; and (B) develop eligibility criteria for, and increase trial recruitment to, clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug, as applicable and as appropriate, while supporting findings of substantial evidence of safety and effectiveness. 3. Improving institutional review board review of single patient expanded access protocol Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs, shall issue guidance or regulations, or revise existing guidance or regulations, to streamline the institutional review board review for individual pediatric and adult patient expanded access protocol under 561(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb(b) ). Such guidance or regulation may include a description of the conditions under which an institutional review board chair (or designee) may review individual patient expanded access protocol submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) for a drug and how centralized institutional review boards may facilitate the use of expanded access protocols. The Secretary shall update any relevant forms associated with individual patient expanded access protocol as necessary. 4. Expanded access policy transparency Section 561A(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–0(f) ) is amended— (1) in the matter preceding paragraph (1), by striking later and inserting earlier ; (2) by striking paragraph (1); (3) by redesignating paragraph (2) as paragraph (1); (4) in paragraph (1) as so redesignated, by striking the period at the end and inserting ; or