medical countermeasure submission
(2) The term “medical countermeasure submission” means an investigational new drug application under section 355(i) of this title , a new drug application under section 355(b) of this title , or an abbreviated new drug application under section 355(j) of this title , a biological product license application under section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [ 42 U.S.C. 262(k) ], a new animal drug application under section 360b(b)(1) of this title or abbreviated new animal drug application under section 360b(b)(2) of this title , an application for conditional approval of a new animal drug under section 360ccc of this title , an investigational device application under section 360j(g) of this title , an application with respect to a device under section 360e(c) of this title , a request for classification of a device under section 360c(f)(2) of this title , a notification with respect to a device under section 360(k) of this title , or a request for an emergency use authorization under section 360bbb–3 of this title to support— (A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or (B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.