[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Page 37864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12961]


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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''; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a guidance entitled ``Guidance for Industry: 
Discontinuation of Donor Deferral Related to Recent Fever with Headache 
as a Symptom of West Nile Virus Infection'' (May 2005 guidance) that 
was issued on May 6, 2005. A guidance 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, is being announced elsewhere in this issue of the 
Federal Register, and supersedes the May 2003 guidance entitled 
``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'' (May 2003 guidance) (68 FR 
25897).

DATES: June 30, 2005.

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: In a notice published in the Federal 
Register of May 23, 2005 (70 FR 29529), FDA announced the availability 
of the May 2005 guidance. This guidance removed FDA's previous 
recommendation concerning deferral of donors of Whole Blood and blood 
components for transfusion and for further manufacturing use on the 
basis of a specific donor question related to West Nile Virus infection 
(i.e., 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). 
Donor deferral based on this information was originally recommended in 
the May 2003 guidance. The guidance 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, 
announced elsewhere in this issue of the Federal Register, supersedes 
the May 2003 guidance and does not recommend donor deferral based upon 
a reported history of fever with headache in the week prior to 
donation. Therefore, the May 2005 guidance is being withdrawn because 
it is no longer necessary.

    Dated: June 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12961 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S