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 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

Livestock Cloning/Product Labeling Cont...
USDA APHIS Animal Care
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative - Research Funding
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act of FY 2010
2007 Farm Bill Implementation
Discussion with EU on Animal Cloning

Foreign Agriculture Biotechnology Laws and Regulations
U.S. Korea Free Trade Agreement and Living Modified Organisms Act Revisions
China Biotechnology Bilateral Discussions
Mexico Biotechnology Bilateral Discussions
EU Biotechnology Bilateral Discussions
Canada Biotechnology Bilateral Discussions
Japan Biotechnology Bilateral Discussions
Argentina Biotechnology Bilateral Discussions
Brazil Biotechnology Bilateral Discussions
APEC Agricultural Biotechnology Discussions
Korean Biosafety Law
Discussions with EU on Animal Cloning
India Bilateral Biotechnology Discussions
Vietnam Biotechnology Regulations

U.S. Policy on International Science-Based Regulations

USDA Export Strategy for Agricultural Biotechnology Products

World Trade Organization on EU Biotech Approvals
EU Biotechnology Negotiations

Genetically Engineered (GE) Animals
USDA APHIS Animal Care - Compliance with the Animal Welfare Act
USDA APHIS Veterinary Service - Import and Export Issues
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations
Act of FY 2010
USDA APHIS Biotechnology Regulatory Services - Regulatory Follow-up
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative, Research Funding
FDA Final Guidance on Regulation of GE Animals
FDA Approval of First Product From GE Animals
Cartagena Biosafety Protocol
U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings

USDA/APHIS Agricultural Biotechnology Regulations
USDA Rulemaking on 7CFR 340
USDA Docket on Corn Amylase Petition (No. APHIS-2007-0016)
Efficient Review of Biotech Products

U.S. Policy on Sustainable Agriculture Standard
American National Standards Institute Sustainable Agriculture Standards (ANSI)
International Standards Organization Standard (ISO)

Funding for the USDA
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for
FY 2010

Biomass Crop Assistance Program (BCAP)
BCAP Rulemaking and Environmental Impact Statement
2007 Farm Bill Implementation
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for
FY 2010

U.S. Government Agriculture Research Funding
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Appropriations Act for
FY 2010
Agriculture Federal Research Initiative for FY 2009

Global Food Security Initiative
U.S. Government Strategy for Global Food Security

Codex Alimentarius Commission
Proposed Draft Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance

UN Climate Change Convention
US Government Position on Ag-biotech and Intellectual Property Rights

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

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

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

Genetically Engineered (GE) Animals
USDA APHIS Animal Care - Compliance with the Animal Welfare Act
USDA APHIS Veterinary Service - Import and Export Issues
Genetically Engineered (GE) Animals Cont...
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
USDA APHIS Biotechnology Regulatory Services - Regulatory Follow-up
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative, Research Funding
FDA Final Guidance on Regulation of GE Animals
FDA Approval of First Product from GE Animals

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 APHIS Animal Care
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative - Research Funding
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
2007 Farm Bill Implementation
Discussion with EU on Animal Cloning

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

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

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. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2010
Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall
Foundation, Center for Veterinary Medicine)
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations
Act for FY 2010 Cont...
Funding for the USDA: Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS),
Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels
(Rural Development))
Genetically Engineered (GE) Animals
Livestock Cloning/Product Labeling
Funding for Biofuels and Bio-based Products
Drug Importation

H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act
for FY 2010
Funding for National Institutes of Health
Funding for Bioterrorism and Emergency Preparedness
Funding for Pandemic Influenza Preparedness
Funding for Biomedical Advanced Research and Development Authority (BARDA)
Drug Importation

H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010
Funding for Biofuels and Bio-based Products

H.R. 3081/S.1434: Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2010
Funding for Biotechnology Research and Development Programs at the Agency for International Development

H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010
Funding for Biofuels at the U.S. Forest Service
Funding for Bio-based Products
Climate Change/Indirect Land Use

Department of Homeland Security Appropriations Act for FY 2010
Drug Importation

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

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

16. Specific lobbying issues

Climate Change Benefits of Biofuels and Bio-based Products
H.R. 2454: American Clean Energy and Security Act of 2009
Clean Energy Jobs and American Power Act of 2009 Senate Discussion Draft
U.S. Government Position for U.N. Convention on Climate Change Negotiations
IP Rights for Environmental Technologies
U.S. Government Position for U.N. Convention on Climate Change Negotiations

Climate Change/Indirect Land Use
H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for 2010

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), 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 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
World Trade Organization Special 301 Submissions

Convention on Biological Diversity Patent Disclosure Requirements

Bayh-Dole Act/Tech Transfer
Gene Patenting
HHS Secretary's Advisory Committee Report

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

PTO Administrative Reforms

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, State - Dept of (DOS), Agriculture - Dept of (USDA), U.S. Trade Representative (USTR), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), Congressional Budget Office (CBO)

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

Genetically Engineered (GE) Animals
USDA APHIS Animal Care - Compliance with the Animal Welfare Act
USDA APHIS Veterinary Service - Import and Export Issues
Genetically Engineered (GE) Animals Cont...
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
USDA APHIS Biotechnology Regulatory Services - Regulatory Follow-up
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative, Research Funding
FDA Final Guidance on Regulation of GE Animals
FDA Approval of First Product from GE Animals

Funding for the Food and Drug Administration
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related agencies
Appropriations Act for FY 2010

Reporting of Physician Payments
S.310: Physician Payments Sunshine Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009
H.R. 3200: America's Affordable Health Choices Act

Drug Safety and Review
E-Pedigree and Anti-counterfeiting
H.R. 2749: Food Safety Enhancement Act of 2009
H.R. 759: FDA Globalization Act of 2009
S. 882: Drugs and Device Accountability Act of 2009
The Food and Drug Administration Amendments Act of 2007 Implementation
Risk Evaluation Mitigation Strategies
Adverse Event Monitoring/Sentinel Network
Advisory Committee System
Critical Path
FDA Regulatory Transparency
Measurement Standards for Review and Approval of Biologics
House Science Committee Hearing

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety Act of 2009
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act
for FY 2010
Department of Homeland Security Appropriations Act for FY 2010
S.1232: Pharmaceutical Market Access Act of 2009
H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009
S.80: Pharmaceutical Market Access Act of 2009



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 APHIS Animal Care
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative - Research Funding
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
2007 Farm Bill Implementation
Discussion with EU on Animal Cloning

USDA/APHIS Agricultural Biotechnology Regulations
USDA Rulemaking on 7CFR 340
USDA Docket on Corn Amylase Petition (No. APHIS-2007-0016)
Efficient Review of Biotech Products

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

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

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

Algae-based Renewable Fuel/Carbon Capture and Conversion
S.1013: Department of Energy Carbon Capture and Sequestration Program Amendments Act of 2009
S.1250: Algae-based Renewable Fuel Promotion Act of 2009

Biofuels
H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010
Loan Guarantees and Grants under S.1: American Recovery and Reinvestment Act

Bio-based Products
H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010
H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
Biopreferred Program Implementation under 2007 Farm Bill
Tax Credit

Climate Change Benefits of Biofuels and Bio-based Products
H.R. 2454: American Clean Energy and Security Act of 2009
Clean Energy Jobs and American Power Act of 2009 Senate Discussion Draft
U.S. Government Position for U.N. Convention on Climate Change Negotiations

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Environmental Protection Agency (EPA), State - Dept of (DOS), U.S. Trade Representative (USTR), Energy - Dept of

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

Genetically Engineered (GE) Animals
USDA APHIS Animal Care - Compliance with the Animal Welfare Act
USDA APHIS Veterinary Service - Import and Export Issues
Genetically Engineered (GE) Animals Cont...
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations
Act of FY 2010
USDA APHIS Biotechnology Regulatory Services - Regulatory Follow-up
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative, Research Funding
FDA Final Guidance on Regulation of GE Animals
FDA Approval of First Product From GE Animals

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 APHIS Animal Care
USDA, Cooperative State Research Education and Extension Service, National Institute of Food & Agriculture,
Agriculture Food Research Initiative - Research Funding
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
2007 Farm Bill Implementation
Discussion with EU on Animal Cloning

Food Safety Funding
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010

Global Food Security Initiative
U.S. Government Strategy for Global Food Security

Codex Alimentarius Commission
Proposed Draft Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance

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

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

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

Algae-based Renewable Fuel/Carbon Capture and Conversion
S.1013: Department of Energy Carbon Capture and Sequestration Program Amendments Act of 2009
S.1250: Algae-based Renewable Fuel Promotion Act of 2009

Biofuels
H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010
Loan Guarantees and Grants under S.1: American Recovery and Reinvestment Act

Bio-based Products
H.R. 3183/S.1436: Energy and Water Development and Related Agencies Appropriations Act for FY 2010
H.R. 2996: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2010
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
Biopreferred Program Implementation under 2007 Farm Bill
Tax Credit

Climate Change Benefits of Biofuels and Bio-based Products
H.R. 2454: American Clean Energy and Security Act of 2009
Clean Energy Jobs and American Power Act of 2009 Senate Discussion Draft
U.S. Government Position for U.N. Convention on Climate Change Negotiations

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Environmental Protection Agency (EPA), Agriculture - Dept of (USDA), State - Dept of (DOS), U.S. Trade Representative (USTR), Energy - Dept of

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

Healthcare Reform
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009
Health Care Reform Cont...
Comparative Effectiveness Research Program Initiatives
Hospital Acquired Infections Policy
In Vitro Diagnostics Regulatory Oversight
Vaccine Access/Financing
Follow-on Biologics
Reporting of Physician Payments
Expansion of 340B Drug Pricing Program
Medicaid Rebates
S.1213: Patient-Centered Outcomes Research Act of 2009
H.R. 2502: Comparative Effectiveness and Research Protection Act
H.R. 2824 Doctor-Patient Relationship and Research Protection Act
Pharmaceutical Excise Tax

Funding for the Food and Drug Administration
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010

Stem Cell Research

Medicaid Rebates
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009

Follow-on Biologics
H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act
H.R. 1548: Pathway for Biosimilars Act of 2009
S. 726: Promoting Innovation and Access to Life-Saving Medicine Act
FTC Report on Follow-on Biologics Marketplace
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009
House Judiciary Committee Hearing on Patent Issues

Drug Safety and Review
E-Pedigree and Anti-counterfeiting
H.R. 2749: Food Safety Enhancement Act of 2009
H.R. 759: FDA Globalization Act of 2009
S. 882: Drugs and Device Accountability Act of 2009
The Food and Drug Administration Amendments Act of 2007 Implementation
Risk Evaluation Mitigation Strategies
Adverse Event Monitoring/Sentinel Network
Advisory Committee System
Critical Path
FDA Regulatory Transparency
Measurement Standards for Review and Approval of Biologics
House Science Committee Hearing



Funding for Biomedical Advanced Research & Development Authority (BARDA)
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

In Vitro Diagnostics
Regulatory Oversight
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009

Comparative Effectiveness Program Initiatives
Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 2502: Comparative Effectiveness Research Act of 2009
H.R. 2824: Doctor-Patient Relationship and Research Protection Act
S.1213: Patient-Centered Outcomes Research Act of 2009
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009

Funding for National Institutes of Health
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

Funding for Bioterrorism and Emergency Preparedness
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

Funding for Pandemic Influenza Preparedness
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

Reporting of Physician Payments
S. 301: Physician Payments Sunshine Act of 2009
H.R. 3200: America's Affordable Health Choices Act
Senate Finance Committee's America's Healthy Future Act of 2009

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety Act of 2009
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act
for FY 2010
Department of Homeland Security Appropriations Act for FY 2010
S.1232: Pharmaceutical Market Access Act of 2009
H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009
S.80: Pharmaceutical Market Access Act of 2009

Vaccine Access/Financing
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009

FDA Regulatory Processes for First-Time Filers

Expansion of 340B Drug Pricing Program
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009
S.1239: 340B Program Improvement and Integrity Act of 2009

Outpatient Prospective Payment System
CY2010 Proposed Regulations
Payment Methodology for Separately Billable Drugs and Biologics

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), Food & Drug Administration (FDA), Natl Institutes of Health (NIH), Congressional Budget Office (CBO), Centers For Medicare and Medicaid Services (CMS),

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. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for
FY 2010

Funding for Biomedical Advanced Research & Development Authority (BARDA)
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

Funding for Bioterrorism and Emergency Preparedness
H.R. 3293: 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,

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 Bioterrorism and Emergency Preparedness
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for
FY 2010

Funding for National Institutes of Health
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

Funding for Biomedical Advanced Research & Development Authority (BARDA)
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

Funding for the Food and Drug Administration
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010

Funding for Pandemic Influenza Preparedness
H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act
for FY 2010

In Vitro Diagnostics
Regulatory Oversight
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009

Stem Cell Research

Comparative Effectiveness Program Initiatives
Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 2502: Comparative Effectiveness Research Act of 2009
H.R. 2824: Doctor-Patient Relationship and Research Protection Act
S.1213: Patient-Centered Outcomes Research Act of 2009
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009

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), 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 MMM

16. Specific lobbying issues

Medicaid Rebates
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009
Outpatient Prospective Payment System
CY2010 Proposed Regulations
Payment Methodology for Separately Billable Drugs and Biologics

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

Small Business Innovation and Research (SBIR) Program Reauthorization
H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009

Biotech Innovation/R&D Initiatives
Research & Development Tax Credit Extension

Measurements Standards for Review and Approval of Biologics
House Science Committee Hearing

Stem Cell Research

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Small Business Adminstration (SBA), Office of Science & Technology Policy (OSTP)

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
H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009

SBA Grant Proposal for Early Stage Investment
SBA Early Stage Investment Act of 2009 Discussion Draft

FDA Regulatory Processes for First-Time Filers

Listing Requirements on Exchanges
SEC Proposed Rules

Therapeutic Development Investment Tax Credit
Tax Legislation
Senate Finance Committee's America's Healthy Future Act of 2009

Small Business Definition Amendment
Investor Protection Act of 2009 House Discussion Draft
SEC Rule 12b-2

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Small Business Adminstration (SBA), Food & Drug Administration (FDA), Securities & Exchange Commission (SEC)

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

Therapeutic Development Investment Tax Credit
Senate Finance Committee's America's Healthy Future Act of 2009
Tax Legislation
Bio-based Products
Tax Credits

Pharmaceutical Excise Tax
Senate Finance Committee's America's Healthy Future Act of 2009

R&D Tax Credit Extension

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 and Living Modified Organisms Act Revisions
China Biotechnology Bilateral Discussions
Mexico Biotechnology Bilateral Discussions
EU Biotechnology Bilateral Discussions
Canada Biotechnology Bilateral Discussions
Japan Biotechnology Bilateral Discussions
Argentina Biotechnology Bilateral Discussions
Brazil Biotechnology Bilateral Discussions
APEC Agricultural Biotechnology Discussions
Korean Biosafety Law
Discussions with EU on Animal Cloning
India Bilateral Biotechnology Discussions
Vietnam Biotechnology Regulations


U.S. Policy on International Science-Based Regulations

USDA Export Strategy for Agricultural Biotechnology Products

World Trade Organization Special 301 Submissions

World Trade Organization on EU Biotech Approvals
EU Biotechnology Negotiations

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety Act of 2009
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act
for FY 2010
Department of Homeland Security Appropriations Act for FY 2010
S.1232: Pharmaceutical Market Access Act of 2009
H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009
S.80: Pharmaceutical Market Access Act of 2009

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

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

16. Specific lobbying issues

Medicaid Rebates
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009
Comparative Effectiveness Program Initiatives
Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009
H.R. 2502: Comparative Effectiveness Research Act of 2009
H.R. 2824: Doctor-Patient Relationship and Research Protection Act
S.1213: Patient-Centered Outcomes Research Act of 2009
H.R. 3200: America's Affordable Health Choices Act
S.1679: America's Affordable Health Choices Act of 2009
Senate Finance Committee's America's Healthy Future Act of 2009

Outpatient Prospective Payment System
CY2010 Proposed Regulations
Payment Methodology for Separately Billable Drugs and Biologics

Drug Safety and Review
E-Pedigree and Anti-counterfeiting
H.R. 2749: Food Safety Enhancement Act of 2009
H.R. 759: FDA Globalization Act of 2009
S. 882: Drugs and Device Accountability Act of 2009
The Food and Drug Administration Amendments Act of 2007 Implementation
Risk Evaluation Mitigation Strategies
Adverse Event Monitoring/Sentinel Network
Advisory Committee System
Critical Path
FDA Regulatory Transparency
Measurement Standards for Review and Approval of Biologics
House Science Committee Hearing

Drug Importation
S.525: Pharmaceutical Market Access and Drug Safety Act of 2009
H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act for FY 2010
H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act
for FY 2010
Department of Homeland Security Appropriations Act for FY 2010
S.1232: Pharmaceutical Market Access Act of 2009
H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009
S.80: Pharmaceutical Market Access Act of 2009

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), Centers For Medicare and Medicaid Services (CMS), 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 FIN

16. Specific lobbying issues

Listing Requirements on Exchanges
SEC Proposed Rules
Small Business Definition Amendment
Investor Protection Act of 2009 House Discussion Draft
SEC Rule 12b-2

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

Securities & Exchange Commission (SEC), 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

​

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