118 STAT. 902 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(1) Except as provided in subsection (c)(2), if the Secretary approves or conditionally approves an application for a des ignated new animal drug, the Secretary may not approve or conditionally approve another application submitted for such new animal drug with the same intended use as the designated new animal drug for another applicant before the expiration of seven years from the date of approval or conditional approval of the application. ‘‘(2) If an application filed pursuant to section 512 or section 571 is approved for a designated new animal drug, the Sec retary may, during the 7 year exclusivity period beginning on the date of the application approval or conditional approval, approve or conditionally approve another application under sec tion 512 or section 571 for such drug for such minor use or minor species for another applicant if— ‘‘(A) the Secretary finds, after providing the holder of such an approved application notice and opportunity for the submission of views, that in the granted exclusivity period the holder of the approved application cannot assure the availability of sufficient quantities of the drug to meet the needs for which the drug was designated; or ‘‘(B) such holder provides written consent to the Sec retary for the approval or conditional approval of other applications before the expiration of such exclusivity period.’’. (5) CONFORMING AMENDMENTS.— (A) Section 201(u) of the Federal Food, Drug, and Cos metic Act is amended by striking ‘‘512’’ and inserting ‘‘512, 571’’. (B) Section 201(v) of the Federal Food, Drug, and Cos metic Act is amended by inserting the following after para graph (2): ‘‘Provided that any drug intended for minor use or use in a minor species that is not the subject of a final regulation published by the Secretary through notice and comment rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the exception to the criterion in paragraph (1) has been met) is a new animal drug.’’. (C) Section 301(e) of the Federal Food, Drug, and Cos metic Act is amended by striking ‘‘512(a)(4)(C), 512(j), (l) or (m)’’ and inserting ‘‘512(a)(4)(C), 512 (j), (l) or (m), 572(i).’’ (D) Section 301(j) of the Federal Food, Drug, and Cos metic Act is amended by striking ‘‘520’’ and inserting ‘‘520, 571, 572, 573.’’ (E) Section 502 of the Federal Food, Drug, and Cos metic Act is amended by adding at the end the following new subsection: ‘‘(w) If it is a new animal drug— ‘‘(1) that is conditionally approved under section 571 and its labeling does not conform with the approved application or section 571(f), or that is not conditionally approved under section 571 and its label bears the statement set forth in section 571(f)(1)(A); or ‘‘(2) that is indexed under section 572 and its labeling does not conform with the index listing under section 572(e) or 572(h), or that has not been indexed under section 572 and its label bears the statement set forth in section 572(h).’’. 21 USC 351. 21 USC 331. 21 USC 321.
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