Document ID: FDA-2008-D-0263-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc);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
Posted Date: 2008-05-21T04:00Z

[Federal Register: May 21, 2008 (Volume 73, Number 99)]
[Notices]               
[Page 29519-29520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my08-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Industry: Requalification Method for Reentry 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 draft 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 2008. The draft guidance document provides 
recommendations to establishments that collect human blood or blood 
components for a requalification method or process to reenter deferred 
donors into a donor pool based on a determination that the previous 
tests that were repeatedly reactive for anti-HBc were falsely positive 
and that there is no evidence of infection with Hepatitis B virus 
(HBV).

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 August 19, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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

[[Page 29520]]

electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Paul E. Levine, 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: Requalification Method for Reentry of Blood 
Donors Deferred Because of Reactive Test Results for Antibody to 
Hepatitis B Core Antigen (Anti-HBc)'' dated May 2008. FDA is providing 
recommendations to establishments that collect human 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. Due to 
the availability of this licensed HBV nucleic acid test and the 
improved specificity of anti-HBc assays, we are recommending a reentry 
algorithm for donors deferred due to a falsely positive repeatedly 
reactive test for anti-HBc in this guidance. Until now FDA has not 
recommended a requalification method or process for reentry of donors 
deferred due to reactive test results for hepatitis B core antigen 
(anti-HBc) due to the lack of licensed tests that could be recommended 
for use in a suitable algorithm for this purpose.
    The 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. Comments

    The draft guidance 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. 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.regulations.gov.

    Dated: May 12, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11433 Filed 5-20-08; 8:45 am]

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