1168 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

(Syphilis), Guidance for Industry’’ dated 

September 2015; 

• ‘‘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; 

• ‘‘Use of Nucleic Acid Tests To 

Reduce the Risk of Transmission of 

West Nile Virus from Living Donors of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps), 

Guidance for Industry’’ dated September 

2016 and corrected May 2017; and 

• ‘‘Revised Recommendations for 

Determining Eligibility of Donors of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products Who Have 

Received Human-Derived Clotting 

Factor Concentrates, Guidance for 

Industry’’ dated November 2016. 

When the general guidance and the 

associated specific guidances are 

finalized, FDA intends to collate 

information from the guidances and 

provide comprehensive lists of 

recommendations on the FDA website 

regarding conditions and behaviors that 

increase the donor’s relevant 

communicable disease risk, examples of 

clinical evidence of relevant 

communicable disease, examples of 

physical evidence of relevant 

communicable disease or high-risk 

behavior associated with these diseases, 

disease agents for which all donors of 

HCT/Ps must be tested, and the types of 

tests we currently consider to be 

adequate and appropriate to meet the 

requirements in 21 CFR 1271.80(c). The 

comprehensive lists will cite to the 

applicable guidance(s) where the 

recommendations are provided. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Recommendations for Determining 

Eligibility of Donors of 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 part 1271 have 

been approved under OMB control 

number 0910–0543. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft 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. 

Dated: December 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31524 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–2707] 

Validation of Certain In Vitro 

Diagnostic Devices for Emerging 

Pathogens During a Section 564 

Declared Emergency; Draft Guidance 

for Industry and Food and Drug 

Administration Staff; 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 the draft 

guidance entitled ‘‘Validation of Certain 

In Vitro Diagnostic Devices for Emerging 

Pathogens During a Section 564 

Declared Emergency.’’ The draft 

guidance describes general 

recommendations for the validation of 

in vitro diagnostic devices (IVDs) for 

emerging pathogens during an 

applicable declaration of public health 

emergency. This guidance and the 

associated template include the 

recommendations that apply to test data 

and information submitted in a preEmergency Use Authorization (EUA), an 

EUA request, or to a test offered as 

described in an applicable enforcement 

discretion policy. This draft guidance is 

not final nor is it for implementation at 

this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 10, 2025 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

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 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–2707 for ‘‘Validation of Certain 

In Vitro Diagnostic Devices for Emerging 

Pathogens During a Section 564 

Declared Emergency.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1169 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Validation of 

Certain In Vitro Diagnostic Devices for 

Emerging Pathogens During a Section 

564 Declared Emergency’’ to the Office 

of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Toby Lowe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3416, Silver Spring, 

MD 20993–0002, 301–796–6512. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The guidance describes general 

recommendations for the validation of 

IVDs for emerging pathogens to help test 

manufacturers better prepare for future 

outbreaks by clarifying FDA’s 

expectations for test validation during 

an applicable declaration under section 

564 of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360bbb–3). Accurate and reliable IVDs 

are critical to the diagnosis, tracking, 

treatment, and interruption of 

transmission of infectious diseases 

during outbreaks, as well as for 

diagnosing and treating diseases or 

conditions caused by chemical, 

biological, radiological, or nuclear 

threats. These recommendations apply 

to test data and information submitted 

in a pre-EUA, an EUA request, or to a 

test offered as described in an 

applicable enforcement discretion 

policy. This draft guidance and the 

associated template address 

recommendations from two 

independent assessments of FDA’s 

response to COVID–19. Specifically, 

FDA selected Booz Allen Hamilton to 

do such an independent assessment, 

which culminated in an October 2021 

report, ‘‘Emergency Use Authorization 

Assessment—Final Report’’ (https://

www.fda.gov/media/152992/download), 

that recommended FDA ‘‘develop a 

framework for how to conduct 

validation of diagnostic tests for 

emerging pathogens in the setting of a 

declared PHE.’’ Similarly, the Office of 

the Inspector General’s September 2022 

report, ‘‘FDA Repeatedly Adapted 

Emergency Use Authorization Policies 

To Address the Need for COVID–19 

Testing’’ (https://oig.hhs.gov/oei/ 

reports/OEI-01-20-00380.pdf), 

recommended that FDA ‘‘develop a 

suite of EUA templates for future 

emergencies involving novel pathogens’’ 

and ‘‘expand and improve resources’’ on 

the EUA process among other actions 

FDA has taken or is taking. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on Validation of Certain In Vitro 

Diagnostic Devices for Emerging 

Pathogens During a Section 564 

Declared Emergency. 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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Validation of Certain 

In Vitro Diagnostic Devices for Emerging 

Pathogens During a Section 564 

Declared Emergency’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00007020 and 

complete title to identify the guidance 

you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

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 the following table have 

been approved by OMB: 

21 CFR part; guidance; or FDA form Topic OMB 

control No. 

‘‘Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders’’.Emergency use authorization ........................................ 0910–0595 

807, subpart E ........................................................................................... Premarket notification .................................................... 0910–0120 

814, subparts A through E ........................................................................ Premarket approval ........................................................ 0910–0231 

814, subpart H .......................................................................................... Humanitarian Use Devices; Humanitarian Device Exemption.0910–0332 

812 ............................................................................................................ Investigational Device Exemption .................................. 0910–0078 


ddrumheller on DSK120RN23PROD with NOTICES1
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