21 C.F.R. § 12.100 — Administrative record of a hearing.
§ 12.100 Administrative record of a hearing. (a) The record of a hearing consists of— (1) The order or regulation or notice of opportunity for hearing that gave rise to the hearing; (2) All objections and requests for hearing filed by the Division of Dockets Management under §§ 12.20 through 12.22; (3) The notice of hearing published under § 12.35; (4) All notices of participation filed under § 12.45; (5) All Federal Register notices pertinent to the proceeding; (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) The transcript, written order, and all other documents relating to the prehearing conference, prepared under § 12.92; (8) All documents relating to any motion for summary decision under § 12.93; (9) All documents of which official notice is taken under § 12.95; (10) All pleadings filed under § 12.96; (11) All documents relating to any interlocutory appeal under § 12.97; (12) All transcripts prepared under § 12.98; and (13) Any other document relating to the hearing and filed with the Division of Dockets Management by the presiding officer or any participant; (b) The record of the administrative proceeding is closed— (1) With respect to the taking of evidence, when specified by the presiding officer; and (2) With respect to pleadings, at the time specified in § 12.96(a) for the filing of briefs. (c) The presiding officer may reopen the record to receive further evidence at any time before the filing of the initial decision.