80258 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

experts, functional areas, and collective 

regulatory experience across different 

offices. 

II. Objectives of QM CoE 

The QM CoE will facilitate and 

coordinate the continuous evolution 

and consistent application of QM for 

drug development and regulatory 

decision-making to advance therapeutic 

medical product development, inform 

regulatory decision-making, and 

promote public health, by: 

• spearheading QM-related policy 

development and best practices to 

facilitate the consistent use of QM 

approaches during the drug 

development and regulatory assessment; 

• providing strategic direction for 

CDER’s QM activities; and 

• coordinating CDER’s efforts around 

QM education, training, and community 

engagement. 

III. Anticipated Outcomes of QM CoE 

The QM CoE will harmonize existing 

activities and identify and initiate new 

activities in the areas of 

multidisciplinary education and 

exchange, science policy development 

and implementation, knowledge 

management, and community 

engagement. The centralization of QM 

efforts across CDER within the CoE will 

allow for operational optimization and 

consistent application of QM 

approaches to advance therapeutic 

medical product development, inform 

regulatory decision-making, and 

promote public health. 

Dated: September 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22580 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–P–2314] 

Determination That AUGMENTIN XR 

(Amoxicillin; Clavulanate Potassium) 

Extended-Release Tablets, 1 Gram; 

Equivalent to 62.5 Milligram Base, Was 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that AUGMENTIN XR 

(amoxicillin; clavulanate potassium) 

Extended-Release Tablets, 1 gram (gm); 

equivalent to (EQ) 62.5 milligram (mg) 

base, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for AUGMENTIN 

XR (amoxicillin; clavulanate potassium) 

Extended-Release Tablets, 1 gm; EQ 62.5 

mg base, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: Awo 

Archampong-Gray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6243, 

Silver Spring, MD 20993–0002, 301– 

796–0110, Awo.Archampong-Gray@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

AUGMENTIN (amoxicillin; 

clavulanate potassium) ExtendedRelease Tablets, 1 gm; EQ 62.5 mg base, 

is the subject of NDA 050785, held by 

US Antibiotics, LLC, and initially 

approved on September 25, 2002. 

AUGMENTIN XR is indicated for 

treatment of adults and pediatric 

patients with community-acquired 

pneumonia or acute bacterial sinusitis 

due to confirmed, or suspected betalactamase-producing pathogens (i.e., H. 

influenzae, M. catarrhalis, H. 

parainfluenzae, K. pneumoniae, or 

methicillin-susceptible S. aureus) and S. 

pneumoniae with reduced susceptibility 

to penicillin (i.e., penicillin minimum 

inhibitory concentrations EQ 2 

microgram/milliliter). 

AUGMENTIN XR (amoxicillin; 

clavulanate potassium) ExtendedRelease Tablets, 1 gm; EQ 62.5 mg base, 

is currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Aurobindo Pharma, USA, Inc. 

submitted a citizen petition dated May 

9, 2024 (Docket No. FDA–2024–P– 

2314), under 21 CFR 10.30, requesting 

that the Agency determine whether 

AUGMENTIN XR (amoxicillin; 

clavulanate potassium) ExtendedRelease Tablets, 1 gm; EQ 62.5 mg base, 

was withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that AUGMENTIN XR 

(amoxicillin; clavulanate potassium) 

Extended-Release Tablets, 1 gm; EQ 62.5 

mg base, was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that 

AUGMENTIN XR (amoxicillin; 

clavulanate potassium) ExtendedRelease Tablets, 1 gm; EQ 62.5 mg base, 

was withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

AUGMENTIN XR (amoxicillin; 

clavulanate potassium) ExtendedRelease Tablets, 1 gm; EQ 62.5 mg base, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list AUGMENTIN XR 

(amoxicillin; clavulanate potassium) 

Extended-Release Tablets, 1 gm; EQ 62.5 

mg base, 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 


lotter on DSK11XQN23PROD with NOTICES1
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