66858 Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—BIOLOGICAL PRODUCTS 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 

600.12; 2 Maintenance of Records .................................................................... 131 40.145 5,259 32 168,288 

600.12(b)(2); Recall Records ............................................................................ 216 3.4028 735 24 17,640 

600.80(c)(1) and 600.80(k); AER Records ....................................................... 109 7,503.95 817,931 1 817,931 

Total ........................................................................................................... .......................... .......................... ........................ ........................ 1,003,859 

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

2The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12. 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN—COMBINATION PRODUCTS 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondents 

Total annual 

disclosures 

Average 

burden per 

disclosure 

(in hours) 

Total 

hours 

4.102, 4.103, 4.104, 4.105; Postmarketing Safety Reporting for Combination 

Products, including associated reports and sharing information with other 

constituent part applicants.

11 18 198 0.35 (21 minutes) ... 69 

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

The burden for this information 

collection has changed since the last 

OMB approval. The reporting and 

recordkeeping burden has increased 

mostly due to an increase in the number 

of AER reports submitted to FDA and 

the associated recordkeeping with these 

reports. We have also added burden we 

believe attributable to post marketing 

safety reporting and attendant 

recordkeeping and disclosures, as 

required under part 4, subpart B. 

Dated: September 23, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21252 Filed 9–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 

General Medical Sciences Special Emphasis 

Panel; Renewal of Centers of Biomedical 

Research Excellence (COBRE) (Phase 2). 

Date: November 7–8, 2023. 

Time: 9:30 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of General Medical 

Sciences, Natcher Building, 45 Center Drive, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Person: Nina Sidorova, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, MSC 6200, Room 3AN18–01, 

Bethesda, Maryland 20892, 301–594–3663, 

sidorova@nigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of MOSAIC K99/R00 

applications. 

Date: November 9, 2023. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of General Medical 

Sciences, Natcher Building, 45 Center Drive, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Person: Rebecca H. Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, MSC 6200, Room 3AN12B, 

Bethesda, Maryland 20892, 301–594–2771, 

johnsonrh@nigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of Support for Research 

Excellence (SuRE) Program (R16). 

Date: November 17, 2023. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of General Medical 

Sciences, Natcher Building, 45 Center Drive, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Person: Rebecca H. Johnson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, MSC 6200, Room 3AN12B, 

Bethesda, Maryland 20892, 301–594–2771, 

johnsonrh@nigms.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: September 22, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–21154 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 1009 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: Heart, Lung, and 

Blood Initial Review Group; NHLBI 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 66859 

Institutional Training Mechanism Study 

Section. 

Date: December 1, 2023. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge I, 6705 Rockledge Drive, Bethesda, 

MD 20892 (Virtual Meeting). 

Contact Person: Michael P. Reilly, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6705 Rockledge Drive, Room 

208–Z, Bethesda, MD 20892, 301–827–7975, 

reillymp@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 22, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–21145 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 1009 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: Heart, Lung, and 

Blood Initial Review Group; Heart, Lung, and 

Blood Program Project Study Section. 

Date: December 1, 2023. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: DoubleTree by Hilton McLean 

Tysons, 1960 Chain Bridge Rd., McLean, VA 

22102. 

Contact Person: Melissa H. Nagelin, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 208–R, 

Bethesda, MD 20892, (301) 827–7951, 

nagelinmh2@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 22, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–21146 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental and 

Craniofacial Research; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 

Dental and Craniofacial Research Special 

Emphasis Panel; Review of NIDCR R03 and 

DSR Member-Conflict Applications. 

Date: November 2, 2023. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Dental and 

Craniofacial Research, 6701 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Yun Mei, MD, Scientific 

Review Officer, Scientific Review Branch, 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health, 6701 

Democracy Boulevard, Bethesda, MD 20892, 

(301) 827–4639, yun.mei@nih.gov. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel; Review of RFA–DE–24–001 

and RFA–DE–24–002. 

Date: November 15, 2023. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Dental and 

Craniofacial Research, 6701 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Christopher T. Campbell, 

Ph.D., MD, Scientific Review Officer, 

Scientific Review Branch, National Institute 

of Dental and Craniofacial Research, National 

Institutes of Health, 6701 Democracy 

Boulevard, Bethesda, MD 20892, (301) 594– 

5593, christopher.campbell@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: September 22, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–21151 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Establishment of the Applied 

Therapeutics for Cancer Integrated 

Review Group 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

1001–1014), the Director, National 

Institutes of Health (NIH) announces the 

establishment of the Applied 

Therapeutics for Cancer Integrated 

Review Group (IRG) as authorized by 42 

U.S.C. 282(b)(16), section 402(b)(16) of 

the Public Health Service Act, as 

amended. 

The Director, NIH, has determined 

that the Applied Therapeutics for 

Cancer IRG is in the public interest in 

connection with the performance of 

duties imposed on NIH by law, and that 

these duties can best be performed 

through the advice and counsel of the 

committee. 

The committee provides advice and 

recommendations on funding 

applications and proposals, including 

but not limited to, the scientific and 

technical merit of applications for 

grants-in-aid for research, research 

training, or research-related grants and 

cooperative agreements, or contract 

proposals relating to scientific areas 

relevant to translational and clinical 

investigations that encompass cancer 

therapeutic development and cancer 

treatment. 

Inquiries may be directed to Claire 

Harris, Director, Office of Federal 

Advisory Committee Policy, Office of 

the Director, National Institutes of 

Health, 6701 Democracy Boulevard, 

Suite 1000, Bethesda, Maryland 20892 

(Mail code 4875), Telephone (301) 496– 

2123, or Claire.Harris@nih.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1