121 STAT. 842
PUBLIC LAW 110–85—SEPT. 27, 2007 by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.’’.
SEC. 106. SUNSET DATES. 21 USC 379g note. 21 USC 379h–2.
(a) AUTHORIZATION.—The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012. (b) REPORTING REQUIREMENTS.—The amendment made by section 105 ceases to be effective January 31, 2013.
21 USC 379g note.
SEC. 107. EFFECTIVE DATE.
21 USC 379g note.
SEC. 108. SAVINGS CLAUSE.
The amendments made by this title shall take effect on October 1, 2007, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1, 2007, regardless of the date of the enactment of this Act. Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008. SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.
(a) Section 739 (21 U.S.C. 379j–11) is amended in the matter preceding paragraph (1) by striking ‘‘subchapter’’ and inserting ‘‘part’’. (b) Paragraph (11) of section 739 (21 U.S.C. 379j–11) is amended by striking ‘‘735(9)’’ and inserting ‘‘735(11)’’.
TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
Medical Device User Fee Amendments of 2007.
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING. 21 USC 301 note.
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21 USC 379i note.
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(a) SHORT TITLE.—This title may be cited as the ‘‘Medical Device User Fee Amendments of 2007’’. (b) REFERENCES IN TITLE.—Except as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (c) FINDING.—The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy