; (3) consideration of whether the guidance or regulations released or updated under section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) have improved access for individual patients who do not qualify for clinical trials of such investigational drugs, and what barriers to such access remain; (4) an assessment of how patients and health care providers navigate different avenues to engage with the Food and Drug Administration or drug sponsors on expanded access; and (5) an analysis of the Secretary's report under subsection (a)(2). (c) Guidance (1) In general Not later than 180 days after the publication of the report under subsection (a) the Secretary, acting through the Commissioner of Food and Drugs, shall issue one or more draft guidances regarding eligibility criteria for clinical trials. Not later than 18 months after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance. (2) Contents The guidance documents described in paragraph (1) shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to— (A) broaden eligibility criteria for clinical trials, especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need