Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Notices 62577 

1For OMUFA purposes, an OTC monograph drug 

is a nonprescription drug without an approved new 

drug application that is governed by the provisions 

of section 505G of the FD&C Act (21 U.S.C. 355h) 

(see section 744L(5) of the FD&C Act); 

2Section 744M(a)(2)(B) of the FD&C Act. 

3The Agency anticipates a greater likelihood of 

OMOR submissions in FY 2024 compared to prior 

fiscal years. 

4Under OMUFA, a Tier 1 OMOR is defined as 

any OMOR that is not a Tier 2 OMOR (see section 

744L(8) of the FD&C Act). Tier 2 OMORs are 

detailed in section 744L(9) of the FD&C Act. 5See section 744M(c)(1)(C) of the FD&C Act. 

accept or review any abbreviated new 

drug application from Ms. Tatsene 

during her period of debarment, other 

than in connection with an audit under 

section 306 of the FD&C Act. Note that, 

for purposes of sections 306 and 307 of 

the FD&C Act, a ‘‘drug product’’ is 

defined as a ‘‘drug subject to regulation 

under section 505, 512, or 802 of this 

Act [(21 U.S.C. 355, 360b, 382)] or under 

section 351 of the Public Health Service 

Act [(42 U.S.C. 262)]’’ (section 201(dd) 

of the FD&C Act (21 U.S.C. 321(dd))). 

Dated: September 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19672 Filed 9–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3573] 

Over-the-Counter Monograph Drug 

User Fee Program—OTC Monograph 

Order Requests Fee Rates for Fiscal 

Year 2024 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the over-the-counter (OTC) 

monograph order request (OMOR) fee 

rates under the OTC monograph drug 

user fee program (OMUFA) for fiscal 

year (FY) 2024. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act) authorizes 

FDA to assess and collect user fees from 

qualifying manufacturers of OTC 

monograph drugs and submitters of 

OMORs. This notice publishes the 

OMOR fee rates under OMUFA for FY 

2024. FDA plans to publish the FY 2024 

OMUFA facility fee rates in a 

subsequent Federal Register notice (and 

anticipates its issuance will generally 

align with the timing of OMUFA facility 

fee rate publication for prior fiscal 

years). 

DATES: These fees are effective on 

October 1, 2023, and will remain in 

effect through September 30, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Olufunmilayo Ariyo, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

6th Floor, Beltsville, MD 20705–4304, 

240–402–4989; or the User Fees Support 

Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 744M of the FD&C Act (21 

U.S.C. 379j–72), authorizes FDA to 

assess and collect: (1) facility fees from 

qualifying owners of OTC monograph 

drug facilities and (2) fees from 

submitters of qualifying OTC 

monograph order requests. These fees 

are to support FDA’s OTC monograph 

drug activities, which are detailed in 

section 744L(6) of the FD&C Act (21 

U.S.C. 379j–71(6)) and include various 

FDA activities associated with OTC 

monograph drugs.1

For OMUFA purposes, an OTC 

monograph order request (OMOR) is a 

request for an administrative order, with 

respect to an OTC monograph drug, 

which is submitted under section 

505G(b)(5) of the FD&C Act (see section 

744L(7) of the FD&C Act). Given that 

OMOR fees are due on the date of 

submission of the OMOR,2 the Agency 

is publishing the OMOR fee rates for FY 

2024 in advance of the fiscal year to 

ensure that applicable OMOR fee rates 

are available in the event that OMORs 

are submitted early in the fiscal year.3

Under section 744M(a)(2)(A) of the 

FD&C Act, the Agency is authorized to 

assess and collect fees from submitters 

of OMORs, except for OMORs that 

request certain safety-related changes 

(as discussed below). There are two 

levels of OMOR fees, based on whether 

the OMOR at issue is a Tier 1 or Tier 

2 OMOR.4

For FY 2024, the OMUFA fee rates 

are: Tier 1 OMOR fees ($537,471), Tier 

2 OMOR fees ($107,494). These fees are 

effective for the period from October 1, 

2023, through September 30, 2024. This 

document is issued pursuant to sections 

744M(a)(4) and 744M(c)(4)(B) of the 

FD&C Act and describes the calculations 

used to set the OMUFA OMOR fees for 

FY 2024 in accordance with the 

directives in the statute. 

II. Determination of FY 2024 OMOR 

Fees 

Under OMUFA, the FY 2024 Tier 1 

OMOR fee is $537,471 and the Tier 2 

OMOR fee is $107,494, including an 

adjustment for inflation (see sections 

744M(a)(2)(A)(i) and (ii) of the FD&C 

Act, respectively). OMOR fees are not 

included in the OMUFA target revenue 

calculation, which is based on the 

facility fees (see section 744M(b) of the 

FD&C Act). 

An OMOR fee is generally assessed to 

each person who submits an OMOR (see 

section 744M(a)(2)(A) of the FD&C Act). 

OMOR fees are due on the date of the 

submission of the OMOR (see section 

744M(a)(2)(B) of the FD&C Act). The 

payor should submit the OMOR fee that 

applies to the type of OMOR they are 

submitting (i.e., Tier 1 or Tier 2). FDA 

will determine whether the appropriate 

OMOR fee has been submitted following 

receipt of the OMOR and the fee. 

An OMOR fee will not be assessed if 

the OMOR seeks to make certain safety 

changes with respect to an OTC 

monograph drug. Specifically, no fee 

will be assessed if FDA finds that the 

OMOR seeks to change the drug facts 

labeling of an OTC monograph drug in 

a way that would add to or strengthen: 

(1) a contraindication, warning, or 

precaution; (2) a statement about risk 

associated with misuse or abuse; or (3) 

an instruction about dosage and 

administration that is intended to 

increase the safe use of the OTC 

monograph drug (see section 

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

III. OMOR Fee Adjustment for Inflation 

Under OMUFA, the OMOR fee is 

adjusted for inflation for FY 2022 and 

each subsequent fiscal year (see section 

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

provision states that the dollar amount 

of the inflation adjustment to the fee for 

OMORs is equal to the product of the 

applicable fee for the preceding fiscal 

year and the inflation adjustment 

percentage.5 For FY 2024, the inflation 

adjustment percentage is equal to the 

sum of 

• (1) the average annual percent 

change in the cost, per full-time 

equivalent position of the FDA, of all 

personnel compensation and benefits 

paid with respect to such positions for 

the first 3 years of the preceding 4 fiscal 

years, multiplied by the proportion of 

personnel compensation and benefits 

costs to total costs of OTC monograph 

drug activities for the first 3 years of the 

preceding 4 fiscal years (see section 

744M(c)(1)(C)(ii)(I) of the FD&C Act); 

and 

• (2) the average annual percent 

change that occurred in the Consumer 

Price Index for urban consumers 

(Washington-Baltimore, DC–MD–VA– 

WV; Not Seasonally Adjusted; All items; 

Annual Index) for the first 3 years of the 

preceding 4 years of available data 

multiplied by the proportion of all costs 


lotter on DSK11XQN23PROD with NOTICES1
62578 Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Notices 

6Under section 744M(f)(1) of the FD&C Act, 

OMUFA fees are authorized to support OTC 

monograph drug activities. Although authority for 

OMUFA fees (and the accompanying OMUFA 

definition of ‘‘OTC monograph drug activities’’) was 

enacted on March 27, 2020, under the CARES Act, 

OMUFA’s first authorized program year was FY 

2021. 

other than personnel compensation and 

benefits costs to total costs of OTC 

monograph drug activities for the first 3 

years of the preceding 4 fiscal years (see 

section 744M(c)(1)(C)(ii)(II) of the FD&C 

Act). 

As a result of a geographical revision 

made by the Bureau of Labor and 

Statistics in January 2018, the 

‘‘Washington, DC-Baltimore’’ index was 

discontinued and replaced with two 

separate indices (i.e., the ‘‘WashingtonArlington-Alexandria’’ and ‘‘BaltimoreColumbia-Towson’’ indices). To 

continue applying a CPI that best 

reflects the geographic region in which 

FDA is located and that provides the 

most current data available, the 

‘‘Washington-Arlington-Alexandria’’ 

index is used in calculating the inflation 

adjustment percentage. 

Table 1 summarizes the actual cost 

and FTE data for the specified fiscal 

years, provides the percent changes 

from the previous fiscal years, and 

provides the average percent changes 

over the first 3 of the 4 fiscal years 

preceding FY 2024. The 3-year average 

is 3.9280 percent. 

TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES

2020 2021 2022 3-year average 

Total PC&B ...................................................................................... $2,875,592,000 $3,039,513,000 $3,165,477,000 ............................

Total FTE ......................................................................................... 17,535 18,501 18,474 ............................

PC&B per FTE ................................................................................. 163,992 164,289 171,348 ............................

Percent Change From Previous Year ............................................. 7.3063 0.1811 4.2967 3.9280 

Under the statute, this 3.9280 percent 

would be multiplied by the proportion 

of PC&B costs to the total FDA costs of 

OTC monograph drug activities for the 

first 3 years of the preceding 4 fiscal 

years (see section 744M(c)(1)(C)(ii) of 

the FD&C Act). Because OMUFA was 

first authorized beginning with FY 2021, 

FDA used cost data of OTC monograph 

drug activities for the preceding 3 fiscal 

years (i.e., FYs 2021–2023) to align with 

OMUFA’s authorization. Because final 

FY 2023 spending data (total FDA PC&B 

costs and OTC monograph drug 

activities cost) were unavailable at the 

time of this fee rate notice, the Agency 

estimated final FY 2023 costs by using 

actual plus planned FY 2023 spending 

on PC&B costs and actual plus planned 

FY 2023 spending on OTC monograph 

drug activities cost. The above approach 

reflects FDA’s application of the 

OMUFA inflation adjustment in a 

manner that aligns with initiation of the 

OMUFA user fee program and the need 

to make FY 2024 OMOR fee rates 

available in a timely manner, so that 

these fees can be assessed to support 

OTC monograph drug activities 

pursuant to the statute.6

Table 2 shows the PC&B and the total 

obligations for OTC monograph drug 

activities for the last 3 fiscal years. 

TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF OTC MONOGRAPH DRUG ACTIVITIES

2021 2022 2023 * 3-year average 

Total PC&B ...................................................................................... $23,133,775.00 $25,415,237.00 $28,622,100.47 ............................

Total Costs ....................................................................................... 35,030,659.00 49,644,273.00 56,038,274.22 ............................

PC&B Percent .................................................................................. 66.0387 51.1947 51.0760 56.1031 

* FY 2023 actual plus planned FY 2023 spending on PC&B costs to the actual plus planned FY 2023 spending on OTC monograph drug activities cost. 

The payroll adjustment is 3.9280 

percent from table 1 multiplied by 

56.1031 percent resulting in 2.2037 

percent. 

Table 3 provides the summary data 

for the percent changes in the specified 

CPI for the Washington-ArlingtonAlexandria, DC–VA–MD–WV. The data 

are published by the Bureau of Labor 

Statistics on its website: https://

data.bls.gov/pdq/SurveyOutput

Servlet?data_tool=dropmap&series_

id=CUURS35ASA0,CUUSS35ASA0. 

TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA, DC– 

VA–MD–WV AREA

Year 2020 2021 2022 3-year average 

Annual CPI ....................................................................................... 267.16 277.73 296.12 ............................

Annual Percent Change .................................................................. 0.8989 3.9568 6.6212 3.8256 

The statute specifies that this 3.8256 

percent be multiplied by the proportion 

of all costs other than PC&B to total 

costs of OTC monograph drug activities. 

Because 56.1031 percent was obligated 

for PC&B (as shown in table 2), 43.8969 

percent is the portion of costs other than 

PC&B (100 percent minus 56.1031 

percent equals 43.8969 percent). The 

non-payroll adjustment is 3.8256 

percent times 43.8969 percent, or 1.6793 

percent. 

Next, we add the payroll adjustment 

(2.2037 percent) to the non-payroll 

adjustment (1.6793 percent), for a total 

inflation adjustment of 3.8830 percent 

(rounded) for FY 2024. 

IV. OMOR Fee Calculations 

Under section 744M(a)(2)(A) of the 

FD&C Act, each person that submits a 


lotter on DSK11XQN23PROD with NOTICES1
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