21 CFR 13.15
§ 13.15 Separation of functions; ex parte communications; administrative support.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 13.15, § 13.15 Separation of functions; ex parte communications; administrative support, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83152
- Permanent ID
ys:prov:83152@1- SHA-256
01b73a0c632a99f9fa9b881fe8b99a2951079e6f8df70e4660ccd1eb549be70a
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Full text
(a) The proceeding of a Board are subject to the provisions of § 10.55 relating to separation of functions and ex parte communications. Representatives of the participants in any proceeding before a Board, including any members of the office of the Chief Counsel of FDA assigned to advise the center responsible for the matter, may have no contact with the members of the Board, except as participants in the proceeding, and may not participate in the deliberations of the Board.
(b) Administrative support for a Board is to be provided only by the office of the Commissioner and the office of the Chief Counsel for FDA.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.