[Federal Register Volume 67, Number 230 (Friday, November 29, 2002)]
[Notices]
[Page 71180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30156]



[[Page 71180]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0467]


``Guidance for Industry: 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: 
Recommendations for the Assessment of Donor Suitability and Blood and 
Blood Product Safety in Cases of Known or Suspected West Nile Virus 
Infection'' dated October 2002. The guidance document provides 
recommendations for assessing donor suitability and product safety for 
donors diagnosed with West Nile Virus (WNV) infections or with 
illnesses potentially caused by WNV. The guidance applies to Whole 
Blood and blood components intended for use in transfusion and blood 
components including recovered plasma, Source Leukocytes, and Source 
Plasma intended for use in further manufacturing into injectable or 
non-injectable products. These recommendations are intended to reduce 
the risk of transfusion transmitted WNV, particularly in areas where 
human cases are occurring.

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

ADDRESSES: Submit written 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 document may also be obtained by mail by 
calling the CBER Voice Information System 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 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: Recommendations for the Assessment of Donor 
Suitability and Blood and Blood Product Safety in Cases of Known or 
Suspected West Nile Virus Infection'' dated October 2002. To address 
the possible risk of transmission of WNV by blood transfusion, we are 
providing recommendations for donor deferral, and for product 
quarantine and retrieval related to reports of post-donation illnesses 
in the donor, or WNV infection in recipients of blood. We are 
continuing to consult with experts on WNV at the Centers for Disease 
Control and Prevention (CDC) and elsewhere to ensure the greatest 
possible safety of the blood supply. In addition, epidemiologic and 
laboratory investigations are rapidly evolving. We will evaluate 
promptly any new data or experiences related to this issue and provide 
further updates as appropriate. FDA developed the recommendations in 
the guidance with other Public Health Service agencies of the 
Department of Health and Human Services.
    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. 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 requirement of the applicable statutes and regulations.

II. Comments

    The agency is soliciting public comment, but is implementing this 
guidance immediately 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 any 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: November 15, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-30156 Filed 11-27-02; 8:45 am]
BILLING CODE 4160-01-S