SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

FDA Advisory Committees

OMB Control Number 0910-0833—Extension

This information collection supports certain Food and Drug Administration (FDA, the Agency, us or we) Advisory Committee administrative activities. FDA Advisory Committees are established to advise or make recommendations on matters of public health that come before the Agency. The Federal Advisory Committee Act (5 U.S.C. App. 2 § 3, Pub. L. 92-463) (“FACA”) defines what constitutes an “advisory committee” under the Act and provides general procedures to follow for the operation of advisory committees. In addition, FACA is designed to ensure that the Congress and the public are kept informed with respect to the purpose, membership, and activities of advisory committees. Public advisory committee regulations in part 14 set forth requirements governing the administrative procedures to follow for the operation of advisory committees. Agency regulations in part 14, subpart A (§§ 14.1 through 14.15) identify scope of coverage, applicable definitions, and establish general provisions. The regulations in part 14, subpart B (§§ 14.20 through 14.39) set forth content and format requirements along with required schedules for submission of information. The regulations in part 14 subparts C, D, and E (§§ 14.40 through 14.95) set forth requirements governing advisory committee establishment, recordkeeping, and maintenance, respectively.

FACA does not specify the manner in which advisory committee members and staff must be appointed. ( See generally 5 U.S.C. App. 2. See also,41 CFR 102-3.105, 102-3.130(a)). FDA's regulations, however, specify that the Commissioner “will publish one or more notices in the Federal Register each year requesting nominations for voting members of all existing standing advisory committees.” (21 CFR 14.82(a)). Nominations must specify the committee for which the nominee is recommended, include a complete curriculum vitae (CV), state that the nominee is aware of the nomination and willing to serve, and state that the nominee appears to have no conflict of interest that would preclude membership. (21 CFR 14.82(c)). In an effort to promote transparency, consistent with FDA and General Services Administration (“GSA”) policy ( See, GSA regulations encouraging agencies to “practice openness” and suggesting that “agencies may wish to explore the use of the internet to post advisory committee information . . .” 41 CFR 102-3.95(b)), and pursuant to a settlement agreement in the case Public Citizen Foundation, Inc. v. Food & Drug Administration, et al., No. 16-cv-781 (D.D.C.), FDA is also ( printed page 50556) seeking consent from nominees for FDA to publicly post their CVs in the event they are selected to serve on an FDA advisory committee.

In the Federal Register of March 23, 2026 (91 FR 13852), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment. The comment suggests our process could be easier if we were to have more on-line tools available. They also commented that FDA should be clearer on how the information is used in decision making.

FDA appreciates the comment. FDA has established an applicant portal on its website at: https://www.accessdata.fda.gov/​scripts/​FACTRSPortal/​FACTRS/​index.cfm through which submissions are made to the Agency. To facilitate reporting we have established a standardized electronic format for information data elements and a separate functionality for uploading necessary documentation, such as CVs and letters of recommendation.

This data and information are made available to Agency staff to allow them to conduct reviews of nominations and coordinate follow-up with the potential candidate to explain the advisory committee process and confirm their willingness to serve. If a candidate is deemed acceptable for participation on a committee, further action is taken to appoint them to a specific advisory committee that is appropriate to their expertise and the committee's function. FDA publishes the CV of new advisory committee members on our website. FDA believes this will increase public confidence that FDA's review of advisory committee membership nominations and the subsequent selection process has been conducted thoroughly and objectively, without regard to politics or relationships with third parties. Applying this policy across all FDA advisory committees further supports FDA's goal of maintaining science as the primary determinant in Agency decision making.

FDA estimates the burden of this collection of information as follows:

91 FR 50555