Page:United States Statutes at Large Volume 121.djvu/851

 121 STAT. 830

PUBLIC LAW 110–85—SEPT. 27, 2007

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‘‘(4) FINAL YEAR ADJUSTMENT.— ‘‘(A) INCREASE IN FEES.—For fiscal year 2012, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for the process for the review of human drug applications for the first 3 months of fiscal year 2013. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2012. If the Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made. ‘‘(B) DECREASE IN FEES.— ‘‘(i) IN GENERAL.—For fiscal year 2012, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), decrease the fee revenues and fees established in subsection (b) by the amount determined in clause (ii), if, for fiscal year 2009 or 2010— ‘‘(I) the amount of the total appropriations for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total appropriations for the Food and Drug Administration for fiscal year 2008 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under paragraph (1); and ‘‘(II) the amount of the total appropriations expended for the process for the review of human drug applications at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations expended for the process for the review of human drug applications at the Food and Drug Administration for fiscal year 2008 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under paragraph (1). ‘‘(ii) AMOUNT OF DECREASE.—The amount determined in this clause is the lesser of— ‘‘(I) the amount equal to the sum of the amounts that, for each of fiscal years 2009 and 2010, is the lesser of— ‘‘(aa) the excess amount described in clause (i)(II) for such fiscal year; or ‘‘(bb) the amount specified in subsection (b)(4)(B)(ii) for such fiscal year; or ‘‘(II) $65,000,000. ‘‘(iii) LIMITATIONS.— ‘‘(I) FISCAL YEAR CONDITION.—In making the determination under clause (ii), an amount described in subclause (I) of such clause for fiscal year 2009 or 2010 shall be taken into account

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