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may obtain the draft guidance at https:// 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finalizes the draft guidance of the same 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
5914 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, 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 document 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 GE of human 

somatic cells. Specifically, the guidance 

provides recommendations regarding 

information that should be provided in 

an 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. 

In the Federal Register of March 16, 

2022 (87 FR 14897), 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 recommendations 

for GE components used only once (for 

example, in the manufacture of a master 

cell bank), expectations for potency 

assays, considerations for nonclinical 

studies with respect to potential for offtarget toxicity, and applicability of 

accelerated approval to GE products. 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 document 

entitled ‘‘Considerations for the 

Development of Chimeric Antigen 

Receptor (CAR) T Cell Products; 

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 ‘‘Human Gene 

Therapy Products Incorporating Human 

Genome Editing.’’ 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 312 have been approved 

under OMB control number 0910–0014; 

the collections of information in 21 CFR 

parts 210 and 211 have been approved 

under OMB control number 0910–0073; 

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. 

Dated: January 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01788 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–2024–N–0016] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Oncologic Drugs 

Advisory Committee (the Committee). 

The general function of the Committee 

is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

March 14, 2024, from 9:30 a.m. to 3 p.m. 

eastern time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–0016. 

The docket will close on March 13, 

2024. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 13, 2024. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Comments received on or before 

February 29, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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’’). 


khammond on DSKJM1Z7X2PROD with NOTICES