; (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) ; and (D) in paragraph (3) by striking meeting under paragraph (2)(C)(i) and inserting meeting under paragraph (2)(C)(i)(II) . (c) Orphan drugs Section 505B(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(k) ) is amended by inserting except in the case of a drug or biological product that 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 a pediatric cancer, after regulation, . (d) Guidance Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance on the implementation of the amendments to section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) made by this section, including— (1) study designs; (2) molecular targets considered to be germane to the growth and progression present in one or more cancers in pediatric populations that may be appropriate for assessment under such section 505B, as so amended; and (3) considerations for implementation of such section 505B, as so amended, and waivers of the requirements of such section 505B with regard to molecular targets for which several drugs may be under investigation. (e) Applicability This section and the amendments made by this section apply with respect to applications for a drug submitted under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) on or after the date that is 18 months after the date of enactment of this Act. (f) Report to Congress Section 508(b) of the FDA Safety and Innovation Act ( 21 U.S.C. 355c–1(b) ) is amended— (1) in paragraph (10), by striking ; and and inserting ;