70 FR 45 pg. 11679 - Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance
Type: NOTICEVolume: 70Number: 45Page: 11679
Docket number: [Docket No. 1993D-0394]
FR document: [FR Doc. 05-4633 Filed 3-8-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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 This document is being withdrawn because it no longer reflects all of FDA's current considerations on a guidance to assist manufacturers of blood and blood components, including blood banks,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 FDA is revising the guidance and a draft guidance for public comment will be issued in the future.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