1. Short title This Act may be cited as the Give Kids a Chance Act of 2023 . 2. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs (a) In general (1) Additional active ingredient for application drug; limitation regarding novel-combination application drug Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(a)(3) ) is amended— (A) by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and (B) by striking subparagraph (A) and inserting the following: (A) In general For purposes of paragraph (1)(B), the investigation described in this paragraph is (as determined by the Secretary) a molecularly targeted pediatric cancer investigation of— (i) the drug or biological product for which the application referred to in such paragraph is submitted; or (ii) such drug or biological product in combination with— (I) an active ingredient of a drug or biological product— (aa) for which an approved application under section 505(j) under this Act or under section 351(k) of the Public Health Service Act is in effect; and (bb) that is determined by the Secretary to be the standard of care for treating a pediatric cancer; or (II) an active ingredient of a drug or biological product— (aa) for which an approved application under section 505(b) of this Act or section 351(a) of the Public Health Service Act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B)