[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61455-61457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16878]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3001]


Over-the-Counter Monograph Drug User Fee Program--OTC Monograph 
Order Request Fee Rates for Fiscal Year 2025

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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) 2025. 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 2025. FDA plans 
to publish the FY 2025 OMUFA facility fee rates, i.e., monograph drug 
facility (MDF) and contract manufacturing organization (CMO) 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 OTC OMORs fees are effective on October 1, 2024, and will 
remain in effect through September 30, 2025.

FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of 
Financial Management, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20903, 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 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).
    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.\2\
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    \2\ 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 2025, the OMUFA fee rates for OTC OMORs are: Tier 1 OMOR 
fees ($559,777), Tier 2 OMOR fees ($111,955). These fees are effective 
for the period from October 1, 2024, through September 30, 2025. This 
document is issued pursuant to section 744M(a)(2) and (c)(4)(B) of the 
FD&C Act and describes the calculations used to set the OMUFA OMOR fees 
for FY 2025 in accordance with the directives in the statute.

II. Determination of FY 2025 OMOR Fees

    Under OMUFA, the FY 2025 Tier 1 OMOR fee is $559,777 and the Tier 2 
OMOR fee is $111,955, 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 FY (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.\3\ For 
FY 2025, the inflation adjustment percentage is equal to the sum of:
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    \3\ See section 744M(c)(1)(C) of the FD&C Act.
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     The average annual percent change in the cost, per full-
time equivalent position of FDA, of all personnel compensation and 
benefits paid with respect to such positions for the first 3 years of 
the preceding 4 FYs, 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 FYs (see section 
744M(c)(1)(C)(ii)(I) of the FD&C Act); and
     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 other than personnel compensation and benefits 
costs to total costs of OTC monograph drug activities for the first 3 
years of the preceding 4 FYs (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 
FYs, provides the percent changes from the previous FYs, and provides 
the average

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percent changes over the first 3 of the 4 FYs preceding FY 2025. The 3-
year average is 3.8539 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
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                                                  2021              2022              2023        3-Year average
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Total PC&B................................    $3,039,513,000    $3,165,477,000    $3,436,513,000  ..............
Total FTE.................................            18,501            18,474            18,729  ..............
PC&B per FTE..............................          $164,289          $171,348          $183,486  ..............
Percent Change from Previous Year.........           0.1811%           4.2967%           7.0838%         3.8539%
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    Under the statute, this 3.8539 percent is 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 FYs (see section 
744M(c)(1)(C)(ii) of the FD&C Act).
    Table 2 shows the PC&B and the total obligations for OTC monograph 
drug activities for the first 3 of the preceding 4 FYs.

                    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       $25,415,237       $39,133,075  ..............
Total Costs...............................       $35,030,659       $49,644,273       $68,480,052  ..............
PC&B Percent..............................          66.0387%          51.1947%          57.1452%        58.1262%
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    The payroll adjustment is 3.8539 percent from table 1 multiplied by 
58.1262 percent resulting in 2.2401 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                           2021              2022              2023        3-Year average
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Annual CPI................................            277.73            296.12            305.32  ..............
Annual Percent Change.....................           3.9568%           6.6212%           3.1069%         4.5616%
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    The statute specifies that this 4.5616 percent be multiplied by the 
proportion of all costs other than PC&B to total costs of OTC monograph 
drug activities. Because 58.1262 percent was obligated for PC&B (as 
shown in table 2), 41.8738 percent is the portion of costs other than 
PC&B (100 percent minus 58.1262 percent equals 41.8738 percent). The 
non-payroll adjustment is 4.5616 percent times 41.8738 percent, or 
1.9101 percent.
    Next, we add the payroll adjustment (2.2401 percent) to the non-
payroll adjustment (1.9101 percent), for a total inflation adjustment 
of 4.1502 percent (rounded) for FY 2025.

IV. OMOR Fee Calculations

    Under section 744M(a)(2)(A) of the FD&C Act, each person that 
submits a 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 FY (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 FY (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 FY shall be equal to the product of:
    (1) The applicable fee under section 744M(a)(2) of the FD&C Act for 
the preceding FY; and
    (2) The inflation adjustment percentage under section 744M(c)(1)(C) 
of the FD&C Act.
    Thus, for FY 2025, the base of OMOR fees taken from the preceding 
FY (i.e., FY 2024) are: Tier 1: $537,471 and Tier 2: $107,494. The FY 
2025 inflation adjustment percentage is: 4.1502%.

V. Fee Schedule

    The fee rates for FY 2025 are displayed in Table 4.

                    Table 4--Fee Schedule for FY 2025
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                                                             FY 2025 fee
                        Fee category                            rates
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OMOR:
  Tier 1...................................................     $559,777
  Tier 2...................................................      111,955
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VI. Fee Payment Options and Procedures

    The new OMOR fee rates are for the period from October 1, 2024, 
through September 30, 2025. To pay the OMOR fees, complete an OTC 
Monograph User Fee Cover Sheet, available at: https://

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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).
    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 (Discover, VISA, 
MasterCard, American Express). 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: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16878 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P