12 2 STA T .35 11 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8for f iscalye ar 201 0 ,$4 , 86 2,000 for fiscal year 2011, $ 5 ,442,000 for fiscal year 2012, a nd $6,061,000 for fiscal year 201 3.’ ’. ( 3 )TOTALFE E R E V E NU E S FOR ESTA B L I S HM ENT FEES. —S ec -t ion 7 40( b )(3) (21 U .S. C . 37 9j– 12(b)(3)) is a m ended by stri k in g‘ ‘$1,250,000’’ and all t h at follo w s thro u gh the p eriod 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.’’. (4) TOTAL FEE REVENUES FOR S P ONSOR FEES.—Section 740(b)(4) (21 U.S.C. 379j–12(b)(4)) 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 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.’’. (c) ADJ USTMENTS TO F EES.—Section 740(c) (21 U.S.C. 379j– 12(c)) is amended— (1) by striking paragraph (1)
(2) by redesignating paragraphs (2) through (5) as para- graphs (1) through (4), respecti v ely; (3) in paragraph (1), as so redesignated— (A) in the matter preceding subparagraph (A), by striking ‘‘After the fee revenues are adjusted for inflation in accordance with paragraph (1), the fee revenues shall be further adjusted each fiscal year after fiscal year 2004’’ and inserting ‘‘The fee revenues shall be adjusted each fiscal year after fiscal year 2009’’; and ( B ) in subparagraph (B), by striking ‘‘, as adjusted for inflation under paragraph (1)’’; and (4) in paragraph (2), as so redesignated— (A) by striking ‘‘2008’’ each place it appears and inserting ‘‘2013’’; and (B) by striking ‘‘2009’’ and inserting ‘‘2014’’. (d) AUTHORI Z ATION OF APPROPRIATIONS.—Subparagraphs (A) through ( E ) of section 740(g)(3) (21 U.S.C. 379j–12(g)(3)) are amended to read as follows
‘‘(A) $15,260,000 for fiscal year 2009; ‘‘(B) $17,280,000 for fiscal year 2010; ‘‘(C) $19,448,000 for fiscal year 2011; ‘‘( D ) $21,768,000 for fiscal year 2012; and ‘‘(E) $24,244,000 for fiscal year 2013;’’. (e) O FFSET.—Section 740(g)(4) (21 U.S.C. 379j–12(g)(4)) is amended to read as follows: ‘‘(4) OFFSET.— I f the sum of the cumulative amount of fees collected under this section for fiscal years 2009 through 2011 and the amount of fees estimated to be collected under this section for fiscal year 2012 e x ceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2009 through 2012, the excess amount shall be credited to the appro- priation account of the Food and Drug Administration as pro- vided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authori z ed to be collected under this section pursuant to appropriation Acts for fiscal year 2013.’’. SEC.104 . R E AUTHO R IZ ATIO N; RE P ORTIN G RE Q UIRE M ENTS. P art 4 of subchapter C of chapter V II (21 U.S.C. 379j–11 et se q .) is amended by inserting after section 740 the following:
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