Page:United States Statutes at Large Volume 90 Part 1.djvu/616

 90 STAT. 566

PUBLIC LAW 94-295—MAY 28, 1976 "Custom Devices "(b) Sections 514 and 515 do not apply to any device which, In order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing) necessarily deviates from an otherwise applicable performance standard or requirement prescribed by or under section 515 if (1) the device is not generally available in finished form for purchase or for dispensing upon prescription and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and (2) such device— "(A)(i) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated) and is to be made in a specific form for such patient, or "(ii) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated), and "(B) is not generally available to or generally used by other physicians or dentists (or other specially qualified persons so designated). "Trade Secrets

Ante, pp. 540, 546, 552, 560, 2Mlsr*^74

" (c) Any information reported to or otherwise obtained by the Secretary or his representative under section 513, 514, 515, 516^ 518, 519, or 704 or under subsection (f) or (g) of this section which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of such section shall be considered confidential and shall not be disclosed and may not be used by the Secretary as the basis for the reclassification of a device under section 513 from class III to class II or as the basis for the establishment or amendment of a performance standard under section 514 for a device reclassified from class III to class II, except that such information may be disclosed to other officers or employees concerned with carrying out this Act or when relevant in any proceeding under this Act (other than section 513 or 514 thereof). "Notices and Findings

" (d) Each notice of proposed rulemaking under section 513,514,515, 516, 518, or 519, or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth— "(1) the manner in which interested persons may examine data and other information on which the notice or findings is based, and Publication in "(2) the period within which interested persons may present Federal Register. their comments on the notice or findings (including the need therefor) orally or in writing, which period shall be at least sixty days but may not exceed ninety days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefor.

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