[Federal Register: March 9, 2005 (Volume 70, Number 45)]
[Notices]
[Page 11679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr05-93]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1993D-0394]


Draft Guideline for the Validation of Blood Establishment
Computer Systems; 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 that was issued on September 28, 1993.

DATES: March 9, 2005.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852,
301-827-6210.

SUPPLEMENTARY INFORMATION: In a notice containing a cumulative list of
guidances available from the agency that published on January 5, 2005
(70 FR 824), FDA included the guidance document entitled, ``Draft
Guideline for the Validation of Blood Establishment Computer Systems.''
This document is being withdrawn because it no longer reflects all of
FDA's current considerations on a guidance to assist manufacturers of
blood and blood components, including blood banks, plasmapheresis
centers, and transfusion services in developing a computerized system
validation program. FDA is revising the guidance and a draft guidance
for public comment will be issued in the future.

    Dated: March 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4633 Filed 3-8-05; 8:45 am]

BILLING CODE 4160-01-S