PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 835
dkrause on GSDDPC44 with PUBLAW
‘‘(i) October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1); or ‘‘(ii) for fiscal year 2008, 120 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 or an earlier date specified by the Secretary. ‘‘(C) LATE NOTICE OF SUBMISSION.—If, in the first fiscal year of a person’s participation in the program under this section, that person submits any DTC advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(E)(ii). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review. ‘‘(D) LATE PAYMENT.— ‘‘(i) IN GENERAL.—Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person required to pay the fee has not paid the complete operating reserve fee by— ‘‘(I) for fiscal year 2008, 150 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 or an earlier date specified by the Secretary; or ‘‘(II) in any subsequent year, November 1. ‘‘(ii) COMPLETE PAYMENT.—The complete operating reserve fee shall be due and payable 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review. ‘‘(iii) AMOUNT.—Notwithstanding any other provision of this section, an operating reserve fee that is regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee that otherwise would have applied pursuant to subsection (d). ‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.—Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections (c) and (g)(4). ‘‘(c) ADJUSTMENTS.— ‘‘(1) INFLATION ADJUSTMENT.—Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of— ‘‘(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established; ‘‘(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance
VerDate Aug 31 2005
13:52 Jan 23, 2009
Effective date. Notice. Federal Register, publication.