[Federal Register Volume 68, Number 93 (Wednesday, May 14, 2003)]
[Notices]
[Pages 25897-25898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0467]


``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;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``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. The guidance provides our revisions to the 
guidance of the same title dated October 2002 in which FDA provided its 
recommendations for assessing donor suitability and product safety for 
donors with proven recent West Nile Virus (WNV) infections or with 
illness potentially due to WNV. The guidance is intended to recommend 
deferral of donors infected or potentially infected with WNV, and to 
recommend quarantine of blood and blood products previously collected 
from such donors. These measures are intended to reduce the possibility 
of WNV transmission by blood and blood products and are for immediate 
implementation. This guidance supersedes the guidance of the same title 
dated October 2002.

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

ADDRESSES: Submit written or electronic requests for single copies of 
this guidance to the Office of Communication, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
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 the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800 or by fax by calling the FAX Information 
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``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. The guidance 
document provides information related to the possible risk of WNV 
transmission by blood or blood products. The presence of WNV in blood 
components and transfusion transmission from blood components has been 
documented. FDA developed this guidance in consultation with other 
Public Health Service agencies of the Department of Health and Human 
Services. The guidance supersedes the guidance of the same title dated 
October 2002.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance document represents 
the agency's current thinking on this topic.

[[Page 25898]]

 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. Comments

    The agency is soliciting public comment, and is recommending the 
implementation of the guidance by June 1, 2003, because of public 
health concerns related to the possible risk of transfusion transmitted 
WNV.
    Interested persons may, at any time, submit written or electronic 
comments to the Dockets Management Branch (see ADDRESSES) regarding 
this guidance document. Two copies of mailed comments are to be 
submitted, except individuals may submit one copy. Comments should be 
identified with the docket number found in the brackets in the heading 
of this document. A copy of the document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

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

    Dated: May 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11980 Filed 5-13-03; 8:45 am]
BILLING CODE 4160-01-S