[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.100]
[Page 129]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 12 FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart F Administrative Record
Sec. 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 Sec. Sec. 12.20 through 12.22;
(3) The notice of hearing published under Sec. 12.35;
(4) All notices of participation filed under Sec. 12.45;
(5) All Federal Register notices pertinent to the proceeding;
(6) All submissions filed under Sec. 12.82, e.g., the submissions
required by Sec. 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 Sec. 12.92;
(8) All documents relating to any motion for summary decision under
Sec. 12.93;
(9) All documents of which official notice is taken under Sec.
12.95;
(10) All pleadings filed under Sec. 12.96;
(11) All documents relating to any interlocutory appeal under Sec.
12.97;
(12) All transcripts prepared under Sec. 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 Sec.
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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