Notice2025-13272
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; Availability
Primary source
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Published
July 16, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry." The draft guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA's recommendations for testing blood and blood components for hepatitis B surface antigen (HBsAg) to reduce the risk of transfusion-transmitted hepatitis B virus (HBV). The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The draft guidance, when finalized, is intended to supersede the recommendations regarding testing of all blood donations for HBsAg in the guidance document entitled "Guidance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" dated October 2012 (October 2012 Guidance). The guidance, when finalized, will also supersede information on the same topic that is in the document entitled "Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)" dated December 1987 (December 1987 Memorandum).
Full Text
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<title>Federal Register, Volume 90 Issue 134 (Wednesday, July 16, 2025)</title>
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[Federal Register Volume 90, Number 134 (Wednesday, July 16, 2025)]
[Notices]
[Pages 32013-32015]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-5942]
Recommendations for Testing Blood Donations for Hepatitis B
Surface Antigen; Draft Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a draft document entitled
``Recommendations for Testing Blood Donations for Hepatitis B Surface
Antigen; Draft Guidance for Industry.'' The draft guidance document
provides blood establishments that collect blood and blood components,
including Source Plasma, with FDA's recommendations for testing blood
and blood components for hepatitis B surface antigen (HBsAg) to reduce
the risk of transfusion-transmitted hepatitis B virus (HBV). The
recommendations contained in the guidance apply to the collection of
Whole Blood and blood components, including Source Plasma. The draft
guidance, when finalized, is intended to supersede the recommendations
regarding testing of all blood donations for HBsAg in the guidance
document entitled ``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'' dated October 2012 (October 2012 Guidance). The
guidance, when finalized, will also supersede information on the same
topic that is in the document entitled ``Recommendations for the
Management of Donors and Units that are Initially Reactive for
Hepatitis B Surface Antigen (HBsAg)'' dated December 1987 (December
1987 Memorandum).
[[Page 32014]]
DATES: Submit either electronic or written comments on the draft
guidance by October 14, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, 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-2024-D-5942 for ``Recommendations for Testing Blood Donations for
Hepatitis B Surface Antigen; Draft Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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. 3103, 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: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Recommendations for Testing Blood Donations for Hepatitis B Surface
Antigen; Draft Guidance for Industry.'' The draft guidance provides
blood establishments that collect blood and blood components, including
Source Plasma, with FDA's recommendations for testing blood and blood
components for HBsAg to reduce the risk of transfusion-transmitted HBV.
The recommendations contained in the guidance apply to the collection
of Whole Blood and blood components, including Source Plasma.
Specifically, the guidance recommends that when the donations are
tested for HBV Deoxyribonucleic acid (DNA) by nucleic acid tests (NAT)
and for antibody to hepatitis B core antigen (anti-HBc) using screening
tests that FDA has licensed, approved, or cleared for such use, in
accordance with the manufacturer's instructions, testing for hepatitis
B surface antigen (HBsAg) is not necessary to reduce adequately and
appropriately the risk of transmission of HBV. Because Source Plasma
donations are not tested for anti-HBc, the draft guidance recommends
the continued testing of Source Plasma donations for HBsAg. The draft
guidance, when finalized, is intended to supersede the recommendations
with respect to blood donations that are tested for HBV NAT and anti-
HBc in the October 2012 Guidance and the information on the same topic
in the December 1987 Memorandum. Upon finalization of the new
recommendations set forth in this draft guidance, we intend to
consolidate all FDA recommendations for testing blood and blood
components for HBV to issue one guidance that includes finalized
recommendations for testing donations to reduce the risk of transfusion
transmission of hepatitis B. Except for conforming changes needed to
reflect the new recommendations in this draft guidance, we do not
intend to revise existing recommendations for HBV donation testing,
quarantine and disposition of reactive units, donor deferral and
requalification.
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
``Recommendations for Testing Blood Donations for Hepatitis B Surface
Antigen.'' It does not establish any
[[Page 32015]]
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.
As we develop any final guidance on this topic, FDA will consider
comments on the applicability of Executive Order 14192, per OMB
guidance M-25-20, and in particular, on any costs or cost savings.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 601 have been approved under OMB control number 0910-
0338 and the collections of information in 21 CFR parts 610 and 630
have been approved under OMB control number 0910-0116.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: July 11, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-13272 Filed 7-15-25; 8:45 am]
BILLING CODE 4164-01-P
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