; (B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act; (C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act, as applicable, that is active; or (ii) that is under investigation in a clinical trial that— (I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and (II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and (D) the active development or production of which— (i) is ongoing; (ii) has not been discontinued by the manufacturer; and (iii) is not the subject of a clinical hold under the regulations implementing section 505(i) or section 351(a)(3) of the Public Health Service Act, as applicable. (3) The term phase 1 trial means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). (4) The term eligible illness means— (A) a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months