[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