Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Cells, Tissues, and Cellular and Tissue-Based Products; Request for Data

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The Food and Drug Administration (FDA) is requesting submission of data related to certain recommendations in the draft guidance entitled, "Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)," that published April 28, 2008. The agency is taking this action to allow interested persons to submit complete data from the 2008 West Nile Virus season concerning the criteria for converting from minipool nucleic acid tests (NAT) to individual donation NAT for donations of Whole Blood and blood components for transfusion.