Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive. It provides product testing and disposition, donor management, methods for donor requalification, and product labeling. It also provides notification that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. To download this guidance, click here. To view this notice, click here.