§ 393a. Office of Pediatric Therapeutics
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/usc/title-21/section-393aA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Establishment The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.
(b)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.
(c)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—
(1)one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population;
(2)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;
(3)one or more additional individuals with expertise in pediatric epidemiology; and
(4)one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b).
(d)Neonatology expertise At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.
(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; Pub. L. 112–144, title V, § 511, July 9, 2012, 126 Stat. 1050; Pub. L. 115–52, title V, § 505(d)(1), Aug. 18, 2017, 131 Stat. 1047.)
Connections15 cite this · traces to 3
Cited by 15 sections
U.S. Code
public-private-law
statute-compilations
statutes-at-large
- Public Law 112–144To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes
- Public Law 107–109To amend the Federal Food, Drug, and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children
- Public Law 110–85To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes
- Public Law 115–52To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes
bill
- Sec. 4Neonatology expertise
- Sec. 505Additional provisions on development of drugs and biological products for pediatric use
- Sec. 505Additional provisions on development of drugs and biological products for pediatric use
- Sec. 505Additional provisions on development of drugs and biological products for pediatric use
- Sec. 4Neonatology expertise
Traces to 3 documents
10 references not yet in our index
- Pub. L. 107–109, § 6
- 115 Stat. 1414
- Pub. L. 110–85, title III, § 306(a)
- 121 Stat. 864
- Pub. L. 112–144, title V, § 511
- 126 Stat. 1050
- 131 Stat. 1047
- Pub. L. 112–144, § 511(1)
- Pub. L. 112–144, § 511(2)
- Pub. L. 110–85
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cites case law
§ 393a
Office of Pediatric Therapeutics
Bills×5
Stat.×4
U.S.C.×3
Stat. Comp.×2
Pub. L.×1
Pub. L.Pub. L. 107–109, § 6
Stat.115 Stat. 1414
Pub. L.Pub. L. 110–85, title III, § 306(a)
Stat.121 Stat. 864
Pub. L.Pub. L. 112–144, title V, § 511
Cites 13 · showing 8Cited by 15 across 5 sources