Reduce Possible Risk of Transmission of CJD and vCJD by Blood – FDA.gov

Docket Number: FDA-2012-D-0307 Issued by:

Guidance Issuing Office

Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. We are revising or removing our recommendations to screen blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy, including time spent on United States (U.S.) military bases in Europe; 2) receipt of a blood transfusion in certain vCJD risk countries; 3) risk factors for iatrogenic CJD (i.e., a history of taking human cadaveric pituitary-derived growth hormone (hGH)); 4) having blood relatives with CJD; and 5) a history of injecting bovine insulin. These changes are summarized in the Appendix of this guidance.

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:

Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0307.

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