Need for an investigational drug may arise in an emergency situation that does not allow time for submission of an IND in accordance with § 312.23 or § 312.34. In such a case, FDA may authorize shipment of the drug for a specified use in advance of submission of an IND. A request for such authorization may be transmitted to FDA by telephone or other rapid communication means. For investigational biological drugs, the request should be directed to the Division of Biological Investigational New Drugs (HFB-230), Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda, MD 20892, 301-443-4864. For all other investigational drugs, the request for authorization should be directed to the Document Management and Reporting Branch (HFD-53), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4320. After normal working hours, eastern standard time, the request should be directed to the FDA Division of Emergency and Epidemiological Operations, 202-857-8400. Except in extraordinary circumstances, such authorization will be conditioned on the sponsor making an appropriate IND submission as soon as practicable after receiving the authorization.