1. Regulations
  2. title 21
  3. chapter I
  4. part 12
  5. subpart A
  6. § 12.1

View all text of Subpart A [§ 12.1 - § 12.1]

§ 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, 321-393, 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: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.

CITE AS: 21 CFR 12.1