[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72950-72951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30449]
-----------------------------------------------------------------------
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Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled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.
-----------------------------------------------------------------------
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 The draft guidance document provides recommendations on the use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 In addition, the draft
guidance provides notification that FDA considers the use of an FDA-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 The draft guidance, when finalized, is intended to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draft guidance before it begins work on the final version of the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]
BILLING CODE 4160-01-P