Document ID: FDA-2011-D-0799-0009
Agency: fda
Document Type: Notice
Title: 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: 2012-11-15T05:00Z

[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68133-68134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27783]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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; 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: 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,'' dated October 2012. 
The 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 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 collect Whole Blood and blood components for transfusion or for 
further manufacture, including recovered plasma, Source Plasma and 
Source Leukocytes. The guidance announced in this notice finalizes the 
draft guidance of the same title, dated November 2011. The guidance 
also supplements 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 donations mentioned in those documents.

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: 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: 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,'' dated October 2012. 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 FDA-licensed HBV NAT, in 
accordance with the requirements under Title 21 Code of Federal 
Regulations, 610.40(a) and (b) (21 CFR 610.40(a) and (b)).
    The guidance supplements 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 donations 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.
    In the Federal Register of November 28, 2011 (76 FR 72950), FDA 
announced the availability of the draft guidance of the same title, 
dated November 2011. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. In addition to minor editorial changes made to improve 
clarity, changes to the draft guidance include revised labeling 
recommendations and an extension of the time for implementation of the 
guidance to 6 months after publication of the final guidance. The 
guidance announced in this notice finalizes the draft guidance dated 
November 2011.
    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 
requirement 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

[[Page 68134]]

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 Sec.  601.12 
and in Sec. Sec.  606.121 and 610.40 have been approved under OMB 
control numbers 0910-0338 and 0910-0116, respectively.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

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: November 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27783 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P