PUBLIC LAW 108–130—NOV. 18, 2003
117 STAT. 1369
‘‘(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 animal drug 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 2003 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 animal drug 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 the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)(ii); and ‘‘(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii). ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated for fees under this section— ‘‘(A) $5,000,000 for fiscal year 2004; ‘‘(B) $8,000,000 for fiscal year 2005; ‘‘(C) $10,000,000 for fiscal year 2006; ‘‘(D) $10,000,000 for fiscal year 2007; and ‘‘(E) $10,000,000 for fiscal year 2008; as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees. ‘‘(4) OFFSET.—Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriations 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 from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year. ‘‘(h) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.
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