80260 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Joyce Frimpong, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–7973, email: EMDAC@fda.hhs.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). A notice in the Federal Register 

about last-minute modifications that 

impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check FDA’s website at 

https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The Committee will discuss 

new drug application 210934, for 

sotagliflozin oral tablet, submitted by 

Lexicon Pharmaceuticals, Inc., for the 

proposed indication, as an adjunct to 

insulin therapy, to improve glycemic 

control in adults with type 1 diabetes 

mellitus and chronic kidney disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at the location 

of the advisory committee meeting and 

at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The online presentation of 

materials will include slide 

presentations with audio and video 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before October 17, 

2024, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 1:15 p.m. and 2:15 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, whether they would like to 

present online or in-person, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 8, 2024. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. Similarly, room for 

interested persons to participate inperson may be limited. If the number of 

registrants requesting to speak in-person 

during the open public hearing is 

greater than can be reasonably 

accommodated in the venue for the inperson portion of the advisory 

committee meeting, FDA may conduct a 

lottery to determine the speakers who 

will be invited to participate in-person. 

The contact person will notify 

interested persons regarding their 

request to speak by October 9, 2024. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Joyce 

Frimpong (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform in conjunction with 

the physical meeting room (see 

location). This waiver is in the interest 

of allowing greater transparency and 

opportunities for public participation, 

in addition to convenience for advisory 

committee members, speakers, and 

guest speakers. The conditions for 

issuance of a waiver under 21 CFR 10.19 

are met. 

Dated: September 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22570 Filed 10–1–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Social 

Psychology and Interpersonal Processes: 

Social Isolation and Loneliness. 

Date: October 28, 2024. 

Time: 8:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: David E. Pollio, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1006F, 

Bethesda, MD 20892, (301) 594–4002, 

polliode@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Topics in 

Health Services Research: Big Data, Health 

Information Technology, and Clinical 

Informatics. 

Date: October 29–30, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Debasmita Patra, Ph.D., 

Scientific Review Officer, Center for 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80261 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1006E, 

Bethesda, MD 20892, (301) 827–5187, 

debasmita.patra@nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Neuronal Communications 

Study Section. 

Date: October 29–30, 2024. 

Time: 9:00 a.m. to 10:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Prithi Rajan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 435–1042, prithi.rajan@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Immune Defense Mechanism to 

Infection. 

Date: October 29, 2024. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Maria Chiara G. MonacoKushner, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Dr., 

Bethesda, MD 20892, (301) 555–1212, 

monaco@csr.nih.gov. 

Name of Committee: Healthcare Delivery 

and Methodologies Integrated Review Group; 

Health Services: Quality and Effectiveness 

Study Section. 

Date: October 30–31, 2024. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Meeting Format: In Person. 

Contact Person: Angela D. Thrasher, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1000J, 

Bethesda, MD 20892, (301) 480–6894, 

thrasherad@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Innate 

Immunity A. 

Date: October 30, 2024. 

Time: 8:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Kenneth M. Izumi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, MSC 7808, 

Bethesda, MD 20892, 301–496–6980, 

izumikm@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group; Biomaterials and Biointerfaces Study 

Section. 

Date: October 30–31, 2024. 

Time: 9:30 a.m. to 6:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Jennifer Fiori O’Connell, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (410) 454–8478, jennifer.oconnell@

nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Advancing Therapeutics. 

Date: October 30, 2024. 

Time: 9:30 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Michael James Knapp, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 402–0600, mike.knapp@nih.gov. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Addiction Risks and Mechanisms 

Study Section. 

Date: October 30–31, 2024. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Kristen Prentice, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3112, 

MSC 7808, Bethesda, MD 20892, (301) 496– 

0726, prenticekj@mail.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; 

Tumor Evolution, Heterogeneity and 

Metastasis Study Section. 

Date: October 30–31, 2024. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Rolf Jakobi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6190, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1718, jakobir@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 27, 2024. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2024–22607 Filed 10–1–24; 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 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 Center for 

Advancing Translational Sciences Special 

Emphasis Panel; CTSA High Impact 

Specialized Innovation Program (RC2) 

Review. 

Date: January 23, 2025. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 9609 Medical Center Drive, 

Rockville, MD 20892 (Virtual). 

Contact Person: Jing Chen, Ph.D., Scientific 

Review Officer, Office of Scientific Review, 

National Center for Advancing Translational 

Sciences, National Institutes of Health, 9609 

Medical Center Drive, Suite 1E504, Bethesda, 

MD 20892, (301) 827–3268, chenjing@

mail.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: September 27, 2024. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2024–22608 Filed 10–1–24; 8:45 am] 

BILLING CODE 4140–01–P 


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