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, 54811-54813 [2016-19588]
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Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
TABLE 3—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
respondents
Information collection activity
Number of
responses per
respondent
Total one-time
responses
Average
burden per
response
Total hours
Initial VQIP application .........................................................
Initial VQIP application w/additional information .................
100
100
1
1
100
100
80
100
8,000
10,000
Total ..............................................................................
........................
........................
........................
........................
18,000
1 There
are no capital or operating and maintenance costs associated with the collection of information.
The guidance will inform food
importers of application procedures for
VQIP. We estimate that up to 200
qualified importers will be accepted in
the first year of VQIP. We estimate that
it will take 80 person-hours to compile
all the relevant information and
complete the application for the VQIP
program. For the purpose of this
analysis, we assume that 50 percent of
all applications received will require
additional information and it would
take an additional 20 person-hours by
the importer to provide that
information. Therefore, we estimate that
100 importers will spend 8,000 hours
(80 hours/importer × 100 importers) and
100 importers will spend 10,000 hours
(100 hours/importer × 100 importers) to
submit their initial VQIP applications
for a total one-time reporting burden of
18,000 hours (see table 3).
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
responses
Information collection activity
Total annual
responses
Average
burden per
response
Total hours
Subsequent year VQIP application ......................................
Request to reinstate participation ........................................
200
2
1
1
200
2
20
10
4,000
20
Total ..............................................................................
........................
........................
........................
........................
4,020
mstockstill on DSK3G9T082PROD with NOTICES
1 There
are no capital or operating and maintenance costs associated with the collection of information.
The guidance states that each VQIP
participant will submit to FDA a notice
of intent to participate in VQIP on an
annual basis. We expect that each of the
expected 200 importers in VQIP would
apply in the subsequent year to
participate in VQIP. We expect that an
application to participate in VQIP in a
subsequent year will take significantly
less time to prepare than the initial
application. We use 25 percent of the
amount of effort to prepare and submit
the initial application for acceptance in
VQIP. Therefore, it is expected that, on
average, each VQIP importer will spend
20 hours to complete and submit a VQIP
application for each subsequent year.
The annual burden of completing a
subsequent year application to
participate in VQIP status by 200
importers is estimated at 4,000 hours
(200 applications × 20 hours/
application) (see table 4).
Finally, we have added to the VQIP
estimated annual reporting burden an
estimate of the burden associated with
importers’ requests to reinstate
participation in VQIP after their
participation is revoked. We believe
most participants will not need to use
this provision, and we have included an
estimate that reflects this. Upon
implementation of the VQIP, we will
reevaluate our estimate for future OMB
submission and revise it accordingly.
VerDate Sep<11>2014
17:38 Aug 16, 2016
Jkt 238001
Dated: August 12, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2016–19643 Filed 8–16–16; 8:45 am]
BILLING CODE 4164–01–P
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 TissueBased Products; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to
E:\FR\FM\17AUN1.SGM
17AUN1
54812
Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
https://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 https://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 https://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
VerDate Sep<11>2014
17:38 Aug 16, 2016
Jkt 238001
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
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: https://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 https://
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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-heartbeating) 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
E:\FR\FM\17AUN1.SGM
17AUN1
Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
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 antiHBc, 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.
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
September 14, 2016, from 8 a.m. to 5:30
p.m.
ADDRESSES: DoubleTree by Hilton Hotel
Bethesda-Washington DC, 8120
Wisconsin Ave., Bethesda, MD 20814,
301–652–2000. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at
www.doubletreebethesda.com/. You
may submit your comments as follows:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 many not wish to be posted,
such as medical information, you 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 https://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’’).
Food and Drug Administration
Written/Paper Submissions
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://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
[Docket No. FDA–2016–N–0567]
Pediatric Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice, establishment of a
public docket; request for comments.
mstockstill on DSK3G9T082PROD with NOTICES
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
of the Pediatric Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
SUMMARY:
VerDate Sep<11>2014
16:39 Aug 16, 2016
Jkt 238001
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 either the Docket No.
FDA–2016–N–0567 for the ‘‘Pediatric
Advisory Committee; Notice of Meeting;
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
54813
Establishment of a Public Docket;
Request for Comments’’; or the Docket
No. FDA–2016–N–2470 for the
‘‘Pediatric-focused Safety Reviews’’,
which will be posted on the Internet,
but not presented at the Pediatric
Advisory Committee meeting. Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://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 thatyou 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 https://
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: https://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 https://
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.
FOR FURTHER INFORMATION CONTACT:
Marieann Brill, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5154, Silver Spring,
MD 20993, 240–402–3838,
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to
[[Page 54812]]
https://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 https://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 https://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 https://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: https://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 https://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 https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
