Page:United States Statutes at Large Volume 111 Part 3.djvu/259

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2347 (C) in paragraph (7), by adding "and" after the semicolon at the end; (D) in paragraph (8)— (i) by striking "manufacturer, importer, or distributor" each place such term appears and inserting "manufacturer or importer"; and (ii) by striking the semicolon at the end and inserting a period; (E) by striking paragraph (9); and (F) by inserting at the end the following sentence: "The Secretary shall by regulation require distributors to keep records and make such records available to the Secretary upon request. Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such paragraphs apply to manufacturers and importers."; (2) by striking subsection (d); and (3) in subsection (f), by striking ", importer, or distributor" each place it appears and inserting "or importer". (b) REGISTRATION.— Section 510(g) (21 U.S.C. 360(g)) is amended— (1) by redesignating paragraph (4) as paragraph (5); (2) by inserting after paragraph (3) the following: "(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or"; and (3) by adding at the end the following flush sentence: "In this subsection, the term 'wholesale distributor' means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.". (c) DEVICE USER FACILITIES.— (1) IN GENERAL.— Section 519(b) (21 U.S.C. 360i(b)) is amended— (A) in paragraph (1)(C)— (i) in the first sentence, by striking "a semi-annual basis" and inserting "an annual basis"; (ii) in the second sentence, by striking "and July 1"; and (iii) by striking the matter after and below clause (iv); and (B) in paragraph (2)— (i) in subparagraph (A), by inserting "or" after the comma at the end; (ii) in subparagraph (B), by striking ", or" at the end and inserting a period; and (iii) by striking subparagraph (C). (2) SENTINEL SYSTEM.— Section 519(b) (21 U.S.C. 360i(b)) is amended— (A) by redesignating paragraph (5) as paragraph (6); and (B) by inserting after paragraph (4) the following paragraph: "(5) With respect to device user facilities: "(A) The Secretary shall by regulation plan and implement a program under which the Secretary limits user reporting

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