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

Sarbanes-Oxley Reform
Section 404
SEC and PCAOB Guidance on Auditing Standard (AS-5)
S.3260: Financial Services and General Government Appropriations Act for FY 2009
International Financial Reporting Standards
Upcoming SEC Proposed Rules

Net Operating Loss Limitation Reform/Internal Revenue Code Section 382
H.R. 3264: American Sciences Competitiveness Act

Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation
H.R. 3221

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Securities & Exchange Commission (SEC), Treasury - 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 AGR

16. Specific lobbying issues

Plant Protection Act Amendments/Penalties
H.R. 6124
Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Marketing and Regulatory Programs, Cloning Transition Period
USDA Economic Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program, Advance Notice of Proposed Rulemaking
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
H.R. 3161
S. 1859
H.R. 992
S. 414
H.R. 1396
S. 536
H.R. 4855
H.R. 2419
S.2663

Foreign Agricultural Biotechnology Laws and Regulations
U.S. Korea Free Trade Agreement
China Biotechnology Trade Negotiations
Mexico Biotechnology Trade Negotiations
Russia Biotechnology Trade Negotiations
Vietnam Biotechnology Negotiations
France Trade Meetings
Taiwan Biotechnology Negotiations
EU Trade Negotiations

EPA Regulation of Plant Incorporated Protectants
Proposed Rule

Adventitious Presence (Low Level Presence)
U.S. Government Policy Position for Codex Guidelines on Adventitious Presence
Korea Trade Negotiations
EU Trade Meetings

Farm Legislation
H.R. 2419 & H.R. 6124
USDA Administrative Proposals
Livestock Cloning/Product Labeling
Plant Protection Act Amendments/Penalties

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

Genetically Engineered (GE) Animals
U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals
FDA and USDA Draft Regulation of GE Animals
H.R. 6432

Biotechnology Crop Stewardship
Biotechnology Quality Management Stewardship


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

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

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

Bio-based Products Tax Credits

EU Tracebility and Labeling Regulations for Ag-Biotech

U.S. Policy on Ag-Biotech Benefits for G-8 Meeting

Policies Impacting Global Trade of Ag-Biotech Products
U.S. Government Positions

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), Food & Drug Administration (FDA), State - Dept of (DOS), U.S. Trade Representative (USTR), Commerce - Dept of (DOC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), U.S. Agency for International Development (USAID), Council of Economic Advisers (CEA), 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 ANI

16. Specific lobbying issues

Genetically Engineered (GE) Animals
U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals
FDA and USDA Draft Regulation of GE Animals
H. R. 6432

Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Marketing and Regulatory Programs, Cloning Transition Period
USDA Economic Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program, Advance Notice of Proposed Rulemaking
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
H.R. 3161
S. 1859
H.R. 992
S. 414
H.R. 1396
S. 536
H.R. 4855
H.R. 2419
S.2663

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 Management & Budget (OMB), Office of Science & Technology Policy (OSTP), U.S. Trade Representative (USTR), State - Dept of (DOS), Commerce - Dept of (DOC), Health & Human Services - Dept of (HHS), Council of Economic Advisers (CEA)

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

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
Funding for the Food and Drug Administration (Human Drug, 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 (Cont...)
Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care &
Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture
Research Service, Biofuels (Rural Development))
Drug Importation

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)
Drug Importation

Energy and Water Development and Related Agencies Appropriations Act for FY 2009
Funding for Biofuels

S.3260: Financial Services and General Government Appropriations Act for FY 2009
Sarbanes Oxley - Section 404

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

FY 2008 Supplemental Appropriations Bill (H.R. 2642)
Funding for National Institutes of Health
Funding for Bioterrorism and Emergency Preparedness
Funding for Pandemic Influenza Preparedness
Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall
Foundation, Center for Veterinary Medicine)
Funding for Biomedical Advanced Research & Development Authority (BARDA)
Funding for USDA/APHIS
Funding for Biorefinery Construction, Research & Development

Department of Homeland Security Appropriations Act for FY 2009
Drug Importation

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

U.S. Agency for International Development (USAID), U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, Health & Human Services - Dept of (HHS), Commerce - Dept of (DOC)

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. 1908
S. 1145

CBD TRIPS Amendment
Patent Disclosure Requirements

PTO Proposed Regulations
Continuation Rules: FR 2005-P-066
Claims Rules: FR 2005-P-067
Information Disclosure Rules: 71-FR-38808
Biologic Deposit Rule: 73-FR-34

Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World
U.S. Government Positions in WTO, WHO Negotiations

Bayh-Dole Act Evaluation

Intellectual Property Enforcement

Gene Patenting

Intellectual Property Provisions in U.S. Trade Agreements
Korean Trade Agreement

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Patent & Trademark Office (PTO), Congressional Budget Office (CBO), State - Dept of (DOS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS), Commerce - Dept of (DOC), 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

Genetically Engineered (GE) Animals
U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals
FDA and USDA Draft Regulation of GE Animals
H. R. 6432
Drug Safety
Implementation of Food & Drug Administration Amendments Act of 2007
Clinical Trial Registry and Results Databases
Risk Management Plans
Heparin Contamination
Counterfeit Drugs
H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008
FDA Globalization Act of 2008
H.R. 3610: The Food and Drug Import Safety Act of 2007

Drug Importation
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
Department of Homeland Security Appropriations Act for FY 2009 (S.3181)
Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009

Adventitious Presence (Low Level Presence)
U.S. Government Policy Position for Codex Guidelines on Adventitious Presence
Korea Trade Negotiations
EU Trade Meetings

Physician Payments Sunshine Act
S.2029

Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Marketing and Regulatory Programs, Cloning Transition Period
USDA Economic Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program, Advance Notice of Proposed Rulemaking
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
H.R. 3161
S. 1859
H.R. 992
S. 414
H.R. 1396
S. 536
H.R. 4855
H.R. 2419
S.2663

Access to Drug Pricing Data
H.R. 5683

Funding for Food Safety at the Food and Drug Administration
Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

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), U.S. Trade Representative (USTR), State - Dept of (DOS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Agriculture - Dept of (USDA), Commerce - Dept of (DOC), Office of Science & Technology Policy (OSTP), Council of Economic Advisers (CEA), 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 ENG

16. Specific lobbying issues

Biofuels Tax Credit
H.R. 2419/H.R. 6124

Biorefinery Construction, Research & Development Appropriations
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Biorefinery Loan Program
H.R. 6124

Biofuels Emission Audits
S. 3036: Lieberman-Warner Climate Security Act of 2008

Farm Legislation
H.R. 2419/H.R. 6124
Biofuels Tax Credit

Funding for Biofuels
Energy and Water Development 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),

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 Position for Codex Guidelines on Adventitious Presence
Korea Trade Negotiations
EU Trade Meetings
Genetically Engineered (GE) Animals
U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals
FDA and USDA Draft Regulation of GE Animals
H. R. 6432

Livestock Cloning/Product Labeling
FDA Risk Assessment on Cloning
USDA Marketing and Regulatory Programs, Cloning Transition Period
USDA Economic Report on Impact of Cloning on US Agriculture and Food Production
USDA National Organic Program, Advance Notice of Proposed Rulemaking
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
H.R. 3161
S. 1859
H.R. 992
S. 414
H.R. 1396
S. 536
H.R. 4855
H.R. 2419
S.2663

Funding for Food Safety at the Food and Drug Administration
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

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

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

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

Biofuels Tax Credit
H.R. 2419/H.R. 6124
Renewable Fuels Standard

Biorefinery Construction, Research & Development Appropriations
H.R. 2642

Biorefinery Loan Program
H.R. 6124

Funding for Biofuels
Energy and Water Development and Related Agencies Appropriations Act for FY 2009

Farm Legislation
H.R. 2419/H.R. 6124
Biofuels Tax Credit

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),

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

Drug Safety
Implementation of Food & Drug Administration Amendments Act of 2007
Clinical Trial Registry and Results Databases
Risk Management Plans
Drug Safety Cont...
Heparin Contamination
Counterfeit Drugs
FDA Globalization Act of 2008
H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008
H.R. 3610: The Food and Drug Import Safety Act of 2007

Stem Cell Research

Medicaid Rebates
H.R. 1424
H.R. 6331
H.R. 3162
H.R. 1367
S.3101
Medicaid/Medicare Packages
Dual Proportionality
Medicaid Rebates in Hospital Outpatient Setting
CMS AMP Regulations

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

Follow-on Biologics
H.R. 1038
H.R. 1956
H.R. 5629
S. 1695

FDA Regulatory Processes for First-Time Filers

Funding for Biomedical Advanced Research & Development Authority (BARDA)
Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Vaccine Financing
National Vaccine Advisory Committee Draft Recommendations

Vaccines for Children Program
National Vaccine Advisory Committee Draft Recommendations

Influenza Vaccine Supply and Immunization Recommendations

Barriers and Incentives Related to Personalized Medicine

Outpatient Prospective Patient Services
S. 3101: Medicare Improvements for Patients and Providers Act of 2008

In Vitro Diagnostics
Regulatory Oversight
Comparative Effectiveness Program Initiatives
H.R. 6331
S. 3101
Medicare/Medicaid Packages

International Market Access for U.S. Healthcare Products
Healthcare Sector Advocacy/Free Trade Agreements
Alliance for Healthcare Competitiveness

Funding for National Institutes of Health
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for Bioterrorism and Emergency Preparedness
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for Pandemic Influenza Preparedness
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for the Food and Drug Administration
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
(Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine)
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Access to Investigation Drugs for Seriously Ill Patents
The Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.1956)

Physician Payments Sunshine Act
S.2029

Access to Drug Pricing Data
H.R. 5683

Drug Importation
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
Department of Homeland Security Appropriations Act for FY 2009
Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009

FDA Debarment
H.R. 6378: The Strengthening of FDA Integrity Act

Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World
U.S. Government Positions in WTO, WHO Negotiations

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), Office of Management & Budget (OMB), White House Office, Office of Science & Technology Policy (OSTP), Centers For Disease Control & Prevention (CDC), Commerce - Dept of (DOC), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Natl Institutes of Health (NIH), U.S. Trade Representative (USTR), State - Dept of (DOS), 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 HOM

16. Specific lobbying issues

Funding for Pandemic Influenza Preparedness
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for Biomedical Advanced Research Development Authority (BARDA)
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for Bioterrorism and Emergency Preparedness
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

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

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

16. Specific lobbying issues

Funding for Bioterrorism and Emergency Preparedness
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for National Institutes of Health
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for Biomedical Advanced Research Development Authority (BARDA)
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for Pandemic Influenza Preparedness
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Funding for the Food and Drug Administration
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009
(Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine)
FY 2008 Supplemental Appropriations Bill (H.R. 2642)

In Vitro Diagnostics
Regulatory Oversight

Comparative Effectiveness Program Initiatives
H.R. 6331
S. 3101
Medicare/Medicaid Packages

Stem Cell Research

Barriers and Incentives Related to Personalized Medicine

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), White House Office, Food & Drug Administration (FDA), 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 MMM

16. Specific lobbying issues

Outpatient Prospective Payment Service
S. 3101: Medicare Improvements for Patients and Providers Act of 2008

Medicaid Rebates
H.R. 1424
H.R. 6331
H.R. 3162
H.R. 1367
S.3101
Medicaid/Medicare Packages
Dual Proportionality
Medicaid Rebates in Hospital Outpatient Setting
CMS AMP Regulations

Access to Drug Pricing Data
H.R. 5683

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), White House Office, 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 PHA

16. Specific lobbying issues

Comparative Effectiveness Program Initiatives
H.R. 6331
S. 3101
Medicare/Medicaid Packages



Medicaid Rebates
H.R. 1424
H.R. 6331
H.R. 3162
H.R. 1367
S.3101
Medicaid/Medicare Packages
Dual Proportionality
Medicaid Rebates in Hospital Outpatient Setting
CMS AMP Regulations

Access to Drug Pricing Data
H.R. 5683

Influenza Vaccine Supply and Immunization Recommendations

Outpatient Prospective Payment Service
S. 3101: Medicare Improvements for Patients and Providers Act of 2008

Drug Importation
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
Department of Homeland Security Appropriations Act for FY 2009 (S.3181)
Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009

Drug Safety
Implementation of Food & Drug Administration Amendments Act of 2007
Clinical Trial Registry and Results Databases
Risk Management Plans
Heparin Contamination
Counterfeit Drugs
H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008
FDA Globalization Act of 2008
H.R. 3610: The Food and Drug Import Safety Act of 2007

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), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS), 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 SCI

16. Specific lobbying issues

Stem Cell Research

Small Business Innovation and Research Program (SBIR)
H.R. 5819: SBIR Reauthorization Act

R&D Tax Credit
H.R. 6049

Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation
H.R. 3221

Technology Transfer Policies

Technology Innovation Program (TIP)
Proposed Rules by National Institutes for Standards & Technology
Funding
--Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), Natl Economic Council (NEC), Commerce - Dept of (DOC), Treasury - Dept of, Small Business Adminstration (SBA), 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 SMB

16. Specific lobbying issues

Small Business Innovation and Research Program (SBIR)
H.R. 5819: SBIR Reauthorization Act

Sarbanes-Oxley Reform
Section 404
SEC and PCAOB Guidance on Auditing Standard (AS-5)
S.3260: Financial Services and General Government Appropriations Act for FY 2009

FDA Regulatory Processes for First-Time Filers

Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation
H.R. 3221

Net Operating Loss Limitation Reform/Internal Revenue Code Section 382
H.R. 3264: American Sciences Competitiveness Act

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Science & Technology Policy (OSTP), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Food & Drug Administration (FDA), Small Business Adminstration (SBA), Treasury - 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 TAX

16. Specific lobbying issues

Biofuels Tax Credit
H.R. 2419/H.R. 6124
Bio-based Products Tax Credits

R&D Tax Credit
H.R. 6049

Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation
H.R. 3221

Net Operating Loss Limitation Reform/Internal Revenue Code Section 382
H.R. 3264: American Sciences Competitiveness Act

Comprehensive Biotechnology Tax Incentives Legislation
H.R. 3264

Taxation of Collaborative Agreements
IRS Coordinated Issue Paper

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Treasury - 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 TRD

16. Specific lobbying issues

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


Foreign Agricultural Biotechnology Laws and Regulations
U.S. Korea Free Trade Agreement
China Biotechnology Trade Negotiations
Mexico Biotechnology Trade Negotiations
Russia Biotechnology Trade Negotiations
Vietnam Biotechnology Negotiations
France Trade Meetings
Taiwan Biotechnology Negotiations
EU Trade Negotiations

Adventitious Presence (Low Level Presence)
U.S. Government Policy Position for Codex Guidelines on Adventitious Presence
Korea Trade Negotiations
EU Trade Meetings

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

CBD TRIPS Amendment
Patent Disclosure Requirements

Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World
U.S. Government Positions in WTO, WHO Negotiations

Policies Impacting Global Trade of Ag-Biotech Products
U.S. Government Positions

International Market Access for U.S. Healthcare Products
Healthcare Sector Advocacy/Free Trade Agreements
Alliance for Healthcare Competitiveness

Drug Importation
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009
Department of Homeland Security Appropriations Act for FY 2009
Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
for FY 2009

Intellectual Property Provisions in U.S. Trade Agreements
Korean Trade Agreement

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), U.S. Trade Representative (USTR), State - Dept of (DOS), Agriculture - Dept of (USDA), Commerce - Dept of (DOC), Patent & Trademark Office (PTO), 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 CIV

16. Specific lobbying issues

Genetic Information Non-Discrimination Act
S.358

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 GOV

16. Specific lobbying issues

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

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

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

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 LAW

16. Specific lobbying issues

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

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

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