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Code · CFR · Title 21 — Food and Drugs · Part 12 — Formal Evidentiary Public Hearing · § 12.100

§ 12.100. Administrative record of a hearing.

254 words·~1 min read·/us/cfr/t21/s§ 12.100

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(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.
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