with clinical centers, investigators, and advocates to support appropriate investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) in an effort to hasten the pace of clinical trials for cerebral cavernous malformation. (d) Adaptive trial design and expedited review pathways The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall coordinate with clinical centers, investigators, and advocates to support domestic and international adaptive trial designs for rare disease research and expedited peer review mechanisms for including orphan drug designation, fast track, breakthrough therapy designation, and priority review or accelerated review, where appropriate, in an effort to hasten the pace of clinical trials for cerebral cavernous malformation.