21 CFR § 12.100 - Administrative record of a hearing.

---
identifier: "/us/cfr/t21/s12.100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 12.100 - Administrative record of a hearing."
title_number: 21
title_name: "Food and Drugs"
section_number: "12.100"
section_name: "Administrative record of a hearing."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "12"
part_name: "FORMAL EVIDENTIARY PUBLIC HEARING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112."
regulatory_source: "44 FR 22339, Apr. 13, 1979, unless otherwise noted."
cfr_part: "12"
---


# 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.