[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: 21CFR12.125]

[Page 141]
 
                        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 Dockets Management Branch, 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 Dockets Management 
Branch (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 Dockets Management Branch, 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]