Skip to Content

Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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 Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection,” dated May 2005.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Brenda R. Friend, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

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. FDA developed the information in this guidance after consulting with other Public Health Service Agencies of the Department of Health and Human Services.

This guidance does the following things:

Start Printed Page 37864
  • Applies to donors of blood and blood components intended for transfusion;
  • Applies to donors of blood components intended for use in further manufacturing into injectable products or noninjectable products, including recovered plasma, Source Leukocytes, and Source Plasma;
  • Provides updated scientific data;
  • Recommends new deferral periods for donors who are diagnosed with or suspected of WNV infection; and
  • Describes the use of the investigational nucleic acid test (NAT) for WNV in deferring reactive donors.

This guidance supersedes “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, and 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.

In the Federal Register of April 20, 2005 (70 FR 20575), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the April 2005 draft guidance and those comments were considered when finalizing the guidance. A summary of changes to the guidance includes the following items: (1) Modifies recommendations on followup testing and reentry of reactive donors, (2) adds recommendations on component retrieval and quarantine for presumptive viremic donors, and (3) discusses preliminary laboratory data indicating WNV infectivity in blood cultures of NAT reactive individuals who were also seropositive for WNV antibodies. In addition, editorial changes were made to improve clarity. Elsewhere in this issue of the Federal Register, FDA is withdrawing the guidance entitled “Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection,” dated May 2005. The May 2005 guidance is no longer necessary because the guidance that is the subject of this notice does not contain the recommendation to defer donors based on recent fever with a headache as a symptom of WNV infection.

The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0338; 21 CFR 606.170(b) has been approved under OMB control number 0910-0116; and 21 CFR 606.171 has been approved under OMB control number 0910-0458.

III. Comments

Interested persons may, at any time, submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) regarding this guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/​cber/​guidelines.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

Start Signature

Dated: June 24, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 05-12960 Filed 6-29-05; 8:45 am]

BILLING CODE 4160-01-S