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
Departments of the Interior, Environment, and Related Agencies Appropriations Act for FY 2013
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)



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)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

Biotechnology Stewardship
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning

Genetically Engineered Animals
Labeling
FDA Approval
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
S. 3187: Food and Drug Administration Safety and Innovation Act of 2012
Amendment to Restrict FDA Approval of GE Salmon

Export Registrations for Products with Expired Patents

Labeling of Genetically Engineered Crops
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)
Amendment to Require Labeling of Biotech Food

TransPacific Partnership
Sanitary and Phytosanitary Issues

Adventitious Presence (Low Level Presence)
U.S. Low Level Presence Policy
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

Funding for 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

Foreign Agricultural Biotechnology Laws and Regulations
Low-Level Presence Foreign Government Policies
EU Biotechnology Bilateral Discussions
China Biotechnology Regulations
European Union Low Level Presence Policy
International Biotechnology Agreement
Asynchrony of International Approvals

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

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

Patent Exhaustion
Ag-biotech Products

Potential Regulation of New Genetic Modification Technologies

Biomass Crop Assistance Program
Funding
Renewal
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)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

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), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), White House Office, 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 ANI

16. Specific lobbying issues

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning


Genetically Engineered Animals
Labeling
FDA Approval
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
S. 3187: Food and Drug Administration Safety and Innovation Act of 2012
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)

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 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: Energy and Water and Related Agencies Appropriations Act for FY 2013
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

Funding for Biofuels
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013

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

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 Renewable Chemicals
S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, 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
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

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),

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,

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
Implementation of H.R. 1249: The America Invents Act of 2011
Technical Corrections of H.R. 1249: The America Invents Act of 2011

World Trade Organization Special 301 Submissions
India Issues

Genetic Resource Patent Disclosure Requirement
World Intellectual Property Organization

DNA Patenting and Licensing
Confirmatory Genetic Diagnostic Testing
Subject Matter Eligibility

Intellectual Property International Enforcement

International Trade Commission Reform
Rep. Devin Nunes Discussion Draft

TransPacific Partnership
Data and Intellectual Property Protections for Pharmaceuticals

Patent Exhaustion
Ag-biotech Products

Process Patents
Subject Matter Eligibility
PTO Guidance

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Patent & Trademark Office (PTO), State - Dept of (DOS), U.S. Trade Representative (USTR), Justice - Dept of (DOJ), 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 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)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

Genetically Engineered Animals
Labeling
FDA Approval
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
S. 3187: Food and Drug Administration Safety and Innovation Act of 2012
Amendment to Restrict FDA Approval of GE Salmon

Labeling of Genetically Engineered Crops
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)
Amendment to Require Labeling of Biotech Food

Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization
Critical Path Initiative
E-Pedigree and Anti-Counterfeiting
Regulatory Reforms for Innovative Products
Supply Chain Integrity
Conflicts of Interest
FDA Mission
Drug Shortages
Expedited Approval Pathways
Access to External Experts
FDA Globalization Act (Discussion Draft)
Senate HELP Committee Discussion Draft
House Energy and Commerce Committee Discussion Draft
H.R.4132: Faster Access to Specialized Treatments (FAST) Act
S. 3187:The Food and Drug Administration Safety and Innovation Act
S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011
H.R.2182: Generating Antibiotic Incentives Now Act of 2011
H.R.3214: Food and Drug Administration Mission Reform Act of 2011
H.R.1483: Drug Safety Enhancement Act of 2011

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

Reporting of Physician Payments
Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

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)

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 Energy Independence and Security Act of 2007
Regulatory Oversight
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013


Biofuels
Funding
Department of Defense Applications of Advanced Biofuels
Biofuels Production Tax Credit Extension
Biofuels Production Tax Credit Modification for Algae-based Biofuels
Next Generation Incentives
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012

Biorefineries
Funding
Renewal of Biorefinery Assistance Program
Next Generation Incentives
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012

Bio-based Products
Funding
Tax Credit
Expansion of DOE and USDA Loan Guarantee Programs
USDA Bio-Preferred Program
Next Generation Incentives
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012

Renewable Chemicals
Funding
New Production Tax Credit/Revisions to Existing Tax Credits
DOE Loan Guarantees
Implementation of the Farm Security and Rural Investment Act of 2002
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
S. 1764: Make It in America Tax Credit Act of 2011
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012



Biomass Crop Assistance Program
Funding
Renewal
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)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

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

U.S. HOUSE OF REPRESENTATIVES, Energy - Dept of, Navy - Dept of, 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 FOO

16. Specific lobbying issues

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning

Genetically Engineered Animals
Labeling
FDA Approval
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
S. 3187: Food and Drug Administration Safety and Innovation Act of 2012
Amendment to Restrict FDA Approval of GE Salmon

Labeling of Genetically Engineered Crops
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)
Amendment to Require Labeling of Biotech Food

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, Agriculture - Dept of (USDA), Food & Drug Administration (FDA), 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 FUE

16. Specific lobbying issues

Renewable Fuels Standard
Implementation of Energy Independence and Security Act of 2007
Regulatory Oversight
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
Biofuels
Funding
Department of Defense Applications of Advanced Biofuels
Biofuels Production Tax Credit Extension
Biofuels Production Tax Credit Modification for Algae-based Biofuels
Next Generation Incentives
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012

Biorefineries
Funding
Renewal of Biorefinery Assistance Program
Next Generation Incentives
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012

Bio-based Products
Funding
Tax Credit
Expansion of DOE and USDA Loan Guarantee Programs
USDA Bio-Preferred Program
Next Generation Incentives
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012

Renewable Chemicals
Funding
New Production Tax Credit/Revisions to Existing Tax Credits
DOE Loan Guarantees
Implementation of the Farm Security and Rural Investment Act of 2002
S.R. 2465/H.R. 5325: Energy and Water and Related Agencies Appropriations Act for FY 2013
S. 1764: Make It in America Tax Credit Act of 2011
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012
H.R. 5955: Rural Energy Investment Act of 2012
S.2155: To Amend the Farm Security and Rural Investment Act of 2002 to Promote Bio-based Manufacturing
S.2270: Rural Energy Investment Act of 2012



Biomass Crop Assistance Program
Funding
Renewal
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)
Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)

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

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

16. Specific lobbying issues

Biosimilars
Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act
Reimbursement Issues

Comparative Effectiveness Research Initiatives
Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

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

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

Reporting of Physician Payments
Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Vaccine Access/Financing
Tax for Seasonal Influenza Funding
Adult Immunization Policies
Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

340B Drug Pricing Program
HRSA Implementation of Program Changes
Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Rare Pediatric & Tropical Disease Drug Development

Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization
Critical Path Initiative
E-Pedigree and Anti-Counterfeiting
Regulatory Reforms for Innovative Products
Supply Chain Integrity
Conflicts of Interest
FDA Mission
Drug Shortages
Expedited Approval Pathways
Access to External Experts
FDA Globalization Act (Discussion Draft)
Senate HELP Committee Discussion Draft
House Energy and Commerce Committee Discussion Draft
H.R.4132: Faster Access to Specialized Treatments (FAST) Act
S. 3187:The Food and Drug Administration Safety and Innovation Act
S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011
H.R.2182: Generating Antibiotic Incentives Now Act of 2011
H.R.3214: Food and Drug Administration Mission Reform Act of 2011
H.R.1483: Drug Safety Enhancement Act of 2011

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

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. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013

Biodefense Research, Development and Procurement (Non-Funding Issues)
S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011

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

TransPacific Partnership
Data and Intellectual Property Protection for Pharmaceuticals
Regulatory Transparency

Therapeutic Discovery Project Tax Credit
Extension
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

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)

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 (Non-Funding Issues)
S. 1855: 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

Comparative Effectiveness Research Initiatives
Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

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

Biodefense Research, Development and Procurement (Non-Funding Issues)
S. 1855: 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, 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

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

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

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)

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

Small Business Innovation Research (SBIR) Program
Rulemaking
Therapeutic Discovery Project Tax Credit
Extension
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

Capital Formation Investment Incentives

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

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

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
Bio-based Products
Tax Credit
Biofuels
Biofuels Production Tax Credit Extension
Biofuels Production Tax Credit Modification for Algae-based Biofuels

Renewable Chemicals
New Production Tax Credit/Revisions to Existing Tax Credits
S. 1764: Make It in America Tax Credit Act of 2011
S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill)
H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012

Therapeutic Discovery Project Tax Credit
Extension
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

Capital Formation Investment Incentives

Research & Development 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

Livestock Cloning/Product Labeling
Discussions with EU on Animal Cloning


World Trade Organization Special 301 Submissions
India Issues

Export Registrations for Products with Expired Patents

International Trade Commission Reform
Rep. Devin Nunes Discussion Draft

Foreign Agricultural Biotechnology Laws and Regulations
Low-Level Presence Foreign Government Policies
EU Biotechnology Bilateral Discussions
China Biotechnology Regulations
European Union Low Level Presence Policy
International Biotechnology Agreement
Asynchrony of International Approvals

Genetic Resource Patent Disclosure Requirement
World Intellectual Property Organization

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

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), State - Dept of (DOS), Patent & Trademark Office (PTO), Commerce - Dept of (DOC), 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

​

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