[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Pages 23824-23825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0019 (formerly Docket No. 2007D-0223)]


Guidance for Industry: ``Computer Crossmatch'' (Computerized 
Analysis of the Compatibility Between the Donor's Cell Type and the 
Recipient's Serum or Plasma Type); 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 document entitled ``Guidance for Industry: `Computer 
Crossmatch' (Computerized Analysis of the Compatibility between the 
Donor's Cell Type and the Recipient's Serum or Plasma Type)'' dated 
April 2011. The guidance document provides blood establishments that 
perform compatibility testing using a computer crossmatch system to 
perform computerized matching of blood with recommendations consistent 
with current good manufacturing practice (CGMP) requirements. Blood 
establishments are required to have standard operating procedures to 
demonstrate incompatibility between the donor's cell type and the 
recipient's serum or plasma type. The guidance describes practices that 
we believe satisfy those requirements to help ensure detection of an 
incompatible crossmatch when using a computerized system for matching a 
donor's cell type with a recipient's serum or plasma type. The guidance 
announced in this notice finalizes the draft guidance entitled 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.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (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 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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Melissa Reisman, 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 document entitled 
``Guidance for Industry: `Computer Crossmatch' (Computerized Analysis 
of the Compatibility between the Donor's Cell Type and the Recipient's 
Serum or Plasma Type)'' dated April 2011. The guidance document 
provides blood establishments that perform compatibility testing using 
a computer crossmatch system to perform computerized matching of blood 
with recommendations consistent with

[[Page 23825]]

CGMP requirements in 21 CFR Parts 210, 211, and 606.
    In the Federal Register of August 6, 2001 (66 FR 40886), FDA issued 
a final rule that revised 21 CFR 606.151(c) to allow for the use of 
either a serologic crossmatch or a computer crossmatch as an acceptable 
method of establishing the compatibility between the donor's cell type 
and recipient's serum or plasma type (i.e., major crossmatch). Prior to 
the issuance of the final rule, a blood establishment could only use a 
computer crossmatch if FDA gave its written approval for the use of a 
computer crossmatch as an alternative procedure under 21 CFR 640.120. 
With this revision to 21 CFR 606.151(c), establishments are no longer 
required to submit an application to FDA to permit use of a computer 
crossmatch as an alterative procedure. The guidance does not apply to 
those circumstances where the donor's blood has not been screened for 
agglutinating, coating and hemolytic antibodies. In such cases, 21 CFR 
606.151(d) requires that ``* * * the recipient's cells shall be tested 
with the donor's serum (minor crossmatch) by a method that will so 
demonstrate.''
    The guidance document describes the practices that FDA believes 
satisfy the requirements in 21 CFR 606.151(c) to help ensure detection 
of an incompatible crossmatch when using a computerized system for 
matching a donor's cell type with a recipient's serum or plasma type. 
We consider computer crossmatch an acceptable method of compatibility 
analysis when it is properly designed, validated, implemented, and 
monitored. In addition, the guidance contains recommendations for blood 
establishments performing compatibility testing that intend to 
implement a computer crossmatch procedure. For licensed establishments, 
the guidance also describes how to report this manufacturing change to 
FDA under 21 CFR 601.12.
    In the Federal Register of June 21, 2007 (72 FR 34259), FDA 
announced the availability of the draft guidance 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. FDA received several comments on the 
draft guidance and those comments were considered as the guidance was 
finalized. In addition, editorial changes were made to improve clarity. 
The guidance announced in this notice finalizes the draft guidance 
dated June 2007.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The 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 211.68(a) and (b) and 211.100(a) 
have been approved under OMB control number 0910-0139. The collections 
of information in 21 CFR 606.100(b), 606.121, 606.151, and 606.160 have 
been approved under OMB control number 0910-0116. The collections of 
information in 21 CFR 601.12 have been approved under OMB control 
number 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen 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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 22, 2011,
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10221 Filed 4-27-11; 8:45 am]
BILLING CODE 4160-01-P