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. 355a D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec355a.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec355a.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec355a 21USC355a http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec355a/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec355a.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec355a.htm 21 U.S.C. 355a 21 USC 355a 21 U.S.C. 355a 21 USC 355a; FOOD AND DRUGS; Pediatric studies of drugs 188 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec355a Sec. 355a section standard June 25, 1938, ch. 675, §505A, as added Pub. L. 105-115, title I, §111, Nov. 21, 1997, 111 Stat. 2305; amended Pub. L. 107-109, §§2, 4, 5(b)(2), 7-11(a), 18(a), 19, Jan. 4, 2002, 115 Stat. 1408, 1411, 1413-1415, 1423, 1424; Pub. L. 108-155, §§2(b)(2), 3(a), (b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-173, title XI, §1104, Dec. 8, 2003, 117 Stat. 2461; Pub. L. 110-85, title V, §502(a)(1), Sept. 27, 2007, 121 Stat. 876; Pub. L. 111-148, title VII, §7002(g)(2)(B), Mar. 23, 2010, 124 Stat. 820. referencesInText The Biologics Price Competition and Innovation Act of 2009, referred to in subsec. (p)(4), is subtitle A (§§7001-7003) of title VII of Pub. L. 111-148, Mar. 23, 2010, 124 Stat. 804, which amended sections 355, 355a, 355c, and 379g of this title, section 2201 of Title 28, Judiciary and Judicial Procedure, section 271 of Title 35, Patents, and sections 262 and 284m of Title 42, The Public Health and Welfare, and enacted provisions set out as notes under section 262 of Title 42. For complete classification of subtitle A to the Code, see Short Title of 2010 Amendment note set out under section 201 of Title 42 and Tables. amendments <b>2010</b>-Subsec. (p)(4) to (6). Pub. L. 111-148 added pars. (4) to (6) and struck out former pars. (4) and (5) which read as follows:“(4) review and assess the pediatric studies of biological products as required under subsections (a) and (b) of section 355c of this title; and“(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics.”<b>2007</b>-Pub. L. 110-85 amended section generally. Prior to amendment, text consisted of subsecs. (a) to (n) relating to pediatric studies of drugs, including market exclusivity, conduct of pediatric studies, delay of effective date for certain applications, notice of determinations on studies requirement, limitations, research requirements, labeling supplements, dissemination of information, prompt approval of drugs, report to Congress not later than Jan. 1, 2001, and sunset provisions.<b>2003</b>-Subsec. (b)(1)(A)(i). Pub. L. 108-173, §1104(1), substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places.Subsec. (b)(1)(A)(ii). Pub. L. 108-173, §1104(2), substituted “(j)(5)(F)” for “(j)(5)(D)”.Subsec. (b)(2). Pub. L. 108-155, §3(a), substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places.Subsec. (c)(1)(A)(i). Pub. L. 108-173, §1104(1), substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places.Subsec. (c)(1)(A)(ii). Pub. L. 108-173, §1104(2), substituted “(j)(5)(F)” for “(j)(5)(D)”.Subsec. (c)(2). Pub. L. 108-155, §3(a), substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places.Subsec. (e). Pub. L. 108-173, §1104(3), substituted “355(j)(5)(F)” for “355(j)(5)(D)”.Subsec. (h). Pub. L. 108-155, §2(b)(2), substituted “pediatric research requirements” for “regulations” in heading and “by a provision of law (including a regulation) other than this section” for “pursuant to regulations promulgated by the Secretary” in text.Subsec. (i)(2). Pub. L. 108-155, §3(b)(1), struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee” wherever appearing.Subsec. (<em>l</em>). Pub. L. 108-173, §1104(3), substituted “355(j)(5)(F)” for “355(j)(5)(D)” wherever appearing.<b>2002</b>-Subsec. (a). Pub. L. 107-109, §19(2), (3), redesignated subsec. (g) as (a). Former subsec. (a) redesignated (b).Subsec. (a)(1)(A). Pub. L. 107-109, §19(1)(A), (B), substituted “(j)(5)(D)(ii)” for “(j)(4)(D)(ii)” in two places in cl. (i) and “(j)(5)(D)” for “(j)(4)(D)” in cl. (ii).Subsec. (b). Pub. L. 107-109, §19(2), (3), redesignated subsec. (a) as (b).Pub. L. 107-109, §2(1), struck out heading and text of subsec. (b). Text read as follows: “Not later than 180 days after November 21, 1997, the Secretary, after consultation with experts in pediatric research shall develop, prioritize, and publish an initial list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. The Secretary shall annually update the list.”Subsec. (c). Pub. L. 107-109, §2(2), in introductory provisions, inserted “determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and” after “the Secretary” and struck out “concerning a drug identified in the list described in subsection (b) of this section” after “such studies)”.Subsec. (c)(1)(A). Pub. L. 107-109, §19(1)(A), (B), substituted “(j)(5)(D)(ii)” for “(j)(4)(D)(ii)” in two places in cl. (i) and “(j)(5)(D)” for “(j)(4)(D)” in cl. (ii).Subsec. (d)(1). Pub. L. 107-109, §19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)” in introductory provisions.Subsec. (d)(2). Pub. L. 107-109, §§18(a), 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)” and inserted “In reaching an agreement regarding written protocols, the Secretary shall take into account adequate representation of children of ethnic and racial minorities.” after first sentence.Subsec. (d)(3). Pub. L. 107-109, §19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)”.Subsec. (d)(4). Pub. L. 107-109, §4, added par. (4).Subsec. (e). Pub. L. 107-109, §19(1)(C), (4), substituted “section 355(j)(5)(D)” for “section 355(j)(4)(D)” and “subsection (b) or (c)” for “subsection (a) or (c)”.Subsec. (g). Pub. L. 107-109, §19(2), (3), (5), redesignated subsec. (h) as (g) and substituted “subsection (b) or (c)” for “subsection (a) or (b)” in introductory provisions. Former subsec. (g) redesignated (a).Pub. L. 107-109, §7, inserted “(including neonates in appropriate cases)” after “pediatric age groups”.Subsec. (h). Pub. L. 107-109, §19(2), (3), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).Subsec. (i). Pub. L. 107-109, §19(2), (3), redesignated subsec. (<em>l</em>) as (i). Former subsec. (i) redesignated (h).Subsec. (j). Pub. L. 107-109, §19(2), (3), redesignated subsec. (m) as (j). Former subsec. (j) redesignated (n).Pub. L. 107-109, §8, added subsec. (j) and struck out heading and text of former subsec. (j). Text read as follows: “A drug may not receive any six-month period under subsection (a) or (c) of this section unless the application for the drug under section 355(b)(1) of this title is submitted on or before January 1, 2002. After January 1, 2002, a drug shall receive a six-month period under subsection (c) of this section if-Subsec. (k). Pub. L. 107-109, §19(2), (3), redesignated subsec. (n) as (k). Former subsec. (k) redesignated (m).Subsec. (<em>l</em>). Pub. L. 107-109, §19(2), (3), redesignated subsec. (<em>o</em>) as (<em>l</em>). Former subsec. (<em>l</em>) redesignated (i).Pub. L. 107-109, §5(b)(2), added subsec. (<em>l</em>).Subsec. (m). Pub. L. 107-109, §19(2), (3), redesignated subsec. (k) as (m). Former subsec. (m) redesignated (j).Pub. L. 107-109, §9, added subsec. (m).Subsec. (n). Pub. L. 107-109, §19(4), which directed substitution of “subsection (b) or (c)” for “subsection (a) or (c)” in subsec. (m), was executed by making the substitution in introductory provisions of subsec. (n), to reflect the probable intent of Congress.Pub. L. 107-109, §19(2), (3), redesignated subsec. (j) as (n). Former subsec. (n) redesignated (k).Pub. L. 107-109, §10, added subsec. (n).Subsec. (<em>o</em>). Pub. L. 107-109, §19(2), (3), redesignated subsec. (<em>o</em>) as (<em>l</em>).Pub. L. 107-109, §11(a), added subsec. (<em>o</em>). effectiveDate amendments Pub. L. 110-85, title V, §502(a)(2), Sept. 27, 2007, 121 Stat. 885, provided that:“(A) <cap-smallcap>In general</cap-smallcap>.-The amendment made by this subsection [amending this section] shall apply to written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) issued on or after the date of the enactment of this Act [Sept. 27, 2007].“(B) <cap-smallcap>Certain written requests</cap-smallcap>.-A written request issued under section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been accepted and for which no determination under subsection (d)(2) of such section has been made before such date of enactment, shall be subject to such section 505A, except that such written requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), (<em>l</em>)(1), and (n) of section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on or after the date of the enactment of this Act.”Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108-155, set out as an Effective Date note under section 355c of this title.Pub. L. 107-109, §11(b), Jan. 4, 2002, 115 Stat. 1416, provided that: “The amendment made by subsection (a) [amending this section] takes effect on the date of enactment of this Act [Jan. 4, 2002], including with respect to applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that are approved or pending on that date.” construction amendments Pub. L. 110-85, title IX, §901(e), Sept. 27, 2007, 121 Stat. 942, provided that: “This title [enacting sections 353b, 355-1, 355e, 360a, and 360bbb-6 of this title, amending sections 331, 333, 334, 352, 355, and 381 of this title and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 331, 352, and 355 of this title] and the amendments made by this title may not be construed as affecting the authority of the Secretary of Health and Human Services to request pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a] or to require such studies under section 505B of such Act [21 U.S.C. 355c].” false false false

Part A Drugs and Devices Title 21 Section 355a Title 21 Section 355c Title 21 Section 355(j) 21 U.S.C. 355a 21 U.S.C. 355c 21 U.S.C. 355(j) Volume 111 Page 2305 111 Stat. 2305 Volume 115 Page 1408 115 Stat. 1408 Volume 115 Page 1416 Volume 115 Page 1421 Volume 115 Page 1423 115 Stat. 1416 115 Stat. 1421 115 Stat. 1423 Volume 117 Page 1941 Volume 117 Page 2461 117 Stat. 1941 117 Stat. 2461 Volume 117 Page 1942 117 Stat. 1942 Volume 121 Page 876 121 Stat. 876 Volume 121 Page 885 Volume 121 Page 942 121 Stat. 885 121 Stat. 942 Volume 124 Page 820 124 Stat. 820 Volume 124 Page 804 124 Stat. 804 Public Law 105-115 Public Law 107-109 Public Law 107-109 Public Law 108-155 Public Law 108-155 Public Law 108-173 Public Law 108-173 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