[Federal Register Volume 72, Number 119 (Thursday, June 21, 2007)]
[Notices]
[Pages 34259-34260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0223]


Draft Guidance for Industry on Use of the Computer Crossmatch; 
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: 
``Computer Crossmatch'' (Electronic Based testing for the Compatibility 
between the Donor's Cell Type and the Recipient's Serum or Plasma 
Type)'' dated June 2007. The draft guidance document provides 
recommendations to blood establishments consistent with current good 
manufacturing practice (CGMP) for the use of a ``computer crossmatch,'' 
also called an ``electronic crossmatch.'' The computer crossmatch is an 
alternative to serologic crossmatch and may be used to demonstrate 
incompatibility between the donor's red blood cell type and the 
recipient's serum or plasma type.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 September 19, 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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 1-800-835-4709 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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: Joseph L. Okrasinski, 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:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: ``Computer Crossmatch'' (Electronic Based 
Testing for the Compatibility between the Donor's Cell Type and the 
Recipient's Serum or Plasma Type)'' dated June 2007. The draft guidance 
document provides recommendations consistent with CGMP for use of a 
``computer crossmatch'' also called an ``electronic crossmatch''. The 
computer crossmatch is an alternative to serologic crossmatch and may 
be used to demonstrate incompatibility between the donor's red blood 
cell type and the recipient's serum or plasma type.
    A final rule published in the Federal Register on August 6, 2001 
(66 FR 40886) revised Sec.  606.151(c) (21 CFR 606.151(c)) to allow 
either a serologic crossmatch or a computer crossmatch. Prior to 
September 5, 2001, a blood establishment could only use a computer 
crossmatch if FDA gave its written approval for the use of a computer 
crossmatch as an alternate procedure under Sec.  640.120 (21 CFR 
640.120). With this revision to Sec.  606.151(c), an application to FDA 
to permit use of computer crossmatch as an alternative procedure under 
Sec.  640.120 is no longer necessary. Licensed establishments that 
change procedures to implement computer crossmatch remain subject to 
Sec.  601.12 (21 CFR 601.12).
    This 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 606.100(b) and 606.160 have been 
approved under OMB control number 0910-0116. The collections of 
information under Sec.  601.12 have been approved under OMB control 
number 0910-0338. The collections of information under 21 CFR 606.171 
have been approved under OMB control number 0910-0458.

III. Comments

    The draft document 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.

[[Page 34260]]

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: June 13, 2007.
Randall W. Lutter,
Acting Deputy Commissioner for Policy.
[FR Doc. E7-11998 Filed 6-20-07; 8:45 am]
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