Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 14897 

adverse event reporting, we assume it 

takes respondents 0.6 hour to submit a 

voluntary adverse event report via the 

SRP, 1 hour to submit a mandatory 

adverse event report via the SRP (except 

CTP, which estimates 0.6 hour), and 0.6 

hour to submit a mandatory AER via the 

ESG (gateway-to-gateway transmission). 

CTP used two data sources to estimate 

the reporting burden for tobacco 

product AEs. CTP researched the 

number of voluntary AE reports 

submitted to the center since the launch 

of the first tobacco questionnaire in the 

SRP in 2014. Our records indicated a 

total of 1,426 initial reports over the last 

7 full calendar years. We used the total 

number of reports to average the number 

of yearly reports to 204. As referenced 

above, the premarket tobacco product 

application rule requires firms to submit 

adverse experience reports for tobacco 

products with marketing orders. The 

burden for these mandatory reports has 

been approved under OMB control 

number 0910–0879. For this collection, 

we have included 1 hour to 

acknowledge the inclusion under this 

collection. Therefore, the estimate for 

CTP voluntary and mandatory reports is 

expected to be 123 hours. 

The submission of mandatory reports 

associated with drug products and 

biological drug products is accounted 

for and approved under OMB control 

number 0910–0230; the submission of 

mandatory reports associated with the 

Vaccine Adverse Event Reporting 

System is accounted for and approved 

under OMB control number 0910–0308; 

medical device report submissions are 

accounted for and approved under OMB 

control number 0910–0437; and the 

submission of mandatory reports 

associated with animal drug products is 

accounted for and approved under OMB 

control number 0910–0284. 

Dated: March 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05514 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–0398] 

Human Gene Therapy Products 

Incorporating Human Genome Editing; 

Draft Guidance for Industry; 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 

document entitled ‘‘Human Gene 

Therapy Products Incorporating Human 

Genome Editing; Draft Guidance for 

Industry.’’ The draft 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 in order to assess the safety 

and quality of the investigational GE 

product, including information on 

product design, product manufacturing, 

product testing, preclinical safety 

assessment, and clinical trial 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–0398 for ‘‘Human Gene 

Therapy Products Incorporating Human 

Genome Editing; 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://

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. 


jspears on DSK121TN23PROD with NOTICES1
14898 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 

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: 

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 guidance document entitled 

‘‘Human Gene Therapy Products 

Incorporating Human Genome Editing; 

Draft Guidance for Industry.’’ The draft 

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 in order to assess the 

safety and quality of the investigational 

GE product as required in 21 CFR 

312.23. This includes information on 

product design, product manufacturing, 

product testing, preclinical safety 

assessment and clinical trial design. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of another human gene 

therapy draft guidance document 

entitled ‘‘Considerations for the 

Development of Chimeric Antigen 

Receptor (CAR) T Cell Products; Draft 

Guidance for Industry.’’ 

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 ‘‘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. 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 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 draft guidance at either 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ or 

https://www.regulations.gov. 

Dated: March 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05538 Filed 3–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; PAR19–319: NIDDK 

Central Repositories Non-renewable Sample 

Access (X01). 

Date: May 6, 2022. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Democracy II, 6707 Democracy Blvd., 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Najma S. Begum, Ph.D. 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health 

Room, 7349, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 11, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05562 Filed 3–15–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Characterization of 

Islet-derived Extracellular Vesicles for 

Improved Detection, Monitoring, 

Classification, and Treatment of Type 1 

Diabetes Special Emphasis Panel. 

Date: April 6, 2022. 

Time: 12:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


jspears on DSK121TN23PROD with NOTICES1