Page:United States Statutes at Large Volume 118.djvu/934

 118 STAT. 904 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(ii) a conditional approval of an application filed pursuant to section 571 with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such conditionally approved application; or ‘‘(iii) an index listing pursuant to section 572 with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such index listing; and ‘‘(B) such animal feed is manufactured at a site for which there is in effect a license issued pursuant to subsection (m)(1) to manufacture such animal feed.’’. (J) Section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘under paragraph (1) or a request for an investigational exemption under subsection (j)’’ and inserting ‘‘under paragraph (1), section 571, or a request for an investigational exemption under subsection (j)’’. (K) Section 512(d)(4) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘have previously been separately approved’’ and inserting ‘‘have previously been separately approved pursuant to an application submitted under section 512(b)(1)’’. (L) Section 512(f) of the Federal Food, Drug, and Cos metic Act is amended by striking ‘‘subsection (d), (e), or (m)’’ and inserting ‘‘subsection (d), (e), or (m), or section 571 (c), (d), or (e)’’. (M) Section 512(g) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘this section’’ and inserting ‘‘this section, or section 571’’. (N) Section 512(i) of the Federal Food, Drug, and Cos metic Act is amended by striking ‘‘subsection (b)’’ and inserting ‘‘subsection (b) or section 571’’ and by inserting ‘‘or upon failure to renew a conditional approval under section 571’’ after ‘‘or upon its suspension’’. (O) Section 512(l)(1) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘subsection (b)’’ and inserting ‘‘subsection (b) or section 571’’. (P) Section 512(m)(1)(C) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘applicable regu lations published pursuant to subsection (i)’’ and inserting ‘‘applicable regulations published pursuant to subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to section 572(e)(2) and the labeling requirements set forth in section 572(h)’’. (Q) Section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act is amended by inserting ‘‘or an index listing pursuant to section 572(e)’’ after ‘‘subsection (i)’’ each place it appears. (R) Section 512(p)(1) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘subsection (b)(1)’’ and inserting ‘‘subsection (b)(1) or section 571(a)’’. (S) Section 512(p)(2) of the Federal Food, Drug, and Cosmetic Act is amended by striking ‘‘subsection (b)(1)’’ and inserting ‘‘subsection (b)(1) or section 571(a)’’. 21 USC 360b.

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