((a)) ** Request by sponsor; response by Secretary** The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—

((1)) it may be approved for such disease or condition under , or

((2)) if the drug is a biological product, it may be licensed for such disease or condition under .

((b)) ** Regulations** The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).