Document ID: FDA-2007-D-0068-0015
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal
Posted Date: 2011-08-17T04:00Z

[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Page 51038]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20862]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0068; formerly Docket No. 2007D-0290]

Draft Guidance for Industry: Cell Selection Devices for Point of 
Care Production of Minimally Manipulated Autologous Peripheral Blood 
Stem Cells; Withdrawal of Draft Guidance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withdrawal of a draft guidance entitled ``Draft Guidance for Industry: 
Cell Selection Devices for Point of Care Production of Minimally 
Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 
2007.

DATES: August 17, 2011.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration (HFM-17), 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 26, 2007 (72 FR 41080), FDA announced the availability 
of a draft guidance entitled ``Draft Guidance for Industry: Cell 
Selection Devices for Point of Care Production of Minimally Manipulated 
Autologous Peripheral Blood Stem Cells (PBSCs).''
    FDA has carefully considered the comments received on the draft 
guidance and, since that document issued in 2007, has gained additional 
experience with point of care devices and the autologous cells selected 
by them. Based on these comments and experience, FDA believes that the 
draft guidance would not, if finalized in current form, reflect FDA's 
current thinking. For these reasons, FDA is withdrawing the draft 
guidance entitled ``Draft Guidance for Industry: Cell Selection Devices 
for Point of Care Production of Minimally Manipulated Autologous 
Peripheral Blood Stem Cells (PBSCs).''

    Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20862 Filed 8-16-11; 8:45 am]
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