[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Pages 37863-37864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0133]


``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 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.

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 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:

[[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.

    Dated: June 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12960 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S