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

Climate Change
---FY 2023 Appropriations
---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021
---H.R.5376: Inflation Reduction Act of 2022
---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
---Fighting Climate Change through Biotechnology Innovation
---SEC Proposed Rule on Climate Risk Disclosures

Foreign Agricultural Biotechnology Laws 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

Funding for the USDA
---FY 2023 Appropriations
---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
---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
---Efficient Science-Based Review of Biotech Products
---FDA Approvals, Guidance, & Regulations
---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)
---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
---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), Natl Security Council (NSC), Securities & Exchange Commission (SEC), Commerce - Dept of (DOC), Natl Economic Council (NEC)

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

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

​

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

15. General issue area code ANI

16. Specific lobbying issues

Genetically Engineered (GE) Animals
---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
---Efficient Science-Based Review of Biotech Products
---FDA Approvals, Guidance, & Regulations
---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)

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

Coronavirus (COVID-19) Pandemic
---FY 2022 Continuing Resolution
---H.R.5376: Inflation Reduction Act of 2022
---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2023 Appropriations
---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
---FY 2022 Continuing Resolution
---FY 2023 Appropriations
---H.R.4521: COMPETES Act
---H.R.5376: Inflation Reduction Act of 2022
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Reauthorization of PAHPA

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---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
---Incentives for Sustainable Aviation Fuels

Funding for Biorefineries
---FY 2023 Appropriations
---Climate Issues & impact on the agriculture, food, and forestry sectors

Funding for FDA
---FY 2023 Appropriations
---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
---Implementation of the Prescription Drug User Fee Act (PDUFA) VI
---Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for Health Resources and Services Administration (HRSA)
---FY 2022 Continuing Resolution
---FY 2023 Appropriations

Funding for National Institutes of Health
---FY 2023 Appropriations
---H.R.623: Gabriella Miller Kids First Research Act 2.0
---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for Renewable Chemicals/Bio-based Products
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2023 Appropriations
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2023 Appropriations

Funding for the USDA
---FY 2023 Appropriations
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act

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

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

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

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

​

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

15. General issue area code CHM

16. Specific lobbying issues

Funding for Renewable Chemicals/Bio-based Products
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act

Renewable Chemicals/Bio-based Products (Non-Funding)
Funding for Renewable Chemicals/Bio-based Products
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Investment Tax Credit
---Production Tax Credit

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), Federal Trade Commission (FTC), Commerce - Dept of (DOC)

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

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

​

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

15. General issue area code CPT

16. Specific lobbying issues

Antitrust Legislation

Bayh-Dole Act/Tech Transfer
---Bayh-Dole Act
---March-In Rights
---NIST Proposed Rulemaking on Bayh-Dole

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

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
---H.R.4811: Medicare Negotiation and Competitive Licensing Act
---S.1435: Affordable Prescriptions for Patients 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.1260: United States Innovation and Competition Act of 2021
------Ownership and Assignments of Patents
---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

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), Federal Trade Commission (FTC)

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

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

​

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

15. General issue area code ENG

16. Specific lobbying issues

Biofuels (Non-Funding)
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---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
---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
---FY 2023 Appropriations
---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021
---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

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---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
---Incentives for Sustainable Aviation Fuels

Renewable Fuel Standard (RFS)
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel

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), Natl Economic Council (NEC), Natl Security Council (NSC), White House Office

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

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

​

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

15. General issue area code FOO

16. Specific lobbying issues

Genetically Engineered (GE) Animals
---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
---Efficient Science-Based Review of Biotech Products
---FDA Approvals, Guidance, & Regulations
---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)

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

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

​

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

15. General issue area code FUE

16. Specific lobbying issues

Biofuels (Non-Funding)
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---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
---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
---FY 2023 Appropriations
---H.R.2820/S.1251: The Growing Climate Solutions Act of 2021
---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

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---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
---Incentives for Sustainable Aviation Fuels

Renewable Fuel Standard (RFS)
---FY 2023 Appropriations
---H.R.5376: Inflation Reduction Act of 2022
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Proposed Rule to set 2021 Renewable Volume Obligations (RVOs) under the Renewable Fuel Standard and the 2022 RVO for Biomass-based Diesel

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), Natl Economic Council (NEC), Natl Security Council (NSC), White House Office

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

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

​

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

15. General issue area code HCR

16. Specific lobbying issues

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

340B Drug Discount Program
---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
---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements
---Biosimilar Copay
---BSUFA Negotiations
---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017
---Reimbursement

Coronavirus (COVID-19) Pandemic
---FY 2022 Continuing Resolution
---H.R.550: Immunization Infrastructure Modernization Act of 2021
---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act
---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
--- In-Home Administration of Part B Drugs
---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
---Small Business Loans
---Supply Chain Issues
---Temporarily Refundable R&D Credit
---TRIPS Waiver

Climate Change
---FY 2023 Appropriations

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.729: Strength in Diversity Act of 2021
---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.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
---Implementation of the Prescription Drug User Fee Act (PDUFA) VI
---Innovation Incentives
---Patient-Focused Drug Development
---Prescription Drug User Fee Act (PDUFA) VII Priorities
---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.7767: 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.
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---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)
---Advanced Manufacturing
---Counterfeiting
---Drug Shortages
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---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
---H.R.4811: Medicare Negotiation and Competitive Licensing Act
---S.1435: Affordable Prescriptions for Patients 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

Drug Pricing
---FY 2023 Appropriations
---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.153: Protecting Consumer Access to Generic Drugs 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.4811: Medicare Negotiation and Competitive Licensing Act
---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.5376: Inflation Reduction Act of 2022
---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program.
---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
---Drug Pricing Provisions
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2023 Appropriations
---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
---FY 2022 Continuing Resolution
---FY 2023 Appropriations
---H.R.4521: COMPETES Act
---H.R.5376: Inflation Reduction Act of 2022
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Reauthorization of PAHPA

Funding for FDA
---FY 2023 Appropriations
---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
---Implementation of the Prescription Drug User Fee Act (PDUFA) VI
---Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for Health Resources and Services Administration (HRSA)
---FY 2022 Continuing Resolution
---FY 2023 Appropriations

Funding for National Institutes of Health
---FY 2023 Appropriations
---H.R.623: Gabriella Miller Kids First Research Act 2.0
---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2023 Appropriations
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2023 Appropriations

Generic Drug Entry
---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021
---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act
---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act
---H.R.7667: The Food and Drug Amendments of 2022
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Generic Drug Application Review Reforms
---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.4293: Pharmacy Benefit Manager Transparency Act of 2022
---Alternative Payment Arrangements for Gene Therapies
---Average Manufacturer Price Calculations
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule

Opioid Crisis
---Coverage and Reimbursement
---FDA Reforms
---Implementation of the SUPPORT for Patients and Communities Act of 2018
---Non-Opioid Analgesics
---Transparency

Orphan Drug Issues
---H.R.5376: Inflation Reduction Act of 2022
---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act
---Orphan Drug Tax Credit

Precision Medicine Initiative

Rare Pediatric Disease Priority Review
---H.R.1730: Speeding Therapy Access Today (STAT) Act
---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.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act
---H.R.5376: Inflation Reduction Act of 2022
---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program.
---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
---Drug Pricing Provisions
---Medicare Part B Physician-Administered Products
---Patient Cost-Sharing and Smoothing
---Protected Classes
---Step Therapy
---Support of Patient Premiums and Cost-Sharing Obligations

Vaccines and Infectious Diseases
---FY 2023 Appropriations
---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.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: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program.
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Adult Immunization
---MCM Manufacturing & Capacity
---MCM R&D Incentives
---Vaccine and Antimicrobial Resistance Product Development and Incentives
---Vaccine Injury Compensation Program

Vaccine Injury Compensation Program
---FY 2023 Appropriations
---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021
---H.R.3656: Vaccine Access Improvement Act of 2021
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---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)

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

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
---FY 2023 Appropriations
---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
---FY 2022 Continuing Resolution
---FY 2023 Appropriations
---H.R.4521: COMPETES Act
---H.R.5376: Inflation Reduction Act of 2022
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---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, Centers For Disease Control & Prevention (CDC)

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

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

​

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

15. General issue area code MED

16. Specific lobbying issues

Biodefense Research, Development and Procurement 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
---FY 2022 Continuing Resolution
---H.R.550: Immunization Infrastructure Modernization Act of 2021
---R&D Funding for Medical Countermeasures
---Senate HELP Pandemic Preparedness White Paper
---Temporarily Refundable R&D Credit

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2023 Appropriations
---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
---FY 2022 Continuing Resolution
---FY 2023 Appropriations
---H.R.4521: COMPETES Act
---H.R.5376: Inflation Reduction Act of 2022
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Reauthorization of PAHPA

Funding for National Institutes of Health
---FY 2023 Appropriations
---H.R.623: Gabriella Miller Kids First Research Act 2.0
---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2023 Appropriations
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic

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)

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

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

340B Drug Discount Program
---Program Implementation & Oversight

Coronavirus (COVID-19) Pandemic
---H.R.550: Immunization Infrastructure Modernization Act of 2021
---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
---FY 2023 Appropriations
---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.4811: Medicare Negotiation and Competitive Licensing Act
---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.5376: Inflation Reduction Act of 2022
---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program.
---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
---Drug Pricing Provisions
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

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.4293: Pharmacy Benefit Manager Transparency Act of 2022
---Alternative Payment Arrangements for Gene Therapies
---Average Manufacturer Price Calculations
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule

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.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act
---H.R.5376: Inflation Reduction Act of 2022
---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program.
---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
---Drug Pricing Provisions
---Medicare Part B Physician-Administered Products
---Patient Cost-Sharing and Smoothing
---Protected Classes
---Step Therapy
---Support of Patient Premiums and Cost-Sharing Obligations

Vaccines and Infectious Diseases
---FY 2023 Appropriations
---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.4127: DISARM Act
---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program.
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022

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

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

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

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

​

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

15. General issue area code 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
---H.R.5376: Inflation Reduction Act of 2022
---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022
---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)
---Reform of New Operating Loss Rules

Capital Market Enhancements
---Accredited Investor Definition
---Amended Definition of Smaller Reporting Company
---Market Liquidity Proposals
---SEC Small Business Forum

Coronavirus (COVID-19) Pandemic
--- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act
---Small Business Loans
---Temporarily Refundable R&D Credit

Small Business Innovation Research (SBIR) Program
---S.4900: 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

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)
---H.R.5376: Inflation Reduction Act of 2022
---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
---H.R.5376: Inflation Reduction Act of 2022
---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022
---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)
---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)
---H.R.5376: Inflation Reduction Act of 2022

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

Research & Development Tax Credit Reforms
---H.R.1304/S.749: American Innovation and Jobs Act
---H.R.5376: Inflation Reduction Act of 2022
---Expensing of R&D Expenditures

Vaccine Injury Compensation Program
---FY 2023 Appropriations
---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021
---H.R.3656: Vaccine Access Improvement Act of 2021
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---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

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
---Executive Order Ensuring Robust Consideration of Evolving National Security Risks by the Committee on Foreign Investment in the United States

Drug Importation

Drug Pricing
---Reference Pricing in Drug Reimbursement

Foreign Agricultural Biotechnology Laws 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
---US-Taiwan 21st Century Trade Initiative

Synthetic Biotech

US-China Trade Agreement
---Ag-Biotech 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)

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:

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

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?
No Yes