Page:United States Statutes at Large Volume 90 Part 1.djvu/607

 PUBLIC LAW 94-295—MAY 28, 1976 I

90 STAT. 557

requirements of the protocol, and (II) any permissible variations in such trials and the results therefrom, "(iv) a description of the methods to be used in, and the facilities and controls to be used for, the manufacture, processing, and, when relevant, packing and installation of the device, " (v) an identifying reference to any performance standard under section 514 to be applicable to any aspect of such device, Ante, p. 546. "(vi) if appropriate, specimens of the labeling proposed to be used for such device, " (vii) such other information relevant to the subject matter of the protocol as the Secretary, with the concurrence of the appropriate panel or panels under section 513, may require, Ante, p. 540. and "(viii) a requirement for submission of progress reports Progress report and, when completed, records of the trials conducted under the protocol which records are adequate to show compliance with the protocol. " (4) The Secretary shall approve or disapprove a proposed product development protocol submitted under paragraph (2) within one hundred and twenty days of its receipt unless an additional period is agreed upon by the Secretary and the person who submitted the protocol. Approval of a protocol or denial of approval of a protocol is final agency action subject to judicial review under chapter 7 of title 5, United States Code. 5 USC 701 et seq. "(5) At any time after a product development protocol for a Notice of device has been approved pursuant to paragraph (4), the person completion. for whom the protocol was approved may submit a notice of completion— " (A) stating (i) his determination that the requirements of the protocol have been fulfilled and that, to the best of his knowledge, there is no reason bearing on safety or effectiveness why the notice of completion should not become effective, and (ii) the data and other information upon which such determination was made, and "(B) setting forth the results of the trials required by the protocol and all the information required by subsection (c)(1). "(6)(A) The Secretary may, after providing the person who has Final order to an approved protocol an opportunity for an informal hearing and revoke protocoll. at any time prior to receipt of notice of completion of such protocol, issue a final order to revoke such protocol if he finds that— "(i) such person has failed substantially to comply with the requirements of the protocol, "(ii) the results of the trials obtained under the protocol differ so substantially from the results required by the protocol that further trials cannot be justified, or "(iii) the results of the trials conducted under the protocol or available new information do not demonstrate that the device tested under the protocol does not present an unreasonable risk to health and safety. "(B) After the receipt of a notice of completion of an approved protocol the Secretary shall, within the ninety-day period beginning on the date such notice is received, by order either declare the protocol completed or declare it not completed. An order declaring a protocol not completed may take effect only after the Secretary has rovided the person who has the protocol opportunity for an informal earing on the order. Such an order may be issued only if the Secretary finds—

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