Page:United States Statutes at Large Volume 116 Part 2.djvu/818

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116 STAT. 1600 PUBLIC LAW 107-250—OCT. 26, 2002 Deadline. Deadline. 21 USC 379j note. 21 USC 379i note. Deadline. from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year. "(i) COLLECTION OF UNPAID FEES. —In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code. "(j) WRITTEN REQUESTS FOR REFUNDS. —To qualify for consideration for a refund under subsection (a)(1)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due. "(k) CONSTRUCTION. —T his 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 device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.". (b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PRE- MARKET REPORTS. — (1) IN GENERAL.— ^A person submitting a premarket report to the Secretary of Health and Human Services is exempt from the fee under section 738(a)(l)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section) if— (A) the premarket report is the first such report submitted to the Secretary by the person; and (B) before October 1, 2002, the person submitted a premarket application to the Secretary for the same device as the device for which the person is submitting the premarket report. (2) DEFINITIONS.— For purposes of paragraph (1), the terms "device", "premarket application", and "premarket report" have the same meanings as apply to such terms for purposes of section 738 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section). SEC. 103. ANNUAL REPORTS. Beginning with fiscal year 2003, 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— (1) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part; and (2) 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 during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102. SEC. 104. POSTMARKET SURVEILLANCE. (a) ADDITIONAL AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out postmarket surveillance of medical devices.