Federal · Title 21 — Food and Drugs

21 U.S.C. § 387l: Judicial review

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the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product standard; or a denial of an application under section 387j(c) of this title , A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary. the record of the proceedings on which the regulation or order was based; and a statement of the reasons for the issuance of such a regulation or order. all notices and other matter published in the Federal Register with respect to the regulation or order reviewed; all information submitted to the Secretary with respect to such regulation or order; proceedings of any panel or advisory committee with respect to such regulation or order; any hearing held with respect to such regulation or order; and any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order. Upon the filing of the petition under subsection (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5 and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in subsection (a) shall be reviewed in accordance with section 706(2)(A) of title 5 . The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28 . The remedies provided for in this section shall be in addition to, and not in lieu of, any other remedies provided by law. To facilitate judicial review, a regulation or order issued under section 387f, 387g, 387h, 387i, 387j, or 387p of this title shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance.

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