EARLY MEETING ON PEDIATRIC STUDY PLAN.

SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN. (a) In general.—Clause (i) of section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) is amended to read as follows: “(i) shall meet with the applicant— “(I) if requested by the applicant with respect to a drug or biological product that is intended to treat a serious or life-threatening disease or condition, to discuss preparation of the initial pediatric study plan, not later than the end-of-Phase 1 meeting (as such term is used in section 312.82(b) of title 21, Code of Federal Regulations, or successor regulations) or within 30 calendar days of receipt of such request, whichever is later; “(II) to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); and “(III) to discuss the bases for the deferral under subsection (a)(4) or a full or partial waiver under subsection (a)(5);” . (b) Conforming Changes.—Section 505B(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended— (1) in the heading of paragraph (2), by striking “meeting” and inserting “meetings”; (2) in the heading of paragraph (2)(C), by striking “Meeting” and inserting “Meetings”; (3) in clauses (ii) and (iii) of paragraph (2)(C), by striking “no meeting” each place it appears and inserting “no meeting under clause (i)(II)”; and (4) in paragraph (3) by striking “meeting under paragraph (2)(C)(i)” and inserting “meeting under paragraph (2)(C)(i)(II)”.