; (II) the date on which a hearing with respect to such order is denied under subparagraph (B) or (C)(i); (III) the date on which a final decision is made following a hearing under subparagraph (C)(v); or (IV) if no hearing is requested, the date on which the time for requesting a hearing expires. (4) Expedited procedure with respect to administrative orders initiated by the Secretary (A) Imminent hazard to the public health (i) In general In the case of a determination by the Secretary that a drug, class of drugs, or combination of drugs subject to this section poses an imminent hazard to the public health, the Secretary, after first making reasonable efforts to notify, not later than 48 hours before issuance of such order under this subparagraph, sponsors who have a listing in effect under section 510(j) for such drug or combination of drugs— (I) may issue an interim final administrative order for such drug, class of drugs, or combination of drugs under paragraph (1), together with a detailed statement of the reasons for such order; (II) shall publish in the Federal Register a notice of availability of any such order; and (III) shall provide for a public comment period of at least 45 calendar days with respect to such interim final order. (ii) Nondelegation The Secretary may not delegate the authority to issue an interim final administrative order under this subparagraph. (B) Safety labeling changes (i) In general In the case of a determination by the Secretary that a change in the labeling of a drug, class of drugs, or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug, the Secretary may— (I) make reasonable efforts to notify informally, not later than 48 hours before the issuance of the interim final order, the sponsors of drugs who have a listing in effect under section 510(j) for such drug or combination of drugs