Funding S:3282: Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

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

False Claims Act Amendment S.2041 H.R. 4854 . Access to Drug Pricing Data H.R. 5683

Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 SBA Proposed Rule on SBIR Award Caps Sarbanes-Oxley Reform Section 404 S.3260: Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221

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

Patent Reform H.R. 1908 S. 1145 S.3600 PTO Reform CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Bayh-Dole Act Evaluation Intellectual Property Enforcement S.3464

Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 SBA Proposed Rule on SBIR Award Caps R&D Tax Credit H.R. 6049 H.R. 1424 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Technology Innovation Program (TIP) Proposed Rules by National Institutes for Standards & Technology Funding S:3282: Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

Human Growth Hormone Regulation S.877

Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP+ 4% Proposed Regulation Medicaid Rebates H.R. 1424 H.R. 6331 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Access to Drug Pricing Data H.R. 5683

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings Taiwan Biotechnology Negotiations EU Trade Negotiations Korea Biotechnology Trade Negotiations Canada Biotechnology Trade Negotiations Japan Biotechnology Trade Negotiations Peru Biotechnology Trade Negotiations Argentina Biotechnology Trade negotiations Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence European Union Low Level Presence Policy World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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

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

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 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 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) 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) In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages Stem Cell Research Barriers and Incentives Related to Personalized Medicine

Human Growth Hormone Regulation S.877 H.R. 4911

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings Taiwan Biotechnology Negotiations EU Trade Negotiations Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings World Trade Organization on EU Biotech Approvals Review of EU Biotechnology Negotiations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness 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 Intellectual Property Provisions in U.S. Trade Agreements Korean Trade Agreement

Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) S.3260: Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Net Operating Loss Limitation Reform/Internal Revenue Code Section 382 H.R. 3264: American Sciences Competitiveness Act

False Claims Act Amendment S.2041 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Access to Drug Pricing Data H.R. 5683

Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act R&D Tax Credit H.R. 6049 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Technology Transfer Policies Technology Innovation Program (TIP) Proposed Rules by National Institutes for Standards & Technology Funding --Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

Plant Protection Act Amendments/Penalties H.R. 6124 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 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings Taiwan Biotechnology Negotiations EU Trade Negotiations EPA Regulation of Plant Incorporated Protectants Proposed Rule Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Farm Legislation H.R. 2419 & H.R. 6124 USDA Administrative Proposals Livestock Cloning/Product Labeling Plant Protection Act Amendments/Penalties World Trade Organization on EU Biotech Approvals Review of EU Biotechnology 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 Biotechnology Crop Stewardship Biotechnology Quality Management Stewardship Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7 CFR 340 U.S. Policy on Sustainable Agriculture Standard American National Standards Institute (ANSI) Bio-based Products Tax Credits EU Tracebility and Labeling Regulations for Ag-Biotech U.S. Policy on Ag-Biotech Benefits for G-8 Meeting Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions

Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 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 Access to Drug Pricing Data H.R. 5683

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 Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act 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 2009 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 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 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 Stem Cell Research S.5 In Vitro Diagnostics Regulatory Oversight Barriers and Incentives Related to Personalized Medicine

Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S. 2663l Imported Food Safety

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Influenza Vaccine Supply and Immunization Recommendations 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 Drug Safety Implementation of Food & Drug Administration Amendments Act Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs

False Claims Act Amendments S.2041

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings French Ban on Cultivation of Biotech Seeds Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings World Trade Organization on EU Biotech Moratorium Review of EU Labeling Regulations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Policies International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements 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

Patent Reform H.R. 1908 S. 1145 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

Human Growth Hormone Abuse S. 877 H.R. 4911

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H. R. 2419 S. 2663l Drug Importation H.R. 3610 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 Department of Homeland Security Appropriations Act for FY 2009 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Imported Food Safety

Stem Cell Research S.5 Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility R&D Tax Credit Extension of Expired R&D Tax Credit Technology Innovation Program (TIP) Proposed Rules Funding -Departments of Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers

Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act 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 2009 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 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 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 Stem Cell Research S.5 In Vitro Diagnostics Regulatory Oversight Barriers and Incentives Related to Personalized Medicine

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings French Ban on Cultivation of Biotech Seeds Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings World Trade Organization on EU Biotech Moratorium Review of EU Labeling Regulations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Policies International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements 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

Human Growth Hormone Abuse S. 877 H.R. 4911

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Influenza Vaccine Supply and Immunization Recommendations 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 Drug Safety Implementation of Food & Drug Administration Amendments Act Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs

Stem Cell Research S.5 Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility R&D Tax Credit Extension of Expired R&D Tax Credit Technology Innovation Program (TIP) Proposed Rules Funding -Departments of Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers

False Claims Act Amendments S.2041

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H. R. 2419 S. 2663l Drug Importation H.R. 3610 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 Department of Homeland Security Appropriations Act for FY 2009 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Imported Food Safety

Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S. 2663l Imported Food Safety

Patent Reform H.R. 1908 S. 1145 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

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings French Ban on Cultivation of Biotech Seeds Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings World Trade Organization on EU Biotech Moratorium Review of EU Labeling Regulations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Policies International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements 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 Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility R&D Tax Credit Extension of Expired R&D Tax Credit Technology Innovation Program (TIP) Proposed Rules Funding -Departments of Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H. R. 2419 S. 2663l Drug Importation H.R. 3610 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 Department of Homeland Security Appropriations Act for FY 2009 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Imported Food Safety

False Claims Act Amendments S.2041

Patent Reform H.R. 1908 S. 1145 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

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

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Influenza Vaccine Supply and Immunization Recommendations 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 Drug Safety Implementation of Food & Drug Administration Amendments Act Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs

Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S. 2663l Imported Food Safety

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