12 2 STA T .35 1 0PUBLIC LA W 110 – 31 6— AU G .1 4, 200 8theanim a ldrug de v el op ment pro c e s s and the revie w o f new and supplemental animal drug applications and investigational animal drug su b missions as set forth in the goals identified , for purposes of part 4 of subchapter C of chapter VI Iofthe F ederal Food, D rug, and Cosmetic A ct, in the letters from the S ecretar y of H ealth and Human Services to the Chairman of the Committee on E nergy and Commerce of the House of R epresentatives and the Chairman of the Committee on Health, Education, L abor, and P ensions of the Senate as set forth in the Congressional Record .SEC.102 . D E FIN I T I O NS. Section 739(21U .S.C. 379 j– 11 ) is amended — (1) in paragraph ( 6 ), by stri k ing ‘ ‘,e x cept for an approved application for which all subject products have been removed from listing under section 5 1 0’ ’ and inserting ‘‘that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary’’
(2) in paragraph ( 8 )(H), by striking ‘‘but not such activities after an animal drug has been approved’’ and inserting ‘‘but not after such application has been approved’’; (3) in paragraph (10), by striking ‘‘year being 2003’’ and inserting ‘‘month being O ctober 2002’’; (4) by redesignating paragraph (11) as paragraph (12); and (5) by inserting after paragraph (10) the following
‘‘(11) T he term ‘person’ includes an affiliate thereof.’’. SEC. 10 3 . AU T H O R IT Y TO ASSESS AND USE ANI M A L DRU G FEES. (a) T YPESOF FEES.—Section 740(a) (21 U.S.C. 379j–12(a)) is amended— (1) in paragraph (1)(A)(i), by inserting after ‘‘for an animal drug application’’ the following: ‘‘, except an animal drug application subject to the criteria set forth in section 512(d)(4)’’; and (2) by amending paragraph (1)(A)(ii) to read as follows: ‘‘(ii) A fee established in subsection (b), in an amount that is e q ual to 50 percent of the amount of the fee under clause (i), for— ‘‘(I) a supplemental animal drug application for which safety or effectiveness data are required; and ‘‘(II) an animal drug application subject to the criteria set forth in section 512(d)(4).’’. (b) FEE A M O UNT S.— (1) TOT AL FEE R E V ENUES FOR APPL IC ATION AN D SUPPLEMENT FEES.—Section 740(b)(1) (21 U.S.C. 379j–12(b)(1)) is amended— (A) by striking ‘‘and supplemental animal drug applica - tion fees’’ and inserting ‘‘and supplemental and other animal drug application fees’’; and ( B ) by striking ‘‘ $ 1,250,000’’ and all that follows through the period at the end and inserting ‘‘$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.’’. (2) TOTAL FEE REVENUES FOR PRODUCT FEES.—Section 740(b)(2) (21 U.S.C. 379j–12(b)(2)) is amended by striking ‘‘$1,250,000’’ and all that follows through the period at the end and inserting ‘‘$3,815,000 for fiscal year 2009, $4,320,000
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