; (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking If an application and all that follows through such license if and inserting During the 7-year period described in subsection (a) for an approved application under section 505 or license under section 351 of the Public Health Service Act, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if ; (B) in paragraph (1), by striking notice and all that follows through assure and inserting of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure ; and (C) in paragraph (2), by striking such holder provides and inserting the holder provides