§16.95. Administrative decision and record for decision.
21 C.F.R. § 16.95
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.
With respect to a regulatory hearing required by the act or a regulation under § 16.1(b)—
The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision;
On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and
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.
Notes, amendments, and revision history
Authority
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
Source
Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.