new safety information
(2) Definitions For purposes of this subsection: (A) Responsible person The term “responsible person” means a person who— (i) has submitted to the Secretary a covered application that is pending; or (ii) is the holder of an approved covered application. (B) Covered application The term “covered application” means— (i) an application under subsection (b) for a drug that is subject to section 353(b) of this title ; and (ii) an application under section 262 of title 42 . (C) New safety information; serious risk The terms “new safety information”, “serious risk”, and “signal of a serious risk” have the meanings given such terms in section 355–1(b) of this title .