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GUIDANCE DOCUMENT

Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products Questions and Answers on Guidance for Industry January 2004

Final

Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

FDA is taking this step as a prudent measure to assure the safety of the blood supply by further reducing the theoretical risk from vCJD. In 1999, we recommended the first donor deferral for people who may have been exposed to the vCJD agent, which is believed to be the same as the agent of bovine spongiform encephalopathy (BSE, or "mad cow" disease). We recommended deferral of donors who resided in the United Kingdom (U.K.) for 6 months or more between 1980 and 1996.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010