Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices 107147 

Silver Spring, MD 20993–0002, 301– 

796–3471, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holder of an approved application to 

market a new drug for human use is 

required to submit annual reports to 

FDA concerning its approved 

application in accordance with 

§§ 314.81 and 314.98 (21 CFR 314.81 

and 314.98). 

In the Federal Register of August 8, 

2024 (89 FR 64936), FDA published a 

notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of two ANDAs 

because the holder of these ANDAs had 

repeatedly failed to submit the required 

annual reports for these ANDAs. The 

holder of these ANDAs did not respond 

to the NOOH. Failure to file a written 

notice of participation and request for 

hearing as required by § 314.200 (21 

CFR 314.200) constitutes a waiver of the 

opportunity for hearing by the holder of 

the ANDAs concerning the proposal to 

withdraw approval of the ANDAs and a 

waiver of any contentions concerning 

the legal status of the drug products. 

Therefore, FDA is withdrawing approval 

of the two applications listed in table 1 

of this document. 

TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED

Application No. Drug Applicant 

ANDA 207309 ... Metronidazole tablet, 250 milligrams (mg) and 500 mg ........... Flamingo Pharmaceuticals Ltd., U.S. Agent for Flamingo 

Pharmaceuticals Ltd., 1125 Gaither Rd., Rockville, MD 

20850. 

ANDA 207938 ... Piroxicam capsule, 10 mg and 20 mg ...................................... Do. 

FDA finds that the holder of the 

ANDAs listed in table 1 has repeatedly 

failed to submit reports required by 

§§ 314.81 and 314.98. In addition, under 

§ 314.200, FDA finds that the holder of 

the ANDAs has waived its opportunity 

for a hearing and any contentions 

concerning the legal status of the drug 

products. Therefore, based on these 

findings and pursuant to the authority 

under section 505(e) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(e)), approval of the ANDAs listed in 

table 1 and all amendments and 

supplements thereto, is hereby 

withdrawn, as of December 31, 2024. 

Dated: December 23, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31360 Filed 12–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2980] 

Evaluating the Immunogenicity Risk of 

Host Cell Proteins in Follow-On 

Recombinant Peptide Products; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period for the 

request for information and comments 

notice entitled ‘‘Evaluating the 

Immunogenicity Risk of Host Cell 

Proteins in Follow-On Recombinant 

Peptide Products,’’ published in the 

Federal Register of July 25, 2024. FDA 

is reopening the comment period to 

update comments and to receive any 

new information. 

DATES: FDA is reopening the comment 

period on the request for information 

and comments notice published July 25, 

2024 (89 FR 60436). Either electronic or 

written comments must be submitted by 

March 3, 2025. 

ADDRESSES: You may submit comments 

as follows. 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 

March 3, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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–2980 for ‘‘Evaluating the 

Immunogenicity Risk of Host Cell 

Proteins in Follow-On Recombinant 

Peptide Products; Request for 

Information and Comments.’’ 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 


khammond on DSK9W7S144PROD with NOTICES
107148 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency 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 to 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 this 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. 

FOR FURTHER INFORMATION CONTACT: 

Kunal Naik, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 240– 

402–8717. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 25, 

2024 (89 FR 60436), FDA requested 

information and comments. Interested 

persons were originally given until 

September 23, 2024, to comment on 

evaluating and mitigating the 

immunogenicity risk of host cell 

proteins. 

Following publication of the July 25, 

2024, notice, FDA received a request to 

allow interested persons additional time 

to comment. The requester asserted that 

the time period of 60 days was 

insufficient to respond fully to FDA’s 

specific requests for comments and to 

allow potential respondents to 

thoroughly evaluate and address 

pertinent issues. 

II. Electronic Access 

Persons with access to the internet 

may obtain relevant guidance at https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

clinical-pharmacology-considerationspeptide-drug-products. 

Dated: December 23, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31365 Filed 12–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5830] 

Advisory Committee; Dermatologic 

and Ophthalmic Drugs Advisory 

Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the 

Dermatologic and Ophthalmic Drugs 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Dermatologic and 

Ophthalmic Drugs Advisory Committee 

for an additional 2 years beyond the 

charter expiration date. The new charter 

will be in effect until the October 7, 

2026, expiration date. 

DATES: Authority for the Dermatologic 

and Ophthalmic Drugs Advisory 

Committee will expire on October 7, 

2026, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

LaToya Bonner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 301– 

796–2855, DODAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Dermatologic and 

Ophthalmic Drugs Advisory Committee 

(the Committee). The Committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of dermatologic and 

ophthalmic disorders and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

Pursuant to its charter, the Committee 

shall consist of a core of 12 voting 

members including 2 Chairpersons. 

Members and the Chairpersons are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

dermatology, ophthalmology, dentistry, 

immunology, epidemiology or statistics, 

and other related professions. Members 

will be invited to serve for overlapping 

terms of up to 4 years. Non-Federal 

members of this committee will serve as 

Special Government Employees or 

representatives. Federal members will 

serve as Regular Government Employees 

or Ex-Officios. The core of voting 

members may include one technically 

qualified member, selected by the 

Commissioner or designee, who is 

identified with consumer interests and 

is recommended by either a consortium 

of consumer-oriented organizations or 

other interested persons. In addition to 

the voting members, the Committee may 

include one non-voting representative 

member who is identified with industry 

interests. There may also be an alternate 

industry representative. 

The Commissioner or designee shall 

have the authority to select members of 

other scientific and technical FDA 

advisory committees (normally not to 

exceed 10 members) to serve 

temporarily as voting members and to 

designate consultants to serve 

temporarily as voting members when: 

(1) expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members), or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 


khammond on DSK9W7S144PROD with NOTICES