Lobbying Filing Details

Activity 1

Genetically Engineered (GE) Animals
-FDA Approval
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
--Amendment to Restrict FDA Approval of GE Salmon
--Amendment on GE Salmon Labeling

Review and Labeling of Food Derived From Biotechnology
-H.R. 1599: Safe and Accurate Food Labeling Act of 2015
-U.S. Government Policy

Funding for the USDA
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Foreign Agricultural Biotechnology Laws and Regulations
-China Biotechnology Regulations
-Asynchrony of International Approvals
-EU Ag-Biotech Policies and Regulations

Potential Regulation of New Genetic Modification Technologies

Funding for Biomass Crop Assistance Program
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Transatlantic Trade and Investment Partnership
-Ag-Biotech Issues

USDA/APHIS Agricultural Biotechnology Regulations
-Coexistence of Production Systems
-Efficient Science-Based Review of Biotech Products

Trade Promotion Authority

Local GE Crop Cultivation Bans

Coordination of Federal Biotechnology Research
-H.R. 591: Engineering Biology Research and Development Act of 2015

Lobbyists (7)

• MR. BRENT ALAN DELMONTE
• MS. ANNA KATHERINE WEINSTEIN
• TRACEY LATURNER
• MR. DANA MAURICE O'BRIEN JR
• JOSEPH DAMOND
• CATHLEEN ENRIGHT
• MR. MATTHEW O'MARA

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 2

Genetically Engineered (GE) Animals
-FDA Approval
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
--Amendment on GE Salmon Labeling
--Amendment to Restrict FDA Approval of GE Salmon

Lobbyists (3)

• MR. BRENT ALAN DELMONTE
• TRACEY LATURNER
• MR. DANA MAURICE O'BRIEN JR

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 3

Funding for the USDA
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for FDA
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
-S 320: Medical Innovation Act of 2015

Funding for Centers for Disease Control and Prevention Vaccine Programs
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for National Institutes of Health
-S 320: Medical Innovation Act of 2015
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for Biomass Crop Assistance Program
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Funding for Renewable Chemicals/Bio-based Products
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Sequestration of PDUFA Fees
-H.R. 1078: FDA Safety over Sequestration Act

Funding for Biofuels
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
-Department of Defense Appropriations Act for FY 2016
-Department of Defense Funding of Advanced Biofuels
-Energy and Water Development and Related Agencies Appropriations Act for FY 2016

Senate Budget Resolution S. Con. Res. 11
- Amendment on Medicare non-interference provision
- Amendment on compounded drugs across state lines

Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative
- Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Lobbyists (13)

• MR. BRENT ALAN DELMONTE
• JEANNE HAGGERTY
• ANDREW EMMETT
• TOM DILENGE
• MS. ANNA KATHERINE WEINSTEIN
• PHYLLIS ARTHUR
• TRACEY LATURNER
• RINA SINGH
• MS. A. CATHARINE HARRIS
• ERICK LUTT
• JEFFREY PETERS
• AMY WALKER
• DERRICK M WHITE

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 4

Genetically Engineered (GE) Animals
-FDA Approval
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
--Amendment on GE Salmon Labeling
--Amendment to Restrict FDA Approval of GE Salmon

Review and Labeling of Food Derived From Biotechnology
-H.R. 1599: Safe and Accurate Food Labeling Act of 2015
-U.S. Government Policy

Drug Evaluation and Review
-Compassionate Use/Expanded Access
-Implementation of the FDA Safety and Innovation Act

Biosimilars
-Biosimilar User Fee Act Implementation
-Colombia Biologics Regulations
-Implementation of Affordable Care Act
-Interchangeability and Pharmacy Substitution
-Mexico Biologics Regulations
-Naming
-Patent Certification

USDA/APHIS Agricultural Biotechnology Regulations
-Coexistence of Production Systems
-Efficient Science-Based Review of Biotech Products

Lobbyists (13)

• MR. BRENT ALAN DELMONTE
• JEANNE HAGGERTY
• ANDREW EMMETT
• TOM DILENGE
• MS. ANNA KATHERINE WEINSTEIN
• TRACEY LATURNER
• MR. DANA MAURICE O'BRIEN JR
• CATHLEEN ENRIGHT
• JEFFREY PETERS
• AMY WALKER
• KATHLEEN "KAY" HOLCOMBE
• MR. MATTHEW O'MARA
• MS. ELIZABETH CARTIER ESHAM

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 5

Patent Reform
-H.R. 9: Innovation Act
-Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft)
-Implementation of the America Invents Act of 2011
-S. 632: STRONG Patents Act

Inter Partes Review
- S. 632: STRONG Patents Act
- Implementation of the America Invents Act of 2011

World Trade Organization Special 301 Submissions

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

TransPacific Partnership
-Data and Intellectual Property Protections for Pharmaceuticals

Transatlantic Trade and Investment Partnership
-Intellectual Property Issues

Patenting of Biological Inventions
-PTO Examination Guidelines

Trade Promotion Authority

Colombia National Development Plan
-Intellectual Property Issues

Lobbyists (9)

• MR. BRENT ALAN DELMONTE
• JEANNE HAGGERTY
• TOM DILENGE
• HANSJORG SAUER
• MS. ANNA KATHERINE WEINSTEIN
• JOSEPH DAMOND
• MR. CHARLES H FRITTS
• JAMIE GREGORIAN
• DERRICK M WHITE

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 6

Biofuels (Non-Funding)
-Department of Defense Application of Advanced Biofuels
-Implementation of the Agricultural Act of 2014
-Production Tax Credit Extension
-Renewable Fuel Standard

Renewable Chemicals/Bio-based Products (Non-Funding)
-New Production Tax Credit
-Expansion of Master Limited Partnerships to Renewable Chemicals

Funding for Renewable Chemicals/Bio-based Products
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Funding for Biomass Crop Assistance Program
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Funding for Biofuels
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
-Department of Defense Appropriations Act for FY 2016
-Department of Defense Funding of Advanced Biofuels
-Energy and Water Development and Related Agencies Appropriations Act for FY 2016

EPA Regulation of Biotechnology
-Interior, Environment, and Related Agencies Appropriations Act for FY 2016

Lobbyists (6)

• MR. BRENT ALAN DELMONTE
• TRACEY LATURNER
• MR. DANA MAURICE O'BRIEN JR
• RINA SINGH
• MR. CHARLES H FRITTS
• ERICK LUTT

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 7

EPA Regulation of Biotechnology
-Interior, Environment, and Related Agencies Appropriations Act for FY 2016

Lobbyists (2)

• MR. BRENT ALAN DELMONTE
• TRACEY LATURNER

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 8

Genetically Engineered (GE) Animals
-FDA Approval
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
--Amendment on GE Salmon Labeling
--Amendment to Restrict FDA Approval of GE Salmon

Review and Labeling of Food Derived From Biotechnology
-H.R. 1599: Safe and Accurate Food Labeling Act of 2015
-U.S. Government Policy

Lobbyists (7)

• MR. BRENT ALAN DELMONTE
• TOM DILENGE
• MS. ANNA KATHERINE WEINSTEIN
• TRACEY LATURNER
• MR. DANA MAURICE O'BRIEN JR
• CATHLEEN ENRIGHT
• MR. MATTHEW O'MARA

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 9

Biofuels (Non-Funding)
-Department of Defense Application of Advanced Biofuels
-Implementation of the Agricultural Act of 2014
-Production Tax Credit Extension
-Renewable Fuel Standard

Renewable Chemicals/Bio-based Products (Non-Funding)
-New Production Tax Credit
-Expansion of Master Limited Partnerships to Renewable Chemicals

Funding for Renewable Chemicals/Bio-based Products
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Funding for Biomass Crop Assistance Program
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016

Funding for Biofuels
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
-Department of Defense Appropriations Act for FY 2016
-Department of Defense Funding of Advanced Biofuels
-Energy and Water Development and Related Agencies Appropriations Act for FY 2016

EPA Regulation of Biotechnology
-Interior, Environment, and Related Agencies Appropriations Act for FY 2016

Lobbyists (6)

• MR. BRENT ALAN DELMONTE
• TRACEY LATURNER
• MR. DANA MAURICE O'BRIEN JR
• RINA SINGH
• MR. CHARLES H FRITTS
• ERICK LUTT

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 10

Biosimilars
-Biosimilar User Fee Act Implementation
-Colombia Biologics Regulations
-Implementation of Affordable Care Act
-Interchangeability and Pharmacy Substitution
-Mexico Biologics Regulations
-Naming
-Patent Certification

Funding for National Institutes of Health
-S 320: Medical Innovation Act of 2015
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for Centers for Disease Control and Prevention Vaccine Programs
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Vaccine Access/Financing
-Adult Immunization (Senate Discussion Draft)
-S.2694: Ensuring Access to Primary Care for Women and Children Act

340B Drug Pricing Program
-Implementation of Affordable Care Act
-Program Implementation & Oversight
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for FDA
-Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016
-S 320: Medical Innovation Act of 2015

Independent Payment Advisory Board

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Biodefense Research, Development, and Procurement Issues (Non-funding)

TransPacific Partnership
-Data and Intellectual Property Protection for Pharmaceuticals
-Regulatory Transparency

Transatlantic Trade and Investment Partnership
-Intellectual Property Issues
-Regulatory Harmonization
-Reimbursement Transparency

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

Sequestration of PDUFA Fees
--H.R. 1078: FDA Safety over Sequestration Act

Drug Evaluation and Review
-Compassionate Use/Expanded Access
-Implementation of the FDA Safety and Innovation Act

Orphan Drug Act Tax Credit

Medicare Physician Payment Sustainable Growth Rate Formula
- HR 2: Medicare Access and CHIP Reauthorization Act of 2015

21st Century Cures Initiative
-Biomarkers and Regulatory Science Improvements
-Communication with Healthcare Professionals
-Expanded Access to Investigational Drugs
-Expedited Pathways
-FDA Hiring Flexibility
-FDA Management and Financial Accountability
-Innovation Incentives
-Longitudinal Study of Chronic Diseases
-Patient Access to Approved Drugs
-Patient-Focused Drug Development
-Use of Real-World Evidence
-Vaccine and Anti-Microbial Resistance Product Development and Incentives
-ADAPT Act (House Discussion Draft)
-Sunshine Act Amendments
-Coding
-Coverage with Evidence Development

Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Senate Budget Resolution S. Con. Res. 11
- Amendment on Medicare non-interference provision
- Amendment on compounded drugs across state lines

Vaccines and Infectious Diseases - General

Colombia National Development Plan
-Regulatory Issues
-Reimbursement Issues
-Intellectual Property Issues

Lobbyists (20)

• MR. BRENT ALAN DELMONTE
• JEANNE HAGGERTY
• ANDREW EMMETT
• TOM DILENGE
• SHELLY MUI-LIPNIK
• HANSJORG SAUER
• LAUREL TODD
• MS. ANNA KATHERINE WEINSTEIN
• PHYLLIS ARTHUR
• TRACEY LATURNER
• JOSEPH DAMOND
• CHARLES CRAIN
• MR. CHARLES H FRITTS
• MS. A. CATHARINE HARRIS
• JEFFREY PETERS
• AMY WALKER
• JAMIE GREGORIAN
• KATHLEEN "KAY" HOLCOMBE
• DERRICK M WHITE
• MS. ELIZABETH CARTIER ESHAM

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 11

Biodefense Research, Development, and Procurement Issues (Non-funding)

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Combating Antibiotic-Resistant Bacteria (CARB) Initiative
-ADAPT Act (House Discussion Draft)

Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Lobbyists (7)

• MR. BRENT ALAN DELMONTE
• TOM DILENGE
• MS. ANNA KATHERINE WEINSTEIN
• PHYLLIS ARTHUR
• TRACEY LATURNER
• AMY WALKER
• DERRICK M WHITE

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 12

Funding for National Institutes of Health
-S 320: Medical Innovation Act of 2015
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

21st Century Cures Initiative
-Longitudinal Study of Chronic Diseases

Combating Antibiotic-Resistant Bacteria (CARB) Initiative
-ADAPT Act (House Discussion Draft)

Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative
-Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016

Lobbyists (12)

• MR. BRENT ALAN DELMONTE
• JEANNE HAGGERTY
• TOM DILENGE
• MS. ANNA KATHERINE WEINSTEIN
• PHYLLIS ARTHUR
• TRACEY LATURNER
• JEFFREY PETERS
• AMY WALKER
• JAMIE GREGORIAN
• KATHLEEN "KAY" HOLCOMBE
• DERRICK M WHITE
• MS. ELIZABETH CARTIER ESHAM

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 13

Independent Payment Advisory Board

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

Medicare Physician Payment Sustainable Growth Rate Formula
-HR 2: Medicare Access and CHIP Reauthorization Act of 2015

21st Century Cures Initiative
-Patient Access to Approved Drugs
-Coding
-Coverage with Evidence Development

Lobbyists (7)

• MR. BRENT ALAN DELMONTE
• JEANNE HAGGERTY
• LAUREL TODD
• MS. ANNA KATHERINE WEINSTEIN
• MS. A. CATHARINE HARRIS
• JEFFREY PETERS
• DERRICK M WHITE

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 14

Sarbanes Oxley Section 404 (b)
-Public Company Accounting Oversight Board Audit Cost Increases

Capital Formation Investment Incentives
-Reform of Capital Gains Rules
-Reform of Net Operating Loss Rules
-Reform of Passive Loss Rules
-PARTNER Act (House Discussion Draft)
-S. 341: Start-up Jobs and Innovation Act
-S. 537: COMPETE Act

Expansion of Exemption under SEC Regulation A
- Proposed Legislation
-Proposed SEC Rule on Reg A+

Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
-Fostering Innovation Act (House Discussion Draft)

XBRL Exemption for Small Public Companies
-H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act
-Small Company Disclosure Simplification Act (House Discussion Draft)

Stock Exchange Tick Size
-H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act

Capital Market Enhancements
-H.R. 1525: Disclosure Modernization and Simplification Act
-H.R. 1723: Small Company Simple Registration Act
-S. 576: Encouraging Employee Ownership Act
-SEC Office of Small Business Policy Responsibilities
-Small Business Freedom to Grow Act (House Discussion Draft)
-Improving Access to Capital for Emerging Growth Companies Act (House Discussion Draft)

Lobbyists (6)

• MR. BRENT ALAN DELMONTE
• TOM DILENGE
• SHELLY MUI-LIPNIK
• CHARLES CRAIN
• MR. CHARLES H FRITTS
• MS. ELIZABETH CARTIER ESHAM

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more

Activity 15

Biofuels
-Production Tax Credit Extension

Research & Development Tax Credit Reforms
-Permanency
-Extension
-S. 537: COMPETE Act
-S. 341: Start-up Jobs and Innovation Act

Capital Formation Investment Incentives
-Reform of Capital Gains Rules
-Reform of Net Operating Loss Rules
-Reform of Passive Loss Rules
-S. 341: Start-up Jobs and Innovation Act
-S. 537: COMPETE Act
-PARTNER Act (House Discussion Draft)

Renewable Chemicals/Bio-based Products
-New Production Tax Credit
-Expansion of Master Limited Partnerships to Renewable Chemicals

Tax Reform

Orphan Drug Act Tax Credit

Lobbyists (9)

• MR. BRENT ALAN DELMONTE
• TOM DILENGE
• SHELLY MUI-LIPNIK
• RINA SINGH
• CHARLES CRAIN
• MR. CHARLES H FRITTS
• ERICK LUTT
• DERRICK M WHITE
• MS. ELIZABETH CARTIER ESHAM

Government Entities (12)

• SENATE
• HOUSE OF REPRESENTATIVES
• White House Office
• U.S. Trade Representative (USTR)
• Agriculture, Dept of (USDA)
• ... and 7 more