Notice2025-14409
Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2026
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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 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2026.
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[Federal Register Volume 90, Number 144 (Wednesday, July 30, 2025)]
[Notices]
[Pages 35889-35894]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14409]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2355]
Animal Generic Drug User Fee Program Rates and Payment Procedures
for Fiscal Year 2026
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 fee rates and payment procedures for fiscal year (FY)
2026 generic new animal drug program user fees. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User
Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees
for certain abbreviated applications for generic new animal drugs, for
certain generic new animal drug products, for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs (JINADs), and
for certain submissions related to JINAD files. This notice establishes
the fee rates for FY 2026.
DATES: The application fee rates are effective for all abbreviated
applications for a generic new animal drug submitted on or after
October 1, 2025, and will remain in effect through September 30, 2026.
The fee rates for requests to establish a JINAD file, and for certain
submissions to JINAD files established prior to October 1, 2023, are
effective on 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-generic-drug-user-fee-act-agdufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa</a>. For general questions, email FDA's Center for
Veterinary Medicine (CVM) at: <a href="/cdn-cgi/l/email-protection#6b081d060a0c0f1e0d0a2b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="0f6c79626e686b7a696e4f696b6e2167677c21686079">[email 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#3267747461725456531c5a5a411c555d44"><span class="__cf_email__" data-cfemail="edb8ababbead8b898cc385859ec38a829b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 741(a) of the FD&C Act (21 U.S.C. 379j-21(a)), establishes
four different types of generic new animal drug user fees: (1) fees for
certain abbreviated applications for generic new animal drugs; (2)
annual fees for certain generic new animal drug products; (3) annual
fees for certain sponsors of abbreviated applications for generic new
animal drugs and/or investigational submissions for generic new animal
drugs; and (4) JINAD file fees. When certain conditions are met,
section 741(d) of the FD&C Act authorizes FDA to waive or reduce fees
for generic new animal drugs intended solely to provide for a minor use
or minor species indication.
Section 741(b)(1) of the FD&C Act establishes a base revenue amount
for each fiscal year. Per section 741(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 FY 2026,
the annual fee revenue amounts are also subject to adjustment to reduce
workload-based increases by the amount of certain excess collections.
Section 741(b) of the FD&C Act establishes fees each year so that the
percentage allocations for each of the fee categories is as follows: 20
percent shall be derived from fees for abbreviated applications for a
generic new animal drug and JINAD file fees; 40 percent shall be
derived from fees for generic new animal drug products; and 40 percent
shall be derived from fees for generic new animal drug sponsors. The
target revenue amounts for each fee category for FY 2026 are as
follows: for application and/or JINAD file fees, the target revenue
amount is $5,448,200; for product fees, the target revenue amount is
$10,896,400; and for sponsor fees, the target revenue amount is
$10,896,400.
For FY 2026, the AGDUFA rates are: $137,853 for each abbreviated
application for a generic new animal drug other than those subject to
the criteria in section 512(d)(4) of the FD&C Act (21 U.S.C.
360b(d)(4)); $68,927 for each abbreviated application for a generic new
animal drug subject to the criteria in section 512(d)(4) of the FD&C
Act; $50,000 for each JINAD file request or certain submissions to
established JINAD files; $16,119 for each generic new animal drug
product; $261,618 for each generic new animal drug sponsor paying 100
percent of the sponsor fee; $196,214 for each generic new animal drug
sponsor paying 75 percent of the sponsor fee; and $130,809 for each
generic new animal drug sponsor paying 50 percent of the sponsor fee.
FDA will issue invoices for FY 2026 product and sponsor fees by
December 31, 2025, and payment will be due by January 31, 2026. The
application fee rates are effective for all abbreviated applications
for a generic new animal drug submitted on or after October 1, 2025,
and will remain in effect through September 30, 2026. The fee rate for
requests to establish a JINAD file, and for certain submissions to
JINAD files established prior to October 1, 2023, is effective on
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 fees owed under the
AGDUFA program. Similarly, a request to establish a JINAD file or a
submission to an existing JINAD file will not be accepted for action by
FDA until FDA has received full payment of all fees owed under the
AGDUFA program.
II. Fee Revenue Amount for FY 2026
A. Statutory Fee Revenue Amounts
Section 741(b)(1) of the FD&C Act specifies that the base fee
revenue amount for FY 2026 for all generic animal drug user fee
categories totals $25,000,000.
B. Inflation Adjustment to Fee Revenue Amount
Section 741(c)(2)(A) of the FD&C Act specifies that the annual fee
revenue amount is to be adjusted for inflation
[[Page 35890]]
increases for FY 2025 and subsequent fiscal years using two separate
factors--one for personnel compensation and benefits (PC&B) costs and
one for non-PC&B costs.
Section 741(c)(2)(A)(ii) of the FD&C Act 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, per full-time
equivalent (FTE) position of FDA, for the first 3 of the preceding 4
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 costs per FTE for the specified
fiscal years, provides the percentage change from the previous fiscal
year, and provides the average percentage 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 Percent 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
Percent Change from Previous Year... 4.2967% 7.0838% 4.9677% 5.4494%.
----------------------------------------------------------------------------------------------------------------
Section 741(c)(2)(A)(ii) of the FD&C Act specifies that the 5.4494
percent should be multiplied by the average 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 costs obligated by FDA for the same 3 fiscal years.
Table 2--PC&B as a Percent of Total Cost
----------------------------------------------------------------------------------------------------------------
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%
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The portion of the inflation adjustment relating to payroll costs
is 5.4494 percent multiplied by 52.2090 percent, or 2.8451 percent.
Section 741(c)(2)(A)(iii) of the FD&C Act specifies that the non-
payroll costs adjustment factor is calculated by multiplying the
average annual percentage change that occurred in the Consumer Price
Index for Urban Consumers (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
by the average proportion of all non-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 percentage change in the specified CPI for the
Washington-Arlington-Alexandria area.\1\
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\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 Percent 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 .................
Annual Percent Change............... 5.3855% 3.5382% 3.5890% 4.1709%
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Section 741(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 (2.8451 percent) to the non-
payroll component (1.9933 percent), for an inflation adjustment of
4.8384 percent for FY 2026.
Section 741(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 (1.03934), which equals 1.0896 (rounded) (1.0896 x 1.0). We
then multiply the base revenue amount for FY 2026 ($25,000,000) by
1.0896, yielding an inflation adjusted amount of $27,240,675
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
Section 741(c)(3)(A) of the FD&C Act specifies that fee revenue
amounts for
[[Page 35891]]
FY 2025 and subsequent fiscal years are subject to adjustment to
account for changes in FDA's review workload. The workload adjustment
would be applied to the inflation adjusted fee revenue amount.
To determine whether a workload adjustment applies, per AGDUFA IV
commitments FDA calculates the weighted average of the change in the
total number of each of the six types of applications and submissions
specified in the workload adjustment provision (abbreviated
applications for generic new animal drugs, manufacturing supplemental
abbreviated applications for generic new animal drugs, investigational
generic new animal drug study submissions, investigational generic new
animal drug protocol submissions, generic investigational new animal
drug file requests, and generic investigational new animal drug meeting
requests) received over the 5-year period that ended on September 30,
2023 (the base years; 2019 through 2023), 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/submission, reflecting how much of the total
FDA generic new 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 1.8988% percent
for FY 2026. This is the workload adjuster for FY 2026.
Table 4--Workload Adjuster Calculation
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Column 1 Column 2 Column 3 Column 4 Column 5
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Application type 5-Year
average (base Latest 5-year Percent change Weighting Weighted
years) average factor percent change
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Abbreviated Application for a 30.80 30.20 -1.9481 0.1033 -0.2013
Generic New Animal Drug
(ANADAs).......................
Manufacturing Supplements ANADAs 264.00 269.60 2.1212 0.2429 0.5153
Generic Investigational Study 166.80 169.60 1.6787 0.4678 0.7853
Submissions....................
Generic Investigational Protocol 50.20 50.80 1.1952 0.0983 0.1175
Submissions....................
Generic Investigational New 47.20 43.60 -7.6271 0.0167 -0.1273
Animal Drug File Requests
(JINAD)........................
Generic Investigational New 29.80 33.20 11.4094 0.0709 0.8094
Animal Drug Meeting Requests
(JINAD)........................
FY 2026 AGDUFA IV Workload .............. .............. .............. .............. 1.8988
Adjuster.......................
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Per section 741(c)(3)(C) of the FD&C Act 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.
For FY 2026 the workload adjustment would not result in fee revenues
less than the base fee revenues as adjusted for inflation, therefore a
workload adjustment of $517,110 shall be applied.
Per section 741(c)(3)(B) of the FD&C Act, for each of fiscal years
2026 through 2028, if application of the workload adjustment increases
the fee revenue amounts otherwise established for the fiscal year, as
adjusted for inflation, such fee revenue increase shall be reduced by
the amount of any excess collections for the second preceding fiscal
year, up to the amount of such fee revenue increase. The second
preceding fiscal year for FY 2026 resulted in excess collections of
$2,776,000, which is higher than the corresponding workload adjustment
for FY 2026, and therefore, the workload adjustment is reduced to $0.
D. FY 2026 Fee Revenue Amounts
AGDUFA IV specifies that the revenue amount of $27,241,000
(rounded) for FY 2026 is to be divided as follows: 20 percent, or a
total of $5,448,200, is to come from application and/or JINAD file
fees; 40 percent, or a total of $10,896,400, is to come from product
fees; and 40 percent, or a total of $10,896,400 is to come from sponsor
fees (See section 741(b) of the FD&C Act).
III. Abbreviated Application Fee and Generic Investigational New Animal
Drug (JINAD) File Fee Calculations for FY 2026
A. Fee Revenues and Numbers of Fee-Paying Applications and Submissions
Section 741(a)(1)(A) of the FD&C Act states that each person who
submits an abbreviated application for a generic new animal drug shall
be subject to an application fee, with limited exceptions. The term
``abbreviated application for a generic new animal drug'' means an
abbreviated application for the approval of any generic new animal drug
submitted under section 512(b)(2) of the FD&C Act. FDA will assess fees
related to JINAD files under section 741(a)(4)(A)(i) of the FD&C Act
when a person submits a request to establish a new JINAD file. FDA will
assess a fee under section 741(a)(4)(A)(ii) and (iii) of the FD&C Act
for a person's first submission, as described below, to a JINAD file on
or after October 1, 2023, where the JINAD file had been established
prior to that date. The JINAD file fee is set in accordance with
section 741(c)(1)(C) of the FD&C Act at $50,000. FDA will set the
abbreviated application fee so that such fees combined with the JINAD
file fees will generate a combined total of $5,448,200 in fee revenue
for FY 2026.
To set fees for abbreviated applications for generic new animal
drugs, FDA must first make some assumptions about the number of fee-
paying abbreviated applications it will receive during FY 2026, the
number of requests to establish new JINAD files it will receive during
FY 2026, and the number of existing (prior to October 1, 2023) JINAD
files to which it will receive submissions during FY 2026.
Regarding the fee for a person's first submission to an existing
(prior to October 1, 2023) JINAD file on or after October 1, 2023, FDA
intends to assess
[[Page 35892]]
a fee only for the first data (or ``P'') submission to the
Bioequivalence (BE) or Chemistry, Manufacturing, and Controls (CMC)
technical sections of the JINAD file. The Agency has selected P
submissions to the BE or CMC technical sections as the basis for
assessing this fee because P submissions to these sections consistently
entail the substantial use of FDA review hours during the phased review
process.
The Agency knows the numbers of applications and submissions that
have been submitted in previous years. Those numbers fluctuate
annually. In estimating the fee revenue to be generated by application
and submission fees in FY 2026, FDA is assuming that the number of
applications and submissions for which fees will be paid in FY 2026
will equal the average number of applications and submissions over the
5 most recently completed fiscal years of the AGDUFA program (FY 2020-
FY 2024).
In addition, under section 741(a)(1)(C)(ii) of the FD&C Act an
abbreviated application for a generic new animal drug subject to the
criteria in section 512(d)(4) of the FD&C Act and submitted on or after
October 1, 2013, shall be subject to 50 percent of the fee applicable
to all other abbreviated applications for a generic new animal drug.
The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed fiscal years is 21.2 applications not subject to the criteria
in section 512(d)(4) of the FD&C Act and 4.0 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number that are subject
to such criteria results in a total of 23.2 anticipated full fees.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 23.2 fee-paying generic new animal drug applications
in FY 2026 (21.2 original applications paying a full fee and 4.0
applications paying a half fee).
For estimating the number of requests to establish a new JINAD file
and the number of P submissions to the BE or CMC section of an existing
(prior to October 1, 2023) JINAD file the Agency will receive in FY
2026, FDA took the number of new JINAD file requests and P submissions
to the BE or CMC section of an existing JINAD file received in FY 2025.
The number of requests to establish new JINAD files and P submissions
to the BE or CMC section of existing JINAD files during FY 2025 as of
June is 45.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 45 fee-paying JINAD file submissions in FY 2026
(including both requests to establish new JINAD files and first P
submissions to the BE or CMC section of existing (prior to October 1,
2023) JINAD files).
B. Application Fee Rates for FY 2026
FDA must set the fee rates for FY 2026 so that the estimated 23.2
abbreviated application fees and 45 JINAD file fees will generate a
total of $5,448,200. The fee for a new JINAD file request or the first
submission to an existing (prior to October 1, 2023) JINAD file is
$50,000 under section 741(c)(1)(C) of the FD&C Act. Therefore, the
JINAD fees will generate a total of $2,250,000. Abbreviated application
fees will have to generate a total of $3,198,200.
To generate this amount, the fee for a generic new animal drug
application will be $137,853 and for those applications that are
subject to the criteria set forth in section 512(d)(4) of the FD&C Act,
50 percent of that amount, or $68,927.
IV. Generic New Animal Drug Product Fee Calculations for FY 2026
A. Product Fee Revenues and Numbers of Fee-Paying Products
The generic new animal drug product fee must be paid annually by
the person named as the applicant in an abbreviated application or
supplemental abbreviated application for a generic new animal drug
product submitted for listing under section 510 of the FD&C Act (21
U.S.C. 360), and who had an abbreviated application or supplemental
abbreviated application for a generic new animal drug product pending
at FDA after September 1, 2008 (21 U.S.C. 379j-21(a)(2)). Section
741(k)(6) of FD&C Act defines ``generic new animal drug product'' as a
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
abbreviated application for a generic new animal drug or supplemental
abbreviated application for a generic new animal drug has been
approved. The product fees are to be set so that they will generate
$10,896,400 in fee revenue for FY 2026.
To set generic new animal drug product fees to realize $10,896,400,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2026. FDA gathered data on all generic
new 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 FDA estimated would have a generic new animal drug application or
supplemental abbreviated application pending after September 1, 2008.
As of May 2025, FDA estimates that there is a total of 679 products
submitted for listing by persons who had an abbreviated application for
a generic new animal drug or supplemental abbreviated application for a
generic new animal drug pending after September 1, 2008. Based on this,
FDA believes that a total of 679 products will be subject to this fee
in FY 2026.
Per section 741(d) of the FD&C Act in estimating the fee revenue to
be generated by generic new animal drug product fees in FY 2026, FDA is
estimating that 0.5 percent of the products invoiced, or 3 products,
will not pay fees in FY 2026, due to fee waivers and reductions. FDA
has made this estimate at 0.5 percent this year, based on historical
data over the past 5 completed fiscal years of the AGDUFA program.
Accordingly, the Agency estimates that a total of 676 (679 minus 3)
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 676
products for which fees are paid will generate a total of $10,896,400.
To generate this amount will require the fee for a generic new animal
drug product, rounded to the nearest dollar, to be $16,119.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2026
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The generic new animal drug sponsor fee must be paid annually by
each person who: (1) is named as the applicant in an abbreviated
application for a generic new animal drug, 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 submission for a generic new animal drug that has not
been terminated or otherwise rendered inactive; and (2) had an
abbreviated application for a generic new animal drug, supplemental
abbreviated
[[Page 35893]]
application for a generic new animal drug, or investigational
submission for a generic new animal drug pending at FDA after September
1, 2008. See section 741(k)(7) and (a)(3) of the FD&C Act.
Per section 741(a)(3)(C) of the FD&C Act, a generic new animal drug
sponsor is subject to only one such fee each fiscal year. Applicants
with more than 6 approved abbreviated applications will pay 100 percent
of the sponsor fee; applicants with more than 1 and fewer than 7
approved abbreviated applications will pay 75 percent of the sponsor
fee; and applicants with 1 or fewer approved abbreviated applications
will pay 50 percent of the sponsor fee. The sponsor fees are to be set
so that they will generate $10,896,400 in fee revenue for FY 2026.
To set generic new animal drug sponsor fees to realize $10,896,400,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2026. FDA developed data on all generic new animal
drug sponsors and matched this to the list of all sponsors who had
pending submissions and applications after September 1, 2008. As of
May, 2025, FDA estimates that in FY 2026, 16 sponsors will pay 100
percent fees, 16 sponsors will pay 75 percent fees, and 29 sponsors
will pay 50 percent fees. The total of these figures is the equivalent
of 42.50 full sponsor fees (16 times 100 percent or 16, plus 16 times
75 percent or 12 plus 29 times 50 percent or 14.5).
FDA estimates that about 2 percent of all of these sponsors, or
0.85, will not pay fees in FY 2026, due to fee waivers and reductions.
FDA has made the estimate of the percentage of sponsors that will not
pay fees at 2 percent this year, based on historical data over the past
5 completed fiscal years of the AGDUFA program. See section 741(d) of
the FD&C Act.
Accordingly, the Agency estimates that the equivalent of 41.65 full
sponsor fees (42.50 minus 0.85) are likely to be paid in FY 2026.
B. Sponsor Fee Rates for FY 2026
FDA must set the fee rates for FY 2026 so that the estimated
equivalent of 41.65 full sponsor fees will generate a total of
$10,896,400. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest dollar,
to be $261,618. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $196,214, and the fee for those paying 50
percent of the full sponsor fee will be $130,809.
VI. 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
User fee category FY 2026
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug $137,853
except those subject to the criteria in section
512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug 68,927
subject to the criteria in section 512(d)(4)...........
Generic Investigational New Animal Drug File Fee (JINAD) 50,000
Generic New Animal Drug Product Fee..................... 16,119
100% Generic New Animal Drug Sponsor Fee \1\............ 261,618
75% Generic New Animal Drug Sponsor Fee \1\............. 196,214
50% Generic New Animal Drug Sponsor Fee \1\............. 130,809
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one fee each fiscal year.
VIII. Fee Waiver or Reduction; Exemption From Fees
Per section 741(d)(1), of the FD&C Act the types of fees waivers
and reductions that applied last fiscal year still exist for FY 2026.
However, after September 30, 2023, there is no longer an exemption for
any person who submits to CVM a supplemental abbreviated application
relating to a generic new animal drug 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 502(w)(3) of the FD&C Act (21
U.S.C. 352(w)(3)).
Waivers or reductions remain available for abbreviated applications
for generic new animal drugs intended solely for a minor use/minor
species indication; see section 741(d) of the FD&C Act.
IX. Procedures for Paying the FY 2026 Fees
A. Abbreviated Application Fees, JINAD File Fees, and Payment
Instructions
The FY 2026 fees established in the new fee schedule must be paid
for the following applications/submissions that are subject to fees
under AGDUFA IV and submitted on or after October 1, 2025: a generic
new animal drug application, a submission requesting to establish a
JINAD file, or the first BE or CMC submission to a JINAD file that was
established prior to October 1, 2023. 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.\2\ 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.
---------------------------------------------------------------------------
\2\ 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
[[Page 35894]]
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 abbreviated application or JINAD submission arrives at
FDA's CVM. FDA records the official abbreviated application or JINAD
submission receipt date as the later of the following: the date the
application or submission 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 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 and JINAD File Submission Cover Sheet Procedures
Step One: Create a user account and password. Log onto the AGDUFA
website at <a href="https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm">https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm</a> and, under Application
Submission Information, click on ``Create AGDUFA User Fee Cover Sheet''
and follow the directions. For security reasons, each firm submitting
an application and/or a JINAD file submission 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 Generic Drug User Fee Cover Sheet,
transmit it to FDA, and print a copy. After logging into your account
with your username and password, complete the steps required to create
an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated application for a generic new animal drug or JINAD
file submission. 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 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 or JINAD file
submission as described in section IX.A.
Step Four: Submit your application or JINAD file submission.
C. Product and Sponsor Fees
By December 31, 2025, FDA will issue invoices and payment
instructions for product 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 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. 2025-14409 Filed 7-29-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>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.