[Federal Register: April 20, 2005 (Volume 70, Number 75)]
[Notices]               
[Page 20575-20576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap05-71]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0133]

 
Draft ``Guidance for Industry: Assessing 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 draft 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 April 2005. 
The draft guidance document provides revisions to the previously 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) infections based on symptoms and laboratory tests. This draft 
guidance proposes revised deferral periods for such donors, and updates 
information on product retrieval and quarantine. When finalized, this 
guidance will supersede ``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.

DATES: Submit written or electronic comments on the draft guidance by 
May 20, 2005, to ensure their adequate consideration in preparation of 
the final guidance. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may also be 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electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 April 2005. FDA developed the information in this 
draft guidance after consulting with other Public Health Service 
agencies of the Department of Health and Human Services.
    This draft guidance:
     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;
     Removes the current recommendation for donor deferral 
based upon a reported history of headache with fever in the week before 
donation;
     Proposes new deferral periods for donors who are diagnosed 
with or suspected of WNV infections;
     Describes the use of the investigational nucleic acid test 
(NAT) for WNV in deferring reactive donors; and
     Provides information about the use of individual donor NAT 
testing to re-enter reactive donors if a blood establishment, at its 
discretion, chooses to reenter such donors.

[[Page 20576]]

    This draft guidance, when finalized, will supersede ``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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. Paperwork Reduction Act of 1995

    This draft 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 
information collection provisions in this guidance for 21 CFR 601.12 
were approved under OMB control number 0910-0338; 21 CFR 606.170(b) was 
approved under OMB control number 0910-0116; and 21 CFR 606.171 was 
approved under OMB control number 0910-0458.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final 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 draft 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 draft guidance 
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.
    Dated: April 13, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7821 Filed 4-19-05; 8:45 am]

BILLING CODE 4160-01-S