[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Notices]
[Pages 62577-62579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19609]


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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.

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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 [email protected].

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\
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    \1\ For 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);
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    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\
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    \2\ Section 744M(a)(2)(B) of the FD&C Act.
    \3\ The Agency anticipates a greater likelihood of OMOR 
submissions in FY 2024 compared to prior fiscal years.
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    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\
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    \4\ Under 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.
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    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
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    \5\ See section 744M(c)(1)(C) of the FD&C Act.
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     (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

[[Page 62578]]

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 
``Washington-Arlington-Alexandria'' and ``Baltimore-Columbia-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
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                                                2020              2021              2022         3-year average
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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
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    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\
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    \6\ Under 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.
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    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
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                                                2021              2022             2023 *        3-year average
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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
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* 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-Arlington-Alexandria, DC-VA-MD-WV. The 
data are published by the Bureau of Labor Statistics on its website: 
https://data.bls.gov/pdq/SurveyOutputServlet?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
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                  Year                          2020              2021              2022         3-year average
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Annual CPI..............................            267.16            277.73            296.12  ................
Annual Percent Change...................            0.8989            3.9568            6.6212            3.8256
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    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

[[Page 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
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                                                                FY 2024
                        Fee category                           fee rates
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OMOR:
  Tier 1....................................................    $537,471
  Tier 2....................................................     107,494
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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