Page:United States Statutes at Large Volume 90 Part 1.djvu/599

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PUBLIC LAW 94-000—MMMM. DD, 1976

PUBLIC LAW 94-295-~MAY 28, 1976 "(B) determines that such performance standard is based upon scientific data and information and has been subjected to scientific consideration, he may, in lieu of accepting any offer to develop such a standard pursuant to a notice published pursuant to subsection (c), accept such standard as a proposed performance standard for such device or as a basis upon which a proposed performance standard may be developed. " (2) If a standard is submitted to the Secretary pursuant to a notice published pursuant to subsection (c) and the Secretary does not accept such standard, he shall publish in the Federal Register notice of that fact together with the reasons therefor. .

90 STAT. 549

Publication in Federal Register.

"Acceptance of Offer To Develop Standard

"(e)(1) Except as provided by subsections (c)(4) and (d), the Secretary shall accept one, and may accept more than one, offer to develop a proposed performance standard for a device pursuant to a notice published pursuant to subsection (c) if he determines that (A) the offeror is qualified to develop such a standard and is technically competent to undertake and complete the development of an appropriate performance standard within the period specified in the notice, and (B) the offeror will comply with procedures prescribed by regulations of the Secretary under paragraph (4) of this subsection. In determining the qualifications of an offeror to develop a standard, the Secretary shall take into account the offeror's financial stability, expertise, experience, and any potential conflicts of interests (including financial interest in the device for which such standard is to be developed) and other information submitted pursuant to subsection (c)(3), which may be relevant with respect to the offeror's qualifications. "(2) The Secretary shall publish in the Federal Register the name and address of each person whose offer is accepted under paragraph (1) and a summary of the terms of such offer as accepted. "(3) If such an offer is accepted, the Secretary may, upon application which may be made prior to the acceptance of the offer, agree to contribute to the offeror's cost in developing a proposed standard if the Secretary determines that such contribution is likely to result in a more satisfactory standard than would be developed without such contribution. The Secretary shall by regulation prescribe the items of cost in which he will participate, except that such items may not include the cost of construction (except minor remodeling) or the acquisition of land or buildings. Payments to an offerer under this paragraph may be made without regard to section 3648 of the Revised Statutes (31 U.S.C. 529). "(4) The Secretary shall prescribe regulations governing the development of proposed standards by persons whose offers are accepted under paragraph (1). Such regulations shall, notwithstanding subsection (b)(A) of section 553 of title 5, United States Code, be promulgated in accordance with the requirements of that section for notice and opportunity for participation and shall— "(A) require that performance standards proposed for promulgation be supported by such test data or other documents or materials as the Secretary may reasonably require to be obtained; " (B) require that notice be given to interested persons of the opportunity to participate in the development of such performance standards and require the provision of such opportunity; "(C) require the maintenance of records to disclose (i) the , course of the development of performance standards proposed for promulgation, (ii) the comments and other information sub-

Publication in Federal Register.

Regulation,

Regulations

Performance standards.

Notice Record maintenance.