§12.1. Scope.
21 C.F.R. § 12.1
The procedures in this part apply when—
A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or
The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.
Source
Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.