"Guidance for Industry: Variances for Blood Collection From Individuals With Hereditary Hemochromatosis;" Availability

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The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Variances for Blood Collection From Individuals With Hereditary Hemochromatosis" dated August 2001. The guidance document provides recommendations to blood establishments that wish to distribute blood and blood components collected from individuals with diagnosed hereditary hemochromatosis without indicating the donor's disease on the container label, or collect blood more frequently from such individuals than every 8 weeks without a physical examination and certification of the donor's health by a physician on the day of donation. This guidance document identifies conditions under which FDA will consider approving the above as alternative procedures, or variances, to the current regulations, and provides guidance on what to submit when requesting these variances. These recommendations apply to all blood establishments, whether or not they hold a U.S. license for the manufacture of blood and blood components. The guidance document announced in this notice finalizes the draft guidance document entitled "Guidance for Industry: Variances for Blood Collection From Indivi