Page:United States Statutes at Large Volume 111 Part 3.djvu/214

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Ill STAT. 2302 PUBLIC LAW 105-115—NOV. 21, 1997 in each of fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and $129,226 in fiscal year 2002. "(2) TOTAL FEE REVENUES FOR ESTABLISHMENT FEES. —The total fee revenues to be collected in establishment fees under subsection (a)(2) shall be $35,600,000 in fiscal year 1998, $36,400,000 in each of fiscal years 1999 and 2000, $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal year 2002. "(3) TOTAL FEE REVENUES FOR PRODUCT FEES.— The total fee revenues to be collected in product fees under subsection (a)(3) in a fiscal year shall be equal to the total fee revenues collected in establishment fees under subsection (a)(2) in that fiscal year. ". (c) INCREASES AND ADJUSTMENTS. — Section 736(c) (21 U.S.C. 379h(c)) is amended— (1) in the subsection heading, by striking "INCREASES AND"; (2) in paragraph (1)— (A) by striking "(1) REVENUE" and all that follows through "increased by the Secretary" and inserting the following: "(1) INFLATION ADJUSTMENT. —The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary^'; (B) in subparagraph (A), by striking "increase" and inserting "change"; (C) in subparagraph (B), by striking "increase" and inserting "change"; and (D) by adding at the end the following flush sentence: "The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 1997 under this subsection."; (3) in paragraph (2), by striking "October 1, 1992," and all that follows through "such schedule." and inserting the following: "September 30, 1997, adjust the establishment and product fees described in subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b)."; and (4) in paragraph (3), by striking "paragraph (2)" and inserting "this subsection", (d) FEE WAIVER OR REDUCTION. —Section 736(d) (21 U.S.C. 379h(d)) is amended— (1) by redesignating paragraphs (1), (2), (3), and (4) as subparagraphs (A), (B), (C), and (D), respectively and indenting appropriately; (2) by striking "The Secretary shall grant a" and all that follows through "finds that—" and inserting the following: "(1) IN GENERAL.— The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that—"; (3) in subparagraph (C) (as so redesignated in paragraph (1)), by striking ", or" and inserting a comma; (4) in subparagraph (D) (as so redesignated in paragraph (1)), by striking the period and inserting ", or"; (5) by inserting after subparagraph (D) (as so redesignated in paragraph (1)) the following: