Document ID: FDA-2011-D-0799-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and
Individual Samples From Donors of Whole Blood and Blood Components,
Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis
B Virus
Posted Date: 2011-11-28T05:00Z

[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72950-72951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30449]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0799]

Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled 
and Individual Samples From Donors of Whole Blood and Blood Components, 
Including Source Plasma, to Reduce the Risk of Transmission of 
Hepatitis B Virus

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: Use 
of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from 
Donors of Whole Blood and Blood Components (including Recovered Plasma, 
Source Plasma and Source Leukocytes) to Adequately and Appropriately 
Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and 
Requalification of Donors Who Test HBV NAT Positive,'' dated November 
2011. The draft guidance document provides recommendations on the use 
of FDA-licensed nucleic acid tests (NAT) to screen blood donors for 
hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations 
for product testing and disposition, donor management, methods for 
donor requalification, and product labeling. In addition, the draft 
guidance provides notification that FDA considers the use of an FDA-
licensed HBV NAT to be necessary to reduce adequately and appropriately 
the risk of transmission of HBV. The guidance is intended for blood 
establishments that

[[Page 72951]]

collect Whole Blood and blood components for transfusion or for further 
manufacture, including recovered plasma, Source Plasma and Source 
Leukocytes. The draft guidance, when finalized, is intended to 
supplement previous memoranda and guidance from FDA concerning the 
testing of donations for hepatitis B surface antigen (HBsAg) and 
antibody to hepatitis B core antigen (anti-HBc), and the management of 
donors and units mentioned in those documents.

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 either electronic or written comments on the draft 
guidance by January 27, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
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 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 electronic comments on the draft 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: Paul 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: Use of Nucleic Acid Tests (NAT) on Pooled and 
Individual Samples from Donors of Whole Blood and Blood Components 
(including Recovered Plasma, Source Plasma and Source Leukocytes) to 
Adequately and Appropriately Reduce the Risk of Transmission of 
Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT 
Positive,'' dated November 2011. FDA is providing blood establishments 
that collect Whole Blood and blood components for transfusion or for 
further manufacture, including recovered plasma, Source Plasma and 
Source Leukocytes; with recommendations concerning the use of FDA-
licensed NAT to screen blood donors for HBV DNA. FDA is also providing 
these blood establishments with recommendations for product testing and 
disposition, donor management, methods for donor requalification, and 
product labeling.
    In addition, FDA is notifying those blood establishments that FDA 
considers the use of an FDA-licensed HBV NAT to be necessary to reduce 
adequately and appropriately the risk of transmission of HBV. FDA-
licensed HBV NAT can detect evidence of infection at an earlier stage 
than is possible using previously approved HBsAg and anti-HBc tests. 
Therefore, FDA is recommending the use of an FDA-licensed HBV NAT, in 
accordance with the requirements under 610.40(a) and (b) (21 CFR 
610.40(a) and (b)).
    The draft guidance, when finalized, is intended to supplement 
previous memoranda and guidance from FDA to blood establishments 
concerning the testing of donations for HBsAg and anti-HBc, and the 
management of donors and units mentioned in those documents. Note that 
testing Whole Blood and blood components for transfusion and Source 
Leukocytes for further manufacture for HBsAg and anti-HBc, and Source 
Plasma for HBsAg should continue when a blood establishment implements 
HBV NAT. FDA may consider advancements in technology for testing blood 
donations, as well as data obtained following the implementation of HBV 
NAT, to make future recommendations on adequate and appropriate testing 
for HBV.
    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. 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 606.121, 610.40 and 640.70 have been 
approved under OMB Control Numbers 0910-0537, 0910-0116, and 0910-0338, 
respectively.

III. 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) 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 draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30449 Filed 11-25-11; 8:45 am]
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