1166 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

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and for the draft guidance related to 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

Docket 

No. Draft guidance document title 

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Draft Guidance for Industry.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Draft Guidance for Industry.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(HCT/Ps); Draft Guidance for Industry.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 TissueBased 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 TissueBased 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-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. 2024–31523 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–2022–D–0464] 

Recommendations for Determining 

Eligibility of Donors of Human Cells, 

Tissues, and Cellular and TissueBased Products; 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 document entitled 

‘‘Recommendations for Determining 

Eligibility of Donors of Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps).’’ This draft guidance 

document includes general information 

on determining eligibility for donors of 

HCT/Ps. In addition, FDA intends to 

issue separate guidance documents with 

recommendations regarding reducing 

the risk of transmission of specific 

communicable disease agents and 

diseases for donors of HCT/Ps. These 

guidance documents are intended to 

update an existing guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 6, 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1167 

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– 

2022–D–0464 for ‘‘Recommendations 

for Determining Eligibility of Donors of 

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 

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 draft 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 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft 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 draft 

guidance document. 

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 

a draft document entitled 

‘‘Recommendations for Determining 

Eligibility of Donors of Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps).’’ This draft guidance 

document is intended to update an 

existing guidance document 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. 

The draft guidance 

‘‘Recommendations for Determining 

Eligibility of Donors of Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ includes general 

information on determining eligibility 

for donors of HCT/Ps. Updates to 

existing guidance recommendations 

include, but are not limited to, revised 

exceptions applicable to certain HCT/ 

Ps, 21 CFR 1271.90 (81 FR 40517, June 

22, 2016); clarifications surrounding the 

donor medical history interview; and 

additional considerations regarding 

specimens for donor testing to avoid 

false negative test results. 

FDA intends to issue separate, 

additional guidance documents with 

recommendations regarding reducing 

the risk of transmission of specific 

communicable disease agents and 

diseases for donors of HCT/Ps as 

follows: human immunodeficiency 

virus, hepatitis B virus, hepatitis C 

virus, Mycobacterium tuberculosis 

(Mtb), sepsis, human transmissible 

spongiform encephalopathies, 

cytomegalovirus, Chlamydia 

trachomatis and Neisseria gonorrhoeae, 

human T-lymphotropic virus, 

Treponema pallidum (syphilis), 

vaccinia virus, West Nile virus, and 

communicable disease risk associated 

with xenotransplantation. Please note 

that FDA has withdrawn the 2018 

guidance for industry ‘‘Donor Screening 

Recommendations to Reduce the Risk of 

Transmission of Zika Virus by Human 

Cells, Tissues, and Cellular and TissueBased Products.’’ FDA has determined 

that Zika virus (ZIKV) is no longer a 

relevant communicable disease agent or 

disease because the available evidence 

demonstrates that ZIKV no longer has 

sufficient incidence and/or prevalence 

to affect the potential HCT/P donor 

population. 

The draft of the general guidance 

document and the associated specific 

guidance documents, when finalized, 

are intended to supersede the following 

guidance documents: 

• ‘‘Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps), Guidance for Industry,’’ dated 

August 2007; 

• ‘‘Use of Donor Screening Tests To 

Test Donors of Human Cells, Tissues 

and Cellular and Tissue-Based Products 

for Infection with Treponema pallidum 


ddrumheller on DSK120RN23PROD with NOTICES1
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