United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-10-24 article Notices D09002ee1c7fae06b D09002ee1c7fae0fc United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "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 The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps, with recommendations for donor testing for West Nile Virus (WNV) using an FDA-licensed donor screening test. The guidance recommends the use of an FDA-licensed nucleic acid test (NAT) for testing donors of HCT/Ps for infection with WNV. The draft guidance replaces the draft guidance entitled "Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood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 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated April 2008, with respect to HCT/ Ps. The testing recommendations in the guidance, when finalized, will supplement the donor screening recommendations for WNV (which will remain in place) that were made in 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). 78 FR 63476 https://www.govinfo.gov/app/details/FR-2013-10-24/2013-24940 2013-24940 fr24oc13-67 4160-01-P Docket No. FDA-2013-D-1143 https://www.govinfo.gov/app/details/FR-2013-10-24/2013-24940 https://www.govinfo.gov/content/pkg/FR-2013-10-24/html/2013-24940.htm https://www.govinfo.gov/content/pkg/FR-2013-10-24/pdf/2013-24940.pdf 2 p. 63476 63477 78 FR 63476 Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and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; Availability; Federal Register Vol. 78, Issue NOTICE 2013-24940 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-1143 4160-01-P 2013-24940 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "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 draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps, with recommendations for donor testing for West Nile Virus (WNV) using an FDA-licensed donor screening test. The guidance recommends the use of an FDA-licensed nucleic acid test (NAT) for testing donors of HCT/Ps for infection with WNV. The draft guidance replaces the draft guidance entitled "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 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated April 2008, with respect to HCT/ Ps. The testing recommendations in the guidance, when finalized, will supplement the donor screening recommendations for WNV (which will remain in place) that were made in 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).

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2014. Benjamin A. Chacko, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852- 1448, 301-827-6210. Draft Guidance for Industry; Availability: 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; Availability , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 78, no. 206 Office of the Federal Register, National Archives and Records Administration 2013-10-24 continuing daily deposited born digital 461 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-10-24 P0b002ee18646064f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24oc13 https://www.govinfo.gov/app/details/FR-2013-10-24 https://www.govinfo.gov/content/pkg/FR-2013-10-24/pdf/FR-2013-10-24.pdf https://www.govinfo.gov/content/pkg/FR-2013-10-24/xml/FR-2013-10-24.xml fdlp 63369 63821 DGPO 2013-10-24 2024-06-03 FR-2013-10-24 machine generated eng FR FR-2013-10-24 78 206