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Statement of Need: In the Federal Register of June 22, 1999 (64 FR 33309), FDA announced the availability of guidance, which updated previous guidance, providing recommendations for donor screening and further testing for antibodies to HCV, notification of consignees, transfusion recipient tracing and notification, and counseling by physicians regarding transfusion with blood components at increased risk for transmitting HCV (often called "lookback"). While available evidence indicates that blood establishments are following these recommendations, FDA believes that regulations should be codified, consistent with the previous recommendations, to assure there is clear enforcement authority in case deficiencies in an establishment's lookback program are found and to provide clear instructions for continuing lookback activities.

Summary of the Legal Basis: The Public Health Service Act (21 U.S.C. 201 et seq.) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) authorize FDA to regulate biological products and to ensure that the products are safe, pure, potent, and effective. The Public Health Service Act also contains authority under which FDA can promulgate regulations to prevent the spread of communicable diseases. These regulations would assure that appropriate action is taken when blood has been collected which may potentially be capable of transmitting HCV; that persons who have been transfused with such blood components are notified so that they receive proper counseling and treatment; and that infected donors are notified. They will therefore help prevent the further transmission of HCV.

Alternatives: FDA has considered permitting continued voluntary compliance with the recommendations that have already issued. However, lookback will remain appropriate for the foreseeable future, and FDA believes that the procedures should be clearly established in the regulations.

Anticipated Costs and Benefits: FDA is in the process of analyzing the costs related to the rulemaking. Monetary burdens will be associated with the tracing of previous donations of donors, quarantining in-date products, identifying the recipients of previous blood donations, and notifying these recipients, as appropriate. FDA believes these costs will be more than compensated by the public health benefits, including benefits related to the notification of past transfusion recipients who may be unaware that they may be infected with HCV.

Risks: FDA believes there are minimum risks posed by requiring that appropriate lookback procedures for HCV be prepared and followed.