21 CFR 12.120 - Initial decision.
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(a) The presiding officer shall prepare and file an initial decision as soon as possible after the filing of briefs and oral argument.
(3) A discussion of the reasons for the findings and conclusions, including a discussion of the significant contentions made by any participant;
(5) An appropriate regulation or order supported by substantial evidence of record and based upon the findings of fact and conclusions of law; and
(c) The initial decision must refrain from disclosing specific details of matters specified in § 10.20(j)(2)(i) (a) and (b), except as specifically authorized in a protective order issued pursuant to § 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 § 12.125(a) or the Commissioner files a notice of review under § 12.125(f).
Title 21 published on 2014-04-01.
No entries appear in the Federal Register after this date, for 21 CFR Part 12.