Page:United States Statutes at Large Volume 121.djvu/859

 121 STAT. 838

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Effective date. Notification.

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PUBLIC LAW 110–85—SEPT. 27, 2007 the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded. ‘‘(2) LATER FISCAL YEARS.—Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall terminate, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year. ‘‘(g) CREDITING AND AVAILABILITY OF FEES.— ‘‘(1) IN GENERAL.—Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising. ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— ‘‘(A) IN GENERAL.—The fees authorized by this section— ‘‘(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and ‘‘(ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of fulltime equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007. ‘‘(B) REVIEW EMPLOYEES.—For purposes of subparagraph (A)(ii), the term ‘full-time equivalent review employees’ means the total combined number of full-time equivalent employees in— ‘‘(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and ‘‘(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration. ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the

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