Source: http://www4.law.cornell.edu/cfr/text/21/16.95
Timestamp: 2013-12-10 18:29:13
Document Index: 175687028

Matched Legal Cases: ['art 16', '§ 16', '§ 16', '§ 16', '§ 16', '§ 16', '§ 10']

21 CFR 16.95 - Administrative decision and record for decision. | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 16 › Subpart E › Section 16.95	prev | next
21 CFR 16.95 - Administrative decision and record for decision.
§ 16.95
Administrative decision and record for decision.
(a) With respect to a regulatory hearing at the Commissioner's initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form.
(b) With respect to a regulatory hearing required by the act or a regulation under § 16.1(b) —
(1) The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision;
(3) For purposes of judicial review under § 10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.