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Public Disclosure of Advisory Committee Members' Financial Interests and Waivers

This guidance outlines FDA's procedures for public disclosure of financial interests and waivers for FDA advisory committee members. It applies to special Government employees (SGEs) and regular Government employees participating in FDA advisory committee meetings subject to the Federal Advisory Committee Act (FACA).

  1. Implement process to collect and review financial interest information from advisory committee members
  2. Develop templates for documenting financial interest disclosures and waivers
  3. Establish procedure for timely posting of disclosure documents on FDA website
  4. Create process for member acknowledgment of public disclosure of financial interests
  5. Set up system to track timing requirements for disclosure postings
  6. Implement confidentiality review process to protect sensitive commercial information
  7. Develop procedure for posting committee member rosters with briefing materials
  8. Create process to handle late-discovered conflicts of interest
  9. Establish documentation system for waiver determinations and justifications

Key Considerations

Other considerations

  • 5 CFR Part 2640: Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts Affecting a Personal Financial Interest)
  • 5 CFR Part 2634: Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture

Original guidance

  • Public Disclosure of Advisory Committee Members’ Financial Interests and Waivers
  • HTML / PDF
  • Issue date: 2014-02-28
  • Last changed date: 2019-04-20
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Food & Color Additives, Biologics, Cosmetics, Advisory Committees
  • ReguVirta summary file ID: 48908fd3e1c6733491393cc3dd83b99f
This post is licensed under CC BY 4.0 by the author.