[Federal Register: June 28, 2005 (Volume 70, Number 123)]
[Notices]               
[Page 37102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn05-70]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0262] (formerly Docket No. 01-0262)

 
Draft ``Guidance for Food and Drug Administration Reviewers: 
Premarket Notification Submissions for Automated Testing Instruments 
Used in Blood Establishments;'' 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withdrawal of a draft guidance that was issued on August 3, 2001.

DATES: June 28, 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-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 3, 2001 (66 FR 40708), FDA announced the 
availability of a draft document entitled ``Guidance for FDA Reviewers: 
Premarket Notification Submissions for Automated Testing Instruments 
Used in Blood Establishments.'' This draft guidance is being withdrawn 
because it no longer reflects the following: (1) All of the information 
FDA reviewers should expect to be included in a premarket notification 
submitted to the Center for Biologics Evaluation and Research for such 
devices and (2) the recommended approach FDA reviewers should take in 
reviewing premarket submissions for automated instruments testing used 
in blood establishments. In the future, FDA may issue for public 
comment draft special control guidances on instrumentation for blood 
borne pathogen donor screening and immunohematology testing.

    Dated: June 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12763 Filed 6-27-05; 8:45 am]

BILLING CODE 4160-01-S