Page:United States Statutes at Large Volume 121.djvu/855

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[121 STAT. 834]
[121 STAT. 834]
PUBLIC LAW 110-000—MMMM. DD, 2007

121 STAT. 834

and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, all advisory review fees for such fiscal year shall be due and payable 20 days before any direct-to-consumer advertisement is submitted to the Secretary for advisory review, and each such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3). ‘‘(ii) EXCEEDING IDENTIFIED NUMBER OF SUBMISSIONS.—If a person submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC advertisement, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3). ‘‘(F) LIMITS.— ‘‘(i) SUBMISSIONS.—For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission. ‘‘(ii) NO REFUNDS.—Except as provided by subsections (d)(4) and (f), fees paid under this section shall not be refunded. ‘‘(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.— The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section. ‘‘(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFERABLE.—The right to an advisory review under this paragraph is not transferable, except to a successor in interest. ‘‘(2) OPERATING RESERVE FEE.— ‘‘(A) IN GENERAL.—Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee established under subsection (d)(2) (referred to in this section as an ‘operating reserve fee’) for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year. ‘‘(B) PAYMENT.—Except as provided in subparagraph (C), the operating reserve fee shall be due no later than—

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PUBLIC LAW 110–85—SEPT. 27, 2007

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