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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and product safety for donors potentially exposed to Bacillus anthracis, the agent of anthrax. This guidance applies to Whole Blood, blood components (including recovered plasma) and Source Plasma collections intended for use in transfusion or for further manufacturing into injectable products. FDA developed the recommendations in this guidance in consultation with other Public Health Service Agencies and with the Blood Safety Committee of the Department of Health and Human Services.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 01D-0545.