Page:United States Statutes at Large Volume 106 Part 5.djvu/857

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PUBLIC LAW 102-571—OCT. 29, 1992 106 STAT. 4495

    • (A) owns a prescription drug establishment, at which

is manufactured at least 1 prescription drug product which is not the, or not the same as a, product approved under an application filed under section 505(b)(2) or 505(j), and

    • (B) after September 1, 1992, had pending before the

Secretary a human drug application or supplement, shall be subject to the annual fee established in subsection (b) for each such establishment, payable on or before January 31 of each year. "(3) PRESCRIPTION DRUG PRODUCT FEE. — "(A) IN GENERAL.— Except as provided in subparagraph (B), each person— "(i) who is named as the applicant in a human drug application for a prescription drug product which is listed under section 510, and "(ii) 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 in subsection (b). Such fee shall be payable at the time of the first such listing of such product in each calendar year. Such fee shall be paid only once each year for each listed prescription drug product irrespective of the number of times such product is listed under section 510. "(B) EXCEPTION. — The listing of a prescription drug product under section 510 shall not require the person who listed such product to pay the fee prescribed by subparagraph (A) if such product is the same product as a product approved under an application filed under section 505(b)(2)or505(j). "(b) FEE AMOUNTS. — "(1) SCHEDULE. —Except as provided in paragraph (2) and subsections (c), (d), (f), and (g), the fees required under subsection (a) shall be paid in accordance with the following schedule: Drug application fee: Subs e ction (a)(l)(A)(i) fee Subsection (a)(l)(A)(ii) fee Annual establishment fee: Fee per estab- Annual product fee: Fee revenue Fiscal Year 1993 $100,000 $50,000 $12,000,000 $60,000 $12,000,000 $6,000 $12,000,000 $36,000,000 Fiscal Year 1994 $150,000 $75,000 $18,000,000 $88,000 $18,000,000 $9,000 $18,000,000 $54,000,000 Fiscal Year 1995 $208,000 $104,000 $25,000,000 $126,000 $25,000,000 $12,600 $25,000,000 $75,000,000 Fiscal Year 1996 $217,000 $108,000 $26,000,000 $131,000 $26,000,000 $13,000 $26,000,000 $78,000,000 Fiscal Year 1997 $233,000 $116,000 $28,000,000 $138,000 $28,000,000 $14,000 $28,000,000 $84,000,000 "(2) SMALL BUSINESS EXCEPTION.—Any business which has fewer than 500 employees, including employees of affiliates, and which does not have a prescription drug product introduced