Source: http://www4.law.cornell.edu/uscode/text/21/393a?quicktabs_8=0
Timestamp: 2013-12-10 16:04:30
Document Index: 252393729

Matched Legal Cases: ['§ 393', '§ 393', '§ 393', '§ 6', '§ 306', '§ 393']

21 USC § 393a - Office of Pediatric Therapeutics | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
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21 USC § 393a - Office of Pediatric Therapeutics
Establishment The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.
Duties The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices.
Staff The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include—
one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population;
subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under section 355a of this title or an assessment under section 355c of this title;
one or more additional individuals with expertise in pediatric epidemiology; and
one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b) of this section.
Neonatology expertise For the 5-year period beginning on July 9, 2012, at least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.
one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population; and
(Pub. L. 107–109, § 6,Jan. 4, 2002, 115 Stat. 1414; Pub. L. 110–85, title III, § 306(a),Sept. 27, 2007, 121 Stat. 864.)
2007—Subsec. (b). Pub. L. 110–85inserted “, including increasing pediatric access to medical devices” before period at end.
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 393a2012112-144 [Sec.] 511126 Stat. 1050 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 5 - ORGANIZATION21 CFR 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION