STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.

SEC. 511. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS. Section 6 of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a) is amended— (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 (2) by adding at the end the following: “(d) Neonatology Expertise. 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.” .