; (2) conduct and submit the results, data, and information generated by any studies required under subsection (b)(2); and (3) make any labeling change described in subsection (c) by the date specified by the Secretary pursuant to such subsection. (b) Data and information (1) In general The Secretary may issue an order requiring the manufacturer of a life-saving drug to submit, in such manner as the Secretary may prescribe, data and information from any stage of development of the drug that are adequate to assess the stability of the drug to determine the longest supported expiration date. (2) Lack of data and information If the data and information required pursuant to an order issued under paragraph (1) are not available or are insufficient, as determined by the Secretary, the Secretary may issue an order requiring the manufacturer of the drug— (A) to conduct studies, which may be a continuation of ongoing studies, to provide data and information adequate to assess the stability of the drug and to determine the longest supported expiration date; and (B) to submit such data and information to the Secretary in such manner as the Secretary may prescribe in the order. (c) Labeling The Secretary may issue an order requiring the manufacturer of a life-saving drug, by a date determined by the Secretary in consultation with the sponsor of the drug, to make any labeling change regarding the expiration date or storage and handling of the drug that the Secretary determines to be appropriate based on the data and information required to be submitted under this section or any other data and information available to the Secretary. (d) Definitions In this section: (1) Life-saving drug The term life-saving drug means a drug, that is— (A) (i) a medical countermeasure; or (ii) on the drug shortage list under section 506E or determined by the Secretary to be at risk of shortage; and (B) (i) life-supporting; (ii) life-sustaining