Page:United States Statutes at Large Volume 90 Part 1.djvu/618

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PUBLIC LAW 94-000—MMMM. DD, 1976

90 STAT. 568

PUBLIC LAW 94-295—MAY 28, 1976

"(iii) contain such other information as the Secretary shall prescribe. "(B) The Secretary may refer to the advisory committee established under paragraph (3) any petition submitted under subparagraph Recommenda(A). The advisory committee shall report its recommendations to the tions. Secretary with respect to a petition referred to it within sixty days of the date of the petition's referral. Within sixty days after— "(i) the date the petition was submitted to the Secretary under subparagraph (A),or "(ii) if the petition was referred to an advisory committee, the expiration of the sixty-day period beginning on the date the petition was referred to the advisory committee, whichever occurs later, the Secretary shall by order either deny the petition or approve it. "(C) The Secretary may approve— "(i) a petition for an exemption for a device from a requirement if he determines that compliance with such requirement is not required to assure that the device will be safe and effective and otherwise in compliance with this Act, and "(ii) a petition for a variance for a device from a requirement if he determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, storage, and installation of the device in lieu of the methods, controls, and facilities prescribed by the requirement are sufficient to assure that the device will be safe and effective and otherwise in compliance with this Act. An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of the device to be granted the variance under the petition as may be necessary to assure that the device will be safe and effective and otherwise in compliance with this Act. Hearing. "(D) After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order. Advisory "(3) The Secretary shall establish an advisory committee for the committee. purpose of advising and making recommendations to him with respect Establishment. to regulations proposed to be promulgated under parargaph (1)(A) and the approval or disapproval of petitions submitted under paraMembership. graph (2). The advisory committee shall be composed of nine members as follows: "(A) Three of the members shall be appointed from persons who are officers or employees of any State or local government or of the Federal Government. "(B) Two of the members shall be appointed from persons who are representative of interests of the device manufacturing industry; two of the members shall be appointed from persons who are representative of the interests of physicians and other health proiessionals; and two of the members shall be representative of the interests of the general public. Members of the advisory committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade 5 USC 5332 note. GS-18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or