Page:United States Statutes at Large Volume 106 Part 1.djvu/272

 106 STAT. 240 PUBLIC LAW 102-300-JUNE 16, 1992 (i) by striking out "aware of information" and inserting in lieu thereof''aware of— ns ,. "(i) information"; and (ii) by striking out Tadlity, the facility and inserting in lieu thereof: nTacility, or "(ii) other significant adverse device experiences as determined l^ the Secretary by regulation to be necessary to be reported, the facility"; and ^(C) in paragraph (5)(B)(iii), by striking out 'immediate". 2iliSC 360i (b) EFFECTIVE DATE.— The amendments made by subsection (a) "°*« shall take eflFect^ (1) 1 year after the date of the enactment of this Act; or (2) on the effective date of regulations of the Secretary to implement such amendments, whichever occurs first. SEC. 6. TECHNICALS. (a) SECTION 201.—Section 201 (21 U.S.C. 321) is amended— (1) in subsection (h), by striking out "any of its principal" and inserting in lieu thereof "its primary"; and (2) by adding at the end the following: "(fif) The term 'Commissioner' means the Commissioner of Food and Drugs.". 0>) REFERENCE. — (1) Subsections (c) and (d) of sections 201, subsections (a), (d), (h), (i), (1), (m), and (o) of section 408, subsections (a) and (Jb) of section 536, section 701(b), and subsections (a) and (b) of section 801 (21 U.S.C. 321 (c) and (d), 346a (a), (d), (h), (i), G), (m), and (o), 360mm (a) and (b), 371(b), and 381 (a) and (b)) and section 351(c) of the Pi:Jt>lic Healui Service Act (42 U.S.C. 262(c)) are each amended by striking out "Health, Education, and Welfare" each place it appears and inserting in lieu thereof "Health and Human Services". (2) Section 201(y), section 506(a), section 507(a), section 702(c), section 702A, and section 706(b)(5)(C)(i) (21 U.S.C. 321(y), 356(a), 357(a), 372(c), 372a, and 376(b)(5)(C)(i)) are each amended by striking out "of Health, Education, and Welfare" each place it appears. (c) SECTION 304.—Section 304(d)(l) (21 U.S.C. 334(d)(l)) is amended— (1) by striking out "801(d)" each place it occurs and inserting in lieu thereof "801(e)"; and (2) by striking out "clauses" and inserting in lieu thereof " paragraphs". (d) SECTION 503.—Section 503(e)(3) (21 U.S.C. 353(g)(3)) is amended by striking out "approval and inserting in lieu thereof "clearance" (e) SECTION 513. —Section 513(f)(3) (21 U.S.C. 360c(f)(3)) is amended by redesignating clauses (i), (ii), and (iii) as subparagraphs (A), (B), and (C), respectivelv, and by striking out "the 510(k)" and inserting in lieu thereof "the section 510(k)". (f) SECTION 517.—Section 517(a)(10) (21 U.S.C. 360g(a)(10)) is amended by striking out "520(c)(4)(B)" and inserting in lieu thereof " 520(h)(4)(B)".

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