121 STAT. 852
PUBLIC LAW 110–85—SEPT. 27, 2007 ‘‘(B) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.’’.
21 USC 379i note.
SEC. 214. SAVINGS CLAUSE.
Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250), and notwithstanding the amendments made by this subtitle, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle, shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, 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. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR POSTMARKET SAFETY INFORMATION.
For the purpose of collecting, developing, reviewing, and evaluating postmarket safety information on medical devices, there are authorized to be appropriated to the Food and Drug Administration, in addition to the amounts authorized by other provisions of law for such purpose— (1) $7,100,000 for fiscal year 2008; (2) $7,455,000 for fiscal year 2009; (3) $7,827,750 for fiscal year 2010; (4) $8,219,138 for fiscal year 2011; and (5) $8,630,094 for fiscal year 2012. 21 USC 379i note.
SEC. 216. EFFECTIVE DATE.
21 USC 379i note.
SEC. 217. SUNSET CLAUSE.
The amendments made by this subtitle shall take effect on October 1, 2007, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all premarket applications, premarket reports, supplements, 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the date of the enactment of this Act. The amendments made by this subtitle cease to be effective October 1, 2012, except that section 738A of the Federal Food, Drug, and Cosmetic Act (regarding annual performance and financial reports) ceases to be effective January 31, 2013.
Subtitle B—Amendments Regarding Regulation of Medical Devices SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.
dkrause on GSDDPC44 with PUBLAW
Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ‘‘2007’’ and inserting ‘‘2012’’.
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