[Federal Register: November 29, 2002 (Volume 67, Number 230)]
[Notices]
[Page 71180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no02-93]
[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default
.htm.
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