21 C.F.R. § 12.100

Current through October 31, 2024
Section 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 Dockets Management Staff 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 Dockets Management Staff 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.

21 C.F.R. §12.100

88 FR 45064 , 7/14/2023