WRITTEN REQUESTS.

SEC. 502. WRITTEN REQUESTS. (a) In General.— (1) Federal food, drug, and cosmetic act.—Subsection (h) of section 505A (21 U.S.C. 355a) is amended to read as follows: “(h) Relationship to Pediatric Research Requirements. Exclusivity under this section shall only be granted for the completion of a study or studies that are the subject of a written request and for which reports are submitted and accepted in accordance with subsection (d)(3). Written requests under this section may consist of a study or studies required under section 505B.” . (2) Public health service act.—Section 351(m)(1) of the Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by striking “(f), (i), (j), (k), (l), (p), and (q)” and inserting “(f), (h), (i), (j), (k), (l), (n), and (p)”. (b) [21 U.S.C. 355a] Neonates.—Subparagraph (A) of section 505A(d)(1) is amended by adding at the end the following: “If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates.”.