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 appropriate adaptive trial designs for rare disease research and expedited review mechanisms for including Fast Track, Breakthrough Therapy Designation, Priority and/or Accelerated Review, where appropriate, in an effort to hasten the pace of clinical trials for cerebral cavernous malformation.