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copies of the draft guidance to the Office 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 The draft guidance may also be 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a draft guidance document entitled 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Draft Guidance for Industry.’’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therapy draft guidance document 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This draft guidance is being issued 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The draft guidance, when finalized, will 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
Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 14899 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Peter J. Kozel, Ph.D., Chief, 

Training and Mentored Research Section, 

Scientific Review Branch, Division of 

Extramural Activities, 6707 Democracy Blvd., 

Room 7009, Bethesda, MD 20892, kozelp@

mail.nih.gov, 301–594–4721. 

(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. 2022–05559 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 Mental Health; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Mental Health Special Emphasis Panel, 

March 24, 2022, 9:00 a.m. to March 24, 

2022, 5:00 p.m., National Institutes of 

Health, Neuroscience Center, 6001 

Executive Boulevard, Rockville, MD, 

20852, which was published in the 

Federal Register on February 28, 2022, 

FR DOC 2022–04158, 87 FR 11080. 

This notice is being amended to 

change the date from March 24, 2022, to 

April 5, 2022. Meeting time and location 

remain the same. The meeting is closed 

to the public. 

Dated: March 11, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05563 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 Allergy and 

Infectious 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; Ruth L. Kirschstein National 

Research Service Award (NRSA) Institutional 

Research Training Grant (Parent T32). 

Date: March 25, 2022. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G51, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Thomas F. Conway, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G51, Rockville, MD 

20852, 240–507–9685, thomas.conway@

nih.gov. 

This notice is being published less 

than 15 days prior to the meeting due 

to the timing limitations imposed by the 

review and funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 11, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05560 Filed 3–15–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; 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 Center for 

Advancing Translational Sciences Special 

Emphasis Panel; National Center for 

Advancing Translational Sciences Special 

Emphasis Panel. 

Date: April 14, 2022. 

Time: 10:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 6701 Democracy Boulevard, Suite 

1037, Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Alumit Ishai, Ph.D., 

Scientific Review Officer, Office of Grants 

Management and Scientific Review, National 

Center for Advancing Translational Sciences, 

National Institutes of Health, 6701 

Democracy Boulevard, Suite 1037, Bethesda, 

MD 20892, 301–496–9539, alumit.ishai@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: March 10, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05485 Filed 3–15–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Enhanced Transparency and Access to 

Information for Debtors and Sureties in 

the Automated Commercial 

Environment 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: General notice. 

SUMMARY: This document announces 

that U.S. Customs and Border Protection 

(CBP) is making three enhancements to 

CBP’s debt management processes to 

increase transparency and access to 

information for debtors and sureties. 

One of the enhancements will support 

importers of record, licensed customs 

brokers, and other Automated 

Commercial Environment (ACE) 

account users who owe debts to CBP by 

enabling the electronic viewing of bill 

sanction status and protest details in the 

unpaid, open bill details report in ACE. 

The other two enhancements will 

facilitate compliance for sureties by 

providing electronic access to the 


jspears on DSK121TN23PROD with NOTICES1