Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus." The 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 virus (HBV) 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. The guidance announced in this notice finalizes the draft guidance titled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen" (July 2025 Draft Guidance). The guidance also supersedes the documents titled "Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)" (December 1987 Memorandum), "FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)" (September 1991 Memorandum), "Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes" (November 2007 Final Guidance), "Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)" (May 2010 Final Guidance), "Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection" (November 2011 Final Guidance), and "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" (October 2012 Final Guidance). The guidance supersedes the recommendations specific to HBV in "Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T- Lymphotropic Virus Type I (HTLV- I)" (July 1996 Memorandum).

Full Text

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<title>Federal Register, Volume 91 Issue 211 (Tuesday, November 3, 2026)</title>
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[Federal Register Volume 91, Number 211 (Tuesday, November 3, 2026)]
[Notices]
[Pages 69258-69259]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-5942]


Recommendations for Reducing the Risk of Transfusion-Transmitted 
Hepatitis B Virus; 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 final guidance titled ``Recommendations for 
Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus.'' The 
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 virus (HBV) 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. The guidance announced in 
this notice finalizes the draft guidance titled ``Recommendations for 
Testing Blood Donations for Hepatitis B Surface Antigen'' (July 2025 
Draft Guidance). The guidance also supersedes the documents titled 
``Recommendations for the Management of Donors and Units that are 
Initially Reactive for Hepatitis B Surface Antigen (HBsAg)'' (December 
1987 Memorandum), ``FDA Recommendations Concerning Testing for Antibody 
to Hepatitis B Core Antigen (Anti-HBc)'' (September 1991 Memorandum), 
``Adequate and Appropriate Donor Screening Tests for Hepatitis B; 
Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole 
Blood and Blood Components, Including Source Plasma and Source 
Leukocytes'' (November 2007 Final Guidance), ``Requalification Method 
for Reentry of Blood Donors Deferred Because of Reactive Test Results 
for Antibody to Hepatitis B Core Antigen (Anti-HBc)'' (May 2010 Final 
Guidance), ``Requalification Method for Reentry of Donors Who Test 
Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent 
Vaccination against Hepatitis B Virus Infection'' (November 2011 Final 
Guidance), and ``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'' (October 2012 Final Guidance). The guidance supersedes the 
recommendations specific to HBV in ``Recommendations for the Quarantine 
and Disposition of Units from Prior Collections from Donors with 
Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), 
Hepatitis C Virus (HCV) and Human T- Lymphotropic Virus Type I (HTLV-
I)'' (July 1996 Memorandum).

DATES: The announcement of the guidance is published in the Federal 
Register on November 3, 2026.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 Reducing the Risk of 
Transfusion-Transmitted Hepatitis B Virus.'' 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.

[[Page 69259]]

    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 guidance to the 
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 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 document titled 
``Recommendations for Reducing the Risk of Transfusion-Transmitted 
Hepatitis B Virus.'' The guidance provides blood establishments that 
collect blood and blood components, including Source Plasma, with FDA's 
recommendations for testing blood and blood components for HBV to 
reduce adequately and appropriately 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 provides recommendations on donation 
testing, donor deferral and requalification of deferred donors. The 
guidance also provides recommendations for product management, 
retrieval and quarantine.
    In the Federal Register of July 16, 2025 (90 FR 32013), FDA 
announced the availability of the draft guidance titled 
``Recommendations for Testing Blood Donations for Hepatitis B Surface 
Antigen'' dated July 2025. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. Editorial changes were made to improve clarity. The guidance 
announced in this notice finalizes the recommendations in the draft 
guidance dated July 16, 2025.
    As such, the guidance recommends the discontinuation of testing 
certain donations for HBsAg and conforming changes for donor 
requalification and labeling. Namely, we recommend that when donations 
are tested for HBV deoxyribonucleic acid (DNA) by nucleic acid tests 
(NAT) and for anti-HBc using screening tests that FDA has licensed, 
approved, or cleared for such use, in accordance with the 
manufacturer's instructions, testing for HBsAg is not necessary to 
reduce adequately and appropriately the risk of transmission of HBV. 
For Source Plasma donations, we continue to recommend that testing for 
HBsAg and HBV DNA by NAT is necessary to reduce adequately and 
appropriately the risk of transmission of HBV.
    In addition, the guidance consolidates FDA's recommendations for 
testing blood and blood components for HBV that have been issued 
previously in various memoranda and guidance documents. In 
consolidating the previous recommendations, minor changes were made to 
reflect advances in the tests used to screen blood donation for HBV and 
for consistency and alignment with current practices. As such, this 
final guidance supersedes the prior memoranda and guidance documents 
containing recommendations on donation testing, donor deferral and 
requalification of deferred donors, and blood product management, 
retrieval and quarantine related to HBV listed in the Summary above.
    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 ``Recommendations for Reducing the Risk of 
Transfusion-Transmitted Hepatitis B Virus.'' 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. 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 601.12 pertaining to licensed blood establishments 
reporting changes to an approved biologics license application have 
been approved under OMB control number 0910-0338. The collections of 
information in 21 CFR parts 610, 630, and 606 pertaining to current 
good manufacturing practices for blood, blood components, donor 
notification, and requirements for donor testing 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>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22369 Filed 11-2-26; 8:45 am]
BILLING CODE 4164-01-P


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