federal_register: 2015-31405
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-31405 | Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry." The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus (WNV). The draft guidance recommends the use of an FDA- licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with WNV. The guidance does not provide recommendations regarding testing of cadaveric HCT/P donors for WNV. The draft guidance replaces the draft guidance entitled "Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated October 2013. The donor testing recommendations in the draft guidance, when finalized, will supplement the donor screening recommendations for WNV (which will remain in place) and supersede the "West Nile Virus (WNV)" section in Appendix 6 of the guidance entitled "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated August 2007 (2007 Donor Eligibility Guidance). | 2015-12-15 | 2015 | 12 | https://www.federalregister.gov/documents/2015/12/15/2015-31405/use-of-nucleic-acid-tests-to-reduce-the-risk-of-transmission-of-west-nile-virus-from-living-donors | https://www.govinfo.gov/content/pkg/FR-2015-12-15/pdf/2015-31405.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and... |