Page:United States Statutes at Large Volume 116 Part 1.djvu/717

 PUBLIC LAW 107-188—JUNE 12, 2002 116 STAT. 691 "(3) FINAL YEAR ADJUSTMENT. —For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees estabhshed in subsection (b) if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug appHcations for the first three months of fiscal year 2008. 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 2007. If the Secretary has carryover balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made."; and (4) in paragraph (4) (as redesignated by paragraph (2) of this subsection), by amending such paragraph to read as follows: "(4) ANNUAL FEE SETTING.— The Secretary shall, 60 days Effective date. before the start of each fiscal year that begins after September 30, 2002, establish, for the next fiscal year, application, product, and establishment fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection.". (d) FEE WAIVER OR REDUCTION.— Section 736(d)) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended— (1) in paragraph (1)— (A) in subparagraph (C), by inserting "or" after the comma at the end; (B) by striking subparagraph (D); and (C) by redesignating subparagraph (E) as subparagraph (D); and (2) in paragraph (3), in each of subparagraphs (A) and (B), by striking "paragraph (1)(E)" each place such term appears and inserting "paragraph (1)(D)". ' (e) ASSESSMENT OF FEES. —Section 736(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended— (1) in the heading for the subsection, by striking "ASSESS- MENT OF FEES.— " and inserting "LIMITATIONS.— "; and (2) in paragraph (1), by striking the heading for the paragraph and all that follows through "fiscal year beginning" and inserting the following: "IN GENERAL.— Fees under subsection (a) shall be refunded for a fiscal year beginning". (f) CREDITING AND AVAILABILITY OF FEES. — (1) IN GENERAL. — Section 736(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(l)) is amended by striking "Fees collected for a fiscal year" and all that follows through "fiscal year limitation." and inserting the following: "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.". (2) COLLECTIONS AND APPROPRIATION ACTS.— Section 736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(2)) is amended— (A) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively;

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