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| Subpart H | Judicial Review | 12.140 – 12.159 | ||||||
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21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.
44 FR 22339, Apr. 13, 1979, unless otherwise noted.
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Nomenclature changes to part 12 appear at 88 FR 45064, July 14, 2023.
(a) The Commissioner's final decision constitutes final agency action from which a participant may petition for judicial review under the statutes governing the matter involved. Before requesting an order from a court for a stay of action pending review, a participant shall first submit a petition for a stay of action under § 10.35.
(b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all petitions related to a particular matter.
The Chief Counsel for FDA has been designated by the Secretary as the officer on whom copies of petitions of judicial review are to be served. This officer is responsible for filing the record on which the final decision is based. The record of the proceeding is certified by the Commissioner.