Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Notices 62579 

qualifying OMOR shall be subject to a 

fee for an OMOR. The amount of such 

fee shall be: 

(1) For a Tier 1 OTC monograph order 

request, $500,000, adjusted for inflation 

for the fiscal year (see section 

744M(c)(1)(B) of the FD&C Act); and 

(2) For a Tier 2 OTC monograph order 

request, $100,000, adjusted for inflation 

for the fiscal year (see section 

744M(c)(1)(B) of the FD&C Act). 

In addition, under section 

744M(c)(1)(B) of the FD&C Act and for 

purposes of section 744M(a)(2) of the 

FD&C Act, the dollar amount of the 

inflation adjustment to the fee for 

OMORs for FY 2022 and each 

subsequent fiscal year shall be equal to 

the product of: 

(1) The applicable fee under section 

744M(a)(2) of the FD&C Act for the 

preceding fiscal year; and 

(2) The inflation adjustment 

percentage under section 744M(c)(1)(C) 

of the FD&C Act. 

Thus, for FY 2024, the base of OMOR 

fees taken from the preceding fiscal year 

(i.e., FY 2023) are: Tier 1: $517,381 and 

Tier 2: $103,476. The FY 2024 inflation 

adjustment percentage is: 3.8830%. 

V. Fee Schedule 

The fee rates for FY 2024 are 

displayed in Table 4. 

TABLE 4—FEE SCHEDULE FOR FY 

2024 

Fee category FY 2024 

fee rates 

OMOR: 

Tier 1 ....................................... $537,471 

Tier 2 ....................................... 107,494 

VI. Fee Payment Options and 

Procedures 

The new OMOR fee rates are for the 

period from October 1, 2023, through 

September 30, 2024. To pay the OMOR 

fees, complete an OTC Monograph User 

Fee Cover Sheet, available at: https://

userfees.fda.gov/OA_HTML/ 

omufaCAcdLogin.jsp. 

A user fee identification (ID) number 

will be generated. Payment must be 

made in U.S. currency by electronic 

check or wire transfer, payable to the 

order of the Food and Drug 

Administration. The preferred payment 

method is online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck) or credit card for 

payments under $25,000 (Discover, 

VISA, MasterCard, American Express). 

FDA has partnered with the U.S. 

Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA website after 

completing the OTC Monograph User 

Fee Cover Sheet and generating the user 

fee ID number. Secure electronic 

payments can be submitted using the 

User Fees Payment Portal at https://

userfees.fda.gov/pay. (Note: Only full 

payments are accepted through https:// 

userfees.fda.gov/pay. No partial 

payments can be made online). Once an 

invoice is located, ‘‘Pay Now’’ should be 

selected to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

For payments made by wire transfer, 

include the unique user fee ID number 

to ensure that the payment is applied to 

the correct fee(s). Without the unique 

user fee ID number, the payment may 

not be applied, which could result in 

FDA not filing an OMOR request, or 

other consequences of nonpayment. The 

originating financial institution may 

charge a wire transfer fee. Applicable 

wire transfer fees must be included with 

payment to ensure fees are fully paid. 

Questions about wire transfer fees 

should be addressed to the financial 

institution. The account information for 

wire transfers is as follows: U.S. 

Department of the Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33. If 

needed, FDA’s tax identification 

number is 53–0196965. 

Dated: September 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19609 Filed 9–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; 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: National Institute on 

Alcohol Abuse and Alcoholism Initial 

Review Group; Clinical, Treatment and 

Health Services Research Study Section. 

Date: October 4, 2023. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700B Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Luis Espinoza, Ph.D., 

Scientific Review Officer, Extramural Project 

Review Branch, National Institute on Alcohol 

Abuse and Alcoholism, 6700B Rockledge 

Drive, Room 2109, Bethesda, MD 20817, 

(301) 443–8599, espinozala@mail.nih.gov. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; NIAAA Fellowship Review 

Panel. 

Date: October 24, 2023. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700B Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Luis Espinoza, Ph.D., 

Scientific Review Officer, Extramural Project 

Review Branch, National Institute on Alcohol 

Abuse and Alcoholism, 6700B Rockledge 

Drive, Room 2109, Bethesda, MD 20817, 

(301) 443–8599, espinozala@mail.nih.gov. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; NIAAA Special Emphasis 

Panel for Member Conflict Applications. 

Date: October 31, 2023. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700B Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Luis Espinoza, Ph.D., 

Scientific Review Officer, Extramural Project 

Review Branch, National Institute on Alcohol 

Abuse and Alcoholism, 6700B Rockledge 

Drive, Room 2109, Bethesda, MD 20817, 

(301) 443–8599, espinozala@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.273, Alcohol Research 

Programs, National Institutes of Health, HHS) 

Dated: September 6, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–19564 Filed 9–11–23; 8:45 am] 

BILLING CODE 4140–01–P 


lotter on DSK11XQN23PROD with NOTICES1