Page:United States Statutes at Large Volume 117.djvu/1389

 117 STAT. 1370

PUBLIC LAW 108–130—NOV. 18, 2003

Deadline.

‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS.—To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due. ‘‘(j) CONSTRUCTION.—This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged. ‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICATIONS.—The Secretary shall— ‘‘(1) to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications, and ‘‘(2) adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.’’.

21 USC 379j–11 note.

SEC. 4. ACCOUNTABILITY AND REPORTS.

Federal Register, publication.

Deadline.

VerDate 11-MAY-2000

10:15 Aug 27, 2004

(a) PUBLIC ACCOUNTABILITY.— (1) CONSULTATION.—In developing recommendations to Congress for the goals and plans for meeting the goals for the process for the review of animal drug applications for the fiscal years after fiscal year 2008, and for the reauthorization of sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (as added by section 3), the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, veterinary professionals, representatives of consumer advocacy groups, and the regulated industry. (2) RECOMMENDATIONS.—The Secretary shall— (A) publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; (B) present the recommendations to the Committees referred to in that paragraph; (C) hold a meeting at which the public may comment on the recommendations; and (D) provide for a period of 30 days for the public to provide written comments on the recommendations. (b) PERFORMANCE REPORTS.—Beginning with fiscal year 2004, not later than 60 days after the end of each fiscal year during which fees are collected under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 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 2(3) of this Act toward expediting the animal drug development

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