Source: http://topics.law.cornell.edu/uscode/text/21/355a?quicktabs_8=2
Timestamp: 2013-12-10 23:27:00
Document Index: 87780380

Matched Legal Cases: ['§ 355', '§ 355', '§ 355', '§ 1104', '§ 502', '§ 7002', '§ 901', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355']

21 USC § 355a - Pediatric studies of drugs | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter V › Part A › § 355a	prevnext
21 USC § 355a - Pediatric studies of drugs
(b)(1) of this title, issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such request to conduct pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such studies.
Relationship to pediatric research requirements Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section.
Dissemination of information regarding labeling changes Beginning on September 27, 2007, the Secretary shall include as a requirement of a written request that the sponsors of the studies that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(3)(F) distribute, at least annually (or more frequently if the Secretary determines that it would be beneficial to the public health), such information to physicians and other health care providers.
Reporting in year one Beginning on September 27, 2007, during the one-year period beginning on the date a labeling change is approved pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics established under section 393a of this title. In considering the reports, the Director of such Office shall provide for the review of the reports by the Pediatric Advisory Committee, including obtaining any recommendations of such Committee regarding whether the Secretary should take action under this chapter in response to such reports.
Reporting in subsequent years Following the one-year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee regarding whether the Secretary should take action in response to such reports.
Referral if pediatric studies not completed (1)
In general Beginning on September 27, 2007, if pediatric studies of a drug have not been completed under subsection (d) and if the Secretary, through the committee established under section 355d of this title, determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall carry out the following:
For a drug for which a listed patent has not expired, make a determination regarding whether an assessment shall be required to be submitted under section 355c
(b) of this title. Prior to making such a determination, the Secretary may not take more than 30 days to certify whether the Foundation for the National Institutes of Health has sufficient funding at the time of such certification to initiate and fund all of the studies in the written request in their entirety within the timeframes specified within the written request. Only if the Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for the National Institutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the Secretary shall consider whether assessments shall be required under section 355c
(b) of this title for such drug.
For a drug that has no listed patents or has 1 or more listed patents that have expired, the Secretary shall refer the drug for inclusion on the list established under section 284m of title 42 for the conduct of studies.
Sunset A drug may not receive any 6-month period under subsection (b) or (c) unless—
on or before October 1, 2012, an application for the drug is accepted for filing under section 355
(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.)
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].”
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 355ant new2012112-144 [Sec.] 509(g)126 Stat. 1050 § 355a2012112-144 [Sec.] 509(a)126 Stat. 1047 § 355ant new2012112-144 [Sec.] 504126 Stat. 1040 § 355a2012112-144 [Sec.] 502(b)126 Stat. 1040 § 355ant new2012112-144 [Sec.] 503126 Stat. 1040 § 355a2012112-144 [Sec.] 502(a)(1)126 Stat. 1040 § 355a2012112-144 [Sec.] 501(a)126 Stat. 1039 This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.21 CFR - Food and Drugs21 CFR 3 - PRODUCT JURISDICTION21 CFR 5 - ORGANIZATION21 CFR 7 - ENFORCEMENT POLICY21 CFR 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR 20 - PUBLIC INFORMATION21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR 201 - LABELING21 CFR 570 - FOOD ADDITIVES21 CFR 571 - FOOD ADDITIVE PETITIONS21 CFR 700 - GENERAL