---
kind: "section"
citation: "21 C.F.R. § 12.1"
title: "21"
number: "12.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/12.1"
---

# §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](/cfr/21/10.50.md); or
- (b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.

## Notes

### 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.