Page:United States Statutes at Large Volume 90 Part 1.djvu/602

 90 STAT. 552

Report and recommendation.

Information, availability to public. Advisory committees. Ante, p. 540.

5 USC 5332 note.

Procedures, regulation.

PUBLIC LAW 94-295—MAY 28, 1976 graph (B), for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment. If a proposed regulation is referred under this subparagraph to an advisory committee, the Secretary shall provide the advisory committee with the data and information on which such proposed regulation is based. The advisory committee shall, within sixty days of the referral of a proposed regulation and after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of such report and recommendation shall be made public by the Secretary. "(B) The Secretary shall establish advisory committees (which nuiy not be panels under section 513) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional background, except that the Secretary may not appoint to such a committee any individual who is in the regular lull-time employ of the United States and engaged in the administration of this Act, Each such committee shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Members of an advisory committee who are not officers or employees of the United States, while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, 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 GS-18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service employed intermittently. The Secretary shall designate one of the members of each advisory committee to serve as chairman thereof. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be followed by each such committee in acting on referrals made under subparagraph (A). 'PREMARKET APPROVAL

"General Requirement 21 USC 360e.

Post, p. 565.

"SEC. 515. (a) A class III device— "(1) which is subject to a regulation promulgated under subsection (b); or " (2) which is a class III device because of section 513(f), is required to have, unless exempt under section 520(g), an approval under this section of an application for premarket approval. "Regulation To Require Premarket Approval " (b)(1) In the case of a class III device which— "(A) was introduced or delivered for introduction into interstate commerce for commercial distribution before the date of enactment of this section; or

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