[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: 21CFR12.125]
[Page 130]
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 G Initial and Final Decisions
Sec. 12.125 Appeal from or review of initial decision.
(a) A participant may appeal an initial decision to the Commissioner
by filing exceptions with the Division of Dockets Management, and
serving them on the other participants, within 60 days of the date of
the initial decision.
(b) Exceptions must specifically identify alleged errors in the
findings of fact or conclusions of law in the initial decision, and
provide supporting citations to the record. Oral argument before the
Commissioner may be requested in the exceptions.
(c) Any reply to the exceptions is to be filed and served within 60
days of the end of the period for filing exceptions.
(d) The Commissioner may extend the time for filing exceptions under
paragraph (a) of this section or replies to exceptions under paragraph
(c) of this section only upon a showing by a participant of
extraordinary circumstances. Such an extension shall be requested by
filing a written request with the Commissioner's Executive Secretariat
(HF-40) and serving copies of the request on the Division of Dockets
Management (HFA-305), the Chief Counsel (GCF.1), and all hearing
participants.
(e) If the Commissioner decides to hear oral argument, the
participants will be informed of the date, time, and place, the amount
of time allotted to each participant, and the issues to be addressed.
(f) Within 10 days following the expiration of the time for filing
exceptions (including any extensions), the Commissioner may file with
the Division of Dockets Management, and serve on the participants, a
notice of the Commissioner's determination to review the initial
decision. The Commissioner may invite the participants to file briefs or
present oral argument on the matter. The time for filing briefs or
presenting oral argument will be specified in that or a later notice.
[44 FR 22339, Apr. 13, 1979, as amended at 53 FR 29453, Aug. 5, 1988]
[[Page 131]]
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