2011 US Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399d)
Subchapter X - MISCELLANEOUS (§§ 391 - 399d)
Section 393a - Office of Pediatric Therapeutics
View Metadata| Publication Title | United States Code, 2006 Edition, Supplement 5, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER X - MISCELLANEOUS Sec. 393a - Office of Pediatric Therapeutics |
| Contains | section 393a |
| Date | 2011 |
| Laws in Effect as of Date | January 3, 2012 |
| Positive Law | No |
| Disposition | standard |
| Source Credit | 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. |
| Statutes at Large References | 115 Stat. 1414 121 Stat. 864 |
| Public Law References | Public Law 107-109, Public Law 110-85 |
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The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.
(b) DutiesThe 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) StaffThe 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; and
(2) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b) of this section.
(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.)
CodificationSection was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
Amendments2007—Subsec. (b). Pub. L. 110–85 inserted “, including increasing pediatric access to medical devices” before period at end.
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