Page:United States Statutes at Large Volume 116 Part 2.djvu/817

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PUBLIC LAW 107-250—OCT. 26, 2002 116 STAT. 1599 " (h) CREDITING AND AVAILABILITY OF FEES.— "(1) IN GENERAL. —Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications. "(2) COLLECTIONS AND APPROPRIATION ACTS. — "(A) IN GENERAL.— The fees authorized by this section— "(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and "(ii) shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2002 multiplied by the adjustment factor. "(B) COMPLIANCE.— The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of device applications— "(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or "(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and "(II) such costs are not more than 5 percent below the level specified in such subparagraph. " (3) AUTHORIZATION OF APPROPRIATIONS.—T here are authorized to be appropriated for fees under this section— "(A) $25,125,000 for fiscal year 2003; " (B) $27,255,000 for fiscal year 2004; "(C) $29,785,000 for fiscal year 2005; " (D) $32,615,000 for fiscal year 2006; and "(E) $35,000,000 for fiscal year 2007, as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by application fees. "(4) OFFSET. —Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted