21 CFR §16.80
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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).
- (5)All letters and memoranda of meetings or communications between participants and the presiding officer or the Commissioner referred to in § 16.44(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.