Notice2022-16176
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2023
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Published
July 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2023 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV), 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 2023.
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[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45339-45345]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16176]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1607]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2023
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fee rates and payment procedures for fiscal year (FY) 2023 animal
drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV),
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 2023.
DATES: The application fee rates are effective for applications
submitted on or after October 1, 2022, and will remain in effect
through September 30, 2023.
FOR FURTHER INFORMATION CONTACT: Visit FDA's website at <a href="https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm">https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/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#ca86a3b9abe481aba8a6af8aacaeabe4a2a2b9e4ada5bc"><span class="__cf_email__" data-cfemail="15597c66743b5e74777970557371743b7d7d663b727a63">[email protected]</span></a>. For general questions, you may also
email FDA's Center for Veterinary Medicine (CVM) at:
<a href="/cdn-cgi/l/email-protection#94f7e2f9f5f0e1f2f5d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="fb988d969a9f8e9d9abb9d9f9ad5939388d59c948d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the FD&C Act (21 U.S.C. 379j-12), as amended by
ADUFA IV, establishes four different types of user fees: (1) fees for
certain types of 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 (21 U.S.C. 379j-12(a)).
When certain conditions are met, FDA will waive or reduce fees (21
U.S.C. 379j-12(d)).
For FYs 2019 through 2023, the FD&C Act establishes the base
revenue amount for each fiscal year (21 U.S.C. 379j-12(b)(1)). Base
revenue amounts are subject to adjustment for inflation and workload
(21 U.S.C. 379j-12(c)(2) and (3)). Beginning with FY 2021, the annual
fee revenue amounts are also subject to adjustment to reduce workload-
based increases by the amount of certain excess collections or to
account for certain collection shortfalls (21 U.S.C. 379j-12(c)(3) and
(g)(5)). Fees for applications, products, establishments, 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 (21 U.S.C. 379j-12(b)(2)). The target
revenue amounts for each fee category for FY 2023, are as follows: for
application fees, the target revenue amount is $6,428,800; for product
fees, the target revenue amount is $8,678,880; for establishment fees,
the target revenue amount is $8,357,440 and for sponsor fees, the
target revenue amount is $8,678,880.
For FY 2023, the animal drug user fee rates are: $659,364 for an
animal drug application; $329,682 for a supplemental animal drug
application for which safety or effectiveness data are required and 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(d)(4)); $11,375 for the
annual product fee; $167,149 for the annual establishment fee; and
$149,636 for an annual sponsor fee. FDA will issue invoices for FY 2023
product, establishment, and sponsor fees by December 31, 2022, and
payment will be due by January 31, 2023. The application fee rates are
effective for applications submitted on or after October 1, 2022, and
will remain in effect through September 30, 2023. 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. Revenue Amount for FY 2023
A. Statutory Fee Revenue Amounts
ADUFA IV, Title I of Public Law 115-234, specifies that the
aggregate base fee revenue amount for FY 2023 for all animal drug user
fee categories is $29,931,240 (21 U.S.C. 379j-12(b)(1)(B)).
B. Inflation Adjustment to Fee Revenue Amount
ADUFA IV specifies that the annual fee revenue amount is to be
adjusted for inflation increases for FY 2020 and subsequent fiscal
years, using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (21 U.S.C. 379j-
12(c)(2)(A)(ii) and (iii)). 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 actual cost and FTE data 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 2023. The 3-year average is 1.3918 percent.
Table 1--FDA PC&B Each Year and Percent Change
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3-Year
FY 2019 FY 2020 FY 2021 average
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Total PC&B................................ $2,620,052,000 $2,875,592,000 $3,039,513,000 ..............
Total FTE................................. 17,144 17,535 18,501 ..............
PC&B per FTE.............................. 152,826 163,992 164,289 ..............
[[Page 45340]]
Percent Change From Previous Year......... -3.3120% 7.3063% 0.1811% 1.3918%
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The statute specifies that this 1.3918 percent should be multiplied
by the proportion of PC&B costs to total FDA costs. 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 Costs at FDA
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3-Year
FY 2019 FY 2020 FY 2021 average
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Total PC&B................................ $2,620,052,000 $2,875,592,000 $3,039,513,000 ..............
Total Costs............................... 5,663,389,000 6,039,321,000 6,049,798,000 ..............
PC&B Percent.............................. 46.2630% 47.6145% 50.2416% 48.0397%
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The portion of the inflation adjustment relating to payroll costs
is 1.3918 percent multiplied by 48.0397 percent, or 0.6686 percent.
The statute 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) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 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 of the 4
preceding fiscal years. As a result of a geographical revision made by
the Bureau of Labor and Statistics in January 2018,\1\ the
``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). To
continue applying a CPI that best reflects the geographic region in
which FDA is headquartered and that provides the most current data
available, FDA is using the Washington-Arlington-Alexandria less food
and energy index when calculating the relevant adjustment factors for
FY 2020 and subsequent 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.
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\1\ <a href="https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm">https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm</a>.
Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI Less Food and
Energy
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3-Year
FY 2019 FY 2020 FY 2021 average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................ 275.84 278.44 287.14 ..............
Annual Percent Change..................... 1.2580% 0.9411% 3.1271% 1.7754%
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To calculate the inflation adjustment for non-payroll costs, we
multiply 1.7754 percent by the proportion of all costs other than PC&B
to total FDA costs. Since 48.0397 percent was obligated for PC&B as
shown in table 2, 51.9603 percent is the portion of costs other than
PC&B (100 percent minus 48.0397 percent equals 51.9603 percent). The
portion of the inflation adjustment relating to non-payroll costs is
1.7754 percent times 51.9603 percent, or 0.9225 percent.
Next, we add the payroll component (0.6686 percent) to the non-
payroll component (0.9225 percent), for an inflation adjustment of
1.5911 percent for FY 2023.
ADUFA IV provides for the inflation adjustment to be compounded
each fiscal year after FY 2020 (see 21 U.S.C. 379j-12(c)(2)(B)). The
inflation adjustment for FY 2023 (1.5911 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2022 (5.7121 percent), as published in the Federal Register on
July 28, 2021 (86 FR 40595), which equals 1.0739 (rounded) (1.0159 x
1.0571) for FY 2023. We then multiply the base revenue amount for FY
2023 ($29,931,240) by 1.0739, yielding an inflation adjusted amount of
$32,144,386.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-12(c)(3)).
To determine whether a workload adjustment applies, 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, 2018 (the base years), and the average number of
each of these types of applications and submissions over the most
recent 5-year period that ended May 31, 2022.
[[Page 45341]]
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 4.5044
percent for FY 2023. This is the workload adjuster for FY 2023.
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 Year average Latest 5-year Weighting Weighted
(base years) average Percent change factor percent change
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New Animal Drug Application 16.40 12.80 -21.9512 0.04 -0.9235
(NADAs)......................
Supplemental NADAs With Safety 11.60 9.00 -22.4138 0.03 -0.5627
or Efficacy Data.............
Manufacturing Supplements..... 353.20 367.80 4.1336 0.19 0.7751
Investigational Study 183.20 170.40 -6.9869 0.57 -3.9856
Submissions..................
Investigational Protocol 236.40 239.00 1.0998 0.17 0.1923
Submissions..................
FY 2023 ADUFA IV Workload .............. .............. .............. .............. -4.5044
Adjuster.....................
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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 (21 U.S.C. 379j-12(c)(3)). FDA will not
adjust the FY 2023 fee revenue amount for workload changes because the
workload adjuster was less than 1 percent.\2\
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\2\ CVM increases the fee revenue amount established for the
fiscal year to reflect changes in workload only if the workload
adjuster is equal to or greater than 1 percent.
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D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections
Under section 740(c)(3)(B) of the FD&C Act, for FYs 2021 through
2023, if application of the workload adjustment increases the amount of
fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections for the second preceding fiscal year, up to the
amount of the fee revenue increase for workload. Since there is no
workload-based increase in FY 2023, this provision does not apply.
E. Recovery of Collection Shortfalls
Under section 740(g)(5)(A)(iii) of the FD&C Act, for FY 2023, the
amount of fees otherwise authorized to be collected shall be increased
by the cumulative amount, if any, by which the amount collected and
appropriated for FY 2021 and FY 2022 (including estimated collections
for FY 2022) falls below the cumulative amount of fees authorized for
FYs 2021 and 2022.
In FY 2021, the total revenue amount authorized was $33,339,000 and
the total amount of fees collected for FY 2021 as of May 31, 2022, was
$33,811,815. The total revenue amount authorized for FY 2022 is
$31,641,000 and the estimated collections for FY 2022 is projected to
be $30,570,000. The cumulative amount of fees collected and estimated
for FYs 2021 and 2022 is below the total authorized revenue amount by
$1,071,000. Therefore, the recovery of collection shortfalls provision
of section 740(g)(5)(A)(iii) is invoked. The next section details the
reduction of the shortfall-based fee increase by prior year excess
collections.
F. Reduction of Shortfall-Based Fee Increase by Prior Year Excess
Collections
Under section 740(g)(5)(B) of the FD&C Act, where FDA's
calculations under section 740(g)(5)(A) would result in a fee increase
for that fiscal year to recover a collection shortfall in a prior year,
FDA must reduce the increase by the amount of any excess collections
for preceding fiscal years (after FY 2018) that have not already been
applied to reduce workload-based fee increases. FDA's calculations
under section 740(g)(5)(A) would result in a fee increase for FY 2023
to recover a collection shortfall of $1,071,000. FDA also calculates
that it had $795,666 of excess collections in FY 2020 and $329,934 of
excess collections in FY 2021 that have not previously been applied to
reduce workload-based fee increases, for a total of $1,125,600 in
excess collections. Because the FYs 2020 and 2021 excess collections
not previously applied to a workload-based fee increase exceed the
projected shortfall in FY 2022, there is a reduction of the shortfall-
based fee increase under section 740(g)(5)(B). Therefore, no recovery
of collections shortfall will be added to the FY 2023 target revenue.
G. Final Year Adjustment
For FY 2023, FDA may, in addition to other adjustments under
section 740(c) of the FD&C Act, further increase the fees, if such an
adjustment is necessary, to provide for up to 3 months of operating
reserves of carryover user fees for the process for the review of
animal drug applications for the first 3 months of FY 2024. If FDA has
carryover balances for the process for the review of animal drug
applications in excess of 3 months of such operating reserves, then
this adjustment will not be made. (See 21 U.S.C. 379j-12(c)(4).) Since
FDA currently has an excess of 3 months of such operating reserves,
this adjustment will not be made for FY 2023.
H. FY 2023 Fee Revenue Amounts
The fee revenue amount for FY 2023, after considering the possible
adjustments under sections 740(c) and (g)(5) of the FD&C Act, is
$32,144,000 (rounded to the nearest thousand dollars). ADUFA IV
specifies that this revenue amount is to be divided as follows: 20
percent, or a total of $6,428,800, is to come from application fees; 27
percent, or a total of $8,678,880, is to come from product fees; 26
percent, or a total of $8,357,440, is to come from establishment fees;
and 27 percent, or a total of $8,678,880, is to come from sponsor fees
(21 U.S.C. 379j-12(b)).
III. Application Fee Calculations for FY 2023
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person who submits an animal drug application or a
supplemental
[[Page 45342]]
animal drug application shall be subject to an application fee, with
limited exceptions (see 21 U.S.C. 379j-12(a)(1)). 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 (21 U.S.C. 360ccc) (see section
739(1) of the FD&C Act (21 U.S.C. 379j-11(1))). As the expanded
definition of ``animal drug application'' includes applications for
conditional approval submitted under section 571 of the FD&C Act, such
applications are now subject to ADUFA fees, except that those fees may
be waived if the drug is intended solely to provide for a minor use or
minor species (MUMS) indication (see 21 U.S.C. 379j-12(d)(1)(D)).
Prior to ADUFA IV, FDA only had authority to grant conditional
approval for drugs intended for a MUMS indication. Under amendments
made to section 571 of the FD&C Act by ADUFA IV, FDA retains authority
to grant conditional approval for drugs intended for MUMS indications
but also will be able to grant conditional approval for certain drugs
not intended for a MUMS indication provided certain criteria are met.
Beginning with FY 2019, ADUFA IV provides 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.
A ``supplemental animal drug application'' is defined as a request
to the Secretary of Health and Human Services (Secretary) to approve a
change in an animal drug application that has been approved, or a
request to the Secretary 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 (21 U.S.C. 379j-11(2)). The
application fees are to be set so that they will generate $6,428,800 in
fee revenue for FY 2023. The fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to criteria set forth in section
512(d)(4) of the FD&C Act is to be set at 50 percent of the animal drug
application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)).
To set animal drug application fees and supplemental animal drug
application fees to realize $6,428,800, FDA must first make some
assumptions about the number of fee-paying applications and
supplemental applications the Agency will receive in FY 2023.
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 2023, FDA is assuming that the number of applications for
which fees will be paid in FY 2023 will equal the average number of
applications over the 4 most recent completed fiscal years of the ADUFA
program (FY 2018 to FY 2021). FDA decided to use a 4-year average for
the FY 2023 fee rate calculation rather than a 5-year average. FDA made
this adjustment because in the past 5 FY, 1 FY had an abnormally low
number of applications. Thus, FDA used a 4-year average to remove this
outlier from the forecast method, which resulted in a lower application
fee rate.
Over the 4 most recent completed fiscal years, the average number
of animal drug applications that would have been subject to the full
fee was 5.25. Over this same period, the average number of supplemental
applications for which safety or effectiveness data are required and
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act that would have been subject to half of the full fee was
9.0.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 9.75 fee-paying animal drug applications in FY 2023
(5.25 applications paying a full fee and 9.00 applications paying a
half fee).
B. Application Fee Rates for FY 2023
FDA must set the fee rates for FY 2023 so that the estimated 9.75
applications that pay the fee will generate a total of $6,428,800. To
generate this amount, the fee for an animal drug application, rounded
to the nearest dollar, will have to be $659,364, and the fee for a
supplemental animal drug application for which safety or effectiveness
data are required and for applications subject to the criteria set
forth in section 512(d)(4) of the FD&C Act will have to be $329,682.
IV. Animal Drug Product Fee Calculations for FY 2023
A. Product Fee Revenues and Numbers of Fee-Paying Products
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 (21 U.S.C. 379j-12(a)(2)). 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 (21 U.S.C. 379j-
11(3)). The product fees are to be set so that they will generate
$8,678,880 in fee revenue for FY 2023.
To set animal drug product fees to realize $8,678,880, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2023. FDA gathered 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 supplemental animal drug application pending after
September 1, 2003. As of May 2022, FDA estimates that there is a total
of 779 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 779
products will be subject to this fee in FY 2023.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2023, FDA is assuming that 2 percent of the products
invoiced, or 16, will not pay fees in FY 2023 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 763 (779 minus
16) products will be subject to product fees in FY 2023.
B. Product Fee Rates for FY 2023
FDA must set the fee rates for FY 2023 so that the estimated 763
products for
[[Page 45343]]
which fees are paid will generate a total of $8,678,880. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest dollar, to be $11,375.
V. Animal Drug Establishment Fee Calculations for FY 2023
A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments
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 (see 21 U.S.C. 379j-12(a)(3)). 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 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 (21 U.S.C. 379j-11(4)). The establishment fees are
to be set so that they will generate $8,357,440 in fee revenue for FY
2023.
To set animal drug establishment fees to realize $8,357,440, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2023. FDA gathered 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 2022, FDA estimates that
there is a total of 54 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 54
establishments will be subject to this fee in FY 2023.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2023, FDA is assuming that 7 percent of the
establishments invoiced, or four establishments, will not pay fees in
FY 2023 due to fee waivers and reductions. FDA has made this estimate
at 7 percent this year, based on historical data over the past 5
completed fiscal years.
Accordingly, the Agency estimates that a total of 50 (54 minus 4)
establishments will be subject to establishment fees in FY 2023.
B. Establishment Fee Rates for FY 2023
FDA must set the fee rates for FY 2023 so that the fees paid for
the estimated 50 establishments will generate a total of $8,357,440. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $167,149.
VI. Animal Drug Sponsor Fee Calculations for FY 2023
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 21
U.S.C. 379j-11(6) and 379j-12(a)(4)). An animal drug sponsor is subject
to only one such fee each fiscal year (see 21 U.S.C. 379j-12(a)(4)).
The sponsor fees are to be set so that they will generate $8,678,880 in
fee revenue for FY 2023.
To set animal drug sponsor fees to realize $8,678,880, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2023. FDA estimates that a total of 182 sponsors will meet
this definition in FY 2023.
In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2023, FDA is assuming that 68 percent of the
sponsors invoiced, or 124, will not pay sponsor fees in FY 2023 due to
fee waivers and reductions. FDA has made this estimate at 68 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 58 (182 minus
124) sponsors will be subject to and pay sponsor fees in FY 2023.
B. Sponsor Fee Rates for FY 2023
FDA must set the fee rates for FY 2023 so that the estimated 58
sponsors that pay fees will generate a total of $8,678,880. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest dollar, to be $149,636.
VII. Fee Schedule for FY 2023
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
The fee rates for FY 2023 are summarized in table 5.
Table 5--FY 2023 Fee Rates
------------------------------------------------------------------------
Fee rate for
Animal drug user fee category FY 2023
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application............................. $659,364
Supplemental Animal Drug Application for Which 329,682
Safety or Effectiveness Data are Required or Animal
Drug Application Subject to the Criteria Set Forth
in Section 512(d)(4) of the FD&C Act...............
Animal Drug Product Fee................................. 11,375
Animal Drug Establishment Fee \1\....................... 167,149
Animal Drug Sponsor Fee \2\............................. 149,636
------------------------------------------------------------------------
[[Page 45344]]
VIII. Fee Waiver or Reduction; Exemption From Fees
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,'' \3\ 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 of these 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 on the basis of 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 2023 will be $22,364,520; 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
2023. Requests for a waiver need to be submitted 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 1 fiscal
year. If a sponsor is not granted a waiver, they are liable for the
fees.
---------------------------------------------------------------------------
\3\ CVM's GFI #170 can be accessed at: <a href="https://www.fda.gov/media/69918/download">https://www.fda.gov/media/69918/download</a>.
---------------------------------------------------------------------------
B. Exemptions From Fees
The types of fee waivers and reductions that applied during ADUFA
III still exist for FY 2023. In addition, ADUFA IV established two new
exemptions and one new exception from fees, as described below:
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 (21 U.S.C. 379j-12(d)(4)(B)).
Fees will not apply to any person who not later than September 30,
2023, 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 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under ADUFA based only on the submission of the supplemental
application (21 U.S.C. 379j-12(d)(4)(A)).
There is also 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 (see
21 U.S.C. 379j-12(a)(1)(C)(ii)).
IX. Procedures for Paying the FY 2023 Fees
A. Application Fees and Payment Instructions
The FY 2023 fee established in the new fee schedule must be paid
for an animal drug application or supplement subject to fees under
ADUFA IV that is submitted on or after October 1, 2022. 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). Secure electronic
payments can be submitted using the User Fees Payment Portal at <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>, 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 search for
and find your invoice, select ``Pay Now'' to be redirected to
<a href="http://www.pay.gov">www.pay.gov</a>. 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. 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 with the letters AD, on the upper right-hand corner of
your completed Animal Drug User Fee Cover Sheet. Also write the FDA
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 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.
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,
Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO
63101. (Note: This address is for courier delivery only. If you have
any questions concerning courier delivery, contact U.S. Bank at 314-
418-4013. 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 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
[[Page 45345]]
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 submitting an application 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 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 are 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 as described in
section IX.A.
Step Four: Submit your application.
C. Product, Establishment, and Sponsor Fees
By December 31, 2022, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2023
using this fee schedule. Payment will be due by January 31, 2023. FDA
will issue invoices in November 2023 for any products, establishments,
and sponsors subject to fees for FY 2023 that qualify for fees after
the December 2022 billing.
Dated: July 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16176 Filed 7-27-22; 8:45 am]
BILLING CODE 4164-01-P
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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.