Docket Number:
FDA-2000-D-0187
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This revised guidance document provides you, blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM).  The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma.  Blood establishments are not required to assess Source Plasma donors for malaria risk (see 21 CFR 630.15(b)(8)).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

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Food and Drug Administration
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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2000-D-0187.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010