Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80259 

discontinued from marketing for reasons 

other than safety or effectiveness. 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: September 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22572 Filed 10–1–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4422] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments—New 

Drug Application 210934 for 

Sotagliflozin Oral Tablet 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Endocrinologic and 

Metabolic Drugs Advisory Committee 

(the Committee). The general function of 

the Committee is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

October 31, 2024, from 9 a.m. to 5 p.m. 

Eastern Time. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

The public will also have the option to 

participate, and the advisory committee 

meeting will be heard, viewed, 

captioned, and recorded through an 

online teleconferencing and/or video 

conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings, including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation, may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–4422. 

The docket will close on October 30, 

2024. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of October 30, 2024. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Comments received on or before 

October 17, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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– 

2024–N–4422 for ‘‘Endocrinologic and 

Metabolic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments— 

New Drug Application 210934 for 

Sotagliflozin Oral Tablet.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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.’’ FDA 

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 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 the 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. 


lotter on DSK11XQN23PROD with NOTICES1
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 


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