Home/Federal/Federal Register/2025-14417

Notice2025-14417

Animal Drug User Fee Rates and Payment Procedures 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

July 30, 2025

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2026 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2026.

Full Text

<html>
<head>
<title>Federal Register, Volume 90 Issue 144 (Wednesday, July 30, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 144 (Wednesday, July 30, 2025)]
[Notices]
[Pages 35883-35889]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14417]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-2488]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2026

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the fee rates and payment procedures for fiscal year (FY)
2026 animal drug user fees. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023
(ADUFA V), authorizes FDA to collect user fees for certain animal drug
applications and supplemental animal drug applications, for certain
animal drug products, for certain establishments where such products
are made, and for certain sponsors of such animal drug applications
and/or investigational animal drug submissions. This notice establishes
the fee rates for FY 2026.

DATES: The application fee rates apply to applications submitted on or
after October 1, 2025, and will remain in effect through September 30,
2026.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at: <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa</a>. For general questions, you may also email FDA's Center for
Veterinary Medicine (CVM) at: <a href="/cdn-cgi/l/email-protection#1172677c7075647770517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="7013061d1114051611301614115e1818035e171f06">[email&#160;protected]</span></a>. For questions
relating to this notice: UFFS, Office of Financial Management, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993;
or email the User Fee Support Staff at <a href="/cdn-cgi/l/email-protection#1540534646557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="1a4f5c49495a7c7e7b34727269347d756c">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

Section 740(a) of the FD&C Act (21 U.S.C. 379j-12), as amended by
ADUFA V, establishes four different types of user fees: (1) fees for
certain animal drug applications and supplemental animal drug
applications; (2) annual fees for certain animal drug products; (3)
annual fees for certain establishments where such products are made;
and (4) annual fees for certain sponsors of animal drug applications
and/or investigational animal drug submissions. When certain conditions
are met, FDA will waive or reduce fees per section 740(d) of the FD&C
Act.
For FYs 2024 through 2028, section 740(b)(1) of the FD&C Act
establishes the base revenue amount for each fiscal year. Per section
740(c)(2) and (3) of the FD&C Act, the base revenue amounts established
for fiscal years after FY 2024 are subject to adjustment for inflation
and workload. Beginning in FY 2025, the annual fee revenue amount is
also subject to an operating reserve adjustment to allow FDA to adjust
the fee revenue amount to maintain a specified operating reserve of
carryover user fees, per section 740(c)(4) of the FD&C Act. FDA may
increase the fee revenue amount to maintain a 12-week minimum. If FDA
has an excess operating reserve, FDA will decrease the fee revenue
amount so that FDA has 22 weeks of operating reserve for FY 2025, 20
weeks for FY 2026, 18 weeks for FY 2027, and 16 weeks for FY 2028.
Per section 740(b)(2) of the FD&C Act, fees for applications,
establishments, products, and sponsors are to be established each year
by FDA so that the percentages of the total revenue that are derived
from each type of user fee will be as follows: (1) revenue from
application fees shall be 20 percent of total fee revenue; (2) revenue
from product fees shall be 27 percent of total fee revenue; (3) revenue
from establishment fees shall be 26 percent of total fee revenue; and
(4) revenue from sponsor fees shall be 27 percent of total fee revenue.
The target revenue amounts for each fee category for FY 2026 are as
follows: for application fees, the target revenue amount is $7,230,400;
for product fees, the target revenue amount is $9,761,040; for
establishment fees, the target revenue amount is $9,399,520; and for
sponsor fees, the target revenue amount is $9,761,010.
For FY 2026, the animal drug user fee rates are: (1) $708,863 for
an animal drug application; (2) $354,431 for a supplemental animal drug
application for which safety or effectiveness data are required, for an
animal drug application subject to the criteria set forth in section
512(d)(4) of the FD&C Act (21 U.S.C. 360b), and for an application for
conditional approval under section 571 of the FD&C Act (21 U.S.C.
360ccc) for which an animal drug application submitted under section
512(b)(1) of the FD&C Act has been previously approved under section
512(d)(1) of the FD&C Act for another intended use; (3) $13,463 for the
annual product fee; (4) $200,000 for the annual establishment fee; and
(5) $165,441 for the annual sponsor fee. FDA will issue invoices for FY
2026 product, establishment, and sponsor fees by December 31, 2025, and
payment will be due by January 31, 2026. The application fee rates are
effective for applications submitted on or after October 1, 2025, and
will remain in effect through September 30, 2026. Applications will not
be accepted for review until FDA has received full payment of
application fees and any other animal drug user fees owed under the
ADUFA program.

II. Fee Revenue Amount for FY 2026

A. Statutory Fee Revenue Amounts

Section 740(b)(1) of the FD&C Act specifies that the base fee
revenue amount for FY 2026 for all animal drug user fee categories
totals $33,500,000.

B. Inflation Adjustment to Fee Revenue Amount

Section 740(c)(2)(A)(ii) and (iii) of the FD&C Act specifies that
the annual fee revenue amount is to be adjusted for inflation increases
for FY 2025 and subsequent fiscal years using two separate adjustments:
one for personnel compensation and benefits (PC&B) and one for non-PC&B
costs. Section 740(c)(2)(A)(ii) of the FD&C Act

[[Page 35884]]

specifies the component of the inflation adjustment for payroll costs
shall be one plus the average annual percent change in the cost of all
PC&B paid per full-time equivalent position (FTE) at FDA for the first
3 of the 4 preceding fiscal years of available data, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years of available data. The data on total PC&B
paid and numbers of FTE paid, from which the average cost per FTE can
be derived, are published in FDA's Justification of Estimates for
Appropriations Committees.
Table 1 summarizes the total PC&B cost per FTE for the specified
fiscal years, provides the percent change from the previous fiscal
year, and provides the average percent change over the first 3 of the 4
fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.

Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percentage Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2022 2023 2024 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $3,165,477,000 $3,436,513,000 $3,791,729,000 .................
Total FTEs.......................... 18,474 18,729 19,687 .................
PC&B per FTE........................ $171,348 $183,486 $192,601 .................
Percentage Change from Previous Year 4.2967% 7.0838% 4.9677% 5.4494%
----------------------------------------------------------------------------------------------------------------

Section 740(c)(2)(A)(ii) of the FD&C Act specifies that this 5.4494
percent should be multiplied by the proportion of PC&B costs to total
FDA costs for the first 3 of the preceding 4 fiscal years for which
data are available. Table 2 shows the amount of PC&B and the total
amount obligated by FDA for the same 3 fiscal years.

Table 2--PC&B as a Percent of Total Cost at FDA
----------------------------------------------------------------------------------------------------------------
Fiscal year 2022 2023 2024 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $3,165,477,000 $3,436,513,000 $3,791,729,000 .................
Total Costs......................... $6,251,981,000 $6,654,058,000 $6,976,495,000 .................
PC&B percent........................ 50.6316% 51.6454% 54.3501% 52.2090%
----------------------------------------------------------------------------------------------------------------

The portion of the inflation adjustment relating to payroll costs
is 5.4494 percent multiplied by 52.2090 percent, or 2.8451 percent.
Section 740(c)(2)(A)(iii) of the FD&C Act specifies that the
portion of the inflation adjustment for non-payroll costs is the
average annual percent change that occurred in the Consumer Price Index
(CPI) (Washington-Arlington-Alexandria, DC-VA-MD-WV; not seasonally
adjusted; all items less food and energy; annual index) for the first 3
years of the preceding 4 years of available data multiplied by the
average proportion of all costs other than PC&B costs to total FDA
costs for the first 3 years of the preceding 4 fiscal years. Table 3
provides the summary data for the percent change in the specified CPI
for the Washington-Arlington-Alexandria area. The data from the Bureau
of Labor Statistics are shown in table 3.\1\
---------------------------------------------------------------------------

\1\ The data is published by the Bureau of Labor Statistics and
can be found on its website at: <a href="https://data.bls.gov/timeseries/CUURS35ASA0L1E">https://data.bls.gov/timeseries/CUURS35ASA0L1E</a>.

Table 3--Annual and 3-Year Average Percentage Change in CPI (Less Food and Energy) for Washington-Arlington-
Alexandria Area
----------------------------------------------------------------------------------------------------------------
Fiscal year 2022 2023 2024 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 302.608 313.315 324.560 4.1709%
Annual Percent Change............... 5.3855% 3.5382% 3.5890%
----------------------------------------------------------------------------------------------------------------

Section 740(c)(2)(A)(iii) of the FD&C Act specifies to calculate
the inflation adjustment for non-payroll costs, we multiply 4.1709
percent by the average proportion of all costs other than PC&B to total
FDA costs for the first 3 years of the preceding 4 fiscal years. Since
52.2090 percent was obligated for PC&B as shown in table 2, 47.7910
percent is the portion of costs other than PC&B (100 percent minus the
PC&B percentage of 52.2090). The portion of the inflation adjustment
relating to non-payroll costs is 4.1709 percent multiplied by 47.7910
percent, or 1.9933 percent.
Next, we add the payroll component (2.8451percent) to the non-
payroll component (1.9933 percent), for an inflation adjustment of
4.8384 percent for FY 2026.
Section 740(c)(2)(B) of the FD&C Act provides for the inflation
adjustment to be compounded each fiscal year after FY 2025. The
inflation adjustment for FY 2026 (4.8384 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2025 (1.0393), which equals 1.0896 (rounded) (1.0393 multiplied
by 1.048384). We then multiply the base revenue amount for FY 2026
($33,500,000) by 1.0896, yielding an inflation adjusted amount of
$36,502,505.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

Section 740(c)(3)(A) of the FD&C Act specifies that the annual fee
revenue amounts in ADUFA V for FY 2025 and subsequent fiscal years are
subject to adjustment to account for changes in FDA's review workload.
The workload adjustment will be applied to the inflation adjusted fee
revenue amount.
To determine whether a workload adjustment applies, per ADUFA V

[[Page 35885]]

commitments FDA calculates the weighted average of the change in the
total number of each of the five types of applications and submissions
specified in the workload adjustment provision (animal drug
applications, supplemental animal drug applications for which data with
respect to safety or efficacy are required, manufacturing supplemental
animal drug applications, investigational animal drug study
submissions, and investigational animal drug protocol submissions)
received over the 5-year period that ended on September 30, 2024 (the
base years; 2020 through 2024), and the average number of each of these
types of applications and submissions over the most recent 5-year
period that ended April 30, 2025.
The results of these calculations are presented in the first two
columns of table 4. Column 3 reflects the percent change in workload
over the two 5-year periods. Column 4 shows the weighting factor for
each type of application/submissions, reflecting how much of the total
FDA animal drug review workload was accounted for by each type of
application or submission in the table during the most recent 5 years.
Column 5 is the weighted percent change in each category of workload
and was derived by multiplying the weighting factor in each line in
column 4 by the percent change from the base years in column 3. At the
bottom right of the table, the sum of the values in column 5 is
calculated, reflecting a total change in workload of negative 3.4253
percent for FY 2025. This is the workload adjuster for FY 2026.

Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application type 5-Year Weighted
average (base Latest 5-year Percent change Weighting percent
years) average factor change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Application 12.40 11.40 -8.0645 0.0408 -0.3290
(NADAs)........................
Supplemental NADAs With Safety 7.20 8.00 11.1111 0.0311 0.3453
or Efficacy Data...............
Manufacturing Supplements....... 377.80 351.0 -7.0937 0.2171 -1.5398
Investigational Study 150.40 149.2 -0.7979 0.5882 -0.4693
Submissions....................
Investigational Protocol 163.00 144.0 -11.6564 0.1229 -1.4324
Submissions....................
FY 2026 ADUFA V Workload .............. .............. .............. .............. -3.4253
Adjuster.......................
----------------------------------------------------------------------------------------------------------------

Section 740(c)(3)(B) of the FD&C Act specifies that under no
circumstances shall the workload adjustment result in fee revenues that
are less than the base fee revenues for that fiscal year as adjusted
for inflation. Additionally, section 740(c)(3)(A)(ii) states that the
workload adjuster must be greater than 3 percent for a second fiscal
year within ADUFA V before FDA can add the adjustment to the target
revenue. For FY 2026 the workload adjuster is below the 3 percent
statute threshold, therefore no workload adjustment shall be applied.

D. Operating Reserve Adjustment to Inflation and Workload Adjusted Fee
Revenue Amount

Section 740(c)(4)(A) of the FD&C Act specifies that for FY 2026,
after the fee revenue amount established under section 740(b) of the
FD&C Act is adjusted for inflation and workload, the Secretary shall
increase the fee revenue amount for such fiscal year, if necessary to
provide an operating reserve of not less than 12 weeks or decrease the
fee revenue amount for such fiscal year, if necessary to provide for
not more than 20 weeks of operating reserves.
To determine the dollar amounts for the 12-week and 20-week
operating reserve thresholds, we divide the adjusted annual fee revenue
amount ($36,502,505) by 52 weeks to generate a 1-week operating reserve
amount of $701,971. The 1-week operating reserve amount is then
multiplied by 12 and 20. This results in a 12-week minimum threshold of
$8,423,544 and a 20-week maximum threshold of $14,039,420.
To estimate the FY 2025 end-of-year operating reserve of carryover
user fees, the Agency projected the user fee carryover amount at the
end of July 2025 using forecasted obligations, collections, and
estimated recoveries but not including carryover use fees that have not
been appropriated. The operating reserve of carryover user fees is
projected to be $14,390,059 or 20.50 weeks ($14,390,059 divided by
$701,971).
Because the estimated FY 2025 end-of-year operating reserve of
carryover user fees is not below the 12-week threshold amount of
$8,423,544, FDA will not increase the fee revenue amount and fees for
FY 2026.
However, because the estimated FY 2025 end-of-year operating
reserve of carryover user fees of $14,390,059 exceeds the 20-week
threshold of $14,039,420, FDA will apply an operating reserve
adjustment of $350,639 to decrease the fee revenue and fees for FY
2026.
With respect to target revenue for FY 2026, subtracting the
operating reserve adjustment amount of $350,639 from the adjusted fee
revenue amount of $36,502,505 results in a total target revenue amount
of $36,152,000 (rounded) for FY 2026.

E. FY 2026 Fee Revenue Amounts

The fee revenue amount for FY 2026 is $36,152,000. Section
740(b)(2) of the FD&C Act specifies that this revenue amount is to be
divided as follows: 20 percent, or a total of $7,260,400 is to come
from application fees; 27 percent, or a total of $9,761,040, is to come
from product fees; 26 percent, or a total of $9,399,520 is to come from
establishment fees; and 27 percent, or a total of $9,761,040 is to come
from sponsor fees.

III. Animal Drug Application Fee Calculations for FY 2026

A. Application Fee Revenues and Numbers of Fee-Paying Applications

Section 740(a)(1)(A) of the FD&C Act states that each person that
submits an animal drug application or a supplemental animal drug
application shall be subject to an application fee, with limited
exceptions. The term ``animal drug application'' means an application
for approval of any new animal drug submitted under section 512(b)(1)
of the FD&C Act or an application for conditional approval of a new
animal drug submitted under section 571 of the FD&C Act. A
``supplemental animal drug application'' is defined as a request to FDA
to approve a change in an approved animal drug application, or a
request to FDA to approve a change to an application approved under
section 512(c)(2) of the FD&C Act for which data with respect to safety
or effectiveness are required. Such applications are subject to ADUFA
fees,

[[Page 35886]]

except those fees may be waived under the circumstances described in
section 740(d)(1)(D) and 740(i) of the FD&C Act.
Furthermore, ADUFA V continues to provide an exception from
application fees for animal drug applications submitted under section
512(b)(1) of the FD&C Act by a sponsor who previously applied for
conditional approval under section 571 of the FD&C Act for the same
product and paid an application fee at the time they applied for
conditional approval. The purpose of this exception is to prevent
sponsors of conditionally approved products from having to pay a second
application fee at the time they apply for full approval of their
products under section 512(b)(1) of the FD&C Act, provided the
sponsor's application for full approval is filed consistent with the
timeframes established in section 571(h) of the FD&C Act.
The application fees are to be set so that they will generate
$7,230,400 in fee revenue for FY 2026. The fee for a supplemental
animal drug application for which safety or effectiveness data are
required, for an animal drug application subject to criteria set forth
in section 512(d)(4) of the FD&C Act, and for an application for
conditional approval under section 571 of the FD&C Act of a new animal
drug for which an animal drug application submitted under section
512(b)(1) of the FD&C Act has been previously approved under section
512(d)(1) for another intended use is to be set at 50 percent of the
animal drug application fee.
To set animal drug application fees and supplemental animal drug
application fees to realize $7,230,400, FDA must first make some
assumptions about the number of fee-paying applications and
supplemental applications the Agency will receive in FY 2026.
The Agency knows the number of applications that have been
submitted in previous fiscal years. That number fluctuates annually. In
estimating the fee revenue to be generated by animal drug application
fees in FY 2026, FDA is assuming that the number of applications for
which fees will be paid in FY 2026 will equal the average number of
applications over the five most recently completed fiscal years of the
ADUFA program (FY 2020 to FY 2024).
Over the 5 most recently completed fiscal years, the average number
of animal drug applications subject to the full fee was 5.80. Over this
same period, the average number of supplemental applications for which
safety or effectiveness data are required, applications subject to the
criteria set forth in section 512(d)(4) of the FD&C Act, and
applications for conditional approval of a new animal drug for which a
section 512(b)(1) application has been previously approved for another
intended use subject to half of the full fee was 8.80.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 10.20 fee-paying animal drug applications in FY 2026
(5.80 applications paying a full fee and 8.80 applications paying a
half fee).

B. Application Fee Rates for FY 2026

FDA must set the fee rates for FY 2026 so that the estimated 10.20
applications that pay the fee will generate a total of $7,230,400. To
generate this amount, the fee for an animal drug application, rounded
to the nearest dollar, will have to be $708,863, and the fee for a
supplemental animal drug application for which safety or effectiveness
data are required, for applications subject to the criteria set forth
in section 512(d)(4) of the FD&C Act, and for an application for
conditional approval under section 571 of the FD&C Act of a new animal
drug for which an animal drug application submitted under section
512(b)(1) of the FD&C Act has been previously approved under section
512(d)(1) for another intended use will have to be $354,431.

IV. Animal Drug Product Fee Calculations for FY 2026

A. Product Fee Revenues and Numbers of Fee-Paying Products

Section 740(a)(2) of the FD&C Act specifies that the animal drug
product fee must be paid annually by the person named as the applicant
in a new animal drug application or supplemental new animal drug
application for an animal drug product submitted for listing under
section 510 of the FD&C Act (21 U.S.C. 360) and who had an animal drug
application or supplemental animal drug application pending at FDA
after September 1, 2003. The term ``animal drug product'' means each
specific strength or potency of a particular active ingredient or
ingredients in final dosage form marketed by a particular manufacturer
or distributor, which is uniquely identified by the labeler code and
product code portions of the National Drug Code, and for which an
animal drug application or a supplemental animal drug application has
been approved (see section 739(3) of the FD&C Act). The product fees
are to be set so that they will generate $9,761,040 in fee revenue for
FY 2026.
To set animal drug product fees to realize $9,761,040, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2026. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an animal drug
application or a supplemental animal drug application pending after
September 1, 2003. As of May 2025, FDA estimates that there are 740
products submitted for listing by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA estimates that a total of 740
products will be subject to this fee in FY 2026.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2026, FDA is assuming that 2 percent of the products
invoiced, or 15, will not pay fees in FY 2026, due to fee waivers and
reductions. FDA has made this estimate at 2 percent this year, based on
historical data over the past 5 completed fiscal years of the ADUFA
program.
Accordingly, the Agency estimates that a total of 725 (740 minus
15) products will be subject to product fees in FY 2026.

B. Product Fee Rates for FY 2026

FDA must set the fee rates for FY 2026 so that the estimated 725
products for which fees are paid will generate a total of $9,761,040.
To generate this amount will require the fee for an animal drug
product, rounded to the nearest dollar, to be $13,463.

V. Animal Drug Establishment Fee Calculations for FY 2026

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

Section 740(a)(3) of the FD&C Act states that the animal drug
establishment fee must be paid annually by the person who: (1) owns or
operates, directly or through an affiliate, an animal drug
establishment; (2) is named as the applicant in an animal drug
application or supplemental animal drug application for an animal drug
product submitted for listing under section 510 of the FD&C Act; (3)
had an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003; and (4) whose establishment
engaged in the manufacture of the animal drug product during the fiscal
year. An establishment subject to animal drug establishment fees is
assessed only one such fee per fiscal year. The term ``animal drug
establishment'' is defined as a foreign or domestic place of business
at one general physical

[[Page 35887]]

location, consisting of one or more buildings, all of which are within
5 miles of each other, at which one or more animal drug products are
manufactured in final dosage form (see section 739(4) of the FD&C Act).
The establishment fees are to be set so that they will generate
$9,399,520 in fee revenue for FY 2026.
To set animal drug establishment fees to realize $9,399,520, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2026. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplemental animal drug application
pending after September 1, 2003. As of May 2025, FDA estimates that
there are a total of 50 establishments owned or operated by persons who
had an animal drug application or supplemental animal drug application
pending after September 1, 2003. Based on this, FDA believes that 50
establishments will be subject to this fee in FY 2026.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2026, FDA is assuming that 6 percent of the
establishments invoiced, or three, will not pay fees in FY 2026 due to
fee waivers and reductions. FDA has made this estimate at 6 percent
this year, based on historical data over the past 5 completed fiscal
years.
Accordingly, the Agency estimates that a total of 47 establishments
(50 minus 3) will be subject to establishment fees in FY 2026.

B. Establishment Fee Rates for FY 2026

FDA must set the fee rates for FY 2026 so that the fees paid for
the estimated 47 establishments will generate a total of $9,399,520. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $200,000.

VI. Animal Drug Sponsor Fee Calculations for FY 2026

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

The animal drug sponsor fee must be paid annually by each person
who: (1) is named as the applicant in an animal drug application,
except for an approved application for which all subject products have
been removed from listing under section 510 of the FD&C Act, or has
submitted an investigational animal drug submission that has not been
terminated or otherwise rendered inactive and (2) had an animal drug
application, supplemental animal drug application, or investigational
animal drug submission pending at FDA after September 1, 2003 (see
sections 739(6) and 740(a)(4) of the FD&C Act). An animal drug sponsor
is subject to only one such fee each fiscal year (see Sec. 740(a)(4)
of the FD&C Act). The sponsor fees are to be set so that they will
generate $9,761,040 in fee revenue for FY 2026.
To set animal drug sponsor fees to realize $9,761,040, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2026. FDA developed data on all animal drug sponsors and
matched this to the list of all sponsors who had pending submissions
and applications after September 1, 2003. As of May 2024, FDA estimates
that a total of 189 sponsors will meet this definition in FY 2026.
In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2026, FDA is assuming that 69 percent of the
sponsors invoiced, or 130, will not pay sponsor fees in FY 2026 due to
fee waivers and reductions. FDA has made this estimate at 69 percent
this year, based on historical data over the past 5 completed fiscal
years of the ADUFA program.
Accordingly, the Agency estimates that a total of 59 sponsors (189
minus 130) will be subject to and pay sponsor fees in FY 2026.

B. Sponsor Fee Rates for FY 2026

FDA must set the fee rates for FY 2026 so that the estimated 59
sponsors that pay fees will generate a total of $9,761,040. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest dollar, to be $165,441.

VII. Fee Schedule for FY 2026

The fee rates for FY 2026 are summarized in table 5.

Table 5--FY 2026 Fee Rates
------------------------------------------------------------------------
Fee rate for
Animal drug user fee category FY 2026
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application $708,863
Supplemental Animal Drug Application for Which 354,431
Safety or Effectiveness Data are Required,
Animal Drug Application Subject to the Criteria Set
Forth in Section 512(d)(4) of the FD&C Act, or
Application for Conditional Approval Under Section
571 of the FD&C Act for Which an Animal Drug
Application Submitted Under Section 512(b)(1) of
the FD&C Act Has Been Previously Approved Under
Section 512(d)(1) for Another Intended Use
Animal Drug Product Fee................................. 13,463
Animal Drug Establishment Fee \1\....................... 200,000
Animal Drug Sponsor Fee \2\............................. 165,441
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
year.

VIII. Fee Waiver or Reduction; Exemption From Fees

The types of fee waivers, fee reductions, and exemptions from fees
that applied during ADUFA IV still exist in ADUFA V, with one
exception. After September 30, 2023, there is no longer an exemption
for any person who submits to CVM a supplemental animal drug
application relating to a new animal drug application approved under
section 512 of the FD&C Act, solely to add the application number to
the labeling of the drug in the manner specified in section 503(w) of
the FD&C Act.
Remaining waivers and reductions apply for the following: barriers
to innovation; where fees will exceed the cost to review the animal
drug application; if the application is related to certain free-choice
medicated feeds; if the application is solely for a MUMS indication; or
if the sponsor is a small business submitting its first animal drug
application. See section 740(d)(1) of the FD&C Act.

[[Page 35888]]

A. Barrier to Innovation Waivers or Fee Reductions

Under section 740(d)(1)(A) of the FD&C Act, an animal drug
applicant may qualify for a waiver or reduction of one or more ADUFA
fees if the fee would present a significant barrier to innovation
because of limited resources available to the applicant or other
circumstances. CVM's guidance for industry (GFI) #170, entitled
``Animal Drug User Fees and Fee Waivers and Reductions,'' \2\ states
that the Agency interprets this provision to mean that a waiver or
reduction is appropriate when: (1) the product for which the waiver is
being requested is innovative, or the requestor is otherwise pursuing
innovative animal drug products or technology and (2) the fee would be
a significant barrier to the applicant's ability to develop,
manufacture, or market the innovative product or technology. Only those
applicants that meet both criteria will qualify for a waiver or
reduction in user fees under this provision (see GFI #170 at pp. 6-8).
For purposes of determining whether the second criterion would be met
based on limited financial resources available to the applicant, FDA
has determined an applicant with financial resources of less than
$20,000,000 (including the financial resources of the applicant's
affiliates), adjusted annually for inflation, has limited resources
available. Using the CPI for urban consumers (U.S. city average; not
seasonally adjusted; all items; annual index), the inflation-adjusted
level for FY 2026 will be $24,384,000; this level represents the
financial resource ceiling that will be used to determine if there are
limited resources available to an applicant requesting a Barrier to
Innovation waiver on financial grounds for FY 2026. Requests for a
waiver must be submitted in writing to FDA each fiscal year not later
than 180 days from when the fees are due. A waiver granted on Barrier
to Innovation grounds (or any of the other grounds listed in section
740(d)(1) of the FD&C Act) is only valid for one fiscal year. If a
sponsor is not granted a waiver, they are liable for the fees.
---------------------------------------------------------------------------

\2\ CVM's GFI #170 is located at: <a href="https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf">https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf</a>.
---------------------------------------------------------------------------

B. Exemption or Exception From Fees

In addition to the waivers and fee reductions described above, one
fee exemption and two exceptions still apply in ADUFA V.
If an animal drug application, supplemental animal drug
application, or investigational submission involves the intentional
genomic alteration of an animal that is intended to produce a human
medical product, any person who is the named applicant or sponsor of
that application or submission will not be subject to sponsor, product,
or establishment fees under ADUFA based solely on that application or
submission (see section 740(d)(4) of the FD&C Act).
There is an exception from application fees for animal drug
applications submitted under section 512(b)(1) of the FD&C Act by a
sponsor who previously applied for conditional approval under section
571 of the FD&C Act for the same product and paid an application fee at
the time they applied for conditional approval, provided the sponsor
has submitted the application under section 512(b)(1) of the FD&C Act
within the timeframe specified in section 571(h) of the FD&C Act. There
is also an exception from application fees for previously filed
applications that were not approved or were withdrawn (without waiver
or refund). Both exceptions are detailed in section 740(a)(1)(C) of the
FD&C Act.

IX. Procedures for Paying the FY 2026 Fees

A. Application Fees and Payment Instructions

The FY 2026 fee established in the new fee schedule must be paid
for an animal drug application or supplement subject to fees under
ADUFA V that is submitted on or after October 1, 2025. 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.\3\ 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.
---------------------------------------------------------------------------

\3\ See ``Change in Federal Payment and Collection Options''
announcement published in the Federal Register on June 27, 2025 (90
FR 27639).
---------------------------------------------------------------------------

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. If a fee is not paid in full, the fee will be
treated as a claim of the U.S. Government (see section 740(h) of the
FD&C Act), meaning the invoice balance due amount must be referred to
collections. 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 transfer: U.S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, account number: 75060099, routing number: 021030004, SWIFT:
FRNYUS33. FDA's tax identification number is 53-0196965.
It is important that the fee arrives at the bank at least a day or
two before the application arrives at FDA's CVM. FDA records the
official application receipt date as the later of the following: the
date the application was received by CVM, or the date U.S. Bank
notifies FDA that your payment in the full amount has been received, or
when the U.S. Department of the Treasury notifies FDA of receipt of an
electronic or wire transfer payment. U.S. Bank and the U.S. Department
of the Treasury are required to notify FDA within 1 working day, using
the PIN described previously. The tax identification number of FDA is
53-0196965.

B. Application Cover Sheet Procedures

Step One: Create a user account and password. Log on to the ADUFA
website at <a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet</a> and, under Application Submission
Information, click on ``Create ADUFA User Fee Cover Sheet.'' For
security reasons, each firm applying will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
Step Two: Create an Animal Drug User Fee Cover Sheet, transmit it
to the

[[Page 35889]]

FDA, and print a copy. After logging into your account with your
username and password, complete the steps required to create an Animal
Drug User Fee Cover Sheet. One cover sheet is needed for each animal
drug application or supplement. Once you are satisfied that the data on
the cover sheet is accurate and you have finalized the cover sheet, you
will be able to transmit it electronically to the FDA and you will be
able to print a copy of your cover sheet showing your unique PIN.
Step Three: Send the payment for your application as described in
section IX.A above.
Step Four: Submit your application.

C. Product, Establishment, and Sponsor Fees

By December 31, 2025, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2026
using this fee schedule. Payment will be due by January 31, 2026. FDA
will issue invoices in November 2026 for any products, establishments,
and sponsors subject to fees for FY 2026 that qualify for fees after
the December 2025 billing.

Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14417 Filed 7-29-25; 8:45 am]
BILLING CODE 4164-01-P

</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on July 30, 2025.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.