81 FR 937 - 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Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 5 (January 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 5 (January 8, 2016)
| Page Range | 937-938 | |
| FR Document | 2016-00149 |
[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)] [Notices] [Pages 937-938] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00149] ----------------------------------------------------------------------- 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Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- 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Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry.'' The draft guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with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 The draft guidance, when finalized, is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 7, 2016.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 [[Page 938]] 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. 2016-00149 Filed 1-7-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices 937
Board of Governors of the Federal Reserve DEPARTMENT OF HEALTH AND the docket unchanged. Because your
System, January 5, 2016. HUMAN SERVICES comment will be made public, you are
Michael J. Lewandowski, solely responsible for ensuring that your
Associate Secretary of the Board. Food and Drug Administration comment does not include any
[FR Doc. 2016–00153 Filed 1–7–16; 8:45 am] [Docket No. FDA–2015–D–5073]
confidential information that you or a
BILLING CODE 6210–01–P third party may not wish to be posted,
Use of Nucleic Acid Tests To Reduce such as medical information, your or
the Risk of Transmission of Hepatitis anyone else’s Social Security number, or
DEPARTMENT OF HEALTH AND B Virus From Donors of Human Cells, confidential business information, such
HUMAN SERVICES Tissues, and Cellular and Tissue- as a manufacturing process. Please note
Based Products; Draft Guidance for that if you include your name, contact
Centers for Disease Control and Industry; Availability information, or other information that
Prevention identifies you in the body of your
AGENCY: Food and Drug Administration, comments, that information will be
Disease, Disability, and Injury HHS. posted on http://www.regulations.gov.
Prevention and Control Special ACTION: Notice of availability. • If you want to submit a comment
Emphasis Panel (SEP): Initial Review with confidential information that you
SUMMARY: The Food and Drug do not wish to be made available to the
In accordance with section 10(a)(2) of
Administration (FDA or Agency) is public, submit the comment as a
the Federal Advisory Committee Act
announcing the availability of a draft written/paper submission and in the
(Pub. L. 92–463), the Centers for Disease
document entitled ‘‘Use of Nucleic Acid manner detailed (see ‘‘Written/Paper
Control and Prevention (CDC)
Tests to Reduce the Risk of Submissions’’ and ‘‘Instructions’’).
announces the aforementioned meeting
Transmission of Hepatitis B Virus from
for the initial review of applications in Written/Paper Submissions
Donors of Human Cells, Tissues, and
response to Funding Opportunity Submit written/paper submissions as
Cellular and Tissue-Based Products;
Announcement (FOA) PAR15–352, follows:
Draft Guidance for Industry.’’ The draft
Occupational Safety and Health • Mail/Hand delivery/Courier (for
Training Project Grants. guidance document provides
establishments that make donor written/paper submissions): Division of
Time and Date: 8:00 a.m.–7:00 p.m., Dockets Management (HFA–305), Food
January 26–28, 2016 (Closed). eligibility determinations for donors of
human cells, tissues, and tissue-based and Drug Administration, 5630 Fishers
Place: Internet Assisted Meeting
products (HCT/Ps), with Lane, Rm. 1061, Rockville, MD 20852.
(IAM)/Virtual Meeting. • For written/paper comments
Status: The meeting will be closed to recommendations concerning the use of
FDA-licensed nucleic acid tests (NAT) submitted to the Division of Dockets
the public in accordance with
in donor testing for hepatitis B virus Management, FDA will post your
provisions set forth in section 552b(c)(4)
(HBV) deoxyribonucleic acid (DNA). comment, as well as any attachments,
and (6), title 5 U.S.C., and the
The draft guidance, when finalized, is except for information submitted,
Determination of the Director,
intended to supplement previous FDA marked and identified, as confidential,
Management Analysis and Services
recommendations to HCT/P if submitted as detailed in
Office, CDC, pursuant to Public Law 92–
establishments concerning donor testing ‘‘Instructions.’’
463. Instructions: All submissions received
Matters for Discussion: The meeting for hepatitis B surface antigen (HBsAg)
and total antibody to hepatitis B core must include the Docket No. FDA–
will include the initial review,
antigen (anti-HBc), in the document 2015–D–5073 for ‘‘Use of Nucleic Acid
discussion, and evaluation of
entitled ‘‘Guidance for Industry: Tests to Reduce the Risk of
applications received in response to
Eligibility Determination for Donors of Transmission of Hepatitis B Virus from
Occupational Safety and Health
Human Cells, Tissues, and Cellular and Donors of Human Cells, Tissues, and
Training Project Grants, FOA PAR15–
Tissue-Based Products (HCT/Ps)’’ dated Cellular and Tissue Based Products;
352, initial review.
August 2007 (2007 Donor Eligibility Draft Guidance for Industry.’’ Received
Contact Person For More Information:
Guidance). comments will be placed in the docket
Donald Blackman, Ph.D., Scientific
and, except for those submitted as
Review Officer, CDC, 2400 Century DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly
Center Parkway NE., 4th Floor, Room any guidance at any time (see 21 CFR viewable at http://www.regulations.gov
4204, Mailstop E–74, Atlanta, Georgia 10.115(g)(5)), to ensure that the Agency or at the Division of Dockets
30345, Telephone: (404) 498–6185, considers your comment on this draft Management between 9 a.m. and 4 p.m.,
DYB7@CDC.GOV. guidance before it begins work on the
The Director, Management Analysis Monday through Friday.
final version of the guidance, submit • Confidential Submissions—To
and Services Office, has been delegated either electronic or written comments submit a comment with confidential
the authority to sign Federal Register on the draft guidance by April 7, 2016. information that you do not wish to be
notices pertaining to announcements of
ADDRESSES: You may submit comments made publicly available, submit your
meetings and other committee
as follows: comments only as a written/paper
management activities, for both the
submission. You should submit two
Centers for Disease Control and Electronic Submissions copies total. One copy will include the
Prevention and the Agency for Toxic
mstockstill on DSK4VPTVN1PROD with NOTICES6
Submit electronic comments in the information you claim to be confidential
Substances and Disease Registry.
following way: with a heading or cover note that states
Catherine Ramadei, • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
Acting Director, Management Analysis and www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Services Office, Centers for Disease Control instructions for submitting comments. Agency will review this copy, including
and Prevention. Comments submitted electronically, the claimed confidential information, in
[FR Doc. 2016–00113 Filed 1–7–16; 8:45 am] including attachments, to http:// its consideration of comments. The
BILLING CODE 4163–18–P www.regulations.gov will be posted to second copy, which will have the
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![938 Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices
claimed confidential information eligibility determinations for donors of HCT/P establishments concerning donor
redacted/blacked out, will be available HCT/Ps, with recommendations testing for HBsAg and total anti-HBc, in
for public viewing and posted on http:// concerning the use of FDA-licensed the 2007 Donor Eligibility Guidance.
www.regulations.gov. Submit both NAT in donor testing for HBV DNA. This draft guidance is being issued
copies to the Division of Dockets FDA considers the use of FDA-licensed consistent with FDA’s good guidance
Management. If you do not wish your HBV NAT in testing HCT/Ps donors to practices regulation (21 CFR 10.115).
name and contact information to be be necessary to adequately and The draft guidance, when finalized, will
made publicly available, you can appropriately reduce the risk of represent the current thinking of FDA
provide this information on the cover transmission of HBV. The FDA-licensed on the ‘‘Use of Nucleic Acid Tests to
sheet and not in the body of your HBV NAT can detect evidence of the Reduce the Risk of Transmission of
comments and you must identify this viral infection at an earlier stage than Hepatitis B Virus from Donors of
information as ‘‘confidential.’’ Any the HBsAg and total anti-HBc tests. Human Cells, Tissues, and Cellular and
information marked as ‘‘confidential’’ Therefore, FDA recommends the use of Tissue-Based Products.’’ It does not
will not be disclosed except in FDA-licensed HBV NAT for testing establish any rights for any person and
accordance with 21 CFR 10.20 and other donors of HCT/Ps for evidence of is not binding on FDA or the public.
applicable disclosure law. For more infection with HBV. You can use an alternative approach if
information about FDA’s posting of HBV is a major global public health it satisfies the requirements of the
comments to public dockets, see 80 FR concern and has been transmitted by applicable statutes and regulations.
56469, September 18, 2015, or access blood transfusions and tissue
transplantation. Available literature has II. Electronic Access
the information at: http://www.fda.gov/
regulatoryinformation/dockets/ indicated possible transmissions of HBV Persons with access to the Internet
default.htm. by hematopoietic stem cells and blood may obtain the draft guidance at either
Docket: For access to the docket to with HBV NAT positive/hepatitis B http://www.fda.gov/BiologicsBlood
read background documents or the surface antigen (anti-HBs) positive/ Vaccines/GuidanceCompliance
electronic and written/paper comments HBsAg negative blood, irrespective of RegulatoryInformation/Guidances/
received, go to http:// anti-HBc test results. In blood donors, default.htm or http://
www.regulations.gov and insert the adding the HBV NAT testing for HBV www.regulations.gov.
docket number, found in brackets in the reduces the residual risk of transmission Dated: January 5, 2016.
heading of this document, into the of HBV infection beyond that which can
Leslie Kux,
‘‘Search’’ box and follow the prompts be achieved by screening donors using
Associate Commissioner for Policy.
and/or go to the Division of Dockets only HBsAg and total anti-HBc tests. In
addition, it can detect breakthrough [FR Doc. 2016–00149 Filed 1–7–16; 8:45 am]
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. infections in previously vaccinated BILLING CODE 4164–01–P
Submit written requests for single individuals who are exposed to the
copies of the draft guidance to the Office virus, and HBV mutants appear to be
more likely detected by HBV NAT than DEPARTMENT OF HEALTH AND
of Communication, Outreach and HUMAN SERVICES
Development, Center for Biologics by HBsAg assays.
In the United States, there are
Evaluation and Research (CBER), Food Food and Drug Administration
currently FDA-licensed HBV NAT
and Drug Administration, 10903 New
assays with an indication for screening [Docket No. FDA–2015–N–0001]
Hampshire Ave., Bldg. 71, Rm. 3128,
donor blood samples for Whole Blood
Silver Spring, MD 20993–0002. Send Gastroenterology and Urology Devices
and Blood components, other living
one self-addressed adhesive label to Panel of the Medical Devices Advisory
donors (individual organ donors when
assist the office in processing your Committee; Notice of Meeting
specimens are obtained while the
requests. The draft guidance may also be
donor’s heart is still beating), and blood AGENCY: Food and Drug Administration,
obtained by mail by calling CBER at 1–
specimens from cadaveric (non-heart- HHS.
800–835–4709 or 240–402–8010. See beating) donors. Some of these are
the SUPPLEMENTARY INFORMATION section ACTION: Notice.
multiplex assays that can
for electronic access to the draft simultaneously detect HIV, HCV, and
guidance document. This notice announces a forthcoming
HBV in a single blood specimen, thus meeting of a public advisory committee
FOR FURTHER INFORMATION CONTACT: improving the feasibility of routine NAT of the Food and Drug Administration
Jessica T. Walker, Center for Biologics testing for HBV. By analogy to the (FDA). The meeting will be open to the
Evaluation and Research, Food and experience in the blood donor setting, it public.
Drug Administration, 10903 New is reasonable to expect that the residual Name of Committee: Gastroenterology
Hampshire Ave., Bldg. 71, Rm. 7301, risk of transmission of HBV infection and Urology Devices Panel of the
Silver Spring, MD 20993–0002, 240– would be reduced by adding HBV NAT Medical Devices Advisory Committee.
402–7911. to the testing strategy for HCT/P donors. General Function of the Committee:
SUPPLEMENTARY INFORMATION: HBV NAT’s potential utility in further To provide advice and
reducing risk of HBV transmission by recommendations to the Agency on
I. Background transplantation is mainly restricted to FDA’s regulatory issues.
FDA is announcing the availability of the early HBsAg-negative phase of Date and Time: The meeting will be
mstockstill on DSK4VPTVN1PROD with NOTICES6
a draft document entitled ‘‘Use of infection. In summary, the available held on February 25, 2016, from 8 a.m.
Nucleic Acid Tests to Reduce the Risk scientific data and the availability of to 6 p.m. and February 26, 2016, from
of Transmission of Hepatitis B Virus FDA-licensed assays support a 8 a.m. to 1 p.m.
from Donors of Human Cells, Tissues, recommendation that all HCT/Ps donors Location: Hilton Washington DC
and Cellular and Tissue-Based Products; should be tested using an FDA-licensed North/Gaithersburg, Salons A, B, and C,
Draft Guidance for Industry.’’ The draft HBV NAT. The draft guidance, when 620 Perry Pkwy., Gaithersburg, MD
guidance document provides finalized, is intended to supplement 20877. The hotel’s telephone number is
establishments that make donor previous FDA recommendations to 301–977–8900.
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Document Created: 2016-01-16 01:14:35
Document Modified: 2016-01-16 01:14:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 937 |
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