Page:United States Statutes at Large Volume 116 Part 1.djvu/715

 PUBLIC LAW 107-188-JUNE 12, 2002 116 STAT. 689 of time after approval of such applications or supplements, not to exceed three years."; and (4) in paragraph (8>— (A) by striking the matter after and below subparagraph (B); (B) by striking subparagraph (B); (C) by striking "is the lower of' and all that follows through "Consumer Price Index" and inserting "is the Consumer Price Index"; and (D) by striking "1997, or" and inserting "1997.". SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES. (a) TYPES OF FEES. —Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended— (1) in the matter preceding paragraph (1), by striking "fiscal year 1998" and inserting "fiscal year 2003"; (2) in paragraph (1)(A)— (A) in each of clauses (i) and (ii), by striking "in subsection (b)" and inserting "under subsection (c)(4)"; and (B) in clause (ii), by adding at the end the following sentence: "Such fee shall be half of the amount of the fee established under clause (i)."; (3) in paragraph (2)(A), in the matter after and below clause (ii)— (A) by striking "in subsection (b)" and inserting "under subsection (c)(4)"; and (B) by striking "payable on or before January 31" and inserting "payable on or before October 1"; and (4) in paragraph (3)— (A) by amending subparagraph (A) to read as follows: "(A) IN GENERAL.— Except as provided in subparagraph (B), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4). Such fee shall be payable on or before October 1 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable."; and (B) in subparagraph (B), by striking "The listing" and all that follows through "filed under section 505(b)(2)" and inserting the following: "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 505(j)(7)(A) with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 505(b)". (b) FEE AMOUNTS. —Section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows: "(b) FEE REVENUE AMOUNTS.—Except as provided in subsections (c), (d), (f), and (g), fees under subsection (a) shall be established to generate the following revenue amounts:

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