Skip to Content

Notice

Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; withdrawal.

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 This document is being withdrawn because it no longer reflects all of FDA's current considerations on a guidance to assist manufacturers of blood and blood components, including blood banks,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 FDA is revising the guidance and a draft guidance for public comment will be issued in the future.

Start Signature

Dated: March 1, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 05-4633 Filed 3-8-05; 8:45 am]

BILLING CODE 4160-01-S