BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Law Enforcement/Crime/Criminal Justice LAW

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

Contacted: Congressional Budget Office (CBO); Natl Institute of Standards & Technology (NIST); Environmental Protection Agency (EPA); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); U.S. Agency for International Development (USAID); Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; Agriculture, Dept of (USDA); Office of Science & Technology Policy (OSTP); Patent & Trademark Office (PTO); Health & Human Services, Dept of (HHS); Commerce, Dept of (DOC); U.S. Trade Representative (USTR); State, Dept of (DOS); Centers For Disease Control & Prevention (CDC); Office of Management & Budget (OMB); SENATE; Natl Institutes of Health (NIH); White House Office; Food & Drug Administration (FDA)

Bills named: H.R. 4911 (110th), S. 877 (110th)

Government Issues GOV

False Claims Act Amendments S.2041

Contacted: Agriculture, Dept of (USDA); Congressional Budget Office (CBO); Treasury, Dept of; White House Office; U.S. Agency for International Development (USAID); Office of Management & Budget (OMB); Office of Science & Technology Policy (OSTP); Centers For Medicare and Medicaid Services (CMS); Natl Institutes of Health (NIH); State, Dept of (DOS); SENATE; Commerce, Dept of (DOC); Natl Economic Council (NEC); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); Natl Institute of Standards & Technology (NIST); U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Centers For Disease Control & Prevention (CDC); Patent & Trademark Office (PTO)

Bills named: S. 2041 (110th)

Accounting ACC

Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009

Contacted: White House Office; Food & Drug Administration (FDA); SENATE; Natl Economic Council (NEC); U.S. Agency for International Development (USAID); Treasury, Dept of; HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); State, Dept of (DOS); Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Office of Management & Budget (OMB); Commerce, Dept of (DOC); Congressional Budget Office (CBO); Centers For Medicare and Medicaid Services (CMS); Natl Institute of Standards & Technology (NIST); Environmental Protection Agency (EPA); Natl Institutes of Health (NIH); Patent & Trademark Office (PTO); Office of Science & Technology Policy (OSTP); Centers For Disease Control & Prevention (CDC)

Medicare/Medicaid MMM

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

Contacted: Environmental Protection Agency (EPA); Natl Institute of Standards & Technology (NIST); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Office of Science & Technology Policy (OSTP); Centers For Disease Control & Prevention (CDC); Commerce, Dept of (DOC); Agriculture, Dept of (USDA); White House Office; Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); Natl Economic Council (NEC); U.S. Agency for International Development (USAID); Congressional Budget Office (CBO); Treasury, Dept of; Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); State, Dept of (DOS); Natl Institutes of Health (NIH); SENATE

Bills named: H.R. 1424 (110th), H.Con.Res. 312 (110th), S.Con.Res. 70 (110th)

Fuel/Gas/Oil FUE

Biofuels Tax Credit Implementation of the Renewable Fuels, Consumer Protection and Energy Efficiency Act of 2007 H.R. 2419 Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels 2007 Farm Bill (H.R. 2419) Biofuels Tax Credit Biomass Energy Reserve/Biomass Crop Transition Program Renewable Fuels Standard

Contacted: U.S. Agency for International Development (USAID); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Commerce, Dept of (DOC); Office of Science & Technology Policy (OSTP); Natl Institute of Standards & Technology (NIST); Environmental Protection Agency (EPA); SENATE; Natl Institutes of Health (NIH); Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); State, Dept of (DOS); White House Office; Centers For Disease Control & Prevention (CDC); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Natl Economic Council (NEC); Congressional Budget Office (CBO); Treasury, Dept of

Bills named: H.R. 2419 (110th)

Science/Technology SCI

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

Contacted: State, Dept of (DOS); SENATE; Environmental Protection Agency (EPA); Congressional Budget Office (CBO); Office of Science & Technology Policy (OSTP); Agriculture, Dept of (USDA); Health & Human Services, Dept of (HHS); Natl Economic Council (NEC); U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); Natl Institutes of Health (NIH); Natl Institute of Standards & Technology (NIST); Commerce, Dept of (DOC); U.S. Agency for International Development (USAID); Patent & Trademark Office (PTO); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); White House Office; Treasury, Dept of

Bills named: S. 5 (110th)

Civil Rights/Civil Liberties CIV

Genetic Information Non-Discrimination Act S. 358

Contacted: Centers For Disease Control & Prevention (CDC); Treasury, Dept of; Natl Institute of Standards & Technology (NIST); Office of Management & Budget (OMB); SENATE; White House Office; Congressional Budget Office (CBO); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); Food & Drug Administration (FDA); Natl Economic Council (NEC); Office of Science & Technology Policy (OSTP); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); Commerce, Dept of (DOC); U.S. Agency for International Development (USAID); Patent & Trademark Office (PTO); State, Dept of (DOS)

Bills named: S. 358 (110th)

Energy/Nuclear ENG

Biofuels Tax Credit H.R. 2419 Implementation of the Renewable Fuels, Consumer Protection and Energy Efficiency Act of 2007 2007 Farm Bill (H.R. 2419) Biofuels Tax Credit Biomass Energy Reserve/Biomass Crop Transition Program Renewable Fuels Standard Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels

Contacted: Treasury, Dept of; Patent & Trademark Office (PTO); SENATE; Natl Institute of Standards & Technology (NIST); Congressional Budget Office (CBO); U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); Natl Economic Council (NEC); State, Dept of (DOS); Natl Institutes of Health (NIH); Office of Management & Budget (OMB); U.S. Agency for International Development (USAID); Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA); Environmental Protection Agency (EPA); Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Health & Human Services, Dept of (HHS); White House Office

Bills named: H.R. 2419 (110th)

Food Industry (safety, labeling, etc.) FOO

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

Contacted: Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH); Congressional Budget Office (CBO); State, Dept of (DOS); Commerce, Dept of (DOC); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Office of Science & Technology Policy (OSTP); Agriculture, Dept of (USDA); Office of Management & Budget (OMB); Food & Drug Administration (FDA); SENATE; Centers For Disease Control & Prevention (CDC); U.S. Agency for International Development (USAID); Treasury, Dept of; Patent & Trademark Office (PTO); Natl Institute of Standards & Technology (NIST); White House Office; Environmental Protection Agency (EPA); U.S. Trade Representative (USTR)

Bills named: H.R. 1396 (110th), H.R. 4855 (110th), H.R. 992 (110th), S. 414 (110th), S. 1859 (110th), H.R. 2419 (110th), S. 536 (110th), H.R. 3161 (110th)

Animals ANI

Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA National Organic Program Advance Notice of Proposed Rulemaking 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

Contacted: Commerce, Dept of (DOC); Environmental Protection Agency (EPA); Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Natl Economic Council (NEC); U.S. Trade Representative (USTR); SENATE; Natl Institute of Standards & Technology (NIST); Treasury, Dept of; Natl Institutes of Health (NIH); Office of Science & Technology Policy (OSTP); U.S. Agency for International Development (USAID); Agriculture, Dept of (USDA); Centers For Disease Control & Prevention (CDC); White House Office; Centers For Medicare and Medicaid Services (CMS); Congressional Budget Office (CBO); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; State, Dept of (DOS); Food & Drug Administration (FDA)

Bills named: H.R. 3161 (110th), H.R. 992 (110th), S. 536 (110th), S. 1859 (110th), S. 414 (110th), H.R. 2419 (110th), H.R. 1396 (110th), H.R. 4855 (110th)

Consumer Issues/Safety/Products CSP

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

Contacted: HOUSE OF REPRESENTATIVES; State, Dept of (DOS); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Centers For Disease Control & Prevention (CDC); Commerce, Dept of (DOC); White House Office; Agriculture, Dept of (USDA); U.S. Agency for International Development (USAID); Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Natl Institutes of Health (NIH); Natl Economic Council (NEC); Natl Institute of Standards & Technology (NIST); Congressional Budget Office (CBO); Treasury, Dept of; Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); SENATE; Office of Management & Budget (OMB); Office of Science & Technology Policy (OSTP)

Bills named: S. 414 (110th), S. 1859 (110th), H.R. 2419 (110th), H.R. 992 (110th), S. 536 (110th), H.R. 1396 (110th), H.R. 3610 (110th), H.R. 3161 (110th), H.R. 4855 (110th)

Trade (domestic/foreign) TRD

Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings French Ban on Cultivation of Biotech Seeds Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings World Trade Organization on EU Biotech Moratorium Review of EU Labeling Regulations CBD TRIPS Amendment Patent Disclosure Requirements Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Policies International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Drug Importation H.R. 3610 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009

Contacted: Agriculture, Dept of (USDA); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Treasury, Dept of; Office of Management & Budget (OMB); Natl Institutes of Health (NIH); Natl Institute of Standards & Technology (NIST); Environmental Protection Agency (EPA); Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Office of Science & Technology Policy (OSTP); Congressional Budget Office (CBO); Food & Drug Administration (FDA); White House Office; Natl Economic Council (NEC); Centers For Disease Control & Prevention (CDC); State, Dept of (DOS); U.S. Agency for International Development (USAID); Health & Human Services, Dept of (HHS); SENATE

Bills named: H.R. 3610 (110th)

Agriculture AGR

Biofuels Tax Credit Implementation of the Renewable Fuels, Consumer Protection and Energy Efficiency Act of 2007 H.R. 2419 Renewable Fuels Standard 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 2007 Farm Bill (H.R. 2419) Biofuels Tax Credit USDA Administrative Proposals Livestock Cloning/Product Labeling Importation of Plant Products Biomass Energy Reserve/Biomass Crop Transition Program Bio-based Product "BioPreferred" Procurement Program Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Trade Negotiations Mexico Biotechnology Trade Negotiations Russia Biotechnology Trade Negotiations Vietnam Biotechnology Negotiations France Trade Meetings French Ban on Cultivating of Biotech Seeds EPA Regulation of Plant Incorporated Protectants Proposed Rule Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings World Trade Organization on EU Biotech Moratorium Review of EU Labeling Regulations Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Biotechnology Crop Stewardship Policies Impacting Global Trade of Ag-Biotech Products U.S. Government Positions Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Bio-based Products Tax Credits USDA/APHIS Agricultural Biotechnology Regulations USDA Rulemaking on 7 CFR 340 Restrictions on Importation of Plant Products/Lacey Act Amendments H.R. 2419

Contacted: Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Centers For Disease Control & Prevention (CDC); Office of Management & Budget (OMB); White House Office; Health & Human Services, Dept of (HHS); Treasury, Dept of; SENATE; Commerce, Dept of (DOC); Natl Institutes of Health (NIH); Natl Institute of Standards & Technology (NIST); Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA); U.S. Agency for International Development (USAID); Patent & Trademark Office (PTO); Agriculture, Dept of (USDA); Congressional Budget Office (CBO); State, Dept of (DOS); Natl Economic Council (NEC); Environmental Protection Agency (EPA); HOUSE OF REPRESENTATIVES

Bills named: H.R. 2419 (110th), H.R. 4855 (110th), H.R. 3161 (110th), S. 414 (110th), S. 536 (110th), S. 1859 (110th), H.R. 992 (110th), H.R. 1396 (110th)

Taxation/Internal Revenue Code TAX

Biofuels Tax Credit Implementation of the Renewable Fuels, Consumer Protection and Energy Efficiency Act of 2007 H.R. 2419 Bio-based Products Tax Credits R&D Tax Credit Extension of Expired R&D Tax Credit Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation S.12 H.R. 5140

Contacted: Centers For Medicare and Medicaid Services (CMS); Centers For Disease Control & Prevention (CDC); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Natl Institutes of Health (NIH); State, Dept of (DOS); Congressional Budget Office (CBO); Office of Science & Technology Policy (OSTP); Natl Economic Council (NEC); Natl Institute of Standards & Technology (NIST); SENATE; White House Office; Food & Drug Administration (FDA); Treasury, Dept of; Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Environmental Protection Agency (EPA); U.S. Agency for International Development (USAID)

Bills named: S. 12 (110th), H.R. 5140 (110th), H.R. 2419 (110th)

Copyright/Patent/Trademark CPT

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

Contacted: U.S. Trade Representative (USTR); U.S. Agency for International Development (USAID); Treasury, Dept of; Agriculture, Dept of (USDA); State, Dept of (DOS); Office of Science & Technology Policy (OSTP); Environmental Protection Agency (EPA); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Natl Economic Council (NEC); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); Commerce, Dept of (DOC); White House Office; Centers For Disease Control & Prevention (CDC); Patent & Trademark Office (PTO); Congressional Budget Office (CBO); SENATE; Food & Drug Administration (FDA); Natl Institute of Standards & Technology (NIST); Natl Institutes of Health (NIH)

Bills named: H.R. 1908 (110th), S. 1145 (110th)

Health Issues HCR

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

Contacted: Natl Institute of Standards & Technology (NIST); U.S. Agency for International Development (USAID); Agriculture, Dept of (USDA); White House Office; State, Dept of (DOS); Office of Science & Technology Policy (OSTP); Environmental Protection Agency (EPA); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); Natl Institutes of Health (NIH); Treasury, Dept of; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); SENATE; Natl Economic Council (NEC); Centers For Disease Control & Prevention (CDC); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Congressional Budget Office (CBO); Patent & Trademark Office (PTO); Food & Drug Administration (FDA)

Bills named: H.R. 4911 (110th), S. 877 (110th), H.R. 1956 (110th), H.R. 3162 (110th), H.R. 1424 (110th), H.R. 2606 (110th), S. 1376 (110th), H.Con.Res. 312 (110th), H.R. 3610 (110th), H.R. 5629 (110th), S.Con.Res. 70 (110th), S. 1695 (110th), H.R. 1038 (110th), S. 5 (110th)

Small Business SMB

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

Contacted: Commerce, Dept of (DOC); U.S. Agency for International Development (USAID); Natl Institutes of Health (NIH); U.S. Trade Representative (USTR); Office of Management & Budget (OMB); Centers For Disease Control & Prevention (CDC); Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA); Treasury, Dept of; Office of Science & Technology Policy (OSTP); Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO); Congressional Budget Office (CBO); State, Dept of (DOS); Centers For Medicare and Medicaid Services (CMS); Agriculture, Dept of (USDA); SENATE; White House Office; Food & Drug Administration (FDA); Natl Institute of Standards & Technology (NIST)

Budget/Appropriations BUD

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

Contacted: SENATE; Office of Management & Budget (OMB); U.S. Trade Representative (USTR); Patent & Trademark Office (PTO); Food & Drug Administration (FDA); State, Dept of (DOS); Natl Economic Council (NEC); Congressional Budget Office (CBO); Centers For Disease Control & Prevention (CDC); Environmental Protection Agency (EPA); U.S. Agency for International Development (USAID); White House Office; Centers For Medicare and Medicaid Services (CMS); Treasury, Dept of; Office of Science & Technology Policy (OSTP); Natl Institute of Standards & Technology (NIST); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH); Commerce, Dept of (DOC); Agriculture, Dept of (USDA)

Pharmacy PHA

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

Contacted: State, Dept of (DOS); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Treasury, Dept of; Commerce, Dept of (DOC); Office of Management & Budget (OMB); Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); U.S. Agency for International Development (USAID); Centers For Disease Control & Prevention (CDC); Environmental Protection Agency (EPA); U.S. Trade Representative (USTR); SENATE; Natl Institutes of Health (NIH); Patent & Trademark Office (PTO); Congressional Budget Office (CBO); Agriculture, Dept of (USDA); White House Office; Natl Institute of Standards & Technology (NIST); HOUSE OF REPRESENTATIVES; Office of Science & Technology Policy (OSTP)

Bills named: H.R. 2606 (110th), H.R. 3610 (110th), H.Con.Res. 312 (110th), S.Con.Res. 70 (110th), H.R. 3162 (110th), H.R. 1424 (110th), S. 1376 (110th)

Homeland Security HOM

Pandemic Influenza Preparedness Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Influenza Vaccine Supply and Immunization Recommendations 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 Bioterrorism and Emergency Preparedness 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

Contacted: HOUSE OF REPRESENTATIVES; Centers For Disease Control & Prevention (CDC); Natl Economic Council (NEC); Office of Science & Technology Policy (OSTP); Office of Management & Budget (OMB); Natl Institute of Standards & Technology (NIST); U.S. Trade Representative (USTR); White House Office; Food & Drug Administration (FDA); Environmental Protection Agency (EPA); SENATE; Centers For Medicare and Medicaid Services (CMS); Congressional Budget Office (CBO); Commerce, Dept of (DOC); State, Dept of (DOS); Agriculture, Dept of (USDA); Patent & Trademark Office (PTO); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); U.S. Agency for International Development (USAID); Treasury, Dept of

Medical/Disease Research/Clinical Labs MED

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

Contacted: State, Dept of (DOS); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Patent & Trademark Office (PTO); Natl Institute of Standards & Technology (NIST); Environmental Protection Agency (EPA); Congressional Budget Office (CBO); Natl Economic Council (NEC); Commerce, Dept of (DOC); Treasury, Dept of; Centers For Medicare and Medicaid Services (CMS); U.S. Agency for International Development (USAID); Office of Science & Technology Policy (OSTP); U.S. Trade Representative (USTR); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); Centers For Disease Control & Prevention (CDC); Agriculture, Dept of (USDA); SENATE; White House Office; Food & Drug Administration (FDA)

Bills named: H.R. 3162 (110th), H.Con.Res. 312 (110th), S. 5 (110th), S.Con.Res. 70 (110th)