medical countermeasure submission

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—