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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1164-1166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31523]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0465, FDA-2022-D-0466, and FDA-2022-D-0467]

Draft Guidances Relating to Recommendations To Reduce the Risk of 
Transmission of Relevant Communicable Disease Agents and Diseases by 
Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft 
Guidances 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 three

[[Page 1165]]

specific draft guidances for industry entitled ``Recommendations to 
Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human 
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);'' 
``Recommendations to Reduce the Risk of Transmission of Hepatitis C 
Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps);'' and ``Recommendations to Reduce the Risk of 
Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' These draft 
guidances are intended to update existing guidances and to assist 
establishments making donor eligibility determinations in understanding 
the requirements for determining donor eligibility, including donor 
screening and testing, for donors of HCT/Ps. These draft guidances are 
also intended to provide establishments making donor eligibility 
determinations with recommendations to reduce the risk of transmission 
of specific communicable disease agents and diseases, specifically, 
hepatitis B virus (HBV), hepatitis C virus (HCV), and human 
immunodeficiency virus (HIV), by HCT/Ps.

DATES: Submit either electronic or written comments on the draft 
guidances by February 6, 2025 to ensure that the Agency considers your 
comment on these draft guidances before it begins work on the final 
versions of the guidances.

ADDRESSES: You may submit comments on any guidance at any time 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 https://www.regulations.gov 
will be posted to the dockets 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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-2022-D-0465 for ``Recommendations to Reduce the Risk of 
Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for 
Industry;'' Docket No. FDA-2022-D-0466 for ``Recommendations to Reduce 
the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft 
Guidance for Industry;'' and Docket No. FDA-2022-D-0467 for 
``Recommendations to Reduce the Risk of Transmission of Human 
Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' Received 
comments will be placed in the dockets and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the dockets to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket numbers, 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 guidances 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 guidances may also be obtained by 
phone by calling CBER at 1-800-835-4709 or 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidances.

FOR FURTHER INFORMATION CONTACT: Victoria Wagman, 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 three draft guidances 
entitled: ``Recommendations to Reduce the Risk of Transmission of 
Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps);'' ``Recommendations to Reduce the Risk 
of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps);'' and ``Recommendations to 
Reduce the Risk

[[Page 1166]]

of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' When 
finalized, these draft guidances will update existing guidance 
documents and assist establishments making donor eligibility 
determinations in understanding the requirements for determining donor 
eligibility, including donor screening and testing, for donors of HCT/
Ps. When finalized, these specific draft guidances will also provide 
establishments making donor eligibility determinations with 
recommendations to reduce the risk of transmission of HBV, HCV, and HIV 
by HCT/Ps. Updates to existing guidance recommendations include but are 
not limited to: revising recommendations for donor screening that 
includes reducing certain time-based risk factors and conditions; 
assessing HCT/P donor eligibility using the same individual risk-based 
questions relevant to risk for every donor regardless of sex or gender, 
and for the draft guidance related to HIV, donor testing and screening 
for HIV-1 group O risk.
    Based on FDA review of the available science, adequacy of available 
test methods, studies used to evaluate risk behaviors, and experiences 
with updated blood donor screening questions, FDA also recommends 
eliminating the HCT/P donor screening questions specific to men who 
have sex with men (MSM) and women who have sex with MSM and, instead 
recommends assessing HCT/P donor eligibility using the same individual 
risk-based questions relevant to HBV, HCV, and HIV risk for every donor 
regardless of sex or gender.

        Table 1--Three Draft Guidances Issued for Public Comment
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               Docket No.                 Draft guidance document title
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FDA-2022-D-0465........................  Recommendations to Reduce the
                                          Risk of Transmission of
                                          Hepatitis B Virus (HBV) by
                                          Human Cells, Tissues, and
                                          Cellular and Tissue-Based
                                          Products (HCT/Ps); Draft
                                          Guidance for Industry.
FDA-2022-D-0466........................  Recommendations to Reduce the
                                          Risk of Transmission of
                                          Hepatitis C Virus (HCV) by
                                          Human Cells, Tissues, and
                                          Cellular and Tissue-Based
                                          Products (HCT/Ps); Draft
                                          Guidance for Industry.
FDA-2022-D-0467........................  Recommendations to Reduce the
                                          Risk of Transmission of Human
                                          Immunodeficiency Virus (HIV)
                                          by Human Cells, Tissues, and
                                          Cellular and Tissue-Based
                                          Products (HCT/Ps); Draft
                                          Guidance for Industry.
------------------------------------------------------------------------

    At a later date, FDA intends to issue additional specific draft 
guidances with recommendations regarding specific communicable disease 
agents and diseases for donors of HCT/Ps as follows: (1) transmissible 
spongiform encephalopathy, (2) Treponema pallidum (syphilis), (3) 
Chlamydia trachomatis and Neisseria gonorrhoeae, (4) vaccinia virus, 
(5) West Nile virus, (6) human T-lymphotropic virus, (7) 
Cytomegalovirus, and (8) communicable disease risks associated with 
xenotransplantation.
    The draft guidances, when finalized, are intended to supersede 
information regarding HBV, HCV, and HIV risk in the document entitled 
``Eligibility Determination for Donors of Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,'' 
dated August 2007. Regarding HBV risk, the draft guidance is also 
intended to supersede the 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'' dated August 2016.
    The three draft guidances are being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). These draft 
guidances, when finalized, will represent the current thinking of FDA 
on ``Recommendations to Reduce the Risk of Transmission of Hepatitis B 
Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps);'' ``Recommendations to Reduce the Risk of 
Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps);'' and ``Recommendations to 
Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) 
by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps).'' They do not establish any rights for any person and are 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 these guidances contains no new collection of information, 
they do 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 (44 U.S.C. 3501-3521). The collections of 
information in 21 CFR part 1271.50 have been approved under OMB control 
number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31523 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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