; and (C) include in such report recommendations for changes to the processes and authorities of the Food and Drug Administration to facilitate development of, and access to, treatments for rare diseases and conditions. (3) Public availability The Comptroller General of the United States shall make each report under paragraph (2) available to the public, including by posting the report on the website of the Government Accountability Office. (c) Review process Subparagraph (A) of section 569(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8(a)(2) ) is amended to read as follows: (A) In general (i) List The Secretary shall develop and maintain a list of external experts who, because of their special expertise, are qualified to provide advice on rare disease and condition issues, including topics described in subsection (b). (ii) Availability at meetings The Secretary shall ensure availability, for consultation purposes, of an external expert on rare diseases, as described in subparagraph (B), in connection with each drug product advisory committee meeting concerning a drug or biological product for a rare disease or condition. (iii) Review of applications The Secretary shall ensure that each review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act for an indication associated with a rare disease or condition includes Food and Drug Administration staff with expertise on rare diseases and conditions as an integral part of the review team. . (d) Risk evaluation and mitigation strategy elements Subsection (a) of section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ) is amended by adding at the end the following new paragraph: (5) Orphan drugs In making any determination regarding the inclusion, in the risk evaluation and mitigation strategy for a drug that has been designated as a drug for a rare disease or condition pursuant to section 526, of an element that requires patient action, restrictions on use of the drug, or