; or (II) more than one active ingredient, if an application for the combination of active ingredients has not previously been approved but each active ingredient has been previously approved to treat an adult cancer. (iii) Results of already-completed preclinical studies of application drug The Secretary may require that reports on an investigation required pursuant to paragraph (1)(B) include the results of all preclinical studies on which the decision to conduct such investigation was based. (iv) Rule of construction regarding inactive ingredients With respect to a combination of active ingredients referred to in subparagraph (A)(ii), such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination. . (2) Determination of applicable requirements Section 505B(e)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(e)(1) ) is amended by adding at the end the following: The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) shall apply with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A). . (3) Clarifying applicability Section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(a)(1) ) is amended by adding at the end the following: (C) Rule of construction No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B). . (4) Conforming amendments Section 505B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(a) ) is amended— (A) in paragraph (3)(C), as redesignated by paragraph (1)(A) of this subsection, by striking investigations described in this paragraph and inserting investigations referred to in subparagraph (A)