; (D) clinical trial designs and methods that increase enrollment of more diverse patient populations while facilitating the collection of data to support substantial evidence of safety and effectiveness; and (E) how changes to clinical trial inclusion and exclusion criteria may impact the complexity of the clinical trial design and length of clinical trials, and potential approaches to mitigating those impacts to ensure that the ability to demonstrate safety and effectiveness is not hindered through potential changes in eligibility criteria. (b) Report Not later than 1 year after the Secretary issues a report on the topics discussed at the public meeting under subsection (a)(2), the Comptroller General of the United States shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on individual access to investigational drugs through the expanded access program under section 561(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb(b) ). The report shall include— (1) a description of actions taken by manufacturers under section 561A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–0 ); (2) consideration of whether Form FDA 3926 and the guidance document entitled Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers , issued by the Food and Drug Administration in June 2016, has reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section 561(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) and improved clarity for patients, physicians, and drug manufacturers about such process