1170 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

21 CFR part; guidance; or FDA form Topic OMB 

control No. 

860, subpart D .......................................................................................... De Novo classification process ...................................... 0910–0844 

‘‘Administrative Procedures for CLIA Categorization’’ and ‘‘Recommendations: Clinical Laboratory Improvement Amendments of 

1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.

CLIA Administrative Procedures; CLIA Waivers ........... 0910–0607 

800, 801, 809, and 830 ............................................................................. Medical Device Labeling Regulations; Unique Device 

Identification.

0910–0485 

820 ............................................................................................................ Current Good Manufacturing Practice (CGMP); Quality 

System (QS) Regulation.

0910–0073 

50, 56 ........................................................................................................ Protection of Human Subjects and Institutional Review 

Boards.

0910–0130 

Dated: December 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31522 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 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 § 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 (§ 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 (§ 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-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–3334] 

Accelerated Approval and 

Considerations for Determining 

Whether a Confirmatory Trial is 

Underway; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Accelerated Approval and 

Considerations for Determining Whether 

a Confirmatory Trial is Underway.’’ For 

drugs granted accelerated approval, 

sponsors conduct confirmatory studies 

that must be completed postapproval to 

verify and describe the anticipated 

effect on irreversible morbidity or 

mortality or other clinical benefit. This 

draft guidance describes FDA’s 

interpretation of the term ‘‘underway’’ 

and discusses policies for implementing 

this requirement, including factors FDA 

intends to consider when determining 

whether a confirmatory trial is 

underway prior to accelerated approval. 


ddrumheller on DSK120RN23PROD with NOTICES1