Page:United States Statutes at Large Volume 116 Part 1.djvu/718

 116 STAT. 692 PUBLIC LAW 107-188-JUNE 12, 2002 (B) by striking "(2) COLLECTIONS" and all that follows through "the amount specified" in clause (i) (as so redesignated) and inserting the following: " (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"; (C) by moving clause (ii) (as so redesignated) two ems to the right; and (D) by adding at the end the following subparagraph: "(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 human 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 such subparagraph; and "(II) such costs are not more than 5 percent below the level specified in such subparagraph.". (3) AUTHORIZATION OF APPROPRIATIONS.— Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking subparagraphs (A) through (E) and inserting the following: " (A) $222,900,000 for fiscal year 2003; "(B) $231,000,000 for fiscal year 2004; "(C) $252,000,000 for fiscal year 2005; "(D) $259,300,000 for fiscal year 2006; and "(E) $259,300,000 for fiscal year 2007;". Effective dates. SEC. 505. ACCOUNTABILITY AND REPORTS. 2rus^c?79g (a) PUBLIC ACCOUNTABILITY. — note. (1) CONSULTATION. — In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of human drug applications for the fiscal years after fiscal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services (referred to in this section as the "Secretary") shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry. Federal Register, (2) RECOMMENDATIONS. —The Secretary shall publish in the publication. Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide

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