60688 Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 

collections of information are subject to 

review by the Office of Management and 

Budget under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 314 have been approved 

under OMB control number 0910–0001. 

The collections of information in 21 

CFR parts 210 and 211 pertaining to 

current good manufacturing practice has 

been approved under OMB control 

number 0910–0139. The collections of 

information in 21 CFR part 11 for 

electronic records and electronic 

signatures have been approved under 

OMB control number 0910–0303. The 

collections of information pertaining to 

the submissions of GDUFA III 

commitment letter, meetings related to 

generic drug development, and the 

Generic Drug User Fee Program have 

been approved under OMB control 

number 0910–0727. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: August 30, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19081 Filed 9–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3575] 

Reauthorization of the Over-theCounter Monograph Drug User Fee 

Program; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing a public meeting to discuss 

proposed recommendations for the 

reauthorization of the Over-the-Counter 

(OTC) Monograph Drug User Fee 

Program (OMUFA) for fiscal years (FYs) 

2026 through 2030. OMUFA authorizes 

FDA to assess and collect user fees to 

support OTC monograph drug activities. 

The current legislative authority for 

OMUFA expires September 30, 2025. At 

that time, new legislation will be 

required to reauthorize the OMUFA 

program for future fiscal years. The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) directs that FDA consult 

with the public as part of the OMUFA 

reauthorization process. FDA invites 

public comment as the Agency begins 

the process to reauthorize the program 

for FYs 2026 through 2030. 

DATES: The public meeting will be held 

on September 28, 2023, from 9 a.m. to 

5 p.m. Registration to attend the meeting 

should be received by September 27, 

2023. Either electronic or written 

comments on this public meeting must 

be submitted by October 27, 2023. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, Rm. 1503, Silver 

Spring, MD 20993. Entrance for the 

public meeting participants (non-FDA 

employees) is through Building 1 where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/about-fda/visitorinformation. Any changes to the public 

meeting location and remote 

information, as appropriate, will be 

posted to https://www.fda.gov/industry/ 

fda-user-fee-programs/over-countermonograph-drug-user-fee-programomufa in advance of the meeting. 

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 October 27, 2023. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is 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– 

2023–N–3575 for ‘‘Reauthorization of 

the Over-the-Counter Monograph Drug 

User Fee Program; Public Meeting; 

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.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 60689 

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. 

Transcripts of the meeting will be 

available on the FDA website at: https:// 

www.fda.gov/industry/fda-user-feeprograms/over-counter-monographdrug-user-fee-program-omufa after the 

meeting. 

FOR FURTHER INFORMATION CONTACT: 

Grace Carmouze-Cunningham, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6170, 

Silver Spring, MD 20993–0002, 301– 

796–4223, Grace.Carmouze@

fda.hhs.gov. 

I. Background 

FDA is announcing a public meeting 

to begin the process for developing 

reauthorization recommendations for 

the OMUFA program under section 

744M of the FD&C Act (21 U.S.C. 379j– 

72). This legislation authorizes FDA to 

assess and collect OMUFA user fees to 

support OTC monograph drug activities, 

including in various components in 

FDA including the Center for Drug 

Evaluation and Research, the Office of 

the Commissioner, and the Office of 

Regulatory Affairs. The current 

authorization of the program (OMUFA I) 

expires in September 2025. New 

legislation is required to reauthorize the 

OMUFA program for future fiscal years, 

to help fund OTC monograph drug 

activities. Section 744N(d) of the FD&C 

Act requires that FDA consult with the 

public on the development of proposed 

reauthorization recommendations. This 

notice, the public meeting, the 30-day 

comment period after the meeting, and 

the posting of the comments on the FDA 

website will help satisfy these 

requirements. The purpose of the 

meeting is to hear stakeholder views on 

OMUFA as we develop 

recommendations for elements to 

propose, update, or possibly 

discontinue in the program. FDA is 

interested in responses to the following 

questions and welcomes any other 

pertinent information stakeholders 

would like to share: 

• What current elements of OMUFA 

should be modified to ensure the 

continued efficiency and effectiveness 

of FDA’s OTC monograph drug 

activities? 

• What new elements should FDA 

consider recommending be added to the 

program to enhance the efficiency and 

effectiveness of the Agency’s OTC 

monograph drug activities? 

II. What is OMUFA? What does it do? 

The following information is provided 

to help potential meeting participants 

better understand the history of OMUFA 

and its status. On March 27, 2020, the 

Coronavirus Aid, Relief, and Economic 

Security Act (CARES Act) available at 

https://www.congress.gov/116/bills/ 

hr748/BILLS-116hr748enr.pdf was 

signed into law. Division A of the 

CARES Act included an important 

legislative initiative, detailed in subtitle 

F of title III, that reformed and 

modernized the way certain 

nonprescription, OTC drugs are 

regulated in the United States. These 

drugs, known as OTC monograph drugs, 

may be marketed without an approved 

drug application under section 505 of 

the FD&C Act (21 U.S.C. 355) if they 

meet the requirements of section 505G 

of the FD&C Act, as well as other 

applicable requirements. Accompanying 

this OTC monograph reform legislation 

were provisions added by the CARES 

Act to the FD&C Act authorizing FDA to 

assess and collect user fees dedicated to 

OTC monograph drug activities. 

This user fee program with respect to 

OTC monograph drugs, which we refer 

to as OMUFA, is modeled after the 

successful Prescription Drug User Fee 

Act (PDUFA). For OMUFA purposes, 

industry-paid fees help support FDA’s 

OTC monograph drug activities, and in 

the OMUFA I commitment letter 

negotiated with industry, FDA agreed to 

adhere to certain performance goals, 

including to review certain submissions 

within specific time frames. As with 

PDUFA, FDA anticipates that 

continuing this user fee program will 

provide additional resources to help the 

Agency conduct these important 

regulatory activities in a timely manner 

and ultimately help provide the public 

with access to innovative OTC 

monograph drugs. 

OMUFA is authorized under sections 

744L and 744M of the FD&C Act, as 

added by the CARES Act, under which 

FDA will assess and collect fees from 

submitters of OTC Monograph Order 

Requests (OMORs), other than OMORs 

for certain safety changes, as well as 

from qualifying manufacturers of OTC 

monograph drugs, to help fund the 

Agency’s OTC monograph drug 

activities. 

OMUFA is intended to provide for 

additional funding so that FDA can hire 

staff, improve systems, and establish 

and better manage the Agency’s OTC 

monograph drug activities, including to 

make important safety-related 

monograph changes and to facilitate 

timely availability of safe, effective, 

high-quality, and innovative OTC 

monograph drugs to the public. As part 

of FDA’s negotiated agreement with 

industry during each reauthorization, as 

reflected in the accompanying OMUFA 

commitment letter, the Agency agrees to 

certain performance and procedural 

goals and other commitments that apply 

to aspects of the Agency’s OTC 

monograph drug activities. These goals 

apply, for example, to the review of 

OMORs, including safety-related 

OMORs. 

A list of the deliverables developed to 

meet OMUFA I commitments is 

available on the FDA web page at: 

https://www.fda.gov/media/146283/ 

download. 

III. Public Meeting Information 

A. Purpose and Scope of the Meeting 

In general, the meeting format will 

include presentations by FDA and a 

series of panels representing different 

stakeholder groups. FDA policy issues 

unrelated to the OMUFA user fee 

program are beyond the scope of these 

reauthorization recommendation 

discussions. Accordingly, the 

presentations should focus on elements 

of the OMUFA user fee program, 

including possible process 

enhancements, and not address other 

FDA matters. Please consider the 

following questions for this meeting: 

• What new elements should FDA 

consider recommending be added to the 

program to enhance the efficiency and 

effectiveness of the Agency’s OTC 

monograph drug activities? 

• What current elements of OMUFA 

should be modified to ensure the 

continued efficiency and effectiveness 

of the Agency’s OTC monograph drug 

activities? 

B. Participating in the Public Meeting 

Registration: Persons interested in 

attending this public meeting should 

register online by 11:59 p.m. Eastern 

Time on September 27, 2023, at https:// 

OMUFA_

Reauthorization.eventbrite.com. Please 


ddrumheller on DSK120RN23PROD with NOTICES1
60690 Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. If time and space permit, 

onsite registration on the day of the 

public meeting will be provided 

beginning at 8 a.m. We will let 

registrants know if registration closes 

before the day of the public meeting. 

If you need special accommodations 

due to a disability, please contact Grace 

Carmouze-Cunningham (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days before the meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. You will be asked to 

indicate in your registration if you plan 

to attend in person or via the webcast. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/ 

industry/fda-user-fee-programs/ 

prescription-drug-user-fee-amendments. 

Dated: August 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19059 Filed 9–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3549] 

Merck Sharp & Dohme LLC, et al.; 

Withdrawal of Approval of 35 New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 35 new drug 

applications (NDAs) 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 5, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table 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. 

Application No. Drug Applicant 

NDA 001546 ...... Guanidine (guanidine hydrochloride (HCl)) Tablets, 125 milligrams (mg).Merck Sharp & Dohme LLC, 126 East Lincoln Ave., P.O. Box 

2000, Rahway, NJ 07065. 

NDA 010841 ...... Peganone (ethotoin) Tablets, 250 mg and 500 mg ................. Recordati Rare Diseases Inc., 100 Corporate Dr., Lebanon, 

NJ 08833. 

NDA 016801 ...... Xylocaine Preservative Free (lidocaine HCl) Injection, 1%, 

2%, 4%, 10%, and 20%.

Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL 

60047. 

NDA 016822 ...... FreAmine 8.5% (amino acids) Injection, 8.5 grams (g)/100 

milliliters (mL).

B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 

18109. 

FreAmine HBC 6.9% (amino acids) Injection, 6.9 g/100 mL.

FreAmine II 8.5% (amino acids) Injection, 8.5 g/100 mL.

FreAmine III 10% (amino acids) Injection, 10 g/100 mL.

FreAmine III 8.5% (amino acids) Injection, 8.5 g/100 mL.

FreAmine III 8.5% with electrolytes (amino acids, magnesium 

acetate, phosphoric acid, potassium acetate, potassium 

chloride, sodium acetate) Injection, 8.5%; 110mg/100mL; 

230mg/100mL; 10mg/100mL; 440mg/100mL; 690mg/ 

100mL.

FreAmine III 3% with electrolytes (amino acids, magnesium 

acetate, phosphoric acid, potassium chloride, sodium acetate, sodium chloride) Injection, 3%; 54mg/100mL; 40mg/ 

100mL; 150mg/100mL; 200mg/100mL; 120mg/100mL.

NDA 017407 ...... Catapres (clonidine HCl) Tablets, 0.1 mg, 0.2 mg, and 0.3 

mg.

Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury 

Rd., P.O. Box 368, Ridgefield, CT 06877. 

NDA 017425 ...... Proglycem (diazoxide) Capsules, 50 mg and 100 mg ............ Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Pkwy., West Chester, PA 19380. 

NDA 017534 ...... Fiorinal (aspirin, butalbital, caffeine) Capsules, 325 mg/50 

mg/40 mg.

AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL 

60064. 

Fiorinal (aspirin, butalbital, caffeine) Tablets, 325 mg/50 mg/ 

40 mg.

NDA 018582 ...... Procalamine (amino acids, calcium acetate, glycerin, magnesium acetate, phosphoric acid, potassium chloride, sodium 

acetate, sodium chloride) Injection, 3%; 26mg/100mL; 3g/ 

100mL; 54mg/100mL; 41mg/100mL; 150mg/100mL; 

200mg/100mL; 120mg/100mL.

B. Braun Medical Inc. 

NDA 018676 ...... HepatAmine 8% (amino acids) Injection, 8g/100mL ............... Do. 

NDA 018878 ...... Indocin (indomethacin sodium) Injection, equivalent to (EQ) 1 

mg base/vial.

Recordati Rare Diseases Inc. 


ddrumheller on DSK120RN23PROD with NOTICES1