Page:United States Statutes at Large Volume 116 Part 2.djvu/814

 116 STAT. 1596 PUBLIC LAW 107-250—OCT. 26, 2002 be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement. " (D) REQUEST FOR FEE WAIVER OR REDUCTION. —An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable. " (e) SMALL BUSINESSES; FEE REDUCTION REGARDING PRE- MARKET NOTIFICATION SUBMISSIONS.— "(1) IN GENERAL. —Where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(l)(A)(vii) may be paid at a reduced rate in accordance with paragraph (2)(C). " (2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS- SIONS.— "(A) DEFINITION. —For purposes of this subsection, the term 'small business' means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms. "(B) EVIDENCE OF QUALIFICATION. —An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate. The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, partners, and parent firms, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, partners, and parent firms, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively. " (C) REDUCED FEES. — "(i) IN GENERAL.— Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 80 percent of the fee that applies under subsection (a)(l)(A)(vii), as adjusted under clause (ii) and as established under subsection (c)(5). " (ii) ADJUSTMENT PER FEE REVENUE AMOUNT. —For fiscal year 2004 and each subsequent fiscal year, the Secretary, in setting the revenue amount under subsection (c)(5) for premarket notification submissions, shall determine the revenue amount that would apply if all such submissions for the fiscal year involved paid a fee equal to 1.42 percent of the amount that applies under subsection (a)(l)(A)(i) for premarket

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