[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22813-22814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10046]
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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 The guidance announced in this notice finalizes the draft
guidance of the same title dated May 2008.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