Reports and guidance documents; availability, etc.: Electronic based testing for compatibility between donor's cell type and recipient's serum or plasma type; computer crossmatch, 34259-34260 [E7-11998]

Agencies

• Food and Drug Administration

[Federal Register: June 21, 2007 (Volume 72, Number 119)]
[Notices]
[Page 34259-34260]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn07-48]

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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Draft Guidance for Industry on Use of the Computer Crossmatch;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 The draft guidance document provides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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of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 https://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 https://www.fda.gov/cber/guidelines.htm or https://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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