Notice2026-05276
Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 18, 2026
Effective
October 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years 2026 through 2030. This notice publishes the OTC monograph drug facility (MDF) fee rates for fiscal year (FY) 2026.
Full Text
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<title>Federal Register, Volume 91 Issue 52 (Wednesday, March 18, 2026)</title>
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[Federal Register Volume 91, Number 52 (Wednesday, March 18, 2026)]
[Notices]
[Pages 13034-13037]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05276]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2362]
Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal
Year 2026
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Over-the-Counter Monograph Drug User Fee Amendments
(herein referred to as ``OMUFA II''), authorizes the Food and Drug
Administration (FDA, the Agency, or we) to assess and collect user fees
from qualifying manufacturers of over-the-counter (OTC) monograph drugs
and submitters of OTC monograph order requests (OMORs) for fiscal years
2026 through 2030. This notice publishes the OTC monograph drug
facility (MDF) fee rates for fiscal year (FY) 2026.
DATES: These facility fees are effective on October 1, 2025, and will
remain in effect through September 30, 2026.
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#6629294b292024274b29202b4b332035354b2109100314080b03081226000207480e0e1548010910"><span class="__cf_email__" data-cfemail="d19e9efc9e979390fc9e979cfc84978282fc96bea7b4a3bfbcb4bfa591b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 744M of the FD&C Act (21 U.S.C. 379j-72), as amended by
OMUFA II,\1\ authorizes FDA to assess and collect, for each of fiscal
years 2026 through 2030: (1) facility fees from qualifying owners of
OTC MDFs and (2) fees from submitters of qualifying OMORs. The OMOR fee
rates for FY 2026 were published on December 29, 2025.\2\ 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
specified FDA activities associated with OTC monograph drugs. For OMUFA
purposes:
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\1\ Over-the-Counter Monograph Drug User Fee Amendments, title V
of Division F of the Continuing Appropriations, Agriculture,
Legislative Branch, Military Construction and Veterans Affairs, and
Extensions Act, 2026 (Pub. L. 119-37).
\2\ <a href="https://www.federalregister.gov/documents/2025/12/29/2025-23852/over-the-counter-monograph-drug-user-fee-amendments-otc-monograph-order-request-fee-rates-for-fiscal">https://www.federalregister.gov/documents/2025/12/29/2025-23852/over-the-counter-monograph-drug-user-fee-amendments-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
2026 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, 2025, through December 31, 2025.\3\ 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 2026 are due on June 1, 2026 (see section 744M(a)(1)(D)(i)(I) of the
FD&C Act).\4\
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\3\ Under section 744M(a)(1)(A)(i) of the FD&C Act, ``Each
person that owns a facility identified as an OTC monograph drug
facility at any time during the applicable period . . . for a fiscal
year shall be assessed an annual fee for each such facility''. The
applicable period for FY 2026 is the 12-month period ending December
31, 2025.
\4\ Assuming that, as we anticipate, the FY 2026 fee
appropriation will occur prior to June 1, 2026. Under section
744M(a)(1)(D)(i), the FY 2026 facility fees are due on the later of:
(1) the first business day of June 2026 (i.e., June 1, 2026) or (2)
the first business day after the enactment of an appropriations Act
providing for the collection and obligation of FY 2026 OMUFA fees.
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As discussed in greater detail below, OTC monograph drug facilities
are exempt from FY 2026 facility fees if they had ceased OTC monograph
drug activities, and updated their registration with FDA to that
effect, prior to January 1, 2025 (see section 744M(a)(1)(B)(i)(I)(aa)
of the FD&C Act).
For FY 2026, the OMUFA facility fee rates are: MDF facility fees
($19,188) and CMO facility fees ($12,792). These fees are effective for
the period from October 1, 2025, through September 30, 2026.\5\ This
document is issued pursuant to section 744M(a)(4) and 744M(c)(5)(B) of
the FD&C Act and describes the calculations used to set the OMUFA
facility fees for FY 2026 in accordance with the directives in the
statute.
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\5\ These OMUFA facility fees are for FY 2026, per section
744M(a) of the FD&C Act.
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II. Facility Fee Revenue Amount for FY 2026
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
2026 is the dollar amount of the total revenue amount for the previous
fiscal year, without certain adjustments made for that previous year,
and is $36,467,438 (see section 744M(b)(2)(A) 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 2026, 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 2026, the
inflation adjustment percentage is equal to the sum of:
<bullet> The average annual percent change in cost, per full-time
equivalent (FTE) position of the FDA, of all personnel compensation and
benefits (PC&B) paid with respect to such positions for the first 3
years of the preceding 4 FYs, multiplied by the proportion of PC&B
costs to total costs of the OTC monograph drug activities for the first
3 years of the preceding 4 FYs (see section 744M(c)(1)(C)(i) of the
FD&C Act); and
<bullet> The average annual percent change that occurred in the
Consumer Price Index (CPI) for urban consumers (Washington-Arlington-
Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4 years of available data
multiplied by the
[[Page 13035]]
proportion of all costs other than PC&B 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) of the FD&C Act).
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 percent changes over the first 3 of the 4 FYs preceding FY
2026. The 3-year average is 5.4494 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Fiscal Year and Percent Changes
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Fiscal year 2022 2023 2024 3-Year average
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Total PC&B.......................... 3,165,477,000 3,436,513,000 3,791,729,000 5.4494%
Total FTEs.......................... 18,474 18,729 19,687 .................
PC&B per FTE........................ 171,348 183,486 192,601 .................
Percent Change From Previous Year... 4.2967% 7.0838% 4.9677% .................
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Under the statute, this 5.4494 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)(i) 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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Fiscal year 2022 2023 2024 3-Year average
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Total PC&B.......................... 25,415,237 39,133,075 41,579,890 56.4429%
Total Costs......................... 49,644,273 68,480,052 68,176,240 .................
PC&B Percent........................ 51.1947% 57.1452% 60.9888% .................
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The payroll adjustment is 5.4494 percent from table 1 multiplied by
56.4429 percent from table 2, resulting in 3.0758 percent.
Table 3 provides the summary data for the percent changes in the
specified CPI for the Washington-Arlington-Alexandria, DC-VA-MD-WV
area.\6\
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\6\ These 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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Fiscal year 2022 2023 2024 3-Year average
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Annual CPI.......................... 296.12 305.32 315.186 4.3202%
Annual Percent Change............... 6.6212% 3.1069% 3.2324%
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The statute specifies that this 4.3202 percent be multiplied by the
proportion of all costs other than PC&B to total costs of OTC monograph
drug activities (see section 744M(c)(1)(C)(ii) of the FD&C Act).
Because 56.4429 percent was obligated for PC&B (as shown in table 2),
43.5571 percent is the portion of costs other than PC&B (100 percent-
56.4429 percent = 43.5571 percent). The non-payroll adjustment is
4.3202 percent x 43.5571 percent, or 1.8818 percent.
Next, we add the payroll adjustment (3.0758 percent) to the non-
payroll adjustment (1.8818 percent), for a total inflation adjustment
of 4.9576 percent (rounded) for FY 2026.
Pursuant to the statute, the FY 2026 base revenue of $36,467,438 is
increased by the total inflation adjustment of 4.9576 percent, yielding
an inflation adjusted base revenue amount of $38,275,348 for FY 2026
(see section 744M(c)(1)(A)).
C. Additional Dollar Amounts
OMUFA II requires that the facility fee revenue be increased by an
additional dollar amount for each of fiscal years 2026-2028. For FY
2026, the inflation adjusted revenue amount of $38,275,348 is increased
by an additional dollar amount of $2,373,000 as specified in the
statute (see section 744M(b)(1)(E)(i) of the FD&C Act). This yields an
adjusted fee revenue subtotal of $40,648,348.
D. Fee Revenue Adjustment for Additional Direct Cost
Fee revenue is further adjusted for additional direct costs as
specified in the statute. In FY 2026, $135,000 is added to the facility
fee revenues to account for additional direct costs (see section
744M(c)(3)(A) of the FD&C Act). Adding the additional direct costs
amount of $135,000 to $40,648,348 yields an additional direct cost
adjusted fee revenue of $40,783,348.
E. Fee Revenue Adjustment for Operating Reserve
Under OMUFA, FDA may further increase the FY 2026 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)(A) of the FD&C Act).
Accordingly, in setting fees for FY 2026, the Agency must estimate its
carryover for FY 2026 to ensure the Agency has sufficient operating
reserves of carryover user fees to mitigate certain financial risks,
such as under collections, unanticipated surges in program costs, or a
lapse in
[[Page 13036]]
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 2026 fee revenues and fees to
provide for not more than 10 weeks of operating reserves of carryover
user fees (see section 744M(c)(2)(B) of the FD&C Act).
Under OMUFA II, OMUFA facility fees will transition to being due
the first business day in October, instead of the third quarter of each
fiscal year (i.e., the first business day in June) (see section
744M(a)(1)(D)).\7\ For FY 2027, OMUFA facility fees will be due in two
equal installments, due the first business day of October and the first
business day of February, respectively.\8\ With this transition, FDA
will no longer need to retain sufficient carryover to sustain its
statutorily-required OTC monograph drug activities until receipt of
annual facility fee funding in the 3rd fiscal quarter. Accordingly, the
additional 35-week continuity set-aside utilized under OMUFA I is no
longer necessary and has been eliminated from fee calculations for FY
2026 and subsequent fiscal years under OMUFA II.
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\7\ Assuming that, as we anticipate, the annual fiscal year
OMUFA fee appropriation will be enacted by October 1 of the fiscal
year. Otherwise, the transitioned due date would be the first
business day after the enactment of an appropriations Act providing
for the collection and obligation of OMUFA fees for the fiscal year,
per section 744M(a)(1)(D).
\8\ See section 744M(a)(1)(D)(ii) of the FD&C Act. For fiscal
year 2028 and subsequent fiscal years, OMUFA facility fees will be
due the first business day of October (or if later, the first
business day after enactment of an appropriations Act providing for
the collection and obligation of OMUFA fees for the fiscal year),
per section 744M(a)(1)(D)(iii) of the FD&C Act.
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To determine the FY 2026 end-of-year operating reserves of
carryover user fees, the Agency assessed the operating reserve of
carryover user fees at the end of January 2026 and forecast collections
and obligations for the remainder of FY 2026. FDA estimates the FY 2026
operating reserve of carryover user fees to be $31,741,457.
To determine whether the carryover is within the 10-week limit for
the operating reserve, the Agency starts with the additional direct
cost adjusted fee revenue of 40,783,348 (calculated in section D),
divides it by 52 to yield a weekly operating amount of $784,295, and
then multiplies the weekly operating reserve amount ($784,295) by 10,
resulting in an operating reserve limit of $7,842,951. Because the
estimated FY 2026 carryover is above the 10-week threshold, FDA is
applying a downward operating reserve adjustment of $23,898,506,
equivalent to approximately 30 weeks, to bring the operating reserve of
carryover user fees to the statutory limit for such operating reserves
(see section 744M(c)(2)(B) of the FD&C Act). The final FY 2026 OMUFA
target facility fee revenue is $16,885,000 (rounded to the nearest
thousand dollars).
III. Facility Fee Calculations
A. Facility Fee Revenues and Fees
For FY 2026, facility fee rates are being established to generate a
total target revenue amount, as determined under the statute, equal to
$16,885,000 (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
2026. 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 2026, FDA utilized data consisting of the number of
facilities that were registered in FDA's Electronic Drug Registration
and Listing System (eDRLS) to manufacture human OTC drug products
produced under a monograph \9\ during the FY 2026 fee-liable period
(i.e., January 1, 2025, through December 31, 2025, 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 2025 (i.e., October 1, 2024, through September
30, 2025) when they were submitting OTC Monograph User Fee Cover Sheets
to pay the FY 2025 fee. This data supported FDA's estimate of the
number of firms operating as MDF and CMO facilities during the FY 2026
fee-liable period (i.e., January 1, 2025, through December 31,
2025),\10\ and informed FDA's calculation of the number and ratio of
MDF and CMO facilities used in determining the FY 2026 fee rates. FDA's
review of data also reflected input received during the FY 2026 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 2026.
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\9\ 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.
\10\ 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).
In undertaking the statutorily directed fee calculations for FY
2026 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 nonprescription
drug products marketed under an approved drug application or
nonprescription animal drug products) were not engaged in manufacturing
or processing the
[[Page 13037]]
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 2025, remain on the arrears list for failure to satisfy the FY
2023, FY 2024, or FY 2025 facility fee are likely to be placed on the
FY 2026 arrears list as well.
Based on the above-referenced factors and assumptions, FDA
estimates there will be 1,039 OMUFA fee-paying units. The Agency
estimates that 54 percent (1,039 x 0.54 = 561, rounded) will incur the
MDF fee and 46 percent (1,039 x 0.46 = 478, 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 (561) and a value of \2/3\ to each CMO (478 x \2/3\ =
319) for a full facility equivalent of 880 (rounded). The target fee
revenue of $16,885,000 is then divided by 880 for an MDF fee of $19,188
and a CMO fee of $12,792.
IV. Fee Schedule for FY 2026
The fee rates for FY 2026 are displayed in table 4.
Table 4--Fee Schedule for FY 2026
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FY 2026 fee
Fee category rates
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MDF..................................................... $19,188
CMO..................................................... 12,792
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V. Electronic Federal Payment Methods
The new facility fee rates are for the period from October 1, 2025,
through September 30, 2026. 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>, and generate a unique user
fee identification (ID) number or use the OMUFA FY 2026 Facility Fee
Invoice that is issued by the Agency in April 2026.\11\
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\11\ The unique user fee identification (ID) number is also
referred to as Payment Identification Number (PIN) in OMUFA
coversheet creation instructions; these terms are used
interchangeably. See <a href="https://userfees.fda.gov/OA_HTML/OMUFAFacilityFeeCoverSheetCreationProcess.pdf">https://userfees.fda.gov/OA_HTML/OMUFAFacilityFeeCoverSheetCreationProcess.pdf</a>.
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Payments made to FDA must be made in U.S. currency drawn on a U.S.
bank by electronic check, credit card, or wire transfer. The preferred
method for payments to FDA is online using electronic check (Automated
Clearing House (ACH), also known as eCheck) or credit card (Discover,
VISA, MasterCard, American Express). FDA has partnered with the U.S.
Department of the Treasury to utilize <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 upon receipt of an invoice or after
completing the User Fee Cover Sheet and generating the user fee ID
number. Secure electronic payments to FDA 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; no partial payments can be made online).
Once an invoice or cover sheet 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 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
or invoice number to ensure that the payment is applied to the correct
fee(s). Without the unique user fee ID or invoice number, the payment
may not be applied. The originating financial institution may charge a
wire transfer fee. Include applicable wire transfer fees with payment
to ensure fees are fully paid. Questions about wire transfer fees
should be addressed to the financial institution. The following account
information should be used to send payments by wire transfers: U.S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Account No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33.
FDA's tax identification number is 53-0196965. If a fee is not paid
in full, the fee will be treated as a claim of the U.S. Government (see
section 744M(g) of the FD&C Act and 45 CFR part 30), meaning the
invoice balance due amount is referred to collection.
If you are assessed an FY 2026 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#ce8d8a8b9c8da1a2a2abadbaa7a1a0bd8ea8aaafe0a6a6bde0a9a1b8"><span class="__cf_email__" data-cfemail="9bd8dfdec9d8f4f7f7fef8eff2f4f5e8dbfdfffab5f3f3e8b5fcf4ed">[email protected]</span></a>.
Grace Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-05276 Filed 3-17-26; 8:45 am]
BILLING CODE 4164-01-P
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