[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: 21CFR12.97]
[Page 128-129]
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 E Hearing Procedures
Sec. 12.97 Interlocutory appeal from ruling of presiding officer.
(a) Except as provided in paragraph (b) of this section and in
Sec. Sec. 12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an
interlocutory appeal is specifically authorized by this subpart, rulings
of the presiding officer may not be appealed to the Commissioner before
the Commissioner's consideration of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory
appeal to the Commissioner if the presiding officer certifies on the
record or in writing that immediate review is necessary to prevent
exceptional delay, expense, or prejudice to any participant, or
substantial harm to the public interest.
(c) When an interlocutory appeal is made to the Commissioner, a
participant may file a brief with the Commissioner only if specifically
authorized by the presiding officer or the Commissioner, and if such
authorization is granted, within the period the Commissioner directs. If
a participant is authorized to file a brief, any other participant may
file a brief in opposition,
[[Page 129]]
within the period the Commissioner directs. If no briefs are authorized,
the appeal will be presented as an oral argument to the Commissioner.
The oral argument will be transcribed. If briefs are authorized, oral
argument will be heard only at the discretion of the Commissioner.
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