Page:United States Statutes at Large Volume 106 Part 5.djvu/859

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PUBLIC LAW 102-571—OCT. 29, 1992 106 STAT. 4497 "(e) EFFECT OF FAILURE TO PAY FEES. —A human drug application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. "(f) ASSESSMENT OP FEES.— "(1) LIMITATION. —Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 1993 unless appropriations for salaries and expenses of the Food and Drug Acuninistration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1992 multiplied by the ac^ustment factor applicable to the fiscal yecur involved. "(2) AUTHORITY. — -If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for human drug applications and supplements, prescription drug establishments, and prescription drug products at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid, "(g) CREDITING AND AVAILABILITY OF FEES.— "(1) IN GENERAL.—Fees collected for a fiscal year pursuant to subsection (a) shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration . and shall be available in accordance with appropriation Acts until expended without fiscal year limitation. "(2) CoLLEcmoNS AND APPROPRIATION ACTS.— The fees authorized by this section— "(A) shall be collected in each fiscal year in an amount equal to the amount specified in appropriation Acts for suchfiscalyear, and "(B) shall only be collected and available to defiray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of fiili-time equivalent positions in the Department of Healtii and Human Services to be engaged in such process) over such costs for fiscal year 1992 multiplied by the adjustment factor. "(3) AUTHORIZATION OF APPROPRIATIONS. —T here are authorized to be appropriated for fees under this section— "(A) $36,000,000 forfiscalyear 1993, "(B) $54,000,000 forfiscalyear 1994, "(C) $75,000,000 forfiscalyear 1995, "(D) $78,000,000 forfiscalyear 1996, and "(E) $84,000,000 forfiscalyear 1997, as adjusted to reflect increases in the total fee revenues made under subsection (c)(D. "(h) COLLECTION OF UNPAID FEES. — In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.