Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices 5911 

specific to autologous or allogeneic CAR 

T cell products are noted in the 

guidance. The guidance also provides 

recommendations for analytical 

comparability studies for CAR T cell 

products. While the guidance 

specifically focuses on CAR T cell 

products, some of the information and 

recommendations provided may also be 

applicable to other genetically modified 

lymphocyte products, such as CAR 

Natural Killer cells or T cell receptor 

modified T cells. 

In the Federal Register of March 16, 

2022 (87 FR 14893), FDA announced the 

availability of the draft guidance of the 

same title dated March 2022. FDA 

received numerous comments on the 

draft guidance and those comments 

were considered as the guidance was 

finalized. Changes to the guidance 

include clarifying the scope, focusing on 

treatment for oncology indications, and 

the recommendations for CAR T cells 

manufactured using cellular starting 

material from patients who have 

received CAR T cells previously, 

potency for CAR T cells that express 

multiple transgene elements, stability 

studies, and clinical monitoring. In 

addition, editorial changes were made 

to improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated March 2022. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of another human gene 

therapy final guidance entitled ‘‘Human 

Gene Therapy Products Incorporating 

Human Genome Editing; Guidance for 

Industry.’’ 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor (CAR) T Cell Products.’’ 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 (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 50 have been approved 

under OMB control number 0910–0130; 

the collections of information in 21 CFR 

part 211 have been approved under 

OMB control number 0910–0139; the 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014; the 

collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338; and 

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 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. 

Date: January 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01789 Filed 1–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–3561] 

Collection of Race and Ethnicity Data 

in Clinical Trials and Clinical Studies 

for Food and Drug AdministrationRegulated Medical 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 for industry entitled 

‘‘Collection of Race and Ethnicity Data 

in Clinical Trials and Clinical Studies 

for FDA-Regulated Medical Products.’’ 

The purpose of this guidance is to 

provide FDA’s expectations for, and 

recommendations on, use of a 

standardized approach for collecting 

and reporting race and ethnicity data in 

submissions including information 

collected and reported from clinical 

studies and clinical trials for FDAregulated medical products. Using 

standard terminology for race and 

ethnicity helps ensure that data are 

collected and reported consistently in 

submissions to FDA. This draft 

guidance revises the final guidance for 

industry and FDA staff entitled 

‘‘Collection of Race and Ethnicity Data 

in Clinical Trials’’ issued on October 26, 

2016. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 29, 2024 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– 

2016–D–3561 for ‘‘Collection of Race 

and Ethnicity Data in Clinical Trials and 

Clinical Studies for FDA-Regulated 

Medical Products.’’ 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
5912 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices 

1https://www.fda.gov/media/89307/download. 

• 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 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002; or 

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 requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 301–796–2500; James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7256, Silver Spring, 

MD 20993, 240–402–7911; or Office of 

Minority Health and Health Equity, 

healthequity@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Collection of Race and Ethnicity Data 

in Clinical Trials and Clinical Studies 

for FDA-Regulated Medical Products.’’ 

FDA’s recommended approach is based 

on the Office of Management and 

Budget (OMB) Statistical Policy 

Directive No. 15 (Policy Directive 15) 

and was developed in accordance with 

section 4302 of the Affordable Care Act 

(42 U.S.C. 300kk); the Health and 

Human Services Implementation 

Guidance on Data Collection Standards 

for Race, Ethnicity, Sex, Primary 

Language, and Disability Status; and the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA) Section 

907 Action Plan.1

OMB standards for the classification 

of Federal data on race and ethnicity 

were developed to provide a common 

framework for uniformity and 

consistency in the collection and use of 

data on race and ethnicity by Federal 

agencies (Policy Directive 15). This 

guidance provides recommendations on: 

1. Meeting the requirements set forth 

in the 1998 final rule (63 FR 6854, 

February 11, 1998) regarding 

presentation of demographic data in 

investigational new drug applications 

and new drug applications (known as 

the Demographic Rule); 

2. Collection of race and ethnicity 

data in biologics license applications 

(BLAs) and medical device applications; 

and 

3. Addressing the FDASIA Section 

907 Action Plan to improve the 

completeness and quality of 

demographic data collection and 

reporting. 

This guidance is also intended to help 

an applicant preparing a BLA or 

medical device application, which 

should be done in accordance with the 

OMB standards described in the 

guidance. 

In the Federal Register of January 27, 

2023 (88 FR 5375) OMB announced a 

formal review of OMB Policy Directive 

15 and requested public comments on 

initial proposals to revise the directive 

to account for large societal, political, 

and economic demographic shifts in the 

United States over the 25 years since its 

publication. FDA intends to update this 

guidance as appropriate if OMB revises 

Policy Directive 15. 

This guidance revises the final 

guidance for industry and FDA staff 

entitled ‘‘Collection of Race and 

Ethnicity Data in Clinical Trials’’ issued 

in October 2016. When finalized, this 

guidance will replace the October 2016 

guidance. Changes from the 2016 

version include broadening the draft 

guidance to include non-interventional 

(observational) clinical studies in 

addition to the interventional clinical 

trials discussed in the 2016 guidance. 

Other changes include a revised title 

and editorial changes for clarity, as well 

as updated references and contact 

information for FDA. 

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 ‘‘Collection of Race and Ethnicity 

Data in Clinical Trials and Clinical 

Studies for FDA-Regulated Medical 

Products.’’ 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 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 (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 312 have been approved 

under OMB Control Number 0910–0014; 

the collections of information in 21 CFR 

part 314 have been approved under 

OMB Control Number 0910–0001; the 

collections of information in 21 CFR 

part 601 have been approved under 

OMB Control Number 0910–0338; the 

collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB Control Number 0910–0120; 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB Control Number 0910–0078; the 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices 5913 

collections of information in 21 CFR 

part 814, subparts A through E, have 

been approved under OMB Control 

Number 0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

Control Number 0910–0332; the 

collections of information in 21 CFR 

part 860, subpart D, have been approved 

under OMB Control Number 0910–0844; 

and the collections of information in 42 

CFR part 11 have been approved under 

OMB Control Number 0925–0586. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: January 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01782 Filed 1–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0398] 

Human Gene Therapy Products 

Incorporating Human Genome Editing; 

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 final 

guidance entitled ‘‘Human Gene 

Therapy Products Incorporating Human 

Genome Editing; Guidance for 

Industry.’’ The guidance document 

provides recommendations to sponsors 

developing human gene therapy 

products incorporating genome editing 

(GE) of human somatic cells. 

Specifically, the guidance provides 

recommendations regarding information 

that should be provided in an 

investigational new drug (IND) 

application to assess the safety and 

quality of the investigational GE 

product, including information on 

product design, product manufacturing 

and testing, nonclinical safety 

assessment, and clinical trial design. 

The guidance announced in this notice 

finalizes the draft guidance of the same 

title dated March 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 30, 2024. 

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– 

2021–D–0398 for ‘‘Human Gene 

Therapy Products Incorporating Human 

Genome Editing.’’ 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 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 guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 


khammond on DSKJM1Z7X2PROD with NOTICES