21 CFR 12.1 - Scope.

Regulations last checked for updates: May 20, 2024

Title 21 - Food and Drugs last revised: May 15, 2024

§ 12.1 - Scope.

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.

authority: 21 U.S.C. 141-149,321,467f,679,821,1034; 42 U.S.C. 201,262,263b,264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558,701; 28 U.S.C. 2112.

source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.

cite as: 21 CFR 12.1