Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket Nos. FDA-2024-D-3067; FDA-2024-D-3863]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

# SUMMARY:

                        The final guidances 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)” and “Recommendations To Reduce the Risk of Transmission of                         *Mycobacterium Tuberculosis*                         (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” are being revised to change the time by which FDA recommends implementation of the recommendations in the guidances.                    

# DATES:

                        The announcement of these guidances is published in the                         **Federal Register**                         on February 3, 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.”       ( print page 8803)      

*Instructions:*                     All submissions received must include the Docket No. FDA-2024-D-3067 for “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)” or 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),” as appropriate. 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 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 21 CFR 10.115(g)(5)).

                    Submit written requests for single copies of the guidances to the 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 labels to assist that office in processing your requests. The guidances 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 documents.                

# FOR FURTHER INFORMATION CONTACT:

James Myers, 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 two revised final guidances, “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)” and “Recommendations to Reduce the Risk of Transmission of                     *Mycobacterium Tuberculosis*                     (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” These guidance documents were originally published in the                     **Federal Register**                     on January 7, 2025 (90 FR 1141; 90 FR 1170). Both guidances recommended that establishments making donor eligibility determinations (establishments) implement the recommendations in the guidances “as soon as feasible, but not later than 4 weeks after the guidance issue date.”                

                    FDA is revising final guidances “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)” and “Recommendations To Reduce the Risk of Transmission of                     *Mycobacterium Tuberculosis*                     (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” to recommend implementation of the guidance recommendations on a longer timeframe, by May 4, 2025. The revised implementation date will permit FDA to consider the comments received thus far prior to the implementation date. Permitting the Agency additional time to further review and consider the guidances, including comments received, as well as seek additional comments is consistent with the President's January 20, 2025, memorandum entitled, “Regulatory Freeze Pending Review.” See paragraph 3 (directing agencies to consider postponing effective dates of certain rules “for the purpose of reviewing any questions of fact, law, and policy that the rules may raise”; “where appropriate and consistent with applicable law, consider opening a comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by the rules postponed under this memorandum”; and consider further delaying such rules “where necessary to continue to review these questions of fact, law, and policy”).                

FDA issued the 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)” to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of disease agents associated with sepsis for donors of human cells, tissues, and cellular and tissue-based products.

                    FDA issued the guidance entitled “Recommendations To Reduce the Risk of Transmission of                     *Mycobacterium Tuberculosis*                     (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” to assist establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products, with recommendations for screening donors for evidence of, and risk factors for, infection with Mtb, the organism that causes tuberculosis.                

                    FDA is issuing these revised guidances consistent with our good guidance practices regulation (§ 10.115 (21 CFR 10.115)). We are implementing these revisions without prior public comment because we have determined that prior public participation is not feasible or appropriate (see § 10.115(g)(2) and section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)). We made this determination because the revisions present a less burdensome policy that is consistent with public health. Although these guidance documents are being implemented immediately, you can comment on any guidance at any time (§ 10.115(g)(5)). FDA has already received comments on the guidances discussed above, and the Agency                           ( print page 8804)                        intends to consider those comments. Please submit any additional comments regarding the guidances that you wish the Agency to consider, including whether it would be appropriate to reissue these guidances in draft form or consider a later implementation date.                

## II. Paperwork Reduction Act of 1995

While these guidance documents contain no 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 (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 is 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 guidances 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.*

Dorothy A. Fink,

Acting Secretary, Department of Health and Human Services.

[FR Doc. 2025-02167 Filed 1-31-25; 8:45 am]

BILLING CODE 4164-01-P