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

EPA Regulations on Agricultural Biotechnology
Reauthorization and Implementation of Pesticide Registration Improvement Act
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)

USDA/APHIS Agricultural Biotechnology Regulations
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
Efficient Science-Based Review of Biotech Products
National Environmental Policy Act Requirements
Coexistence of Production Systems

Biomass Crop Assistance Program
Funding
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning

Genetically Engineered (GE) Animals
FDA Approval
Labeling
S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon

Export Registrations for Products with Expired Patents

Labeling of Genetically Engineered Crops
U.S. Government Policy

U.S. Policy on International Science-Based Regulations

TransPacific Partnership
Sanitary and Phytosanitary Issues

Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service)
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

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

Agricultural Biotechnology Regulatory Reform and Modernization
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)

Benefits of Ag-Biotech Research and Innovation
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)

Potential Regulation of New Genetic Modification Technologies


Patent Exhaustion
Ag-biotech Products

Foreign Agricultural Biotechnology Laws and Regulations
Low-Level Presence Foreign Government Policies
China Biotechnology Regulations
International Biotechnology Agreement
Asynchrony of International Approvals

Adventitious Presence (Low Level Presence)
U.S. Low Level Presence Policy

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), U.S. Trade Representative (USTR), Food & Drug Administration (FDA), White House Office, Health & Human Services - Dept of (HHS), Office of Science & Technology Policy (OSTP), Justice - Dept of (DOJ)

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
Discussions with EU on Animal Cloning

Genetically Engineered (GE) Animals
FDA Approval
Labeling
S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), U.S. Trade Representative (USTR), Agriculture - Dept of (USDA), 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 BUD

16. Specific lobbying issues

Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service)
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013



Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure)
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

Funding for Bio-based Products
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)

Funding for Biofuels
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)

Funding for Biorefineries
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)

Funding for Centers for Disease Control and Prevention Vaccine Programs
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Funding for National Institutes of Health
Cures Acceleration Network
National Center for Advancing Translational Science (NCATS)
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Funding for Biomass Crop Assistance Program
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)

Funding for Renewable Chemicals
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)

Sequestration of PDUFA Fees
Implementation of P.L. No: 112-25: Budget Control Act of 2012

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

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

16. Specific lobbying issues

Climate Change Benefits of Biofuels
Department of Defense Applications of Advanced Biofuels

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Navy - Dept of, 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 CPT

16. Specific lobbying issues

Bayh-Dole Act/Tech Transfer
Commercialization of Federally Funded Research Initiative

Genetic Resource Patent Disclosure Requirement
World Intellectual Property Organization

DNA Patenting and Licensing
Australia Compulsory Licensing Parliamentary Inquiry
Confirmatory Genetic Diagnostic Testing

Intellectual Property International Enforcement

Patent Exhaustion
Ag-biotech Products

International Trade Commission Reform
Rep. Devin Nunes Discussion Draft

TransPacific Partnership
Data and Intellectual Property Protection for Pharmaceuticals

Patent Reform
Implementation of the America Invents Act of 2011

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Patent & Trademark Office (PTO), U.S. Trade Representative (USTR), Justice - Dept of (DOJ), Intl Trade Administration (ITA), 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 CSP

16. Specific lobbying issues

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning

USDA/APHIS Agricultural Biotechnology Regulations
Efficient Science-Based Review of Biotech Products
National Environmental Policy Act Requirements
Coexistence of Production Systems
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)

Genetically Engineered (GE) Animals
FDA Approval
Labeling
S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon

Reporting of Physician Payments
Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act

Labeling of Genetically Engineered Crops
U.S. Government Policy

Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization
Access to External Experts
Conflicts of Interest
Drug Shortages
E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft )
Expedited Approval Pathways
FDA Mission
Regulatory Reforms for Innovative Products
Supply Chain Integrity
Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act

Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2)
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013

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), White House Office, U.S. Trade Representative (USTR), 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 ENG

16. Specific lobbying issues

Renewable Fuels Standard
Implementation of P.L. No: 112-140: Energy Independence and Security Act
S. 3428/H.R. 3097: Renewable Fuel Standard Flexibility Act of 2012
S. 1085/H.R. 2009: Fuels Feedstock Freedom Act of 2012
Biofuels
Funding
Department of Defense Applications of Advanced Biofuels
Production Tax Credit Extension
Production Tax Credit Modification for Algae-based Biofuels
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2770: Rural Energy Investment Act of 2012
H.R. 2219: Department of Defense Appropriations Act for FY 2012
S. 3521: Family and Business Tax Cut Certainty Act of 2012

Biorefineries
Funding
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013

Bio-based Products
Funding
Tax Credit
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
S.2770: Rural Energy Investment Act of 2012
S.1255: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012

Renewable Chemicals
Funding
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
S. 1764: Make It in America Tax Credit Act of 2011
S.1255: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012

Biomass Crop Assistance Program
Funding
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act

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), Navy - Dept of, 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 FOO

16. Specific lobbying issues

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning

Genetically Engineered (GE) Animals
FDA Approval
Labeling
S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon

Labeling of Genetically Engineered Crops
U.S. Government Policy

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), 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 FUE

16. Specific lobbying issues

Renewable Fuels Standard
Implementation of P.L. No: 112-140: Energy Independence and Security Act
S. 3428/H.R. 3097: Renewable Fuel Standard Flexibility Act of 2012
S. 1085/H.R. 2009: Fuel Feedstock Freedom Act 0f 2012
Biofuels
Funding
Department of Defense Applications of Advanced Biofuels
Production Tax Credit Extension
Production Tax Credit Modification for Algae-based Biofuels
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2770: Rural Energy Investment Act of 2012
H.R. 2219: Department of Defense Appropriations Act for FY 2012
S. 3521: Family and Business Tax Cut Certainty Act of 2012

Biorefineries
Funding
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013

Bio-based Products
Funding
Tax Credit
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
S.2770: Rural Energy Investment Act of 2012
S.1255: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012

Renewable Chemicals
Funding
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
S. 1764: Make It in America Tax Credit Act of 2011
S.1255: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012

Biomass Crop Assistance Program
Funding
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Navy - Dept of, Environmental Protection Agency (EPA), 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 HCR

16. Specific lobbying issues

Pharmaceutical Industry Annual Fee
Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act
Treasury and IRS Regulations Implementing the Law

Biosimilars
Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act
Colombia Biologics Regulations

Funding for National Institutes of Health
Cures Acceleration Network
National Center for Advancing Translations Science (NCATS)
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Funding for Centers for Disease Control and Prevention Vaccine Programs
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Reporting of Physician Payments
Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act

Vaccine Access/Financing
Tax for Seasonal Influenza Funding
Taxable Vaccines Act (Discussion Draft)

340B Drug Pricing Program
HRSA Implementation of Program Changes
Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act

Average Manufacturer Price Calculations

Therapeutic Discovery Project Tax Credit
S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension

Rare Pediatric & Tropical Disease Drug Development

Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization
Access to External Experts
Conflicts of Interest
Drug Shortages
E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft)
Expedited Approval Pathways
FDA Mission
Regulatory Reforms for Innovative Products
Supply Chain Integrity
Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act

Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2)
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013
Independent Payment Advisory Board
H.R. 5: Protecting Access to Healthcare Act of 2011

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Biodefense Research, Development, and Procurement
HHS Countermeasures Review
S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

TransPacific Partnership
Data and Intellectual Property Protection for Pharmaceuticals
Regulatory Transparency

Reimbursement for Innovative Products
Medicare Part D Prescription Drug Program
Medicare Part B Physician-Administered Products

Sequestration of PDUFA Fees
Implementation of P.L. No: 112-25: Budget Control Act

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), Health & Human Services - Dept of (HHS), 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 HOM

16. Specific lobbying issues

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013


Biodefense Research, Development, and Procurement
HHS Countermeasures Review
S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

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

Biodefense Research, Development, and Procurement
HHS Countermeasures Review
S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011

Funding for National Institutes of Health
Cures Acceleration Network
National Center for Advancing Translation Science (NCATS)
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Rare Pediatric & Tropical Disease Drug Development

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Natl Institutes of Health (NIH), 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 MMM

16. Specific lobbying issues

Reimbursement for Innovative Products
Medicare Part D Prescription Drug Program
Medicare Part B Physician-Administered Products
Average Manufacturer Price Calculations

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

Research & Development Tax Credit Extension
Innovative Research and Competitiveness Act (Senator Carper Discussion Draft)
Startup Innovation Credit (Senator Coons Discussion Draft)




Small Business Innovation Research (SBIR) Program
Rulemaking

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Small Business Adminstration (SBA), 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 SMB

16. Specific lobbying issues

Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
H.R. 6161: Fostering Innovation Act

Reform of SEC Regulation D
Therapeutic Discovery Project Tax Credit
S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to
Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension

Capital Formation Investment Incentives
H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012

Small Business Innovation Research (SBIR) Program
Rulemaking

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Small Business Adminstration (SBA), Securities & Exchange Commission (SEC), 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 TAX

16. Specific lobbying issues

Vaccine Access/Financing
Tax for Seasonal Influenza Funding
Taxable Vaccines Act (Discussion Draft)

Tax Reform

Bio-based Products
Tax Credit
S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012

Therapeutic Discovery Project Tax Credit
S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension

Pharmaceutical Industry Annual Fee
Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act
Treasury and IRS Regulations Implementing the Law

Biofuels
Biofuels Production Tax Credit Modification for Algae-based Biofuels
Biofuels Production Tax Credit Extension
S. 3521: Family and Business Tax Cut Certainty Act of 2012

Research & Development Tax Credit Extension
Innovative Research and Competitiveness Act (Senator Carper Discussion Draft)
Startup Innovation Credit (Senator Coons Discussion Draft)

Capital Formation Investment Incentives
H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012

Renewable Chemicals
S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill)
S. 1764: Make It in America Tax Credit Act of 2011

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Navy - 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

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning





Export Registrations for Products with Expired Patents

U.S. Policy on International Science-Based Regulations

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

Genetic Resource Patent Disclosure Requirement
World Intellectual Property Organization

TransPacific Partnership
Data and Intellectual Property Protection for Pharmaceuticals
Sanitary and Phytosanitary Issues
Regulatory Transparency

International Trade Commission Reform
Rep. David Nunes Discussion Draft

Intellectual Property International Enforcement

Biosimilars
Colombia Biologics Regulations
Foreign Agricultural Biotechnology Laws and Regulations
Low-Level Presence Foreign Government Policies
China Biotechnology Regulations
International Biotechnology Agreement
Asynchrony of International Approvals

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, U.S. Trade Representative (USTR), Agriculture - Dept of (USDA), Patent & Trademark Office (PTO), 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