121 STAT. 866
PUBLIC LAW 110–85—SEPT. 27, 2007
‘‘(1) IN GENERAL.—Each’’; (B) by striking ‘‘The Secretary, in consultation’’ and inserting ‘‘Except as provided in paragraph (2), the Secretary, in consultation’’; (C) by striking ‘‘Any determination’’ and inserting ‘‘Except as provided in paragraph (2), any determination’’; and (D) by adding at the end the following: ‘‘(2) LONGER SURVEILLANCE FOR PEDIATRIC DEVICES.—The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device. ‘‘(c) DISPUTE RESOLUTION.—A manufacturer may request review under section 562 of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the device subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of section 301(q)(1)(C), adulterated under section 501(f)(1), misbranded under section 502(t)(3), or in violation of, as applicable, section 510(k) or section 515, unless deemed necessary to protect the public health.’’.
TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007
Pediatric Research Equity Act of 2007. 21 USC 301 note.
SEC. 401. SHORT TITLE.
This title may be cited as the ‘‘Pediatric Research Equity Act of 2007’’. SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.
(a) IN GENERAL.—Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended to read as follows: ‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS.
dkrause on GSDDPC44 with PUBLAW
‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— ‘‘(1) IN GENERAL.—A person that submits, on or after the date of the enactment of the Pediatric Research Equity Act of 2007, an application (or supplement to an application)— ‘‘(A) under section 505 for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration, or ‘‘(B) under section 351 of the Public Health Service Act (42 U.S.C. 262) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration, shall submit with the application the assessments described in paragraph (2). ‘‘(2) ASSESSMENTS.— ‘‘(A) IN GENERAL.—The assessments referred to in paragraph (1) shall contain data, gathered using appropriate
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