21 CFR 12.140 - Review by the courts.

Regulations last checked for updates: Nov 23, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

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§ 12.159 - Copies of petitions for judicial review.

§ 12.140 - Review by the courts.

(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.

§ 12.159 - Copies of petitions for judicial review.

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.

authority: 21 U.S.C. 141-149,321,467f,679,821,1034; 42 U.S.C. 201,262,263b,264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558,701; 28 U.S.C. 2112.

source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.

cite as: 21 CFR 12.140