121 STAT. 840
PUBLIC LAW 110–85—SEPT. 27, 2007 ‘‘(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and ‘‘(E) terminating the program under this section pursuant to subsection (f)(2) if that becomes necessary. ‘‘(10) The term ‘resubmission’ means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary’s comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement. ‘‘(11) The term ‘submission for advisory review’ means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.’’.
SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.), as amended by section 104, is further amended by inserting after section 736A the following: 21 USC 379h–2.
dkrause on GSDDPC44 with PUBLAW
Web site.
VerDate Aug 31 2005
08:41 Jul 13, 2009
‘‘SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort. ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year. ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration. ‘‘(d) REAUTHORIZATION.— ‘‘(1) CONSULTATION.—In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with— ‘‘(A) the Committee on Energy and Commerce of the House of Representatives;
Jkt 059194
PO 00001
Frm 00018
Fmt 6580
Sfmt 6581
O:\FROMSTAT\PUBL085.121
APPS10
PsN: PUBL085
�
