121 STAT. 828
‘‘(B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)). ‘‘(2) TYPES OF FEES.—Of the total revenue amount determined for a fiscal year under paragraph (1)— ‘‘(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements); ‘‘(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and ‘‘(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products). ‘‘(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL YEAR 2007.—For purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of commercial investigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12month period for which data on such submissions is available. ‘‘(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY.— ‘‘(A) IN GENERAL.—For each of the fiscal years 2008 through 2012, paragraph (1)(A) shall be applied by substituting the amount determined under subparagraph (B) for ‘$392,783,000’. ‘‘(B) AMOUNT DETERMINED.—For each of the fiscal years 2008 through 2012, the amount determined under this subparagraph is the sum of— ‘‘(i) $392,783,000; plus ‘‘(ii)(I) for fiscal year 2008, $25,000,000; ‘‘(II) for fiscal year 2009, $35,000,000; ‘‘(III) for fiscal year 2010, $45,000,000; ‘‘(IV) for fiscal year 2011, $55,000,000; and ‘‘(V) for fiscal year 2012, $65,000,000.’’. (c) ADJUSTMENTS TO FEES.— (1) INFLATION ADJUSTMENT.—Section 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended— (A) in the matter preceding subparagraph (A), by striking ‘‘The revenues established in subsection (b)’’ and inserting ‘‘For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)’’; (B) in subparagraph (A), by striking ‘‘or’’ at the end; (C) in subparagraph (B), by striking the period at the end and inserting ‘‘, or’’; (D) by inserting after subparagraph (B) the following: ‘‘(C) the average annual change in the cost, per fulltime equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.’’; and (E) in the matter following subparagraph (C) (as added by subparagraph (D)), by striking ‘‘fiscal year 2003’’ and inserting ‘‘fiscal year 2008’’.
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