[Federal Register: May 23, 2005 (Volume 70, Number 98)]
[Notices]               
[Page 29529-29530]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my05-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0467]

 
``Guidance for Industry: Discontinuation of Donor Deferral 
Related to Recent Fever with Headache as a Symptom of 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: 
Discontinuation of Donor Deferral Related to Recent Fever with Headache 
as a Symptom of West Nile Virus Infection,'' dated May 2005. The 
guidance document removes FDA's previous recommendation concerning 
deferral on the basis of a specific donor question related to West Nile 
Virus (WNV) infection. This guidance pertains solely to this specific 
donor deferral recommendation; all other recommendations in the 
``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 May 2003 remain in effect. 
This guidance applies to Whole Blood and blood components intended for 
transfusion, and blood components intended for use in further 
manufacturing into injectable products or noninjectable products, 
including recovered plasma, Source Leukocytes and Source Plasma. This 
guidance has an immediate implementation date due to the approaching 
season during which an outbreak of WNV can occur.

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 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 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: Astrid Szeto, 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: Discontinuation of Donor Deferral Related to 
Recent Fever with Headache as a Symptom of West Nile Virus Infection,'' 
dated May 2005. The guidance document removes FDA's previous 
recommendation to defer donors each year between June 1 and November 30 
when the donor reports a history of fever with headache in the past 
week. We no longer recommend asking this question as it relates to WNV. 
This donor deferral was originally recommended in the ``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.'' Since the issuance of this May 2003 guidance, new 
data were presented at the October 22, 2004, Blood Products Advisory 
Committee Meeting indicating that self-reported fever with headache in 
the past week did not appear to be predictive of WNV infection and did 
not correlate with peak periods of WNV incidence as determined by WNV 
nucleic acid test prevalence in the donor pool.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance 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 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 
information collection provisions in this guidance for 21 CFR 601.12 
have been approved under OMB control number 0910-0338.

III. Comments

    FDA is soliciting public comment, but is implementing this guidance 
immediately because the agency has determined that prior public 
participation is not feasible or appropriate. This is because blood 
establishments need to establish suitable standard operating procedures 
as soon as possible in preparation for the approaching season during 
which an outbreak of WNV can occur. 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

[[Page 29530]]

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://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: May 16, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10222 Filed 5-20-05; 8:45 am]

BILLING CODE 4160-01-S