Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ACC

16. Specific lobbying issues

Accelerating of NOLs in Lieu of Other Tax Benefits (Refundable Tax Credit/Grant Proposals)
H.R. 1. and S. Amdt. 570: American Recovery & Reinvestment Act of 2009

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code AGR

16. Specific lobbying issues

Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program
Livestock Cloning/Product Labeling Cont...
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009
USDA APHIS Animal Care
USDA National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Foreign Agriculture Biotechnology Laws and Regulations
U.S. Korea Free Trade Agreement
China Biotechnology Bilateral Discussions
Mexico Biotechnology Bilateral Discussions
Taiwan Biotechnology Bilateral Discussions
EU Biotechnology Bilateral Discussions
Canada Biotechnology Bilateral Discussions
Japan Biotechnology Bilateral Discussions
Argentina Biotechnology Bilateral Discussions
Brazil Biotechnology Bilateral Discussions
Colombia Biotechnology Bilateral Discussions
Negotiations of Trans Pacific Partnership
APEC Agricultural Biotechnology Discussions
Korean Biosafety Law
Discussions with EU on Animal Cloning

Adventitious Presence (Low Level Presence)
U.S. Government Policy for Codex Guidelines on Adventitious Presence
European Union Low Level Presence Policy
Philippines Low Level Presence Policy

World Trade Organization on EU Biotech Approvals
Review of EU Biotechnology Negotiations

Genetically Engineered (GE) Animals
Coordination Between Federal Agencies
FDA Final Guidance on Regulation of GE Animals
FDA CBER Blood Products Advisory Committee Meeting
FDA Approval of First Product from GE Animal
USDA APHIS Biotechnology Research Service Request for Information
USDA APHIS Animal Care
USDA APHIS Veterinary Service
USDA National Institute of Food & Agriculture, Agriculture Food Research Institute, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Cartagena Biosafety Protocol
U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings

USDA/APHIS Agricultural Biotechnology Regulations
USDA Rulemaking on 7CFR 340

U.S. Policy on Sustainable Agriculture Standard



Funding for the USDA
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for FY 2010

Biomass Crop Assistance Program (BCAP)
BCAP Rulemaking and Environmental Impact Statement
2007 Farm Bill Implementation

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Commerce - Dept of (DOC), Food & Drug Administration (FDA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), State - Dept of (DOS), U.S. Trade Representative (USTR), Environmental Protection Agency (EPA), U.S. Agency for International Development (USAID),

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ANI

16. Specific lobbying issues

Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program
Livestock Cloning/Product Labeling Cont...
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009
USDA APHIS Animal Care
USDA National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Genetically Engineered (GE) Animals
Coordination Between Federal Agencies
FDA Final Guidance on Regulation of GE Animals
FDA CBER Blood Products Advisory Committee Meeting
FDA Approval of First Product from GE Animal
USDA APHIS Biotechnology Research Service Request for Information
USDA APHIS Animal Care
USDA APHIS Veterinary Service
USDA National Institute of Food & Agriculture, Agriculture Food Research Institute, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Commerce - Dept of (DOC), Food & Drug Administration (FDA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), State - Dept of (DOS), U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path,
Reagan-Udall Foundation, Center for Veterinary Medicine)
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations
Act for FY 2009 Cont...
Funding for the USDA: Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade
Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels
(Rural Development))
Drug Importation
Livestock Cloning/Product Labeling
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 and Development Authority (BARDA)
Drug Importation
Energy and Water Development and Related Agencies Appropriations Act for FY 2009
Biofuels Funding at the Department of Energy
Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
Funding for Technology Innovation Program at National Institute of Standards and Technology
Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009
Funding for Biotechnology Research and Development Programs at the Agency for International Development

H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
Comparative Effectiveness Research
Funding for National Institutes of Health
Funding for Bioterrorism and Emergency Preparedness
Funding for Pandemic Influenza Preparedness
Funding for Biofuels
Funding for Biomedical Advanced Research and Development Authority (BARDA)
Funding for Technology Innovation Program at National Institute of Standards and Technology
Funding for the USDA: Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade
Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels
(Rural Development))

H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010
Medicaid Rebates
Healthcare Reform
Follow-on Biologics
Economic Incentives for Biotech Industry

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010
Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path,
Reagan-Udall Foundation, Center for Veterinary Medicine) .
Funding for the USDA: Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade
Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural
Development))
Genetically Engineered (GE) Animals
Livestock Cloning/Product Labeling




Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010
Funding for National Institutes of Health
Funding for Bioterrorism and Emergency Preparedness
Funding for Pandemic Influenza Preparedness
Funding for Biomedical Advanced Research and Development Authority (BARDA)

Energy and Water Development and Related Agencies Appropriations Act for FY 2010
Funding for Biofuels at the Department of Energy

Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2010
Funding for Technology Innovation Program at National Institute of Standards and Technology

Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2010
Funding for Biotechnology Research and Development Programs at the Agency for International Development

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Natl Institutes of Health (NIH), Food & Drug Administration (FDA), White House Office, Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CAW

16. Specific lobbying issues

Biotech Incentives in Climate Change Legislation
American Clean Energy and Security Act of 2009 (Discussion Draft)
Offsets and Credits for Biotech Solutions

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CPT

16. Specific lobbying issues

Patent Reform
H.R. 1260: The Patent Reform Act of 2009
S. 515. The Patent Reform Act of 2009
S. 610: The Patent Reform Act of 2009
PTO Reform

CBD TRIPS Amendment
Patent Disclosure Requirements

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Commerce - Dept of (DOC), Patent & Trademark Office (PTO), State - Dept of (DOS), U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CSP

16. Specific lobbying issues

Adventitious Presence (Low Level Presence)
U.S. Government Policy for Codex Guidelines on Adventitious Presence
European Union Low Level Presence Policy
Philippines Low Level Presence Policy
Genetically Engineered (GE) Animals
Coordination Between Federal Agencies
FDA Final Guidance on Regulation of GE Animals
FDA CBER Blood Products Advisory Committee Meeting
FDA Approval of First Product from GE Animal
USDA APHIS Biotechnology Research Service Request for Information
USDA APHIS Animal Care
USDA APHIS Veterinary Service
USDA National Institute of Food & Agriculture, Agriculture Food Research Institute, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Drug Safety
Implementation of Food & Drug Administration Act of 2007
E-Pedigree and Anti-counterfeiting
Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft)
FDA Globalization Act of 2009 (House Discussion Draft)
S.525: Pharmaceutical Market Access and Drug Safety
The Drug and Device Accountability Act of 2009 (Senate Discussion Draft)

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

Funding for the Food and Drug Administration
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Reporting of Physician Payments
S:310: Physician Payments Sunshine Act of 2009

Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009
USDA APHIS Animal Care
USDA National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Commerce - Dept of (DOC), Food & Drug Administration (FDA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), State - Dept of (DOS), Health & Human Services - Dept of (HHS), U.S. Trade Representative (USTR), Natl Institutes of Health (NIH), U.S. Agency for International Development (USAID)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ECN

16. Specific lobbying issues

Economic Incentives for Biotech Industry
H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE,

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ENG

16. Specific lobbying issues

Renewable Fuels Standard
EPA Rulemaking on Life Cycle Greenhouse Gas Emissions Requirements
Implementation of Energy Independence and Security Act of 2007

Biofuels
Investment in Commercialization
Investment in Distribution and Delivery Infrastructure
Increase in Federal R&D Investment
H.R. 1. and S.Amdt. 570: American Recovery & Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Energy and Water Development and Related Agencies Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Energy and Water Development and Related Agencies Appropriations Act for FY 2010
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Bio-based Products
Investment in Distribution and Delivery Infrastructure
Investment in Commercialization
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009

Biotech Incentives in Climate Change Legislation
American Clean Energy and Security Act of 2009 (Discussion Draft)
Offsets and Credits for Biotech Solutions

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Management & Budget (OMB), Agriculture - Dept of (USDA), Environmental Protection Agency (EPA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FOO

16. Specific lobbying issues

Adventitious Presence (Low Level Presence)
U.S. Government Policy for Codex Guidelines on Adventitious Presence
European Union Low Level Presence Policy
Philippines Low Level Presence Policy
Genetically Engineered (GE) Animals
Coordination Between Federal Agencies
FDA Final Guidance on Regulation of GE Animals
FDA CBER Blood Products Advisory Committee Meeting
FDA Approval of First Product from GE Animal
USDA APHIS Biotechnology Research Service Request for Information
USDA APHIS Animal Care
USDA APHIS Veterinary Service
USDA National Institute of Food & Agriculture, Agriculture Food Research Institute, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Economic Research Service Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009
USDA APHIS Animal Care
USDA National Institute of Food & Agriculture, Agriculture Food Research Initiative, Research Funding
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Food Safety Funding
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 1010

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Commerce - Dept of (DOC), Food & Drug Administration (FDA), Office of Science & Technology Policy (OSTP), Office of Management & Budget (OMB), State - Dept of (DOS), U.S. Trade Representative (USTR), U.S. Agency for International Development (USAID)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FUE

16. Specific lobbying issues

Renewable Fuels Standard
EPA Rulemaking on Life Cycle Greenhouse Gas Emissions Requirements
Implementation of Energy Independence and Security Act of 2007

Biofuels
Investment in Commercialization
Investment in Distribution and Delivery Infrastructure
H.R. 1. and S.Amdt. 570: American Recovery & Reinvestment Act of 2009
Increase in Federal R&D Investment
H.R. 1105: Omnibus Appropriations for FY 2009
Energy and Water Development and Related Agencies Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Energy and Water Development and Related Agencies Appropriations Act for FY 2010
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Bio-based Products
Investment in Distribution and Delivery Infrastructure
Investment in Commercialization
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009

Biotech Incentives in Climate Change Legislation
American Clean Energy and Security Act of 2009 (Discussion Draft)
Offsets and Credits for Biotech Solutions

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Office of Management & Budget (OMB), Environmental Protection Agency (EPA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

Health Care Reform
H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Goverment for FY 2010

Drug Safety
Implementation of Food & Drug Administration Act of 2007
E-Pedigree and Anti-counterfeiting
Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft)
FDA Globalization Act of 2009 (House Discussion Draft)
S.525: Pharmaceutical Market Access and Drug Safety
The Drug and Device Accountability Act of 2009 (Senate Discussion Draft)

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

Funding for the Food and Drug Administration
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Stem Cell Research
Executive Order

Medicaid Rebates
H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

Follow-on Biologics
H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act
H.R. 1548: Pathway for Biosimilars Act of 2009
S. 726: Promoting Innovation and Access to Life-Saving Medicine Act
H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

Funding for Biomedical Advanced Research & Development Authority (BARDA)
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009

Vaccine Financing
National Vaccine Advisory Committee Draft Recommendations

In Vitro Diagnostics
Regulatory Oversight

Comparative Effectiveness Program Initiatives
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009

Funding for National Institutes of Health
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010


Funding for Bioterrorism and Emergency Preparedness
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

Funding for Pandemic Influenza Preparedness
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

Reporting of Physician Payments
S. 301: Physician Payments Sunshine Act of 2009

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH), White House Office, Food & Drug Administration (FDA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HOM

16. Specific lobbying issues

Funding for Pandemic Influenza Preparedness
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009


Funding for Pandemic Influenza Preparedness Cont...
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

Funding for Biomedical Advanced Research Development Authority (BARDA)
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

Funding for Bioterrorism and Emergency Preparedness
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Natl Institutes of Health (NIH)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MED

16. Specific lobbying issues

Funding for the Food and Drug Administration
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010
Funding for Bioterrorism and Emergency Preparedness
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

Funding for National Institutes of Health
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

Funding for Biomedical Advanced Research Development Authority (BARDA)
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

Funding for Pandemic Influenza Preparedness
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 1105: Omnibus Appropriations for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010

In Vitro Diagnostics
Regulatory Oversight

Comparative Effectiveness Program Initiatives
H.R. 1. and S. Amdt. 570: American Recovery and Reinvestment Act of 2009

Stem Cell Research
Executive Order

Drug Safety
Implementation of Food & Drug Administration Act of 2007
E-Pedigree and Anti-counterfeiting
Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft)
FDA Globalization Act of 2009 (House Discussion Draft)
S.525: Pharmaceutical Market Access and Drug Safety
The Drug and Device Accountability Act of 2009 (Senate Discussion Draft)

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), White House Office, Natl Institutes of Health (NIH),

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

Medicaid Rebates
H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code SCI

16. Specific lobbying issues

Stem Cell Research
Executive Order

Small Business Innovation and Research (SBIR) Program
Reauthorization
SBA Grant Proposal for High-Growth Companies

Technology Innovation Program (TIP)
H.R. 1105: Omnibus Appropriations for FY 2009
Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2010

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code SMB

16. Specific lobbying issues

Small Business Innovation and Research (SBIR) Program
Reauthorization
SBA Grant Proposal for High-Growth Companies
Accelerating of NOLs in Lieu of Other Tax Benefits (Refundable Tax Credits/Grant Proposals)
H.R. 1. and S. Amdt. 570: American Recovery & Reinvestment Act of 2009

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TAX

16. Specific lobbying issues

Accelerating of NOLs in Lieu of Other Tax Benefits (Refundable Tax Credits/Grant Proposals)
H.R. 1. and S. Amdt. 570: American Recovery & Reinvestment Act of 2009

Investment Tax Credit for Therapeutic Development

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TRD

16. Specific lobbying issues

Cartagena Biosafety Protocol
U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings

Foreign Agriculture Biotechnology Laws and Regulations
U.S. Korea Free Trade Agreement
China Biotechnology Bilateral Discussions
Mexico Biotechnology Bilateral Discussions
Taiwan Biotechnology Bilateral Discussions
EU Biotechnology Bilateral Discussions
Canada Biotechnology Bilateral Discussions
Japan Biotechnology Bilateral Discussions
Argentina Biotechnology Bilateral Discussions
Brazil Biotechnology Bilateral Discussions
Colombia Biotechnology Bilateral Discussions
Negotiations of Trans Pacific Partnership
APEC Agricultural Biotechnology Discussions
Korean Biosafety Law
Discussions with EU on Animal Cloning

Adventitious Presence (Low Level Presence)
U.S. Government Policy for Codex Guidelines on Adventitious Presence
European Union Low Level Presence Policy
Philippines Low Level Presence Policy

World Trade Organization on EU Biotech Approvals
Review of EU Biotechnology Negotiations

CBD TRIPS Amendment
Patent Disclosure Requirements

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Commerce - Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), State - Dept of (DOS), U.S. Trade Representative (USTR), U.S. Agency for International Development (USAID), Patent & Trademark Office (PTO)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code PHA

16. Specific lobbying issues

Comparative Effectiveness Program Initiatives
H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009


Drug Safety
Implementation of Food & Drug Administration Act of 2007
E-Pedigree and Anti-counterfeiting
Safeguarding America's Pharmaceuticals Act of 2009 (House Discussion Draft)
FDA Globalization Act of 2009 (House Discussion Draft)
S.525: Pharmaceutical Market Access and Drug Safety
The Drug and Device Accountability Act of 2009 (Senate Discussion Draft)

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009

Funding for the Food and Drug Administration
H.R. 1105: Omnibus Appropriations for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010

Medicaid Rebates
H.Con. Res. 85/S.Con. Res 13: Setting Forth the Congressional Budget for the United States Government for FY 2010

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address: BIO maintains a list of all of its members on its website at http://bio.org/membership/index.asp

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization