21 CFR §13.40

1. (a)The administrative record of a hearing before a Board consists of the following:
   1. (1)All relevant Federal Register notices.
   2. (2)All written submissions under § 13.20.
   3. (3)The transcripts of all hearings of the Board.
   4. (4)The initial decision of the Board.
2. (b)The record of the administrative proceeding is closed—
   1. (1)Relevant to receiving information and data, at the time specified in § 13.30(i); and
   2. (2)Relevant to pleadings, at the time specified in § 13.30(i) for filing a written statement of position with proposed findings and conclusions.
3. (c)The Board may, in its discretion, reopen the record to receive further evidence at any time before filing an initial decision.