Fast-breaking News from AABB PulsePoints The following has been reproduced from the August 8, 2006 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

August 8, 2006
No. 747

FDA Draft Guidance Amending Guidance to Reduce Transmission of vCJD

AABB PulsePoints

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) issued draft guidance Aug. 8, 2006, to amend "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and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."

The draft guidance recommends deferral of donors who have received a transfusion of blood or blood components in France since 1980. This revision to the CJD/vCJD guidance originally issued in 2002 is based on data that shows an increased likelihood of exposure to the bovine spongiform encephalopathy (BSE) agent in that country. Whole Blood and blood components intended for transfusion as well as blood components intended for use in further manufacturing into injectable products, including Recovered Plasma, Source Leukocytes and Source Plasma, are all affected by this draft guidance. Special provisions apply to donors of blood components intended solely for manufacturing of non-injectable products.

The deadline for comments on this draft guidance will be announced through a Federal Register notice, which has not yet been published. However, FDA recommends that facilities implement this donor deferral recommendation within six months of the date when the draft guidance is finalized. The AABB Donor History Task Force will review the recommendation contained in this draft guidance and develop the appropriate language to be added to the Donor History Questionnaire.

To view the draft guidance document in its entirety, visit http://www.fda.gov/cber/guidelines.htm#cjdfrance.