```

[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1170-1171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31544]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-3863]

Recommendations To Reduce the Risk of Transmission of 
Mycobacterium Tuberculosis by 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, Agency, or we) is 
announcing the availability of a final guidance for immediate 
implementation entitled ``Recommendations To Reduce the Risk of 
Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' FDA is 
issuing this guidance to assist establishments that make donor 
eligibility determinations for donors of human cells, tissues, and 
cellular and tissue-based products (HCT/Ps), with recommendations for 
screening donors for evidence of, and risk factors for, infection with 
Mycobacterium tuberculosis (Mtb), the organism that causes 
tuberculosis. The guidance also recommends additional steps that HCT/P 
establishments should take to reduce risk of transmission of Mtb until 
such time as appropriate FDA-licensed, approved, or cleared donor 
screening tests are available for use to test donors for Mtb infection. 
The guidance identifies Mtb as a relevant communicable disease agent or 
disease (RCDAD) and supplements the recommendations contained in other 
donor eligibility guidance documents for donors of HCT/Ps. This 
guidance is being issued to address the urgent public health need to 
reduce the risk of transmission of Mtb by HCT/Ps.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025.

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:
     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 
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-2024-D-3863 for ``Recommendations To Reduce the Risk of 
Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' 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 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

[[Page 1171]]

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 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 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 Sec.  
10.115(g)(5) (21 CFR 10.115(g)(5))).
    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 
two self-addressed adhesive labels to assist that 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: Jessica Gillum, 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 final guidance for 
immediate implementation entitled ``Recommendations To Reduce the Risk 
of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps).'' FDA is 
issuing this guidance to provide establishments that make donor 
eligibility determinations for donors of HCT/Ps with recommendations 
for screening for evidence of, and risk factors for, infection with 
Mtb, the organism that causes tuberculosis. The guidance also 
recommends additional steps that HCT/P establishments should take to 
reduce risk of transmission of Mtb until such time as appropriate FDA-
licensed, approved, or cleared donor screening tests are available for 
use to test donors for Mtb infection.
    In addition, this guidance identifies Mtb as an RCDAD as defined in 
21 CFR 1271.3(r)(2) and supplements the recommendations contained in 
other donor eligibility guidance documents for donors of HCT/Ps.
    In 2021 and 2023, multistate outbreaks of Mtb in the United States 
were linked to transplantation of bone allograft products and resulted 
in significant morbidity and mortality. Because Mtb transmission can 
occur from HCT/P donors with unrecognized and undiagnosed tuberculosis 
infection, these circumstances demand heightened awareness when 
screening donors of HCT/Ps.
    We are issuing this guidance consistent with our good guidance 
practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). We are 
implementing this guidance without prior public comment because we have 
determined that prior public participation is not feasible or 
appropriate (Sec.  10.115(g)(2)). We made this determination because of 
the urgent public health need to provide recommendations to industry to 
reduce the risk of transmission of Mtb by HCT/Ps. Although this 
guidance document is immediately in effect, it remains subject to 
comment in accordance with FDA's GGP.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of another immediately in effect guidance entitled 
``Recommendations To Reduce the Risk of Transmission of Disease Agents 
Associated with Sepsis by Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps)'' with recommendations to reduce the 
risk of transmission of disease agents associated with sepsis, 
including mycobacterial agents such as Mtb, which can be a cause of 
sepsis.
    The guidance represents the current thinking of FDA on 
``Recommendations To Reduce the Risk of Transmission of Mycobacterium 
Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-
Based Products (HCT/Ps).'' 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 1271 relating to HCT/Ps, including establishing and 
maintaining records, investigation and reporting of adverse actions and 
documentation of methods used in facilities related to HCT/Ps, which, 
includes but not limited to donor screening, donor testing, and 
labeling have been approved under OMB control number 0910-0543.

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. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31544 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
```