Page:United States Statutes at Large Volume 90 Part 1.djvu/598

 90 STAT. 548

Regulation.

PUBLIC LAW 94-295—MAY 28, 1976 developed, which period may be extended by the Secretary for good cause shown; and "(B) shall include— " (i) a description or other designation of the device, "(ii) a statement of the nature of the risk or risks associated with the use of the device and intended to be controlled by a performance standard, "(iii) a summary of the data on which the Secretary has found a need for initiation of the proceeding to develop a performance standard, and "(iv) identification of any existing performance standard known to the Secretary which may be relevant to the proceeding"(3) The Secretary shall by regulation require that an offeror of an offer to develop a proposed performance standard submit (and if the offeror is a business entity, require that appropriate directors, officers, and employees of, and consultants to, the business entity submit) to the Secretary such information concerning the offeror as the Secretary determines is relevant with respect to the offeror's qualifications to develop a proposed performance standard for a device, including information respecting the offeror's financial stability, expertise, and experience, and any potential conflicts of interest, including financial interest in the device for which the proposed standard is to be developed, current industrial or commercial affiliates of the offeror, current sources of financial support for research, and business entities in which the offeror has a financial interest, which may be relevant with respect to the offeror's qualifications. Such information submitted by an offeror may not be made public by the Secretary unless required by section 552 of title 5, United States Code, except that in the case of information submitted by an offeror whose offer has been accepted, the Secretary shall make such information (other than information which because of subsection (b)(4) of section 552, title 5, United States Code, is exempt from disclosure pursuant to subsection (a) of such section) public at the time the offer is accepted. " (4) If the Secretary determines that a performance standard can be developed by any Federal agency (including an agency within the Department of Health, Education, and Welfare), the Secretary may— "(A) if such determination is made with respect to an agency within such Department, develop such a standard in lieu of accepting any offer to develop such a standard pursuant to a notice published pursuant to this subsection, or "(B) if such determination is made with respect to any other agency, authorize such agency to develop such a standard in lieu of accepting any such offer. In making such a determination respecting a Federal agency, the Secretary shall take into account the personnel and expertise within such agency. The requirements described in subparagraphs (B) and (C) of subsection (e)(4) shall apply to development of a standard under this paragraph. "Acceptance of Certain Existing Standards "(d)(1) If the Secretary— "(A) determines that a performance standard has been issued or adopted or is being developed by any Federal agency or by any other qualified entity or receives a performance standard submitted pursuant to a notice published pursuant to subsection (c), and

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