ELI JOSEPH

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

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

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

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

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

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

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

Medicaid Rebates H.R. 1424 Senate Medicare Package H. Con. Res 312 & S. Con. Res. 70 Medicare Hospital Outpatient Drug Reimbursement Policies

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

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

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

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

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

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2008 Clinical Trial Registry and Results Databases Drug Safety Cont... 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 Stem Cell Research Medicaid Rebates Medicaid/Medicare Packages Dual Proportionality Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 Federal Trade Commission Review of Competition & IP Issues FDA Regulatory Processes for First-Time Filers 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 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations 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 Setting Comparative Effectiveness Program Initiatives S. 3101 S.3408 International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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 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 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 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) S: 3230: 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 Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP + 4% Proposed Regulation In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Human Subject Protections in Clinical Trials International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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 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 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 Pandemic Influenza Preparedness 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 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 Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation S.3230: 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. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

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

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

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

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

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) S: 3230: 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 Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP + 4% Proposed Regulation In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Human Subject Protections in Clinical Trials International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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 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 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 Pandemic Influenza Preparedness 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 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 Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation S.3230: 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. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

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

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)

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)

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

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

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 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

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

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

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 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

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

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

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

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

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

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

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

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

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2008 Clinical Trial Registry and Results Databases Drug Safety Cont... 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 Stem Cell Research Medicaid Rebates Medicaid/Medicare Packages Dual Proportionality Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 Federal Trade Commission Review of Competition & IP Issues FDA Regulatory Processes for First-Time Filers 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 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations 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 Setting Comparative Effectiveness Program Initiatives S. 3101 S.3408 International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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 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 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 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

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

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

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) S: 3230: 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 Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP + 4% Proposed Regulation In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Human Subject Protections in Clinical Trials International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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 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 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 Pandemic Influenza Preparedness 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 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 Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation S.3230: 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. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

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

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

Drug Safety 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

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

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

Biofuels Tax Credit H.R. 2419/H.R. 6124 Bio-based Products Tax Credits R&D Tax Credit H.R. 6049 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 Comprehensive Biotechnology Tax Incentives Legislation H.R. 3264 Taxation of Collaborative Agreements IRS Coordinated Issue Paper

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

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

Biofuels Tax Credit 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 Comprehensive Biotechnology Tax Incentives Legislation H.R. 3264

Biofuels Tax Credit H.R. 2419/H.R. 6124 Bio-based Products Tax Credits R&D Tax Credit H.R. 6049 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 Comprehensive Biotechnology Tax Incentives Legislation H.R. 3264 Taxation of Collaborative Agreements IRS Coordinated Issue Paper

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)

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

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

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

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

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

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

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

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

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

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

Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages 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 Influenza Vaccine Supply and Immunization Recommendations Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 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 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 Safety Implementation of Food & Drug Administration Amendments Act of 2007 Heparin Contamination/Imported Drugs and Drug Products Counterfeit Drugs Drug Importation H.R. 3610 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Stem Cell Research S.5 Medicaid Rebates H.R. 1424 H. Con. Res. 312 S. Con. Res. 70 Senate Medicare Package Human Growth Hormone Abuse S. 877 H.R. 4911 340B of the Public Health Service Act/Drug Prices for Covered Entities H.R. 2606 S. 1376 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Biomedical Advanced Research & Development Authority (BARDA) Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Pandemic Influenza Preparedness Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Medicare Hospital Outpatient Drug Reimbursement Policies In Vitro Diagnostics Regulatory Oversight Critical Path Initiative Comparative Effectiveness Program Initiatives H.R. 3162 H. Con. Res. 312 S. Con. Res. 70 Medicare Packages Comparative Effectiveness Research Act of 2008 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

Drug Safety 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

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) S: 3230: 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 Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP + 4% Proposed Regulation In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Human Subject Protections in Clinical Trials International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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 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 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 Pandemic Influenza Preparedness 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 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 Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation S.3230: 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. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages 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 Influenza Vaccine Supply and Immunization Recommendations Outpatient Prospective Payment Service S. 3101: Medicare Improvements for Patients and Providers Act of 2008 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 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 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

False Claims Act Amendment S.2041 H.R. 4854 . 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)

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 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

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

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

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

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)

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 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

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

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

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

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

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

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

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

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

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

Drug Safety 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

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

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 S.3409: Safeguarding America's Pharmaceuticals Act of 2008 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) S: 3230: 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 Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Payment System S. 3101: Medicare Improvements for Patients and Providers Act of 2008 CMS ASP + 4% Proposed Regulation In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 S.3408 Medicare/Medicaid Packages Human Subject Protections in Clinical Trials International Market Access for U.S. Healthcare Products Alliance for Healthcare Competitiveness 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 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 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 Pandemic Influenza Preparedness 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 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 Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation S.3230: 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. 3289: Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations