PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 829
dkrause on GSDDPC44 with PUBLAW
(2) WORKLOAD ADJUSTMENT.—Section 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended— (A) in the matter preceding subparagraph (A), by striking ‘‘Beginning with fiscal year 2004,’’ and inserting ‘‘For fiscal year 2009 and subsequent fiscal years,’’; (B) in subparagraph (A), in the first sentence— (i) by striking ‘‘human drug applications,’’ and inserting ‘‘human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph),’’; (ii) by striking ‘‘commercial investigational new drug applications,’’; and (iii) by inserting before the period the following: ‘‘, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available’’; (C) in subparagraph (B), by adding at the end the following: ‘‘Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.’’; and (D) by adding at the end the following: ‘‘(C) The Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees and revenue amounts for fiscal year 2009 and to make recommendations, if warranted, for future changes in the methodology for calculating the adjustment. After review of the recommendations, the Secretary shall, if warranted, make appropriate changes to the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The Secretary shall not make any adjustment for changes in review activities for any fiscal year after 2009 unless such study has been completed.’’. (3) RENT AND RENT-RELATED COST ADJUSTMENT.—Section 736(c) (21 U.S.C. 379h(c)) is amended— (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and (B) by inserting after paragraph (2) the following: ‘‘(3) RENT AND RENT-RELATED COST ADJUSTMENT.—For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, before making adjustments under paragraphs (1) and (2), decrease the fee revenue amount established in subsection (b) if actual costs paid for rent and rent-related expenses for the preceding fiscal year are less than estimates made for such year in fiscal year 2006. Any reduction made under this paragraph shall not exceed the amount by which such costs fall below the estimates made in fiscal year 2006 for such fiscal year, and shall not exceed $11,721,000 for any fiscal year.’’. (4) FINAL YEAR ADJUSTMENT.—Paragraph (4) of section 736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), is amended to read as follows:
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