Page:United States Statutes at Large Volume 117.djvu/1386

 PUBLIC LAW 108–130—NOV. 18, 2003

117 STAT. 1367

review of animal drug applications in excess of 3 months of such operating reserves, then this adjustment will 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 2008. ‘‘(4) ANNUAL FEE SETTING.—The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2003, for that fiscal year, animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection. ‘‘(5) LIMIT.—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 animal drug applications. ‘‘(d) FEE WAIVER OR REDUCTION.— ‘‘(1) IN GENERAL.—The Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection (a) where the Secretary finds that— ‘‘(A) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, ‘‘(B) the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of animal drug applications for such person, ‘‘(C) the animal drug application or supplemental animal drug application is intended solely to provide for use of the animal drug in— ‘‘(i) a Type B medicated feed (as defined in section 558.3(b)(3) of title 21, Code of Federal Regulations (or any successor regulation)) intended for use in the manufacture of Type C free-choice medicated feeds, or ‘‘(ii) a Type C free-choice medicated feed (as defined in section 558.3(b)(4) of title 21, Code of Federal Regulations (or any successor regulation)), ‘‘(D) the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication, or ‘‘(E) the sponsor involved is a small business submitting its first animal drug application to the Secretary for review. ‘‘(2) USE OF STANDARD COSTS.—In making the finding in paragraph (1)(B), the Secretary may use standard costs. ‘‘(3) RULES FOR SMALL BUSINESSES.— ‘‘(A) DEFINITION.—In paragraph (1)(E), the term ‘small business’ means an entity that has fewer than 500 employees, including employees of affiliates. ‘‘(B) WAIVER OF APPLICATION FEE.—The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all

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