Scope.
21 C.F.R. § 12.1
in effectEffective: 2024-07-01The procedures in this part apply when—
(a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or
(b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
