---
kind: "section"
citation: "21 C.F.R. § 16.80"
title: "21"
number: "16.80"
heading: "Administrative record of a regulatory hearing."
url: "https://uscodex.org/cfr/21/16.80"
---

# §16.80. Administrative record of a regulatory hearing.

- (a) **The administrative record of the regulatory hearing consists of the following—**
  - (1) **The notice of opportunity for hearing and the response.**
  - (2) All written information and views submitted to the presiding officer at the hearing or after if specifically permitted by the presiding officer.
  - (3) **Any transcript of the hearing.**
  - (4) The presiding officer's report of the hearing and comments on the report under [§ 16.60(e)](/cfr/21/16.60.md?p=e).
  - (5) All letters and memoranda of meetings or communications between participants and the presiding officer or the Commissioner referred to in [§ 16.44(c)](/cfr/21/16.44.md?p=c).
- (b) The record of the regulatory hearing is closed to the submission of information and views, at the close of the hearing, unless the presiding officer specifically permits additional time for a further submission.

## 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.