Page:United States Statutes at Large Volume 122.djvu/3541

 12 2 STA T .35 1 8PUBLIC LA W 11 0– 31 6— AU G .1 4, 2008 3months o f o pera t i n g reser v es of c arr y over u ser fees for the process for the revie w ofa b breviate d app l ications for generic new animal drugs for the first 3 months of fiscal year 2014.I f the F ood and D rug A dministration has carryover balances for the process for the review of abbreviated applications for generic new animal drugs in e x cess of 3 months of such oper - ating reserves , then this ad j ustment shall not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2013. ‘ ‘ ( 3 ) A N N UALFE E S E T T I N G . —T he S ecretary shall establish, 6 0 days before the start of each fiscal year beginning after September 30, 200 8, for that fiscal year, abbreviated application fees, generic new animal drug sponsor fees, and generic new animal drug product fees based on the revenue amounts estab- lished under subsection (b) and the adjustments provided under this subsection. ‘‘(4) L I M IT.—The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of abbreviated applications for generic new animal drugs. ‘‘(d) FEE W AI V E RO R R E D U C TION.—The Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication. ‘‘(e) E FFECT OF FAILURE TO P A Y FEES.—An abbreviated applica- tion for a generic new animal drug 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. An investigational submission for a generic new animal drug that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due. ‘‘(f) ASSESSMENT OF FEES.— ‘‘(1) LIMITATION.—Fees may not be assessed under sub- section (a) for a fiscal year beginning after fiscal year 2008 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are e q ual to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved. ‘‘(2) AUT H ORITY.—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 Deadlin e .Ef fe ct i v e date.

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