Clerk of the House of Representatives
Legislative Resource Center
135 Cannon Building
Washington, DC 20515
http://lobbyingdisclosure.house.gov 		Secretary of the Senate
Office of Public Records
232 Hart Building
Washington, DC 20510
http://www.senate.gov/lobby
LOBBYING REPORT

Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

1. Registrant Name Organization/Lobbying Firm Self Employed Individual
Biotechnology Innovation Organization

2. Address

Address1
1201 New York Avenue NW
 Address2
​Suite 1300
City
Washington
 State
DC
 Zip Code
20005
 Country
USA

3. Principal place of business (if different than line 2)

City
​
State
​
Zip Code
​
Country
​
4a. Contact Name b. Telephone Number c. E-mail
​Mr.
​Nick Shipley
​2025259298
​nshipley@bio.org
5. Senate ID#
​6245-12
7. Client Name Self Check if client is a state or local government or instrumentality
​Biotechnology Innovation Organization
6. House ID#
​325050000
TYPE OF REPORT 8. Year
​2022
 Q1 (1/1 - 3/31) Q2 (4/1 - 6/30) Q3 (7/1 - 9/30) Q4 (10/1 - 12/31)

9. Check if this filing amends a previously filed version of this report

10. Check if this is a Termination Report Termination Date
​
11. No Lobbying Issue Activity
INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13
12. Lobbying 13. Organizations
INCOME relating to lobbying activities for this reporting period was: EXPENSE relating to lobbying activities for this reporting period were:
Less than $5,000
Less than $5,000
$5,000 or more $
​
$5,000 or more $
​3,740,000.00
Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options.
Method A. Reporting amounts using LDA definitions only

Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code

Method C. Reporting amounts under section 162(e) of the Internal Revenue Code

Signature
Digitally Signed By: Nick Shipley
 Date
1/19/2023 10:23:56 AM

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

Climate Change
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---Fighting Climate Change through Biotechnology Innovation
---Implementation of the Inflation Reduction Act (IRA) of 2022

Foreign Agricultural Biotechnology Laws and Regulations
---Mexico Draft Decree Banning Genetically Modified Corn
---Mexico Import Approval Delays of Ag Biotech

Funding for the USDA
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Biotechnology and Agriculture Trade Program
---Farm Bill Programs Energy Title IX

Genetically Engineered (GE) Animals
---ADUFA
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Efficient Science-Based Review of Biotech Products
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---FDA Revised EIS on Genetically Engineered Salmon
---International Consistency of Regulation for Gene Edited Products
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Genetically Engineered (GE) Plants
---Climate Issues & impact on the agriculture, food, and forestry sectors
---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs)
---EPA Regulatory Approach to Gene Editing
---FDA Proposed guidance on Gene Editing
---International Consistency of Regulation for Gene Edited Products

Synthetic Biotech

USDA/APHIS Agricultural Biotechnology Regulations
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Farm Bill Reauthorization
---Regulatory Treatment of Gene Edited Products
---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act
---USDA Part 340 Draft Rule
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), U.S. Trade Representative (USTR), Food & Drug Administration (FDA), Environmental Protection Agency (EPA), White House Office

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Erick
Lutt
​
​
Nick
Shipley
​
​
Aiken
Hackett
​
​
John
Murphy
​
​
Justin
Pine
​
​
Kristin
Murphy
​
​
Amber
Manko
​
​
Kathleen
Callanan
​
​

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
---ADUFA
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Efficient Science-Based Review of Biotech Products
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---FDA Revised EIS on Genetically Engineered Salmon
---International Consistency of Regulation for Gene Edited Products
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

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

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

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Erick
Lutt
​
​
Nick
Shipley
​
​
Aiken
Hackett
​
​
John
Murphy
​
​

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

Coronavirus (COVID-19) Pandemic
---H.R.2617: Consolidated Appropriations Act of 2023
---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Antimicrobial Resistance (AMR) Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)
---H.R.4127: DISARM Act
---H.R.7900: National Defense Authorization Act for FY 2023
---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels

Funding for Biorefineries
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for FDA
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for Health Resources and Services Administration (HRSA)
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for National Institutes of Health
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act

Funding for Renewable Chemicals/Bio-based Products
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for the USDA
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Biotechnology and Agriculture Trade Program
---Farm Bill Programs Energy Title IX

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Erick
Lutt
​
​
Joel
Straus
​
​
Phyllis
Arthur
​
​
Emily
Wheeler
​
​
Kristin
Murphy
​
​
Nick
Shipley
​
​
Cartier
Esham
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
Kathleen
Callanan
​
​
Alexander
May
​
​

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 CHM

16. Specific lobbying issues

Funding for Renewable Chemicals/Bio-based Products
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Inflation Reduction Act (IRA) of 2022

Renewable Chemicals/Bio-based Products (Non-Funding)
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---Investment Tax Credit

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

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

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Erick
Lutt
​
​
Nick
Shipley
​
​
Aiken
Hackett
​
​

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

Antitrust Legislation
---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021

Bayh-Dole Act/Tech Transfer
---Bayh-Dole Act
---March-In Rights

Compulsory Licensing
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.4811: Medicare Negotiation and Competitive Licensing Act

Coronavirus (COVID-19) Pandemic
---Restrictions on Intellectual Property Rights
---TRIPS Waiver

Data Privacy Issues
---H.R.8152: American Data Privacy and Protection Act
---S.2499: Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act

Diversity in Patenting
---H.R.1723/S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021

Drug Patenting
---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications
---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021
---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act
---S.1435: Affordable Prescriptions for Patients Act of 2021
---S.2773: Unleashing American Innovators Act of 2021
---S.2774: Pride in Patent Ownership Act
---S.2891: Restoring the America Invents Act
---S.4430: Interagency Patent Coordination and Improvement Act of 2022
---Restrictions on Intellectual Property Rights

Intellectual Property Enforcement
---TRIPS Waiver

Inter Partes Review
---H.R.5874: Restoring America's Leadership in Innovation Act
---S.2774: Pride in Patent Ownership Act
---S.2891: Restoring the America Invents Act
---Implementation of the America Invents Act of 2011
---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft)

Patent Reform
---S.4417: Patent Trial and Appeal Board Reform Act of 2022
---S.4430: Interagency Patent Coordination and Improvement Act of 2022
---Patent Litigation Reform

Patenting of Biological Inventions
---35 USC Section 101 on Patent Eligibility
---Section 101 Modernization

Patenting of Humanitarian Technologies
---H.R.5796: Patents for Humanity Act of 2021

United States-Mexico-Canada Agreement (USMCA)
---Mexico Draft Decree Banning Genetically Modified Corn

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Patent & Trademark Office (PTO), Commerce - Dept of (DOC), Health & Human Services - Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), State - Dept of (DOS), White House Office

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
David
Lachmann
​
​
Hans
Sauer
​
​
Aiken
Hackett
​
​
Nick
Shipley
​
​
Nancy
Travis
​
​
Kathleen
Callanan
​
​
Amber
Manko
​
​
Kristin
Murphy
​
​
John
Murphy
​
​
Justin
Pine
​
​

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 (Non-Funding)
---H.R.2617: Consolidated Appropriations Act of 2023
---A Clean Fuel Standard or Low Carbon Fuel Standard
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit

Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Biorefineries (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Climate Change
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Fighting Climate Change through Biotechnology Innovation
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels

Renewable Fuel Standard (RFS)
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), Environmental Protection Agency (EPA), White House Office, U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Erick
Lutt
​
​
Nick
Shipley
​
​
Aiken
Hackett
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FOO

16. Specific lobbying issues

Genetically Engineered (GE) Animals
---ADUFA
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Efficient Science-Based Review of Biotech Products
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---FDA Revised EIS on Genetically Engineered Salmon
---International Consistency of Regulation for Gene Edited Products
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

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

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

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Erick
Lutt
​
​
Nick
Shipley
​
​
Aiken
Hackett
​
​
John
Murphy
​
​

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 (Non-Funding)
---H.R.2617: Consolidated Appropriations Act of 2023
---A Clean Fuel Standard or Low Carbon Fuel Standard
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit

Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Biorefineries (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Climate Change
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Fighting Climate Change through Biotechnology Innovation
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels

Renewable Fuel Standard (RFS)
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), Environmental Protection Agency (EPA), White House Office, U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Erick
Lutt
​
​
Nick
Shipley
​
​
Aiken
Hackett
​
​

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

21st Century Cures Act 2.0
---H.R.6000: Cures 2.0 Act

340B Drug Discount Program
---Executive Order on Access to Affordable Life-Saving Medications
---Program Implementation & Oversight

Biodefense Research, Development and Procurement Issues (Non-Funding)
---Executive Order on Modernizing Influenza Vaccines
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---Reauthorization of PAHPA
---White House National Biodefense Strategy

Biosimilars
---BSUFA Negotiations
---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022
---Reimbursement

Coronavirus (COVID-19) Pandemic
---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act
---H.R.2617: Consolidated Appropriations Act of 2023
---S.2327: Seniors Prescription Drug Relief Act
---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
---COVID-19 Lessons Learned
---COVID-19 Pricing-Related Provisions
---COVID-19 Vaccine Distribution
---Drug Supply Chain Management
---Healthcare Disparities
---Medicare Reimbursement Policies
---Monoclonal Antibody Coverage and Utilization
---Patient Cost-Sharing and Smoothing
---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement
---R&D Funding for Medical Countermeasures
---Restrictions on Intellectual Property Rights
---Senate HELP Pandemic Preparedness White Paper
---Supply Chain Issues
---Temporarily Refundable R&D Credit
---TRIPS Waiver

Climate Change
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Inflation Reduction Act (IRA) of 2022

Data Privacy
---H.R.8152: American Data Privacy and Protection Act

Diagnostics and Personalized Medicine Regulation and Oversight
---H.R.4128/S.2209: VALID Act

Diversity & Inclusion
---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021
---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act
---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Clinical Trial Diversity

Drug Evaluation and Review
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.6963: Accelerated Approval Integrity Act
---H.R.6972/S.4215: Give Kids a Chance Act of 2022
---H.R.6996: Accelerating Approval for Patients Act
---H.R.7008: The Pre-Approval Information Exchange Act
---S.1644: Promising Pathway Act
---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act
---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---COVID-19 Lessons Learned
---Compassionate Use/Expanded Access
---Expedited Pathways
---Innovation Incentives
---Patient-Focused Drug Development
---Prescription Drug User Fee Act (PDUFA) VII Priorities
---Priority Review Voucher Programs
---Reforms to the Accelerated Approval Pathway
---Regulatory Reform & Modernization
---Use of Real-World Evidence

Drug Importation
---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022

Drug Manufacturing, Quality & Distribution
---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act
---H.R.6988: Drug Manufacturing Innovation Act
---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act
---H.R.7667: The Food and Drug Amendments of 2022
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Advanced Manufacturing
---Counterfeiting
---Drug Shortages
---Supply Chain Integrity and Traceability

Drug Patenting
---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021
---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications
---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021
---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act
---S.1435: Affordable Prescriptions for Patients Act of 2021
---S.4430: Interagency Patent Coordination and Improvement Act of 2022
---Restrictions on Intellectual Property Rights

Drug Pricing
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act
---H.R.19/S.2164: Lower Costs, More Cures Act of 2021
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.9358: Access to Innovative Treatments Act of 2022
---S.1388: Prescription Pricing for the People Act of 2021
---S.1435: Affordable Prescriptions for Patients Act of 2021
---S.4293: Pharmacy Benefit Manager Transparency Act of 2022
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---CMMI Authority
---COVID-19 Pricing-Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---National Coverage Determination

Foreign Drug Data Protection Laws
---Regulatory Harmonization

Funding for Antimicrobial Resistance (AMR) Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)
---H.R.4127: DISARM Act
---H.R.7900: National Defense Authorization Act for FY 2023
---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

Funding for FDA
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for Health Resources and Services Administration (HRSA)
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for National Institutes of Health
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---H.R.2617: Consolidated Appropriations Act of 2023

Generic Drug Entry
---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021
---H.R.2883: Stop Stalling Access to Affordable Medications Act
---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act
---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Incentives for Generic Entry

Medicaid
---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022
---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019
---S.4293: Pharmacy Benefit Manager Transparency Act of 2022
---Alternative Payment Arrangements for Gene Therapies
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Pricing and Rebates

Opioid Crisis
---Non-Opioid Analgesics

Orphan Drug Issues
---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Orphan Drug Tax Credit

Rare Pediatric Disease Priority Review
---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act
---H.R.6972/S.4215: Give Kids a Chance Act of 2022

Reimbursement and Coverage of Innovative Products
---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act
---H.R.19/S.2164: Lower Costs, More Cures Act of 2021
---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.9358: Access to Innovative Treatments Act of 2022
---S.2327: Seniors Prescription Drug Relief Act
---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021
---Administration Rebate Rule
---CMMI Authority
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Medicare Part B Physician-Administered Products
---National Coverage Determination
---Patient Cost-Sharing and Smoothing
---Step Therapy

Vaccines and Infectious Diseases
---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021
---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021
---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021
---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021
---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)
---H.R.4127: DISARM Act
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.9358: Access to Innovative Treatments Act of 2022
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---S.4509 Vaccine and Coverage Certainty (VACC) Act
---Adult Immunization
---Maternal Immunization
---MCM Manufacturing & Capacity
---MCM R&D Incentives
---Monoclonal Antibody Coverage and Utilization
---National Coverage Determination
---Vaccine and Antimicrobial Resistance Product Development and Incentives
---Vaccine Injury Compensation Program
---Vaccine Safety

Vaccine Injury Compensation Program
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021
---H.R.3656: Vaccine Access Improvement Act of 2021
---S.3087: Vaccine Access Improvement Act of 2021
---S.3810: Countermeasure Injury Compensation Fund Amendment Act
---VICP CICP (Discussion Draft)

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), Food & Drug Administration (FDA), White House Office, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce - Dept of (DOC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), Office of Science & Technology Policy (OSTP), State - Dept of (DOS), U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
Cartier
Esham
​
​
Camelia
Thompson
​
​
Hans
Sauer
​
​
John
Murphy
​
​
Phyllis
Arthur
​
​
Joel
Straus
​
​
Kathleen
Callanan
​
​
Kristin
Murphy
​
​
Nick
Shipley
​
​
David
Lachmann
​
​
Emily
Wheeler
​
​
Alexander
May
​
​
Amber
Manko
​
​
Erick
Lutt
​
​
Justin
Pine
​
​

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

Biodefense Research, Development and Procurement Issues (Non-Funding)
---Executive Order on Modernizing Influenza Vaccines
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---Reauthorization of PAHPA
---White House National Biodefense Strategy

Funding for Antimicrobial Resistance (AMR) Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)
---H.R.4127: DISARM Act
---H.R.7900: National Defense Authorization Act for FY 2023
---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

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

First Name Last Name Suffix Covered Official Position (if applicable) New
Phyllis
Arthur
​
​
Joel
Straus
​
​
Nick
Shipley
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
Emily
Wheeler
​
​
Kathleen
Callanan
​
​
Kristin
Murphy
​
​

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 Issues (Non-Funding)
---Executive Order on Modernizing Influenza Vaccines
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---Reauthorization of PAHPA
---White House National Biodefense Strategy

Coronavirus (COVID-19) Pandemic
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---R&D Funding for Medical Countermeasures
---Senate HELP Pandemic Preparedness White Paper
---Temporarily Refundable R&D Credit

Funding for Antimicrobial Resistance (AMR) Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)
---H.R.4127: DISARM Act
---H.R.7900: National Defense Authorization Act for FY 2023
---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

Funding for National Institutes of Health
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

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, Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), Natl Institutes of Health (NIH)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Phyllis
Arthur
​
​
Joel
Straus
​
​
Kathleen
Callanan
​
​
Nick
Shipley
​
​
Emily
Wheeler
​
​
Kristin
Murphy
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
Erick
Lutt
​
​
Cartier
Esham
​
​

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

21st Century Cures Act 2.0
---H.R.6000: Cures 2.0 Act

340B Drug Discount Program
---Executive Order on Access to Affordable Life-Saving Medications
---Program Implementation & Oversight

Coronavirus (COVID-19) Pandemic
---S.2327: Seniors Prescription Drug Relief Act
---COVID-19 Pricing-Related Provisions
---Patient Cost-Sharing and Smoothing

Data Privacy
---H.R.8152: American Data Privacy and Protection Act

Drug Pricing
---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act
---H.R.19/S.2164: Lower Costs, More Cures Act of 2021
---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.9358: Access to Innovative Treatments Act of 2022
---S.1388: Prescription Pricing for the People Act of 2021
---S.1435: Affordable Prescriptions for Patients Act of 2021
---S.4293: Pharmacy Benefit Manager Transparency Act of 2022
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---CMMI Authority
---COVID-19 Pricing-Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---National Coverage Determination

Medicaid
---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022
---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019
---S.4293: Pharmacy Benefit Manager Transparency Act of 2022
---Alternative Payment Arrangements for Gene Therapies
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Pricing and Rebates

Reimbursement and Coverage of Innovative Products
---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act
---H.R.19/S.2164: Lower Costs, More Cures Act of 2021
---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.9358: Access to Innovative Treatments Act of 2022
---S.2327: Seniors Prescription Drug Relief Act
---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021
---Administration Rebate Rule
---CMMI Authority
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Medicare Part B Physician-Administered Products
---National Coverage Determination
---Patient Cost-Sharing and Smoothing
---Step Therapy

Vaccines and Infectious Diseases
---H.R.1978/S.912: Protecting Seniors through Immunizations Act
---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.4127: DISARM Act
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.9358: Access to Innovative Treatments Act of 2022
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---National Coverage Determination

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, Centers For Medicare and Medicaid Services (CMS)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
Joel
Straus
​
​
Kathleen
Callanan
​
​
Kristin
Murphy
​
​
Nick
Shipley
​
​
Amber
Manko
​
​
Phyllis
Arthur
​
​
Emily
Wheeler
​
​
John
Murphy
​
​

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

Capital Formation Incentives
---H.R.1304/S.749: American Innovation and Jobs Act
---H.R.3448: Helping Startups Continue to Grow Act
---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act
---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft)
---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft)
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Reform of New Operating Loss Rules

Capital Market Enhancements
---Accredited Investor Definition
---JOBS Act 4.0
---Market Liquidity Proposals

Coronavirus (COVID-19) Pandemic
---Temporarily Refundable R&D Credit

Proxy Advisory Services
---Impact of Policies on Small Public Companies

Small Business Innovation Research (SBIR) Program
---Implementation of SBIR and STTR Extension Act of 2022

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

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

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Nick
Shipley
​
​
Kathleen
Callanan
​
​
Kristin
Murphy
​
​
Cameron
Arterton
​
​
Amber
Manko
​
​
David
Lachmann
​
​
Aiken
Hackett
​
​
Erick
Lutt
​
​

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 (Non-Funding)
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit

Capital Formation Incentives
---H.R.1304/S.749: American Innovation and Jobs Act
---H.R.3448: Helping Startups Continue to Grow Act
---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act
---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft)
---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft)
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Reform of New Operating Loss Rules

Coronavirus (COVID-19) Pandemic
---Temporarily Refundable R&D Credit

Orphan Drug Issues
---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act
---Tax Credit

Qualified Small Business Stock (QSBS)
---Draft Legislation to modify and expand the Section 1202 exclusion for gain from QSBS
---Implementation of the Inflation Reduction Act (IRA) of 2022

Renewable Chemicals/Bio-based Products (Non-Funding)
---Investment Tax Credit

Research & Development Tax Credit Reforms
---H.R.1304/S.749: American Innovation and Jobs Act
---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft)
---Expensing of R&D Expenditures
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---R&D Payroll Credit

Vaccine Injury Compensation Program
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021
---H.R.3656: Vaccine Access Improvement Act of 2021
---S.3087: Vaccine Access Improvement Act of 2021
---S.3810: Countermeasure Injury Compensation Fund Amendment Act
---VICP CICP (Discussion Draft)

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

First Name Last Name Suffix Covered Official Position (if applicable) New
Cameron
Arteron
​
​
Kathleen
Callanan
​
​
Nick
Shipley
​
​
Erick
Lutt
​
​
Aiken
Hackett
​
​
Cartier
Esham
​
​
Kristin
Murphy
​
​
Amber
Manko
​
​
Phyllis
Arthur
​
​
Joel
Straus
​
​
Emily
Wheeler
​
​

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

CFIUS and Foreign Investment
---H.R.6329/S.1854: National Critical Capabilities Defense Act of 2021

Drug Importation

Drug Pricing
---Reference Pricing in Drug Reimbursement

Foreign Agricultural Biotechnology Laws and Regulations
---EU Ag-Biotech Policies and Regulations
---International Consistency of Regulation for Gene Edited Products
---Korea Biotechnology Regulations
---Mexico Draft Decree Banning Genetically Modified Corn
---Mexico Import Approval Delays of Ag Biotech

Genetically Engineered (GE) Animals
---International Consistency of Regulation for Gene Edited Products

Genetically Engineered (GE) Plants
---International Consistency of Regulation for Gene Edited Products

Indo-Pacific Economic Framework (IPEF)

Intellectual Property International Enforcement
---TRIPS Waiver

Synthetic Biotech

US-China Trade Agreement
---Ag-Biotech Provisions
---IP Provisions

World Trade Organization
---MC-12 Meeting
---TRIPS Waiver

World Health Organization (WHO)
---TRIPS Waiver

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Agriculture - Dept of (USDA), Natl Security Council (NSC), Patent & Trademark Office (PTO), Commerce - Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Natl Economic Council (NEC), State - Dept of (DOS), Health & Human Services - Dept of (HHS), White House Office

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
David
Lachmann
​
​
Erick
Lutt
​
​
Hans
Sauer
​
​
Nick
Shipley
​
​
Kathleen
Callanan
​
​
John
Murphy
​
​
Nancy
Travis
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
Kristin
Murphy
​
​
Cameron
Arterton
​
​
Justin
Pine
​
​

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

Address
​
City
​
State
​
Zip Code
​
Country
​

21. Client new principal place of business (if different than line 20)

City
​
State
​
Zip Code
​
Country
​

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

First Name
Last Name
Suffix
First Name
Last Name
Suffix
1
​Kate
​Donigan
​
3
​
​
​
2
​
​
​
4
​
​
​

ISSUE UPDATE

24. General lobbying issue that no longer pertains

​
​
​
​
​
​
​
​
​

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

Name Address Principal Place of Business
(city and state or country)
Street Address
City State/Province Zip Country
City
State Country

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

1 2 3

FOREIGN ENTITIES

27. Add the following foreign entities:

Name Address Principal place of business
(city and state or country) 		Amount of contribution for lobbying activities Ownership percentage in client
Street Address
City State/Province Country
City
State Country
%

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization

1 3 5
2 4 6

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?

Lobbyist Name Description of Offense(s)