PUBLIC LAW 94-295—MAY 28, 1976 market application, a regulation under paragraph (4) of that section amending or revoking a regulation under paragraph (3), or an order pursuant to section 515(g)(1) or 515 (g)(2)(C), "(5) the promulgation of a regulation under section 516 (other than a proposed regulation made effective under subsection (b) of such section upon the regulation's publication) making a device a banned device, "(6) the issuance of an order under section 520(f)(2), or "(7) an order under section 620(g)(4) disapproving an application for an exemption of a device for investigational use or an order under section 520(g)(5) withdrawing such an exemption for a device, any person adversely affected by such regulation or order may file a petition with the United States Court of Appeals for the District of Columbia or for the circuit wherein such person resides or has his principal place of business for judicial review of such regulation or order. A copy of the petition shall be transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary shall file in the court the record of the proceedings on which the Secretary based his regulation or order as provided m section 2112 of title 28, United States Code. For purposes of this section, the term 'record' means 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.
90 STAT. 561
Ante, p. 552. Ante, p,560.
Post, p. 565.
"Record."
"Additional Data, Views, and Arguments "(b) If the petitioner applies to the court for leave to adduce additional data, views, or arguments respecting the regulation or order being reviewed and shows to the satisfaction of the court that such additional data, views, or arguments are material and that there were reasonable grounds for the petitioner's failure to adduce such data, views, or arguments in the proceedings before the Secretary, the court may order the Secretary to provide additional opportunity for the oral presentation of data, views, or arguments and for written submissions. The Secretary may modify his findings, or make new findings Modifications, by reason of the additional data, views, or arguments sc taken and shall file with the court such modified or new findings, and his recommendation, if any, for the modification or setting aside of the regulation or order being reviewed, with the return of such additional data, views, or arguments. "Standard for Review "(c) Upon the filing of the petition under subsection (a) of this section 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, United States Code, and to grant appropriate 5 USC 701 et seq. relief, including interim relief, as provided in such chapter. A regulation described in paragraph (2) or (5) of subsection (a) and an order issued after the review provided by section 515(g) shall not be affirmed if it is found to be unsupported by substantial evidence on the record taken as a whole.
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