[Federal Register Volume 72, Number 143 (Thursday, July 26, 2007)]
[Notices]
[Pages 41080-41081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0290]


Draft Guidance for Industry: Cell Selection Devices for Point of 
Care Production of Minimally Manipulated Autologous Peripheral Blood 
Stem Cells; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: Cell 
Selection Devices for Point of Care Production of Minimally Manipulated 
Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007. The 
draft guidance document discusses certain cell selection devices that 
minimally manipulate autologous PBSCs at the point of care for specific 
clinical indications, and the applicability of the requirements to such 
PBSCs. The guidance also discusses the submission of data intended to 
support approval of cell selection devices.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance submit written or electronic comments on the draft guidance by 
October 24, 2007.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling CBER at 1-

[[Page 41081]]

800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Cell Selection Devices for Point of Care 
Production of Minimally Manipulated Autologous Peripheral Blood Stem 
Cells (PBSCs)'' dated July 2007. The draft guidance document discusses 
certain cell selection devices that minimally manipulate autologous 
PBSCs at the point of care for specific clinical indications, and the 
applicability of the requirements of 21 CFR part 1271 to such PBSCs. 
The guidance also discusses the submission of data intended to support 
approval of cell selection devices.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 812 have been approved under 
0910-0078; the collections of information in 21 CFR part 814 have been 
approved under 0910-0231; the collections of information in 21 CFR part 
820 have been approved under 0910-0073; and the collections of 
information in 21 CFR part 822 have been approved under 0910-0449.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in the brackets in 
the heading of this document. A copy of the draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: July 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-3659 Filed 7-23-07; 12:02 pm]
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