; or (ii) for a pediatric cancer indication, if the drug is intended for the treatment of an adult cancer and is directed at a molecular target considered to be germane to the growth and progression of such pediatric cancer; or ; and (3) by amending paragraph (2) of subsection (c) to read as follows: (2) the drug or biological product is in a class of products, is for an indication, or is directed at a specific molecular target in an adult cancer and such molecular target is germane to the growth or progression of cancer in a pediatric cancer, for which there is need for additional options. . (b) Early meeting on pediatric study plan (1) 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 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 312.47(b) of title 21, Code of Federal Regulations, or successor regulations) or within 30 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 any scientific or operational challenges that may be the basis of a deferral under subsection (a)(3) or a full or partial waiver under subsection (a)(4); . (2) Conforming changes Section 505B(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(e) ) is amended— (A) in the heading of paragraph (2), by striking meeting and inserting meetings ; (B) in the heading of paragraph (2)(C), by striking Meeting and inserting Meetings ; (C) 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)