[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: 21CFR12.120]
[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. 12.120 Initial decision.
(a) The presiding officer shall prepare and file an initial decision
as soon as possible after the filing of briefs and oral argument.
(b) The initial decision must contain--
(1) Findings of fact based issued upon relevant, material, and
reliable evidence of record;
(2) Conclusions of law;
(3) A discussion of the reasons for the findings and conclusions,
including a discussion of the significant contentions made by any
participant;
(4) Citations to the record supporting the findings and conclusions;
(5) An appropriate regulation or order supported by substantial
evidence of record and based upon the findings of fact and conclusions
of law; and
(6) An effective date for the regulation or order.
(c) The initial decision must refrain from disclosing specific
details of matters specified in Sec. 10.20(j)(2)(i) (a) and (b), except
as specifically authorized in a protective order issued pursuant to
Sec. 10.20(j)(3).
(d) The initial decision is to be filed with the Division of Dockets
Management and served upon all participants. Once the initial decision
is filed with the Division of Dockets Management, the presiding officer
has no further jurisdiction over the matter, and any motions or requests
filed with the Division of Dockets Management will be decided by the
Commissioner.
(e) The initial decision becomes the final decision of the
Commissioner by operation of law unless a participant files exceptions
with the Division of Dockets Management under Sec. 12.125(a) or the
Commissioner files a notice of review under Sec. 12.125(f).
(f) Notice that an initial decision has become the decision of the
Commissioner without appeal to or review by the Commissioner will be
published in the Federal Register, or the Commissioner may publish the
decision when it is of widespread interest.
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