Home/Federal/Federal Register/2024-16885

Notice2024-16885

Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2025

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 31, 2024

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2025 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 (JINAD's), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2025.

Full Text

<html>
<head>
<title>Federal Register, Volume 89 Issue 147 (Wednesday, July 31, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61465-61470]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16885]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3481]

Animal Generic Drug User Fee Program Rates and Payment Procedures
for Fiscal Year 2025

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rates and payment procedures for fiscal year (FY)
2025 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 (JINAD's), and
for certain submissions related to JINAD files. This notice establishes
the fee rates for FY 2025.

DATES: The application fee rates are effective for all abbreviated
applications for a generic new animal drug submitted on or after
October 1, 2024, and will remain in effect through September 30, 2025.
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, 2024, and will remain in effect through
September 30, 2025.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at: <a href="https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm">https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm</a> or contact: Lisa Kable, Center for Veterinary Medicine
(HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-6888, <a href="/cdn-cgi/l/email-protection#bef2d7cddf90f5dfdcd2dbfed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="6f23061c0e41240e0d030a2f090b0e4107071c41080019">[email&#160;protected]</span></a>. For general questions,
you may also email the Center for Veterinary Medicine (CVM) at:
<a href="/cdn-cgi/l/email-protection#492a3f24282e2d3c2f28092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="80e3f6ede1e7e4f5e6e1c0e6e4e1aee8e8f3aee7eff6">[email&#160;protected]</span></a>.
For questions relating to this notice: Olufunmilayo Ariyo, Office
of Financial Management, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903, 240-402-4989; or the User Fee
Support Staff at <a href="/cdn-cgi/l/email-protection#afe0e082e0e9edeeff82e0e9e282fae9e9fc82e8c0d9caddc1c2cac1dbefc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="8dc2c2a0c2cbcfccdda0c2cbc0a0d8cbcbdea0cae2fbe8ffe3e0e8e3f9cdebe9eca3e5e5fea3eae2fb">[email&#160;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 2025 are as
follows: for application and/or JINAD file fees, the target revenue
amount is $5,196,700; for product fees, the target revenue amount is
$10,393,400; and for sponsor fees, the target revenue amount is
$10,393,400.
For FY 2025, the AGDUFA rates are: $161,907 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)); $80,954 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; $16,139 for each generic new animal drug
product; $270,204 for each generic new animal drug sponsor paying 100
percent of the sponsor fee; $202,653 for each generic new animal drug
sponsor paying 75 percent of the sponsor fee; and $135,102 for each
generic new animal drug sponsor paying 50 percent of the sponsor fee.
FDA will

[[Page 61466]]

issue invoices for FY 2025 product and sponsor fees by December 31,
2024, and payment will be due by January 31, 2025. The application fee
rates are effective for all abbreviated applications for a generic new
animal drug submitted on or after October 1, 2024, and will remain in
effect through September 30, 2025. 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, 2024,
and will remain in effect through September 30, 2025.
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 2025

A. Statutory Fee Revenue Amounts

Section 741(b)(1) of the FD&C Act specifies that the base fee
revenue amount for FY 2025 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 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 the 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 2025. The 3-year average is 3.8539
percent.

Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $3,039,513,000 $3,165,477,000 $3,436,513,000 ..............
Total FTEs................................ 18,501 18,474 18,729 ..............
PC&B per FTE.............................. $164,289 $171,348 $183,486 ..............
Percent Change from Previous Year......... 0.1811% 4.2967% 7.0838% 3.8539%
----------------------------------------------------------------------------------------------------------------

Section 741(c)(2)(A)(ii) of the FD&C Act specifies that the 3.8539
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 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $3,039,513,000 $3,165,477,000 $3,436,513,000 ..............
Total Costs............................... $6,049,798,000 $6,251,981,000 $6,654,058,000 ..............
PC&B percent.............................. 50.2416% 50.6316% 51.6454% 50.8395%
----------------------------------------------------------------------------------------------------------------

The portion of the inflation adjustment relating to payroll costs
is 3.8539 percent multiplied by 50.8359 percent, or 1.9593 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\
---------------------------------------------------------------------------

\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 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................ 287.144 302.608 313.315 ..............
Annual Percent Change..................... 3.1271% 5.3855% 3.5382% 4.0169%
----------------------------------------------------------------------------------------------------------------

[[Page 61467]]

Section 741(c)(2)(A)(iii) of the FD&C Act specifies to calculate
the inflation adjustment for non-payroll costs, we multiply 4.0169
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
50.8395 percent was obligated for PC&B as shown in table 2, 49.1605
percent is the portion of costs other than PC&B (100 percent minus the
PC&B percentage of 50.8395). The portion of the inflation adjustment
relating to non-payroll costs is 4.0169 percent multiplied by 49.1605
percent, or 1.9747 percent.
Next, we add the payroll component (1.9593 percent) to the non-
payroll component (1.9747 percent), for an inflation adjustment of
3.9340 percent for FY 2025.
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 2025 (3.9340 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2024 (zero percent), which equals 1.0393 (rounded) (1.0393 x
1.0). We then multiply the base revenue amount for FY 2025
($25,000,000) by 1.0393, yielding an inflation adjusted amount of
$25,983,500.

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 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, 2024.
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 negative 0.9977
percent for FY 2025. This is the workload adjuster for FY 2025.

Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application type 5-Year average Latest 5-year Weighting Weighted
(base years) average Percent change factor percent change
----------------------------------------------------------------------------------------------------------------
Abbreviated Application for a 28.00 31.60 12.8571 0.0902 1.1600
Generic New Animal Drug
(ANADAs).......................
Manufacturing Supplements ANADAs 249.40 249.20 -0.0802 0.2321 -0.0186
Generic Investigational Study 171.80 167.00 -2.7939 0.4759 -1.3296
Submissions....................
Generic Investigational Protocol 58.00 54.60 -5.8621 0.1068 -0.6263
Submissions....................
Generic Investigational New 49.20 47.20 -4.0650 0.0183 -0.0744
Animal Drug File Requests
(JINAD)........................
Generic Investigational New 28.20 27.80 -1.4184 0.0767 -0.1087
Animal Drug Meeting Requests
(JINAD)........................
-------------------------------------------------------------------------------
FY 2025 AGDUFA IV Workload .............. .............. .............. .............. -0.9977
Adjuster...................
----------------------------------------------------------------------------------------------------------------

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 2025 the workload adjustment would result in fee revenues less
than the base fee revenues as adjusted for inflation, therefore no
workload adjustment shall be applied.

E. FY 2025 Fee Revenue Amounts

AGDUFA IV specifies that the revenue amount of $25,983,500 for FY
2025 is to be divided as follows: 20 percent, or a total of $5,196,700,
is to come from application and/or JINAD file fees; 40 percent, or a
total of $10,393,400, is to come from product fees; and 40 percent, or
a total of $10,393,400 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 2025

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

[[Page 61468]]

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 $5,196,700 in fee revenue
for FY 2025.
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 2025, the
number of requests to establish new JINAD files it will receive during
FY 2025, and the number of existing (prior to October 1, 2023) JINAD
files to which it will receive submissions during FY 2025.
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 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 2025, FDA is assuming that the number of
applications and submissions for which fees will be paid in FY 2025
will equal the average number of applications and submissions over the
5 most recently completed fiscal years of the AGDUFA program (FY 2019-
FY 2023).
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 15 applications not subject to the criteria
in section 512(d)(4) of the FD&C Act and 6.4 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 18.20 anticipated full fees.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 18.20 fee-paying generic new animal drug
applications in FY 2025 (15.0 original applications paying a full fee
and 6.4 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
2025, 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 2024.
The number of requests to establish new JINAD files and P submissions
to the BE or CMC section of existing JINAD files during FY 2024 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 2025
(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 2025

FDA must set the fee rates for FY 2025 so that the estimated 18.20
abbreviated application fees and 45 JINAD file fees will generate a
total of $5,196,700. 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 $2,946,700.
To generate this amount, the fee for a generic new animal drug
application will be $161,907 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 $80,954.

IV. Generic New Animal Drug Product Fee Calculations For FY 2025

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
$10,393,400 in fee revenue for FY 2025.
To set generic new animal drug product fees to realize $10,393,400,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2025. 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 2024, FDA estimates that there is a total of 651 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 651 products will be subject to this fee
in FY 2025.
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 2025, FDA is
estimating that 1 percent of the products invoiced, or 7 products, will
not pay fees in FY 2025, due to fee waivers and reductions. FDA has
made this estimate at 1 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 644 (651 minus 7)
products will be subject to product fees in FY 2025.

B. Product Fee Rates for FY 2025

FDA must set the fee rates for FY 2025 so that the estimated 644
products for which fees are paid will generate a total of $10,393,400.
To generate this amount will require the fee for a generic new animal
drug product, rounded to the nearest dollar, to be $16,139.

[[Page 61469]]

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2025

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 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 $10,393,400 in fee revenue for FY 2025.
To set generic new animal drug sponsor fees to realize $10,393,400,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2025. 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, 2024, FDA estimates that in FY 2025, 15 sponsors will pay 100
percent fees, 15 sponsors will pay 75 percent fees, and 26 sponsors
will pay 50 percent fees. The total of these figures is the equivalent
of 39.25 full sponsor fees (15 times 100 percent or 15, plus 15 times
75 percent or 11.25 plus 26 times 50 percent or 13).
FDA estimates that about 2 percent of all of these sponsors, or
0.79, will not pay fees in FY 2025, 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 38.47 full
sponsor fees (39.25 minus 0.78) are likely to be paid in FY 2025.

B. Sponsor Fee Rates for FY 2025

FDA must set the fee rates for FY 2025 so that the estimated
equivalent of 38.47 full sponsor fees will generate a total of
$10,393,400. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest dollar,
to be $270,204. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $202,653, and the fee for those paying 50
percent of the full sponsor fee will be $135,102.

VI. Fee Schedule for FY 2025

The fee rates for FY 2025 are summarized in table 5.

Table 5--FY 2025 Fee Rates
------------------------------------------------------------------------
Fee rate for
User fee category FY 2025
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug $161,907
except those subject to the criteria in section
512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug 80,954
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..................... 16,139
100% Generic New Animal Drug Sponsor Fee \1\............ 270,204
75% Generic New Animal Drug Sponsor Fee \1\............. 202,653
50% Generic New Animal Drug Sponsor Fee \1\............. 135,102
------------------------------------------------------------------------
\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 2025.
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 FY 2025 Fees

A. Abbreviated Application Fees, JINAD File Fees, and Payment
Instructions

The FY 2025 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, 2024: 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. The payment must be made in U.S.
currency from a U.S. bank by one of the following methods: wire
transfer, electronically, check, bank draft, or U.S. postal money order
made payable to the Food and Drug Administration. The preferred payment
method is online using electronic check (Automated Clearing House
(ACH), also known as eCheck) or credit card (Discover, VISA,
MasterCard, American Express). Electronic payment options are based on
the balance due. Payment by credit card is available only for balances
that are less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Secure electronic payments can be
submitted using the User Fees Payment Portal at <a href="https://userfees.fda.gov/">https://userfees.fda.gov/</a>pay or the <a href="http://Pay.gov">Pay.gov</a> payment option is available to you
after you submit a cover sheet. (Note: only full payments are accepted.
No partial payments can be made online.) Once you find your invoice,
select ``Pay Now'' to be redirected to <a href="http://Pay.gov">Pay.gov</a>. Payments must be made
using U.S. bank accounts as well as U.S. credit cards.
When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning

[[Page 61470]]

with the letters ``AG'', on the upper right-hand corner of your
completed Animal Generic Drug User Fee Cover Sheet. Also write FDA's
post office box number (P.O. Box 979033) and PIN on the enclosed check,
bank draft, or money order. Mail the payment and a copy of the
completed Animal Generic Drug User Fee Cover Sheet to: Food and Drug
Administration, P.O. Box 979033, St. Louis, MO 63197-9000. Note: In no
case should the payment for the fee be submitted to FDA with the
application or JINAD file submission.
When paying by wire transfer, the invoice number or PIN needs to be
included. Without the invoice number or PIN, the payment may not be
applied, and the invoice amount would be referred to collections. The
originating financial institution may charge a wire transfer fee. If
the financial institution charges a wire transfer fee, it is required
to add that amount to the payment to ensure that the invoice is paid in
full. Use the following account information when sending a payment by
wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Account Name: Food and Drug Administration,
Account Number: 75060099, U.S. Department of the Treasury routing/
transit number: 021030004, SWIFT Number: FRNYUS33.
To send a check by a courier such as FedEx, the courier must
deliver the check and printed copy of the cover sheet to U.S. Bank:
U.S. Bank, Attn: Government Lockbox 979033, 3180 Rider Trail S, Earth
City, MO 63045. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at 855-259-3064. This telephone number is only for questions about
courier delivery.)
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, 2024, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2025 using this fee
schedule. Payment will be due by January 31, 2025. FDA will issue
invoices in November 2025 for any products and sponsors subject to fees
for FY 2025 that qualify for fees after the December 2024 billing.

Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16885 Filed 7-30-24; 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 31, 2024.

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.