2011-20862. Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance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.

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The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled “Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)” dated July 2007.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In a notice published in the Federal Register of July 26, 2007 (72 FR 41080), FDA announced the availability of a draft guidance entitled “Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs).”

FDA has carefully considered the comments received on the draft guidance and, since that document issued in 2007, has gained additional experience with point of care devices and the autologous cells selected by them. Based on these comments and experience, FDA believes that the draft guidance would not, if finalized in current form, reflect FDA's current thinking. For these reasons, FDA is withdrawing the draft guidance entitled “Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs).”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.