PUBLIC LAW 109–43—AUG. 1, 2005
119 STAT. 439
Public Law 109–43 109th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act with respect to medical device user fees.
Aug. 1, 2005 [H.R. 3423]
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE.
21 USC 301 note.
This Act may be cited as the ‘‘Medical Device User Fee Stabilization Act of 2005’’. SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) DEVICE USER FEES.—Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— (1) in subsection (b)— (A) after ‘‘2004;’’, by inserting ‘‘and’’; and (B) by striking ‘‘2005;’’ and all that follows through ‘‘2007’’ and inserting ‘‘2005’’; (2) in subsection (c)— (A) by striking the heading and inserting ‘‘Annual Fee Setting.—’’; (B) by striking paragraphs (1), (2), (3), and (4); (C) by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively; (D) in paragraph (1), as so redesignated, by— (i) striking the heading and inserting ‘‘IN GENERAL.—’’; (ii) striking ‘‘establish, for the next fiscal year, and’’ and all that follows through ‘‘the fees’’ and inserting ‘‘publish in the Federal Register fees under subsection (a). The fees’’; (iii) striking ‘‘2003’’ and inserting ‘‘2006’’; and (iv) striking ‘‘$154,000.’’ and inserting ‘‘$259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.’’; and (E) by adding at the end the following: ‘‘(3) SUPPLEMENT.— ‘‘(A) IN GENERAL.—For fiscal years 2006 and 2007, the Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of fiscal year 2008.
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