[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draft guidance of the same title, dated November 2011.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