---
kind: "section"
citation: "21 C.F.R. § 16.95"
title: "21"
number: "16.95"
heading: "Administrative decision and record for decision."
url: "https://uscodex.org/cfr/21/16.95"
---

# §16.95. Administrative decision and record for decision.

- (a) With respect to a regulatory hearing at the Commissioner's initiative under [§ 16.1(a)](/cfr/21/16.1.md?p=a), the Commissioner shall consider the administrative record of the hearing specified in [§ 16.80(a)](/cfr/21/16.80.md?p=a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form.
- (b) With respect to a regulatory hearing required by the act or a regulation under [§ 16.1(b)](/cfr/21/16.1.md?p=b)—
  - (1) The administrative record of the hearing specified in [§ 16.80(a)](/cfr/21/16.80.md?p=a) constitutes the exclusive record for decision;
  - (2) On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and
  - (3) For purposes of judicial review under [§ 10.45](/cfr/21/10.45.md), the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.

## Notes

### Authority

Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

### Source

Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.