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Notification Process for Transfusion Related Fatalities
and Donation Related Deaths

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Initial notification of transfusion related fatalities and donation related deaths may be made to FDA's Center for Biologics Evaluation and Research (CBER) 24 hours per day, 7 days per week. One of the following options may be used:

Voice-mail: 301-827-6220
E-mail: fatalities2@cber.fda.gov
Fax: 301-827-6748

Follow-up contact by CBER will be made as soon as possible to obtain more detailed information. This does not replace the 7-day written report regarding the fatality and all related information that is required by 21 CFR 606.170(b).

The 7-day written report should be sent to:

Center for Biologics Evaluation and Research (CBER)
Director, Office of Compliance and Biologics Quality
Attn: Fatality Program Manager (HFM-650)
1401 Rockville Pike
Rockville, MD 20852-1448

During regular business hours, transfusion related fatalities and donation related deaths should be reported to CBER's fatality program contact within the Division of Inspections and Surveillance at 301-827-6220.

Updated MaY 15, 2002
 
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