21 C.F.R. § 12.1
Scope.
Cite as 21 C.F.R. § 12.1 (2026)
The 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.
- Cross-references to the CFR
- 10.50