Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76849 

www.healthaffairs.org/doi/full/10.1377/ 

hlthaff.25.2.313. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21433 Filed 9–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4289] 

Allergan, Inc., et al.; Withdrawal of 

Approval of Nine Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of nine 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

applicants notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

October 21, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 301– 

796–3471, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in table 1 have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Drug Applicant 

ANDA 062452 .... Gentamicin Sulfate solution/drop, Equivalent to (EQ) 0.3% 

base.

Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 

92612. 

ANDA 064124 .... Cefuroxime Sodium injectable, EQ 7.5 grams (g) base/vial ... ACS Dobfar S.p.A., U.S. Agent Interchem Corp., 120 Route 

17 North, Paramus, NJ 07652. 

ANDA 077151 .... Milrinone Lactate injectable, EQ 40 milligrams (mg) base/200 

milliliters (mL) (EQ 0.2 mg base/mL) EQ 20 mg base/100 

mL (EQ 0.2 mg base/mL).

Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite 

A, Wixom, MI 48393. 

ANDA 079032 .... Ondansetron Hydrochloride preservative free injectable, EQ 

2 mg base/mL.

American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967. 

ANDA 079075 .... Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, 

EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base.

Watson Laboratories, Inc., (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Bldg. A, Parsippany, NJ 07054. 

ANDA 206155 .... Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 

20 mg.

Indoco Remedies Ltd., U.S. Agent RegCon Solutions, LLC, 

9920 Pacific Heights Blvd., Suite 250, San Diego, CA 

92121. 

ANDA 206204 .... Piperacillin Sodium and Tazobactam Sodium injectable, EQ 

12 gm base/vial, EQ 1.5 gm base/vial.

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 

ANDA 207919 .... Acyclovir Sodium injectable, EQ 50 mg base/mL ................... Dr. Reddy’s Laboratories, Inc., 107 College Rd. East, Princeton, NJ 08540. 

ANDA 209708 .... Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2 

mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/ 

mL).

Woodward Pharma Services, LLC. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of October 21, 

2024. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from table 1. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in table 1 without an approved 

new drug application or ANDA violates 

sections 505(a) and 301(d) of the Federal 

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

355(a) and 331(d)). Drug products that 

are listed in table 1 that are in inventory 

on October 21, 2024 may continue to be 

dispensed until the inventories have 

been depleted or the drug products have 

reached their expiration dates or 

otherwise become violative, whichever 

occurs first. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21432 Filed 9–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4189] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments: Strain 

Selection for Influenza Vaccines 

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 Vaccines and Related 


lotter on DSK11XQN23PROD with NOTICES1
76850 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

Biological Products Advisory 

Committee (the Committee). The general 

function of the Committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The Committee will 

meet in open session to discuss three 

separate topics. At least one portion of 

the meeting will be closed to the public. 

FDA is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held 

virtually on October 10, 2024, from 8 

a.m. to 5:30 p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

The online web conference meeting 

will be available at the following link on 

the day of the meeting: https://

youtube.com/live/RXdJ2BfutAE. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–4189. 

The docket will close on October 9, 

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 9, 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 2, 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–4189 for ‘‘Vaccines and Related 

Biological Products Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for 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 

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. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Hayes or Sussan Paydar, 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 202–657–8533, 

CBERVRBPAC@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 meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. On October 10, 

2024, the Committee will meet in open 

session to discuss the following three 

separate topics. Under Topic I, the 

Committee will discuss and make 

recommendations on the strain selection 

for the influenza virus vaccines for the 

2025 southern hemisphere influenza 

season. Under Topic II, the Committee 

will discuss pandemic preparedness for 

highly pathogenic avian influenza virus 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76851 

including considerations for vaccine 

composition for (H5) vaccines. Under 

Topic III, the Committee will hear an 

overview of the research programs in 

the Laboratory of Pediatric & 

Respiratory Viral Diseases and the 

Laboratory of DNA Viruses in the 

Division of Viral Products, Office of 

Vaccines Research and Review, CBER. 

After the open session, the meeting will 

be closed to the public for committee 

deliberations. 

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: https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting 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: On October 10, 2024, from 

8 a.m. to 11:15 a.m. Eastern Time for 

Topic I, from 11:45 a.m. to 2:30 p.m. 

Eastern Time for Topic II, and from 2:40 

p.m. to 4:20 p.m. Eastern Time for Topic 

III, the meeting is open to the public. 

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 2, 

2024, will be provided to the 

Committee. Comments received on or 

after October 2, 2024, and by October 9, 

2024, will be taken into consideration 

by FDA. Oral presentations from the 

public will be scheduled between 

approximately 9:55 a.m. to 10:15 a.m. 

Eastern Time for Topic I, 1:10 p.m. to 

1:30 p.m. Eastern Time for Topic II, and 

4 p.m. to 4:20 p.m. Eastern Time for 

Topic III. 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, along with their 

names, email addresses, and direct 

contact phone numbers of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 12 p.m. 

Eastern Time on September 24, 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. The contact 

person will notify interested persons 

regarding their request to speak by 

September 27, 2024. 

Closed Committee Deliberations: On 

October 10, 2024, the meeting will be 

closed from 4:30 p.m. to 5:30 p.m. to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The recommendations of the 

advisory committee regarding the 

progress of the individual investigators’ 

research programs, along with other 

information, will be discussed during 

this session. We believe that public 

discussion of these discussions and 

committee recommendations on 

individual scientists would constitute 

an unwarranted invasion of personal 

privacy. 

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 Kathleen 

Hayes or Sussan Paydar (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/Advisory

Committees/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. 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 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21431 Filed 9–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0022] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

User Fee Cover Sheet, Form FDA 3601 

and Device Facility User Fee Cover 

Sheet, Form 3601a 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 21, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0511. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device User Fee Cover Sheet, 

Form FDA 3601 and Device Facility 

User Fee Cover Sheet, Form FDA 3601a 

OMB Control Number 0910–0511— 

Revision 

This information collection supports 

the FDA medical device and device user 

fee programs. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the Medical Device User 

Fee and Modernization Act of 2002 


lotter on DSK11XQN23PROD with NOTICES1