Document ID: FDA-2015-D-5073-0024
Agency: fda
Document Type: Notice
Title: 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; Guidance for Industry; Availability
Posted Date: 2016-08-17T04:00Z

[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54811-54813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19588]

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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; 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 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; Guidance 
for Industry.'' The guidance document provides establishments that make 
donor eligibility determinations for donors of human cells, tissues, 
and cellular 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 
guidance finalizes the draft guidance of the same title dated January 
2016 and supplements 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: Submit either electronic or written comments on Agency guidances 
at any time.

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

[[Page 54812]]

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; 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 
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 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 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Angela Moy, 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 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; Guidance for Industry.'' The guidance 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/P 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 antibody 
(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 intended to screen blood samples from donors of 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/P donors should be tested 
using an FDA-licensed HBV NAT.
    In the Federal Register of January 8, 2016 (81 FR 937), FDA 
announced the

[[Page 54813]]

availability of the draft guidance of the same title dated January 
2016. FDA received a few comments on the draft guidance and those 
comments were considered as the guidance was finalized. The guidance 
announced in this notice finalizes the draft guidance of the same title 
dated January 2016 and supplements previous FDA recommendations to HCT/
P establishments concerning donor testing for HBsAg and total antibody 
to anti-HBc, in the 2007 Donor Eligibility Guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 11, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19588 Filed 8-16-16; 8:45 am]
 BILLING CODE 4164-01-P