[Federal Register: May 14, 2003 (Volume 68, Number 93)]
[Notices]
[Page 25897-25898]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my03-66]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0467]
``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;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document 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'' dated May 2003. The guidance provides our revisions to the
guidance of the same title dated October 2002 in which FDA provided its
recommendations for assessing donor suitability and product safety for
donors with proven recent West Nile Virus (WNV) infections or with
illness potentially due to WNV. The guidance is intended to recommend
deferral of donors infected or potentially infected with WNV, and to
recommend quarantine of blood and blood products previously collected
from such donors. These measures are intended to reduce the possibility
of WNV transmission by blood and blood products and are for immediate
implementation. This guidance supersedes the guidance of the same title
dated October 2002.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written or electronic requests for single copies of
this 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 guidance may also be
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800 or by fax by calling the FAX Information
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit written comments on the guidance document to the Dockets
Management Branch (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: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document 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'' dated May 2003. The guidance
document provides information related to the possible risk of WNV
transmission by blood or blood products. The presence of WNV in blood
components and transfusion transmission from blood components has been
documented. FDA developed this guidance in consultation with other
Public Health Service agencies of the Department of Health and Human
Services. The guidance supersedes the guidance of the same title dated
October 2002.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance document represents
the agency's current thinking on this topic.
[[Page 25898]]
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. Comments
The agency is soliciting public comment, and is recommending the
implementation of the guidance by June 1, 2003, because of public
health concerns related to the possible risk of transfusion transmitted
WNV.
Interested persons may, at any time, submit written or electronic
comments to the Dockets Management Branch (see ADDRESSES) regarding
this guidance document. Two copies of mailed comments are to be
submitted, except individuals may submit one copy. Comments should be
identified with the docket number found in the brackets in the heading
of this document. A copy of the document and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm
Dated: May 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11980 Filed 5-13-03; 8:45 am]
BILLING CODE 4160-01-S