77594 Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Notices 

relevant literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this drug product was 

not withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list COGENTIN (benztropine 

mesylate) Injection, 1 mg/1 mL, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: November 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24882 Filed 11–9–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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: National Institute on 

Drug Abuse Special Emphasis Panel; High 

Priority HIV and Substance Use Research. 

Date: December 11, 2023. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Trinh T. Tran, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Office of Extramural Policy, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 827–5843, trinh.tran@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: November 7, 2023. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2023–24970 Filed 11–9–23; 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 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01 Clinical 

Trial Not Allowed). 

Date: January 9, 2024. 

Time: 1:00 p.m. to 3:00 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 3E71, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Samita S. Andreansky, 

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 3E71, 

Rockville, MD 20852, 240–669–2915, 

samita.andreansky@nih.gov. 

(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: November 7, 2023. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2023–24967 Filed 11–9–23; 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 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Autoimmunity Centers of 

Excellence, Clinical Research Program (UM1 

Clinical Trial Required). 

Date: December 12–13, 2023. 

Time: 10:00 a.m. to 5:00 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 3G41, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Kelly L. Hudspeth, 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 3G41, Rockville, MD 

20852, 240–669–5067, kelly.hudspeth@

nih.gov. 

(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: November 7, 2023. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2023–24968 Filed 11–9–23; 8:45 am] 

BILLING CODE 4140–01–P 


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