21 CFR §12.100

1. (a)The record of a hearing consists of—
   1. (1)The order or regulation or notice of opportunity for hearing that gave rise to the hearing;
   2. (2)All objections and requests for hearing filed by the Dockets Management Staff under §§ 12.20 through 12.22;
   3. (3)The notice of hearing published under § 12.35;
   4. (4)All notices of participation filed under § 12.45;
   5. (5)All Federal Register notices pertinent to the proceeding;
   6. (6)All submissions filed under § 12.82, e.g., the submissions required by § 12.85, all other documentary evidence and written testimony, pleadings, statements of position, briefs, and other similar documents;
   7. (7)The transcript, written order, and all other documents relating to the prehearing conference, prepared under § 12.92;
   8. (8)All documents relating to any motion for summary decision under § 12.93;
   9. (9)All documents of which official notice is taken under § 12.95;
   10. (10)All pleadings filed under § 12.96;
   11. (11)All documents relating to any interlocutory appeal under § 12.97;
   12. (12)All transcripts prepared under § 12.98; and
   13. (13)Any other document relating to the hearing and filed with the Dockets Management Staff by the presiding officer or any participant;
2. (b)The record of the administrative proceeding is closed—
   1. (1)With respect to the taking of evidence, when specified by the presiding officer; and
   2. (2)With respect to pleadings, at the time specified in § 12.96(a) for the filing of briefs.
3. (c)The presiding officer may reopen the record to receive further evidence at any time before the filing of the initial decision.