United States Government Printing Office printer prt distributor dst United States Congress House of Representatives Office of the Law Revision Counsel author aut Government Organization text government publication eng USCODE Bills and Statutes 2006_uscode_suppl_4 legislative 2011-09-06 Sec. 355c D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec355c.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec355c.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec355c 21USC355c http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec355c/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec355c.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec355c.htm 21 U.S.C. 355c 21 USC 355c 21 U.S.C. 355c 21 USC 355c; FOOD AND DRUGS; Research into pediatric uses for drugs and biological products 190 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec355c Sec. 355c section standard June 25, 1938, ch. 675, §505B, as added Pub. L. 108-155, §2(a), Dec. 3, 2003, 117 Stat. 1936; amended Pub. L. 110-85, title IV, §402(a), Sept. 27, 2007, 121 Stat. 866; Pub. L. 111-148, title VII, §7002(d)(2), Mar. 23, 2010, 124 Stat. 816. amendments <b>2010</b>-Subsec. (n). Pub. L. 111-148 added subsec. (n).<b>2007</b>-Pub. L. 110-85 amended section generally. Prior to amendment, section related to required submission of assessments with an application for a new drug or new biological product and by order of the Secretary for certain marketed drugs and biological products used for pediatric patients, a definition of meaningful therapeutic benefit, consequences of failure to submit required assessments, meetings of the Secretary and the sponsor of a new drug or biological product, a limitation of the scope of the Secretary's authority, application to orphan drugs, and integration with other pediatric studies. effectiveDate amendments Pub. L. 110-85, title IV, §402(b), Sept. 27, 2007, 121 Stat. 875, provided that:“(1) <cap-smallcap>In general</cap-smallcap>.-Notwithstanding subsection (h) of section 505B of the Federal Food, Drug and Cosmetic Act [21 U.S.C. 355c(h)], as in effect on the day before the date of the enactment of this Act [Sept. 27, 2007], a pending assessment, including a deferred assessment, required under such section 505B shall be deemed to have been required under section 505B of the Federal Food, Drug and Cosmetic Act as in effect on or after the date of the enactment of this Act.“(2) <cap-smallcap>Certain assessments and waiver requests</cap-smallcap>.-An assessment pending on or after the date that is 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure requirements established under such section 505B, as in effect on or after such date of enactment, except that any such assessments submitted or waivers of such assessments requested before such date of enactment shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such section 505B.” effectiveDate Pub. L. 108-155, §4, Dec. 3, 2003, 117 Stat. 1942, provided that:“(a) <cap-smallcap>In General</cap-smallcap>.-Subject to subsection (b), this Act [enacting this section, amending sections 355, 355a, and 355b of this title and sections 262 and 284m of Title 42, The Public Health and Welfare, enacting provisions set out as a note under section 301 of this title, and amending provisions set out as notes under section 355a of this title and section 284m of Title 42] and the amendments made by this Act take effect on the date of enactment of this Act [Dec. 3, 2003].“(b) <cap-smallcap>Applicability to New Drugs and Biological Products.-</cap-smallcap>“(c) <cap-smallcap>No Limitation of Authority</cap-smallcap>.-Neither the lack of guidance or regulations to implement this Act or the amendments made by this Act nor the pendency of the process for issuing guidance or regulations shall limit the authority of the Secretary of Health and Human Services under, or defer any requirement under, this Act or those amendments.” false false false

Part A Drugs and Devices Title 21 Section 355c(a) Title 21 Section 355c(a)(2) Title 21 Section 355c(h) 21 U.S.C. 355c(a) 21 U.S.C. 355c(a)(2) 21 U.S.C. 355c(h) Volume 117 Page 1936 117 Stat. 1936 Volume 117 Page 1942 117 Stat. 1942 Volume 121 Page 866 121 Stat. 866 Volume 121 Page 875 121 Stat. 875 Volume 124 Page 816 124 Stat. 816 Public Law 108-155 Public Law 108-155 Public Law 110-85 Public Law 110-85 Public Law 111-148 Public Law 111-148 U.S. Government Printing Office 2010-12-31 monographic 2010 annual deposited born digital 711 p. Y 1.2/5: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21 P0b002ee180df746e 000645501 21USC DGPO 2011-09-06 2011-09-06 USCODE-2010-title21 machine generated eng fdlp USCODE USCODE-2010-title21 21 true 4 2006 false false 2011-01-07 false false USCODE-title21 Title 21 http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21.htm http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21.pdf U.S.C. Title 21, 2010