; and (2) not later than 18 months after the date of enactment of this Act, finalize such draft guidance. (c) Content of guidance The guidance under subsection (b) shall address the following: (1) Information regarding how full and partial waivers under subsections (a)(5)(A), (a)(5)(B), and (b)(2) of section 505B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c ) for 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 ) will be granted (including a description of impossible or highly impracticable studies for indications for which orphan designation has been granted under such section 526). (2) Application of the requirements of section 505B(e) of such Act ( 21 U.S.C. 355c(e) ) to drugs or biological products for an indication for which orphan designation has been granted under section 526 of such Act ( 21 U.S.C. 360bb ), including submission and timing of planned requests for full or partial waivers and responses by the Food and Drug Administration to those requests. (3) Process for regularly updating conditions that automatically qualify for a waiver under subsection (a)(5)(A) or (b)(2)(A) of section 505B of such Act ( 21 U.S.C. 355c ). (4) Situations where the initial pediatric study plan under section 505B(e) of such Act ( 21 U.S.C. 355c(e) ) includes a plan to study the drug or biological product in all relevant pediatric age groups. (5) Consideration of how the Secretary of Health and Human Services will balance the unique scientific challenges of rare disease drug development with the need for improved pediatric labeling of drugs and biological products for indications for which orphan designation has been granted under section 526 of such Act ( 21 U.S.C. 360bb ). (6) Applicability of real-world evidence in the fulfillment of requirements under section 505B of such Act ( 21 U.S.C. 355c ). (7) Consideration of input received from the public meeting set forth in subsection (d). (d) Public meeting The