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 This document is being withdrawn because it no longer reflects all of FDA's current considerations on a guidance to assist manufacturers of blood and blood components, including blood banks,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 FDA is revising the guidance and a draft guidance for public comment will be issued in the future.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