1. Short title This Act may be cited as the Innovation in Pediatric Drugs Act of 2023 . 2. Pediatric studies of orphan drugs (a) Application of pediatric research requirements to orphan drugs (1) In general Section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) is amended by striking subsection (k). (2) Applicability The amendment made by paragraph (1) applies only to applications described in subparagraph (A) or (B) of section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(a)(1) ) that are submitted on or after the date that is 18 months after the date of enactment of this Act. (b) Guidance The Secretary of Health and Human Services (referred to in this Act as the Secretary ) shall— (1) not later than 6 months after the date of enactment of this Act, issue draft guidance describing how, upon the applicability of the amendment made by subsection (a)(1), the requirements of section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) will apply with respect to any drug or biological product for an indication for which orphan designation has been granted under section 526 of such Act ( 21 U.S.C. 360bb )