Page:United States Statutes at Large Volume 111 Part 3.djvu/213

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2301 only one fee per establishment, notwithstanding the number of prescription drug products manufactured at the establishment. In the event an establishment is listed in a human drug application by more than one applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the applicants whose prescription drug products are manufactured by the establishment during the fiscal year and assessed product fees under paragraph (3). " (B) EXCEPTION.—I f, during the fiscal year, an applicant initiates or causes to be initiated the manufacture of a prescription drug product at an establishment listed in its human drug application— "(i) that did not manufacture the product in the previous fiscal year; and "(ii) for which the full establishment fee has been assessed in the fiscal year at a time before manufacture of the prescription drug product was begun; the applicant will not be assessed a share of the establishment fee for the fiscal year in which the manufacture of the product began."; and (4) in paragraph (3)— (A) in subparagraph (A)— (i) in clause (i), by striking "is listed" and inserting "has been submitted for listing'; and (ii) by striking "Such fee shall be payable" and all that follows through "section 510." and inserting the following: "Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 510, or is submitted for relisting under section 510 if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 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 "505(j)." and inserting the following: "505(j), under an abbreviated application filed under section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.". (b) FEE AMOUNTS. —Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows: "(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), (f), and (g), the fees required under subsection (a) shall be determined and assessed as follows: " (1) APPLICATION AND SUPPLEMENT FEES. — "(A) FULL FEES.— The application fee under subsection (a)(l)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 in each of fiscal years 1999 and 2000, $267,606 in fiscal year 2001, and $258,451 in fiscal year 2002. "(B) OTHER FEES.— The fee under subsection (a)(l)(A)(ii) shall be $125,352 in fiscal year 1998, $128,169

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