"Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;" Availability

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The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection" dated June 2005. This guidance document provides revisions to the previously published recommendations for assessing donor suitability and product safety when donors are diagnosed with or suspected of West Nile Virus (WNV) infection based on symptoms and laboratory tests. This guidance revises recommended deferral periods for such donors, and updates information on component retrieval and quarantine. This guidance finalizes the draft "Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection" dated April 2005 and supersedes the final "Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection" dated May 2003. Elsewhere in this issue of the Federal Register, FDA is withdrawing the guidance entitled "Guidance for Industry: Discontinuation of Donor D