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Home » 2016 Issues » 81 FR (09/29/2016) » 2016-23514. 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; Guidance for Industry; Correction

  2016-23514. 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; Guidance for Industry; Correction  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability; correction.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is correcting a notice that appeared in the Federal Register of Tuesday, September 13, 2016 (81 FR 62910). The document announced the availability of a guidance for industry 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). The document was published with incorrect information of a comment period due date. This document corrects that error.

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    FOR FURTHER INFORMATION CONTACT:

    Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

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    SUPPLEMENTARY INFORMATION:

    In the Federal Register of September 13, 2016, in FR Doc. 2016-21969, on page 62910, the following correction is made:

    On page 62910, in the first column under the DATES: caption, the sentence is corrected to read, “Submit either electronic or written comments on Agency guidances at any time.”

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    Dated: September 23, 2016.

    Leslie Kux,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2016-23514 Filed 9-28-16; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Published:
09/29/2016
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability; correction.
Document Number:
2016-23514
Dates:
caption, the sentence is corrected to read, ``Submit either electronic or written comments on Agency guidances at any time.''
Pages:
66967-66967 (1 pages)
Docket Numbers:
Docket No. FDA-2013-D-1143
PDF File:
2016-23514.pdf
Supporting Documents:
» Reference 9 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus October 2013
» Reference 6 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus April 2008
» Reference 44 West Nile virus infection transmitted by granulocyte transfusion
» Reference 43 West Nile encephalitis in 2 Hematopoietic Stem Cell Transplant Recipients: Case Series and Literature Review
» Reference 42 Fatal West Nile Virus Encephalitis in a Renal Transplant Recipient
» Reference 41 West Nile Virus Transmission Through Organ Transplantation in North Eastern Italy A Case Report and Implications for Pre-Procurement Screening
» Reference 40 Absence of Neuroinvasive Disease in a Liver Transplant Recipient Who Acquired West Nile Virus (WNV) Infection from the Organ Donor and Who Received WNV Antibodies Prophylactically
» Reference 39 West Nile Virus Infections in Organ Transplant Recipients-New York and Pennsylvania, August - September 2005
» Reference 38 Update Investigations of West Nile Virus Infections in Recipients of Organ Transplantation and Blood Transfusion
» Reference 37 Organ Procurement Transplantation Network Guidance for Identifying Risk Factors for West Nile Virus during Evaluation of Potential Living Donors