[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: 21CFR12.130]
[Page 131]
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. 12.130 Decision by Commissioner on appeal or review of initial decision.
(a) On appeal from or review of the initial decision, the
Commissioner has all the powers given to make the initial decision. On
the Commissioner's own initiative or on motion, the Commissioner may
remand the matter to the presiding officer for any further action
necessary for a proper decision.
(b) The scope of the issues on appeal is the same as the scope of
the issues at the public hearing unless the Commissioner specifies
otherwise.
(c) As soon as possible after the filing of briefs and any oral
argument, the Commissioner will issue a final decision in the
proceeding, which meets the requirements established in Sec. 12.120 (b)
and (c).
(d) The Commissioner may adopt the initial decision as the final
decision.
(e) Notice of the Commissioner's decision will be published in the
Federal Register, or the Commissioner may publish the decision when it
is of widespread interest.
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