[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.100]

[Page 140]
 
                        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 Dockets 
Management Branch under Secs. 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 
Dockets Management Branch 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.