Document ID: FDA-2008-D-0263-0012
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results, etc.
Posted Date: 2010-04-30T04:00Z

[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Notices]               
[Page 22813-22814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap10-92]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0263]

 
Guidance for Industry: Requalification Method for Reentry of 
Blood Donors Deferred Because of Reactive Test Results for Antibody to 
Hepatitis B Core Antigen (Anti-HBc); 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: 
Requalification Method for Reentry of Blood Donors Deferred Because of 
Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-
HBc),'' dated May 2010. The guidance document provides recommendations 
to establishments that collect Whole Blood or blood components intended 
for transfusion, with recommendations for a requalification method or 
process for reentering deferred donors into the donor pool based on a 
determination that previous tests that were repeatedly reactive for 
antibodies to hepatitis B core antigen (anti-HBc) were falsely positive 
and that there is no evidence of infection with hepatitis B virus 
(HBV). These recommendations are based on the recent availability of 
FDA-licensed hepatitis B virus nucleic acid tests (HBV NAT) that are 
particularly sensitive when single samples are tested. These tests 
provide an additional, powerful method of determining whether a donor 
who has been deferred because of anti-HBc reactivity is truly infected 
by HBV. The guidance announced in this notice finalizes the draft 
guidance of the same title dated May 2008.

DATES: Submit written or electronic 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 written comments on the 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, 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 document entitled 
``Guidance for Industry: Requalification Method for Reentry of Blood 
Donors Deferred Because of Reactive Test Results for Antibody to 
Hepatitis B Core Antigen (Anti-HBc),'' dated May 2010. The guidance 
document provides recommendations to establishments that collect Whole 
Blood or blood components for a requalification method or process for 
the reentry of deferred donors into the donor pool based on a 
determination that previous tests that were repeatedly reactive for 
anti-HBc were falsely positive and that there is no evidence of 
infection with HBV. Currently, donors who are repeatedly reactive on 
more than one occasion for anti-HBc (samples from more than one 
collection from the donor are repeatedly reactive for anti-HBc) must be 
indefinitely deferred in accordance with current regulations. 
Situations have occurred with some frequency in which two anti-HBc 
tests are false positives because of the relative non-specificity of 
these tests. The result is that many otherwise suitable donors are 
indefinitely deferred because of their anti-HBc test results even 
though medical follow-up of such donors indicates that they are not 
infected with HBV. FDA-licensed HBV NAT assays, which are particularly 
sensitive when single samples are tested, are now available and provide 
an additional, powerful method of determining whether a donor who has 
been deferred because of anti-HBc reactivity is truly infected by HBV. 
Due to the availability of FDA-licensed HBV NAT assays and the improved 
specificity of anti-HBc assays, FDA is recommending in the guidance a 
reentry algorithm for donors deferred due to falsely positive 
repeatedly reactive tests for anti-HBc.
    In the Federal Register of May 21, 2008 (73 FR 29519), FDA 
announced the availability of the draft guidance of the same title. 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 May 2008.
    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

    This 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 601.12 have been approved under 
OMB control number 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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

[[Page 22814]]

with the docket number found in brackets in the heading of this 
document. A copy of the 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 guidance at 
either: http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://
www.fda.gov/cber/guidelines.htm or http://www.regulations.gov.

    Dated: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10046 Filed 4-29-10; 8:45 am]
BILLING CODE 4160-01-S