Page:United States Statutes at Large Volume 116 Part 1.djvu/716

 s 116 STAT. 690 PUBLIC LAW 107-188-JUNE 12, 2002 'Type of Fee Revenue Application/Sup- Establishment Product Total Fee Revenue Fiscal Year 2003 $74,300,000 $74,300,000 $74,300,000 $222,900,000 Fiscal Year 2004 $77,000,000 $77,000,000 $77,000,000 $231,000,000 Fiscal Year 2005 $84,000,000 $84,000,000 $84,000,000 $252,000,000 Fiscal Year 2006 $86,434,000 $86,433,000 $86,433,000 $259,300,000 Fiscal Year 2007 $86,434,000 $86,433,000 $86,433,000 $259,300,000 Effective date. Federal Register, publication. If, after the date of the enactment of the Prescription Drug User Fee Amendments of 2002, legislation is enacted requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of human drug applications. ". (c) ADJUSTMENTS. —Section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended— (1) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking "fees and total fee revenues" and inserting "revenues"; (B) in subparagraph (A)— (i) by striking "during the preceding fiscal year"; and (ii) by striking ", or" and inserting the following: "for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or; (C) in subparagraph (B), by striking "for such fiscal year" and inserting "for the previous fiscal year"; and (D) in the matter after and below subparagraph (B), by striking "fiscal year 1997"; and inserting "fiscal year 2003"; (2) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; (3) by inserting after paragraph (1) the following paragraphs: "(2) WORKLOAD ADJUSTMENT. —Beginning with fiscal year 2004, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of human drug applications. With respect to such adjustment: "(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary. The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies. "(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues for the fiscal year established in subsection (b), as adjusted for inflation under paragraph (1).

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