§ 393a. Office of Pediatric Therapeutics

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 6 · 115 Stat. 1408

   Enacted · 21 U.S.C. § 393a

   Pub. L. 107–109, § 6, Jan. 4, 2002, 115 Stat. 1414

   Source evidence

   Code source credit
   Pub. L. 107–109, § 6, Jan. 4, 2002, 115 Stat. 1414

   Enacted provision · exact public law section
   SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS. (a) Establishment.— The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Ding 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. (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; and (2) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b).

2. 2007

   Pediatric Medical Device Safety and Improvement Act of 2007

   Pub. L. 110–85 title III § 306(a) · 121 Stat. 823

   Inserted · 21 U.S.C. § 393a(b)

   Pub. L. 110–85 inserted “, including increasing pediatric access to medical devices” before period at end

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 110–85 inserted “, including increasing pediatric access to medical devices” before period at end.

   Enacted provision · exact public law section
   (a) Office of Pediatric Therapeutics.— Section 6(b) of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is amended by inserting “, including increasing pediatric access to medical devices” after “pediatric issues”.

3. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 511(1) · 126 Stat. 993

   1. Added · 21 U.S.C. § 393a(c)(2)(4)

      Pub. L. 112–144, § 511(1), added pars. (2) and (3)

   2. Redesignated · 21 U.S.C. § 393a(c)(2)(4)

      Pub. L. 112–144, § 511(1), redesignated former par. (2) as (4)

   Source evidence

   Code amendment note
   Subsec. (c)(2) to (4). Pub. L. 112–144, § 511(1), added pars. (2) and (3) and redesignated former par. (2) as (4).

   Enacted provision · exact public law section
   (1) in subsection (c)— (A) in paragraph (1), by striking “and” at the end; (B) by redesignating paragraph (2) as paragraph (4); and (C) by inserting after paragraph (1) the following: “(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 505A of the Federal Food, Drug, and Cosmetic Act or an assessment under section 505B of such Act; “(3) one or more additional individuals with expertise in pediatric epidemiology; and” ; and

4. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 511(2) · 126 Stat. 993

   Added · 21 U.S.C. § 393a(d)

   Pub. L. 112–144, § 511(2), added subsec. (d)

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 112–144, § 511(2), added subsec. (d).

   Enacted provision · exact public law section
   (2) by adding at the end the following: “(d) Neonatology Expertise.— Time period. Effective date. For the 5-year period beginning on the date of enactment of this subsection, at least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.” .

5. 2017

   FDA Reauthorization Act of 2017

   Pub. L. 115–52 title V § 505(d)(1) · 131 Stat. 1005

   Substituted · 21 U.S.C. § 393a(d)

   Pub. L. 115–52 substituted “At least” for “For the 5-year period beginning on July 9, 2012, at least”

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 115–52 substituted “At least” for “For the 5-year period beginning on July 9, 2012, at least”.

   Enacted provision · exact public law section
   (1) In general.— Section 6(d) of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a(d)) is amended by striking “For the 5-year period beginning on the date of enactment of this subsection, at” and inserting “At”.

6 of 6 references resolved to an enrolled provision