General Requirements for Blood, Blood Components, and Blood Derivatives; Notification of Deferred Donors

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The Food and Drug Administration (FDA) is proposing to require blood and plasma establishments to notify donors of their deferral due to test results for communicable disease agents or failure to satisfy suitability criteria with the intent of reducing the risk of transmission of communicable disease through the use of blood, blood components, and blood derivatives. Under the proposed rule, blood and plasma establishments would notify the donors that they have been deferred and the reason for the deferral; provide information concerning appropriate medical followup and counseling; describe the types of donations the donors should not make in the future; and discuss the possibility that the donor may be found suitable in the future, where appropriate. FDA is issuing this rule as part of the agency's ``Blood Initiative'' in which FDA is reviewing and, when appropriate, revising its regulations, policies, guidance, and procedures related to blood and blood products, including blood derivatives.