
[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)]
[Notices]
[Pages 937-938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-5073]


Use of Nucleic Acid Tests To Reduce the Risk of Transmission of 
Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Use of Nucleic Acid 
Tests to Reduce the Risk of Transmission of Hepatitis B Virus from 
Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; 
Draft Guidance for Industry.'' The draft guidance document provides 
establishments that make donor eligibility determinations for donors of 
human cells, tissues, and tissue-based products (HCT/Ps), with 
recommendations concerning the use of FDA-licensed nucleic acid tests 
(NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic 
acid (DNA). The draft guidance, when finalized, is intended to 
supplement previous FDA recommendations to HCT/P establishments 
concerning donor testing for hepatitis B surface antigen (HBsAg) and 
total antibody to hepatitis B core antigen (anti-HBc), in the document 
entitled ``Guidance for Industry: Eligibility Determination for Donors 
of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-5073 for ``Use of Nucleic Acid Tests to Reduce the Risk of 
Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, 
and Cellular and Tissue Based Products; Draft Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the

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claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. 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 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of 
Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products; Draft Guidance for Industry.'' The draft 
guidance document provides establishments that make donor eligibility 
determinations for donors of HCT/Ps, with recommendations concerning 
the use of FDA-licensed NAT in donor testing for HBV DNA. FDA considers 
the use of FDA-licensed HBV NAT in testing HCT/Ps donors to be 
necessary to adequately and appropriately reduce the risk of 
transmission of HBV. The FDA-licensed HBV NAT can detect evidence of 
the viral infection at an earlier stage than the HBsAg and total anti-
HBc tests. Therefore, FDA recommends the use of FDA-licensed HBV NAT 
for testing donors of HCT/Ps for evidence of infection with HBV.
    HBV is a major global public health concern and has been 
transmitted by blood transfusions and tissue transplantation. Available 
literature has indicated possible transmissions of HBV by hematopoietic 
stem cells and blood with HBV NAT positive/hepatitis B surface antigen 
(anti-HBs) positive/HBsAg negative blood, irrespective of anti-HBc test 
results. In blood donors, adding the HBV NAT testing for HBV reduces 
the residual risk of transmission of HBV infection beyond that which 
can be achieved by screening donors using only HBsAg and total anti-HBc 
tests. In addition, it can detect breakthrough infections in previously 
vaccinated individuals who are exposed to the virus, and HBV mutants 
appear to be more likely detected by HBV NAT than by HBsAg assays.
    In the United States, there are currently FDA-licensed HBV NAT 
assays with an indication for screening donor blood samples for Whole 
Blood and Blood components, other living donors (individual organ 
donors when specimens are obtained while the donor's heart is still 
beating), and blood specimens from cadaveric (non-heart-beating) 
donors. Some of these are multiplex assays that can simultaneously 
detect HIV, HCV, and HBV in a single blood specimen, thus improving the 
feasibility of routine NAT testing for HBV. By analogy to the 
experience in the blood donor setting, it is reasonable to expect that 
the residual risk of transmission of HBV infection would be reduced by 
adding HBV NAT to the testing strategy for HCT/P donors. HBV NAT's 
potential utility in further reducing risk of HBV transmission by 
transplantation is mainly restricted to the early HBsAg-negative phase 
of infection. In summary, the available scientific data and the 
availability of FDA-licensed assays support a recommendation that all 
HCT/Ps donors should be tested using an FDA-licensed HBV NAT. The draft 
guidance, when finalized, is intended to supplement previous FDA 
recommendations to HCT/P establishments concerning donor testing for 
HBsAg and total anti-HBc, in the 2007 Donor Eligibility Guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the ``Use of 
Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B 
Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products.'' It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. 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: January 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-149 Filed 1-7-16; 8:45 am]
BILLING CODE 4164-01-P


