Notice2024-16878
Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Request Fee Rates for Fiscal Year 2025
Primary source
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Published
July 31, 2024
Effective
October 1, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 147 (Wednesday, July 31, 2024)</title>
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[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61455-61457]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#c28d8def8d84808392ef8d848fef97849191ef85adb4a7b0acafa7acb682a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="307f7f1d7f767271601d7f767d1d657663631d775f4655425e5d555e44705654511e5858431e575f46">[email protected]</span></a>.
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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<bullet> 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
<bullet> 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:
<a href="https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0">https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0</a>.
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
<a href="http://Pay.gov">Pay.gov</a>, a web-based payment application, for online electronic
payment. The <a href="http://Pay.gov">Pay.gov</a> 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 <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>. (Note:
Only full payments are accepted through <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>.
No partial payments can be made online). Once an invoice is located,
``Pay Now'' should be selected to be redirected to <a href="http://Pay.gov">Pay.gov</a>. 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
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