Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 14893 

letter with a detailed description and 

justification for our determination. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; guidance for industry (GFI) section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Existing Accessory Request; GFI VI.A ................................ 10 1 10 40 400 

New Accessory Request ...................................................... 5 1 5 40 200 

Total .............................................................................. ........................ ........................ ........................ ........................ 600 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on an evaluation of the 

information collection, we have reduced 

the estimated number of existing 

requests from 15 to 10, and we have 

reduced the estimated number of new 

requests from 10 to 5. This adjustment 

results in an overall reduction to the 

information collection by 10 responses 

and 400 hours annually. We believe 

these adjustments more accurately 

reflect the current number of requests 

associated with medical device 

accessory classifications. 

Dated: March 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05517 Filed 3–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0404] 

Considerations for the Development of 

Chimeric Antigen Receptor T Cell 

Products; Draft Guidance for Industry; 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 the draft 

guidance entitled ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor T Cell Products; Draft 

Guidance for Industry.’’ The draft 

guidance document is intended to assist 

sponsors, including industry and 

academic sponsors, developing 

Chimeric Antigen Receptor (CAR) T cell 

products. The draft guidance includes 

CAR T cell-specific recommendations 

regarding chemistry, manufacturing, 

and control (CMC), pharmacology and 

toxicology, and clinical study design. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 14, 2022 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– 

2021–D–0404 for ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor (CAR) T Cell Products; Draft 

Guidance for Industry.’’ 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:// 


jspears on DSK121TN23PROD with NOTICES1
14894 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 

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 

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 draft document entitled 

‘‘Considerations for the Development of 

Chimeric Antigen Receptor (CAR) T Cell 

Products; Draft Guidance for Industry.’’ 

The draft guidance document is 

intended to assist sponsors, including 

industry and academic sponsors, 

developing CAR T cell products. The 

guidance includes CAR T cell-specific 

recommendations regarding CMC, 

pharmacology and toxicology, and 

clinical study design. While the 

guidance specifically focuses on CAR T 

cell products, much of the information 

and recommendations provided will 

also be applicable to other genetically 

modified lymphocyte products, such as 

CAR Natural Killer cells or T cell 

receptor-modified T cells. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of another human gene 

therapy draft guidance document 

entitled ‘‘Human Gene Therapy 

Products Incorporating Human Genome 

Editing: Draft Guidance for Industry.’’ 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance, when finalized, will 

represent 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. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 50 have been 

approved under OMB control number 

0910–0755; 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 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: March 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05539 Filed 3–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1960] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; MedWatch: The 

Food and Drug Administration Safety 

Information and Adverse Event 

Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by April 15, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0291. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–45, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

MedWatch: The FDA Safety 

Information and Adverse Event 

Reporting Program 

OMB Control Number 0910–0291— 

Revision 

I. Background 

MedWatch is FDA’s program for 

reporting serious reactions, product 

quality problems, therapeutic 

inequivalence/failure, and product use 

errors associated with FDA-regulated 


jspears on DSK121TN23PROD with NOTICES1