21 C.F.R. § 15.40 – Administrative record.

(a) The administrative record of a public hearing before the Commissioner consists of the following:
1. (1) All relevant Federal Register notices, including any documents to which they refer.
2. (2) All written submissions under § 15.25.
3. (3) The transcript of the oral hearing.
(b) The record of the administrative proceeding will be closed at the time specified in § 15.25.