Notice2025-04860
Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2025
Primary source
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Published
March 21, 2025
Effective
October 1, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the over-the-counter (OTC) monograph drug facility (MDF) 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 OTC monograph order requests (OMORs). This notice publishes the OMUFA facility fee rates for FY 2025.
Full Text
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<title>Federal Register, Volume 90 Issue 54 (Friday, March 21, 2025)</title>
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[Federal Register Volume 90, Number 54 (Friday, March 21, 2025)]
[Notices]
[Pages 13371-13375]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04860]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0648]
Over-the-Counter Monograph Drug User Fee Program--Facility 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, the Agency, or we) is
announcing the over-the-counter (OTC) monograph drug facility (MDF) 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 OTC monograph
order requests (OMORs). This notice publishes the OMUFA facility fee
rates for FY 2025.
DATES: These facility 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 20993, 240-402-4989; or the User Fees Support
Staff at <a href="/cdn-cgi/l/email-protection#e7a8a8caa8a1a5a6caa8a1aacab2a1b4b4caa088918295898a828993a7818386c98f8f94c9808891"><span class="__cf_email__" data-cfemail="b5fafa98faf3f7f498faf3f898e0f3e6e698f2dac3d0c7dbd8d0dbc1f5d3d1d49bddddc69bd2dac3">[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 OMORs. The OTC OMOR fee rates for FY 2025 were published on July
31, 2024.\1\ OMUFA 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. For OMUFA purposes:
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\1\ <a href="https://www.federalregister.gov/documents/2024/07/31/2024-16878/over-the-counter-monograph-drug-user-fee-program-otc-monograph-order-request-fee-rates-for-fiscal">https://www.federalregister.gov/documents/2024/07/31/2024-16878/over-the-counter-monograph-drug-user-fee-program-otc-monograph-order-request-fee-rates-for-fiscal</a>.
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<bullet> 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);
<bullet> An OTC MDF is a foreign or domestic business or other
entity that, in addition to meeting other criteria, is engaged in
manufacturing or processing the finished dosage form of an OTC
monograph drug (see section 744L(10) of the FD&C Act); and
<bullet> A contract manufacturing organization (CMO) facility is an
OTC monograph drug facility where neither the owner nor any affiliate
of the owner or facility sells the OTC monograph drug produced at such
facility directly to wholesalers, retailers, or consumers in the United
States (see section 744L(2) of the FD&C Act).
Under section 744M(a)(1)(A) of the FD&C Act, a facility fee for FY
2025 shall be assessed with respect to each facility that is identified
as an OTC monograph drug facility during the fee-liable period from
January 1, 2024, through December 31, 2024.\2\ Consistent with the
statute, FDA will assess and collect facility fees with respect to the
two types of OTC monograph drug facilities--MDF and CMO facilities. A
full facility fee will be assessed to each qualifying person that owns
a facility identified as an MDF (see section 744M(a)(1)(A) of the FD&C
Act), and a reduced facility fee of two-thirds will be assessed to each
qualifying person that owns a facility identified as a CMO facility
(see section 744M(a)(1)(B)(ii) of the FD&C Act). The facility fees for
FY 2025 are due on June 2, 2025 (see section 744M(a)(1)(D)(ii) of the
FD&C Act).\3\
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\2\ Under section 744M(a)(1) of the FD&C Act, ``Each person that
owns a facility identified as an OTC monograph drug facility on
December 31 of the fiscal year or at any time during the preceding
12-month period shall be assessed an annual fee for each such
facility.'' For purposes of FY 2025 facility fees, that time period
is January 1, 2024, through December 31, 2024.
\3\ Assuming that, as we anticipate, the FY 2025 fee
appropriation will occur prior to June 3, 2025. Under section
744M(a)(1)(D)(ii), the FY 2025 facility fees are due on the later
of: (1) the first business day of June 2025 (i.e., June 3, 2025) or
(2) the first business day after the enactment of an appropriations
Act providing for the collection and obligation of FY 2025 OMUFA
fees.
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As discussed in greater detail below:
<bullet> OTC monograph drug facilities are exempt from FY 2025
facility fees if they had ceased OTC monograph drug activities, and
updated their registration with FDA to that effect, prior to December
31, 2023 (see section 744M(a)(1)(B)(i) of the FD&C Act).
<bullet> Entities that registered with FDA during the Coronavirus
Disease 2019 (COVID-19) pandemic whose sole activity with respect to
OTC monograph drugs during the pandemic consisted of manufacturing OTC
hand sanitizer
[[Page 13372]]
products \4\ and had ceased manufacturing hand sanitizer products and
delisted and deregistered in FDA's Electronic Drug Registration and
Listing System (eDRLS) accordingly before 12 a.m. Eastern Time on
December 31, 2024, are not identified as OTC monograph drug facilities
subject to OMUFA facility fees for FY 2025.\5\
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\4\ The term ``hand sanitizer'' commonly refers to consumer
antiseptic rubs. However, because the Department of Health and Human
Services (HHS) notice published January 12, 2021, referred to
``persons that entered the over-the-counter drug market to supply
hand sanitizer products in response to the COVID-19 Public Health
Emergency'' (86 FR 2420, <a href="https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during">https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during</a>), we are using
the same terminology--``hand sanitizer products''--to refer to OTC
monograph drug products intended for use (without water) as
antiseptic hand rubs or antiseptic hand wipes by consumers or
healthcare personnel.
\5\ See HHS Federal Register notice of January 12, 2021, 86 FR
2420, <a href="https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during">https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during</a>.
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For FY 2025, the OMUFA facility fee rates are: MDF facility fees
($37,556) and CMO facility fees ($25,037). These fees are effective for
the period from October 1, 2024, through September 30, 2025.\6\ This
document is issued pursuant to section 744M(a)(4) and 744M(c)(4)(B) of
the FD&C Act and describes the calculations used to set the OMUFA
facility fees for FY 2025 in accordance with the directives in the
statute.
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\6\ These OMUFA facility fees are for FY 2025, per section
744M(a) of the FD&C Act.
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II. Facility Fee Revenue Amount for FY 2025
A. Base Fee Revenue Amount
Under OMUFA, FDA sets annual facility fees to generate the total
facility fee revenues for each fiscal year established by section
744M(b) of the FD&C Act. The yearly base revenue amount is the starting
point for setting annual facility fee rates. The base revenue for FY
2025 is the dollar amount of the total revenue amount for the previous
fiscal year, without certain adjustments made for that previous year,
and is $29,253,365 (see section 744M(b)(3)(B) of the FD&C Act).
B. Fee Revenue Adjustment for Inflation
Under OMUFA, the annual base revenue amount for facility fees is
adjusted for inflation for FY 2025, per section 744M(c)(1) of the FD&C
Act. That provision states that the dollar amount of the inflation
adjustment is equal to the product of the annual base revenue for the
fiscal year and the inflation adjustment percentage. For FY 2025 the
inflation adjustment percentage is the sum of:
<bullet> (I) the average annual percent change in cost, per full-
time equivalent (FTE) position of 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 (PC&B) costs to total costs of the
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
<bullet> (II) the average annual percent change that occurred in
the Consumer Price Index (CPI) 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 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 2025. The 3-year average is 3.8539 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Fiscal Year and Percent Changes
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Fiscal year 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 3.8539%
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%
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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 fiscal years (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 fiscal years.
Table 2--PC&B as a Percent of Total Cost of OTC Monograph Drug Activities
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Fiscal year 2021 2022 2023 3-Year average
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Total PC&B.............................. 23,133,775 25,415,237 39,133,075 58.1262%
Total Costs............................. 35,030,659 49,644,273 68,480,052
PC&B Percent............................ 66.0378% 51.1947% 57.1452%
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The payroll adjustment is 3.8539 percent from table 1 multiplied by
58.1262 percent from table 2 resulting in 2.2401 percent.
Table 3 provides the summary data for the percent changes in the
specified
[[Page 13373]]
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 4.5616%
Annual Percent Change................... 3.9568% 6.6212% 3.1069%
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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 for the first 3 years of the preceding 4 fiscal years.
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 nonpayroll
adjustment is 4.5616 percent times 41.8738 percent, or 1.9101 percent.
Next, we add the payroll adjustment (2.2401 percent) to the
nonpayroll adjustment (1.9101 percent), for a total inflation
adjustment of 4.1502 percent (rounded) for FY 2025.
Pursuant to the statute, the FY 2025 base revenue of $29,253,365 is
increased by the total inflation adjustment of 4.1502 percent, yielding
an inflation adjusted base revenue amount of $30,467,438 for FY 2025
(see section 744M(c)(1)(A)).
C. Additional Dollar Amounts
For FY 2025, the inflation adjusted revenue amount of $30,467,438
is increased by an additional dollar amount of $3 million as specified
in the statute (see section 744M(b)(2)(E) of the FD&C Act). This yields
an adjusted fee revenue subtotal of $33,467,438.
D. Fee Revenue Adjustment for Additional Direct Cost
Fee revenue is further adjusted for additional direct costs as
specified in the statute. In FY 2025, $3 million is added to the
facility fee revenues to account for additional direct costs (see
section 744M(c)(3)(E) of the FD&C Act). Adding the additional direct
costs amount of $3 million to $33,467,438 yields an additional direct
cost adjusted fee revenue of $36,467,438.
E. Fee Revenue Adjustment for Operating Reserve
Under OMUFA, FDA may further increase the FY 2025 facility fee
revenue and fees if such an adjustment is necessary to provide up to 10
weeks of operating reserves of carryover user fees for OTC monograph
drug activities (see section 744M(c)(2)(B) of the FD&C Act).
Accordingly, in setting fees for FY 2025, the Agency must estimate its
carryover for FY 2025 to ensure the Agency has sufficient carryover to
continue its OTC monograph drug activities, as required under the
statute, including an operating reserve to mitigate certain financial
risks, such as under collections, unanticipated surges in program
costs, or a lapse in appropriations. Under the statute, if FDA has
carryover for OTC monograph drug activities that would exceed 10 weeks
of such operating reserves, FDA is required to decrease FY 2025 fee
revenues and fees to provide for not more than 10 weeks of operating
reserves of carryover user fees (see section 744M(c)(2)(C) of the FD&C
Act).
Per the statute, OMUFA facility fees are not due until the third
quarter of each fiscal year (i.e., the first business day in June). To
address this timing of facility fee collections for late in the fiscal
year, the Agency must set aside additional carryover, beyond that for
an operating reserve, to sustain the Agency's OTC monograph drug
activities until the facility fees for the subsequent fiscal year are
due and payable on the first business day in June (i.e., June 1, 2026).
Thus, the Agency will require FY 2025 carryover sufficient to cover
payroll and operating expenses for the first 8 months (i.e., 35 weeks
rounded) of the following fiscal year (i.e., October 1, 2025, to May
31, 2026). We refer to the amount of carryover needed to cover this 35-
week period as the continuity set-aside, consistent with the annual
OMUFA Financial Reports.\7\
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\7\ <a href="https://www.fda.gov/about-fda/user-fee-financial-reports/omufa-financial-reports">https://www.fda.gov/about-fda/user-fee-financial-reports/omufa-financial-reports</a>.
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To determine the amount of this continuity set-aside, the Agency
starts with the additional direct cost adjusted fee revenue of
$36,467,438 (calculated in section D), divides it by 52 to yield a
weekly operating amount of $701,297, and then multiplies the weekly
operating amount by 35. Based on this calculation, FDA requires
$24,545,391 to support the program until the FY 2026 facility fees are
due. After running analyses on the projected collections and
obligations for FY 2025, including accounting for possible financial
risks described above, FDA estimates the FY 2025 carryover to be
$28,026,448 which is $3,481,057 above the continuity set-aside amount
needed to support the program through the 35-week period until the FY
2026 facility fees are due.
To determine whether the carryover above this continuity set-aside
is within the 10-week limit for the operating reserve, FDA multiplies
the weekly operating amount ($701,297) by 10, resulting in an operating
reserve limit of $7,012,969. Because the estimated FY 2025 carryover
above the continuity set-aside is below the 10-week threshold, FDA will
not increase or reduce the FY 2025 fees or fee revenue under the
statutory provision for an operating reserve adjustment. The final FY
2025 OMUFA target facility fee revenue is $36,467,000 (rounded to the
nearest thousand dollars).
III. Facility Fee Calculations
A. Facility Fee Revenues and Fees
For FY 2025, facility fee rates are being established to generate a
total target revenue amount, as determined under the statute, equal to
$36,467,000 (rounded to the nearest thousand dollars). FDA used the
methodology described below to determine the appropriate number of MDF
and CMO facilities to be used in setting the OMUFA facility fees for FY
2025. FDA took into consideration that the CMO facility fee is equal to
two-thirds of the amount of the MDF facility fee (see section
744M(a)(1)(B)(ii) of the FD&C Act).
B. Calculating the Number of Qualifying Facilities and Setting the
Facility Fees
For FY 2025, FDA utilized data consisting of the number of
facilities that were registered in FDA's eDRLS to manufacture human OTC
drug products produced under a monograph \8\ during
[[Page 13374]]
the FY 2025 fee-liable period (i.e., January 1, 2024, through December
31, 2024, and that paid prior FY OMUFA facility fees, as the primary
sources for estimating the number of each facility fee type (i.e., MDF
and CMO)). In addition, the Agency considered data provided by firms
regarding their operation as MDFs and CMOs during FY 2024 (i.e.,
October 1, 2023, through September 30, 2024) when they were submitting
OTC Monograph User Fee Cover Sheets to pay the FY 2024 fee. These data
helped FDA estimate the number of firms operating as MDF and CMO
facilities during the FY 2025 fee-liable period (i.e., January 1, 2024,
through December 31, 2024),\9\ and thus informed FDA's calculation of
the number and ratio of MDF and CMO facilities used in determining the
FY 2025 fee rates. FDA's review of data also reflected input received
during the FY 2025 fee-liable period from facilities whose
manufacturing or processing practices meet the definition of fee-
eligible OTC monograph drug facilities, to help capture those
facilities that are in the market and intend to remain in the market
for FY 2025.
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\8\ See section 744M(d) of the FD&C Act. OTC monograph drug
facilities had selected in the eDRLS the business operation
qualifiers of ``manufactures human over-the-counter drug products
produced under a monograph'' or ``contract manufacturing for human
over-the-counter drug products produced under a monograph'' and
indicated at least one of the following business operations:
finished dosage form manufacture, label, manufacture, pack, relabel,
or repack.
\9\ FDA considers relabelers and repackagers to be a category of
OTC monograph drug facilities subject to OMUFA facility fees. See
section 744L(10)(A); see also section 744L(10)(A)(iii) of the FD&C
Act, excluding from the definition of ``OTC monograph drug
facility'' those facilities whose manufacturing or processing
consists solely of a narrow range of specified activities (e.g.,
placement of outer overpackaging on products already in final
packaged form); cf section 744A(6)(A)(ii) of the FD&C Act (which
expressly excludes from the definition of ``facility'', for purposes
of Generic Drug User Fee Amendments facility fees, a business or
other entity whose only manufacturing or processing activities are
repackaging, relabeling, or testing). See also 21 CFR 207.1
(addressing drug establishment registration), stating that
``[m]anufacture means each step in the manufacture, preparation,
propagation, compounding, or processing of a drug,'' and indicating
that ``the term `manufacture, preparation, propagation, compounding,
or processing,' as used in section 510 of the Federal Food, Drug,
and Cosmetic Act, includes relabeling, repackaging, and salvaging
activities.''
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Those facilities that only manufacture the active pharmaceutical
ingredient of an OTC monograph drug do not meet the definition of an
OTC monograph drug facility (see section 744L(10)(A)(i)(II)) of the
FD&C Act). Likewise, a facility is not an OTC monograph drug facility
if its only manufacturing or processing activities are one or more of
the following: (1) production of clinical research supplies; (2)
testing; or (3) placement of outer packaging on packages containing
multiple products, for such purposes as creating multipacks, when each
monograph drug product contained within the overpackaging is already in
a final packaged form prior to placement in the outer overpackaging
(see section 744L(10)(A)(iii) of the FD&C Act).
Consistent with the January 12, 2021 HHS Federal Register notice
\10\ (HHS FRN) and FDA's subsequent Federal Register notices published
on March 26, 2021, March 16, 2022, March 27, 2023, and March 29, 2024,
announcing the FY 2021, FY 2022, FY 2023, and FY 2024 OMUFA fees
(respectively),<SUP>11 12 13 14</SUP> facilities are not identified as
an ``OTC monograph drug facility'' and will not be assessed a FY 2025
OMUFA facility fee if they: (1) were not registered with FDA as OTC
drug manufacturers prior to the HHS declaration of the COVID-19 public
health emergency (PHE) on January 27, 2020; \15\ (2) registered with
FDA on or after the declaration of the COVID-19 PHE on January 27,
2020; (3) registered for the sole purpose of producing hand sanitizer
products during the COVID-19 PHE; and (4) ceased manufacturing hand
sanitizer products and delisted and deregistered in eDRLS before 12
a.m. Eastern Time on December 31, 2024. We note that under the FD&C
Act, whether an entity is subject to OMUFA fees has no bearing on
whether the entity or the entity's products are subject to other
requirements under the FD&C Act. FDA will continue to use its
regulatory compliance and enforcement tools to protect consumers,
including from hand sanitizers or other drugs that are potentially
dangerous or subpotent.
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\10\ See 86 FR 2420, <a href="https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during">https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during</a>.
\11\ See 86 FR 16223, <a href="https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021">https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021</a>.
\12\ See 87 FR 14888, <a href="https://www.federalregister.gov/documents/2022/03/16/2022-05542/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2022">https://www.federalregister.gov/documents/2022/03/16/2022-05542/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2022</a>.
\13\ See 88 FR 18156, <a href="https://www.federalregister.gov/documents/2023/03/27/2023-06299/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2023">https://www.federalregister.gov/documents/2023/03/27/2023-06299/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2023</a>.
\14\ See 88 FR 22156, <a href="https://www.federalregister.gov/documents/2024/03/29/2024-06723/over-the-counter-monograph-drug-user-fee-program-facility-fee-rates-for-fiscal-year-2024">https://www.federalregister.gov/documents/2024/03/29/2024-06723/over-the-counter-monograph-drug-user-fee-program-facility-fee-rates-for-fiscal-year-2024</a>.
\15\ See https://aspr.hhs.gov/legal/PHE/Pages/2019-
nCoV.aspx#:~:text=As%20a%20result%20of%20confirmed,January%2027%2C%20
2020%2C%20nationwide.
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The January 12, 2021 HHS FRN explains that ``[t]he Department's
conclusion [that certain hand sanitizer manufacturers are not
identified as OTC monograph drug facilities] does not apply to such
persons which (1) manufacture, distribute, and sell over-the-counter
drugs in addition to hand sanitizer or (2) continue to manufacture (as
opposed to hold, distribute, or sell existing inventories) hand
sanitizer products as of December 31 of the year immediately following
the year during which the COVID-19 Public Health Emergency is
terminated. In those cases, the Department may identify such persons as
OTC drug manufacturing facilities'' \16\ (emphasis added). Accordingly,
as the PHE expired on May 11, 2023, those facilities which ``continue
to manufacture'' solely hand sanitizer products as of December 31,
2024, are identified as OTC monograph drug facilities and are subject
to an OMUFA facility fee for FY 2025. Conversely, if such facilities
ceased manufacturing hand sanitizer products and delisted and
deregistered to reflect that before 12 a.m. Eastern Time on December
31, 2024, they are not identified as an OTC monograph drug facility
\17\ and would not be considered fee liable for purposes of FY 2025
OMUFA facility fees.\18\ FDA communicated this deadline to stakeholders
on multiple occasions, including in the FY 2024 OMUFA Facility Fee
FRN,\19\ presentations to industry, and OMUFA listserv emails.
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\16\ See <a href="https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during">https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during</a>.
\17\ Id.
\18\ Id.
\19\ Available at <a href="https://www.federalregister.gov/documents/2024/03/29/2024-06723/over-the-counter-monograph-drug-user-fee-program-facility-fee-rates-for-fiscal-year-2024">https://www.federalregister.gov/documents/2024/03/29/2024-06723/over-the-counter-monograph-drug-user-fee-program-facility-fee-rates-for-fiscal-year-2024</a>.
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In undertaking the statutorily directed fee calculations for FY
2024 fees, the Agency also made certain assumptions, including that:
(1) facilities using expired Structured Product Labeling codes in
eDRLS, that have not reregistered, were no longer manufacturing and
marketing OTC monograph drugs; (2) facilities that have deregistered in
eDRLS have exited the market; (3) facilities that FDA believes
registered incorrectly as OTC monograph drug facilities (for example,
because the associated drug listings for these facilities did not
include OTC monograph drugs but instead indicated such products as OTC
drug products under an approved drug application or OTC animal drug
products) were not engaged in manufacturing or processing
[[Page 13375]]
the finished dosage form of an OTC monograph drug; (4) facilities that
registered but did not have an active OTC monograph drug product
listing associated in their registration profile were not manufacturing
or processing such drug products; (5) a portion of facilities that
newly registered during the fee liable period are estimated to be in
arrears based on a review of the prior 3-year average of newly
registered facilities in arrears; and (6) facilities that, at the close
of FY 2024, remain on the arrears list for failure to satisfy the FY
2022, FY 2023, or FY 2024 facility fee are likely to be placed on the
FY 2025 arrears list as well.
In addition, the Agency made certain assumptions with respect to
hand sanitizer manufacturers that remained registered after 12 a.m.
Eastern Time on December 31, 2024, including that: (1) hand sanitizer
manufactures that have deregistered in eDRLS after December 31, 2024,
have exited the market; (2) hand sanitizer manufacturers that did not
actively update their registration in eDRLS during the FY 2025 fee
liable period and let their registration lapse have likely exited the
market; and (3) for the remaining hand sanitizer manufacturers that are
newly fee liable, FDA estimated a portion will be in arrears based on a
review of the prior 3-year average for newly registered facilities in
arrears.
Based on the above-referenced factors and assumptions, FDA
estimates there will be 1,134 OMUFA fee-paying units. The Agency
estimates that 57 percent (1,134 x 0.57 = 646, rounded) will incur the
MDF fee and 43 percent (1,134 x 0.43 = 488, rounded) will incur the CMO
fee.
To determine the number of full fee-paying equivalents (the
denominator) to be used in setting the OMUFA fees, FDA assigns a value
of 1 to each MDF (646) and a value of \2/3\ to each CMO (488 x 2/3 =
325) for a full facility equivalent of 971 (rounded). The target fee
revenue of $36,467,000 is then divided by 971 for an MDF fee of $37,556
and a CMO fee of $25,037.
IV. Fee Schedule for FY 2025
The fee rates for FY 2025 are displayed in table 4.
Table 4--Fee Schedule for FY 2025
------------------------------------------------------------------------
FY 2025 fee
Fee category rates
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MDF........................................................ $37,556
CMO........................................................ 25,037
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V. Fee Payment Options and Procedures
The new facility fee rates are for the period from October 1, 2024,
through September 30, 2025. To pay the MDF and CMO fees, complete an
OTC Monograph User Fee Cover Sheet, available at: <a href="https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp">https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp</a>.
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.\20\
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\20\ 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.
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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 consequences of nonpayment per section 744M(e)(1)
of the FD&C Act. 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.
If you are assessed an FY 2025 OMUFA facility fee and believe your
facility is not an OTC monograph drug facility as described in this
notice, please contact <a href="/cdn-cgi/l/email-protection#296a6d6c7b6a4645454c4a5d4046475a694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="a0e3e4e5f2e3cfccccc5c3d4c9cfced3e0c6c4c18ec8c8d38ec7cfd6">[email protected]</span></a>.
Dated: March 18, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04860 Filed 3-20-25; 8:45 am]
BILLING CODE 4164-01-P
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