21 U.S.C. § 387l Judicial Review

• Library: United States Statutes
• Edition: 2023 Edition
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)

(a) Right to review

(1) In general

Not later than 30 days after-

(A) the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product standard; or

(B) a denial of an application under section 387j(c) of this title,

any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.

(2) Requirements

(A) Copy of petition

A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary.

(B) Record of proceedings

On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed-

(i) the record of the proceedings on which the regulation or order was based; and

(ii) a statement of the reasons for the issuance of such a regulation or order.

(C) Definition of record

In this section, the term "record" means-

(i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;

(ii) all information submitted to the Secretary with respect to such regulation or order;

(iii) proceedings of any panel or advisory committee with respect to such regulation or order;

(iv) any hearing held with respect to such regulation or order; and

(v) 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.