Page:United States Statutes at Large Volume 121.djvu/860

This page needs to be proofread.
[121 STAT. 839]
[121 STAT. 839]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 839

dkrause on GSDDPC44 with PUBLAW

fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under subsection (d). ‘‘(4) OFFSET.—Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year. ‘‘(h) DEFINITIONS.—For purposes of this section: ‘‘(1) The term ‘advisory review’ means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this Act prior to its initial public dissemination. ‘‘(2) The term ‘advisory review fee’ has the meaning indicated for such term in subsection (a)(1)(D). ‘‘(3) The term ‘carry over submission’ means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year. ‘‘(4) The term ‘direct-to-consumer television advertisement’ means an advertisement for a prescription drug product (as defined in section 735(3)) intended to be displayed on any television channel for less than 3 minutes. ‘‘(5) The term ‘DTC advertisement’ has the meaning indicated for such term in subsection (a)(1)(A). ‘‘(6) The term ‘operating reserve fee’ has the meaning indicated for such term in subsection (a)(2)(A). ‘‘(7) The term ‘person’ includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest. ‘‘(8) The term ‘process for the advisory review of prescription drug advertising’ means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination. ‘‘(9) The term ‘resources allocated for the process for the advisory review of prescription drug advertising’ means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for— ‘‘(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, and to contracts with such contractors; ‘‘(B) management of information, and the acquisition, maintenance, and repair of computer resources; ‘‘(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;

VerDate Aug 31 2005

13:52 Jan 23, 2009

Jkt 059194

PO 00001

Frm 00837

Fmt 6580

Sfmt 6581

M:\STATUTES\2007\59194PT1.001

APPS10

PsN: 59194PT1