Notice2021-16043
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2022
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 28, 2021
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) 2022 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 2022.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40595-40601]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16043]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0706]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2022
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fee rates and payment procedures for fiscal year (FY) 2022 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 2022.
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#1e52776d7f30557f7c727b5e787a7f3076766d30797168"><span class="__cf_email__" data-cfemail="5f13362c3e71143e3d333a1f393b3e7137372c71383029">[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#a2c1d4cfc3c6d7c4c3e2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="8fecf9e2eeebfae9eecfe9ebeea1e7e7fca1e8e0f9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the FD&C Act (21 U.S.C. 379j-12) 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 aggregate
yearly base revenue amounts 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, establishments, products, and
sponsors are to be established each year by FDA so that the percentages
of the total revenue that are derived from each type of user fee will
be as follows: (1) Revenue from application fees shall be 20 percent of
total fee revenue; (2) revenue from product fees shall be 27 percent of
total fee revenue; (3) revenue from establishment fees shall be 26
percent of
[[Page 40596]]
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)).
For FY 2022, the animal drug user fee rates are: $580,569 for an
animal drug application; $290,284 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)); $10,787 for an annual
product fee; $155,220 for an annual establishment fee; and $137,791 for
an annual sponsor fee. FDA will issue invoices for FY 2022 product,
establishment, and sponsor fees by December 31, 2021, and payment will
be due by January 31, 2022. The application fee rates are effective for
applications submitted on or after October 1, 2021, and will remain in
effect through September 30, 2022. 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 Animal Drug User Fee Act
program (ADUFA program).
II. Revenue Amount for FY 2022
A. Statutory Fee Revenue Amounts
ADUFA IV, Title I of Public Law 115-234, specifies that the
aggregate base fee revenue amount for FY 2022 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. 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 that actual cost and FTE data for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2022. The 3-year average is 2.7383 percent.
Table 1--FDA PC&B Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2018 2019 2020 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B...................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ..................
Total FTE....................... 17,023 17,144 17,535 ..................
PC&B per FTE.................... $158,061 $152,826 $163,992 ..................
Percent Change from Previous 4.2206% -3.3120% 7.3063% 2.7383%
Year...........................
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 2.7383 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
----------------------------------------------------------------------------------------------------------------
Fiscal year 2018 2019 2020 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B...................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ..................
Total Costs..................... $5,370,935,000 $5,663,389,000 $6,039,321,000 ..................
PC&B Percent.................... 50.0970% 46.2630% 47.6145% 47.9915%
----------------------------------------------------------------------------------------------------------------
The portion of the inflation adjustment relating to payroll costs
is 2.7383 percent multiplied by 47.9915 percent, or 1.3142 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.
---------------------------------------------------------------------------
\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>.
[[Page 40597]]
Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI Less Food and
Energy
----------------------------------------------------------------------------------------------------------------
Year 2018 2019 2020 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................... 272.414 275.841 278.437 ..............
Annual Percent Change........................... 2.0671% 1.2580% 0.9411% 1.4221%
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-payroll costs, we
multiply 1.4221 percent by the proportion of all costs other than PC&B
to total FDA costs. Since 47.9915 percent was obligated for PC&B as
shown in table 2, 52.0085 percent is the portion of costs other than
PC&B (100 percent minus 47.9915 percent equals 52.0085 percent). The
portion of the inflation adjustment relating to non-payroll costs is
1.4221 percent times 52.0085 percent, or 0.7396 percent.
Next, we add the payroll component (1.3142 percent) to the non-
payroll component (0.7396 percent), for an inflation adjustment of
2.0538 percent for FY 2022.
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 2022 (2.0538 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2021 (3.5847 percent), as published in the Federal Register on
August 3, 2020 (85 FR 46635), which equals 1.057121 (rounded) (1.020538
x 1.035847) for FY 2022. We then multiply the base revenue amount for
FY 2022 ($29,931,240) by 1.057121, yielding an inflation adjusted
amount of $31,640,942.
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, 2021.
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,
which 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 added,
reflecting a total change in workload of 0.6187 percent for FY 2022.
This is the workload adjuster for FY 2022.
Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application type Weighted
5-Year average Latest 5-year Percent change Weighting percent change
(base years) average (%) factor (%)
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications 16.4 14.6 -10.9756 0.0442 -0.4852
(NADAs)........................
Supplemental NADAs with Safety 11.6 9.0 -22.4138 0.0241 -0.5392
or Efficacy Data...............
Manufacturing Supplements....... 353.2 382.4 8.2673 0.1826 1.5093
Investigational Study 183.2 175.2 -4.3668 0.5544 -2.4208
Submissions....................
Investigational Protocol 236.4 267.4 13.1134 0.1948 2.5547
Submissions....................
FY 2022 ADUFA IV Workload .............. .............. .............. .............. 0.6187
Adjuster.......................
----------------------------------------------------------------------------------------------------------------
Under no circumstances will 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 2022 fee revenue amount for workload changes because the
workload adjuster was less than 1 percent.\2\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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. Because there is no
workload-based increase in FY 2022, this provision does not apply.
E. Recovery of Collection Shortfalls
Under section 740(g)(5)(A) of the FD&C Act, for FY 2022, the amount
of fees otherwise authorized to be
[[Page 40598]]
collected shall be increased by the amount, if any, by which the amount
collected and appropriated for FY 2020 falls below the amount of fees
authorized for FY 2020.
In FY 2020, the total revenue amount was $30,611,000 and the total
amount of fees collected as of May 31, 2021, was $31,261,667. Because
the amount of fees collected exceeded the total revenue amount, there
was no collection shortfall in FY 2020 and therefore no increase in
fees will be made under section 740(g)(5)(A).
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) result in a fee increase for
that fiscal year to recover a collection shortfall, 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 for purposes
of reducing workload-based fee increases. Because FDA's calculations
under section 740(g)(5)(A) do not result in a fee increase for FY 2022
to recover a collection shortfall, there will be no reduction of a
shortfall-based increase under section 740(g)(5)(B).
G. FY 2022 Fee Revenue Amounts
The fee revenue amount for FY 2022, after considering the possible
adjustments under sections 740(c) and (g)(5) of the FD&C Act, is
$31,641,000 (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 $6,328,200, is to come from application fees; 27
percent, or a total of $8,543,070, is to come from product fees; 26
percent, or a total of $8,226,660 is to come from establishment fees;
and 27 percent, or a total of $8,543,070 is to come from sponsor fees
(21 U.S.C. 379j-12(b)).
III. Application Fee Calculations for FY 2022
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person that submits an animal drug application or a
supplemental 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 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 $6,328,200 in
fee revenue for FY 2022. 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 $6,328,200, FDA must first make some
assumptions about the number of fee-paying applications and
supplemental applications the Agency will receive in FY 2022.
The Agency knows the number of applications that have been
submitted in previous years, which fluctuates annually. In estimating
the fee revenue to be generated by animal drug application fees in FY
2022, FDA is assuming that the number of applications for which fees
will be paid in FY 2022 will equal the average number of submissions
over the 5 most recent completed fiscal years of the ADUFA program (FY
2016 to FY 2020).
Over the 5 most recent completed fiscal years, the average number
of animal drug applications that would have been subject to the full
fee was 6.4. 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.
B. Application Fee Rates for FY 2022
FDA must set the fee rates for FY 2022 so that the estimated 6.4
applications for which the full fee will be paid and the estimated 9.0
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 for which half of the full fee will be paid
will generate a total of $6,328,200. To generate this amount, the fee
for an animal drug application, rounded to the nearest dollar, will
have to be $580,569, 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 $290,284.
IV. Product Fee Calculations for FY 2022
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
[[Page 40599]]
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 $8,543,070 in fee revenue for
FY 2022.
To set animal drug product fees to realize $8,543,070, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2022. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. As of May 2021, FDA estimates that there are a total
of 808 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 808
products will be subject to this fee in FY 2022.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2022, FDA is assuming that 2 percent of the products
invoiced, or 16, will not pay fees in FY 2022 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 792 (808 minus
16) products will be subject to product fees in FY 2022.
B. Product Fee Rates for FY 2022
FDA must set the fee rates for FY 2022 so that the estimated 792
products for which fees are paid will generate a total of $8,543,070.
To generate this amount will require the fee for an animal drug
product, rounded to the nearest dollar, to be $10,787.
V. Establishment Fee Calculations for FY 2022
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 $8,226,660 in fee revenue for FY
2022.
To set animal drug establishment fees to realize $8,226,660, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2022. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplemental animal drug application
pending after September 1, 2003. As of May 2021, FDA estimates that
there are a total of 58 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 58
establishments will be subject to this fee in FY 2022.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2022, FDA is assuming that 8 percent of the
establishments invoiced, or five, will not pay fees in FY 2022 due to
fee waivers and reductions. FDA has made this estimate at 8 percent
this year, based on historical data over the past 5 completed fiscal
years.
Accordingly, the Agency estimates that a total of 53 establishments
(58 minus 5) will be subject to establishment fees in FY 2022.
B. Establishment Fee Rates for FY 2022
FDA must set the fee rates for FY 2022 so that the fees paid for
the estimated 53 establishments will generate a total of $8,226,660. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $155,220.
VI. Sponsor Fee Calculations for FY 2022
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 $8,543,070 in
fee revenue for FY 2022.
To set animal drug sponsor fees to realize $8,543,070, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2022. FDA estimates that a total of 187 sponsors will meet
this definition in FY 2022.
In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2022, FDA is assuming that 67 percent of the
sponsors invoiced, or 125, will not pay sponsor fees in FY 2022 due to
fee waivers and reductions. FDA has made this estimate at 67 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 62 sponsors (187
minus 125) will be subject to and pay sponsor fees in FY 2022.
B. Sponsor Fee Rates for FY 2022
FDA must set the fee rates for FY 2022 so that the estimated 62
sponsors that pay fees will generate a total of $8,543,070. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest dollar, to be $137,791.
VII. Fee Schedule for FY 2022
The fee rates for FY 2022 are summarized in table 5.
[[Page 40600]]
Table 5--FY 2022 Fee Rates
------------------------------------------------------------------------
Fee rate for
Animal drug user fee category FY 2022
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application............................. $580,569
Supplemental Animal Drug Application for Which 290,284
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................................. 10,787
Animal Drug Establishment Fee \1\....................... 155,220
Animal Drug Sponsor Fee \2\............................. 137,791
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
year.
VIII. Fee Waiver or Reduction; Exemption From Fees
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
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 2022 will be $21,896,240; 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
2022. 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 one
fiscal year. If a sponsor is not granted a waiver, they are liable for
the fees.
---------------------------------------------------------------------------
\3\ CVM's GFI #170 is located at: <a href="https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf">https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf</a>.
---------------------------------------------------------------------------
B. Exemptions From Fees
The types of fee waivers and reductions that applied during ADUFA
III still exist for FY 2022. 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 (21
U.S.C. 379j-12(a)(1)(C)(ii)).
IX. Procedures for Paying the FY 2022 Fees
A. Application Fees and Payment Instructions
The appropriate application 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, 2021. The
payment must be made in U.S. currency 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="https://www.pay.gov/">https://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
[[Page 40601]]
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, FDA Deposit 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 Federal Express, 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 CVM. FDA records the official
application receipt date as the later of the following: The date the
application was received by CVM, or the date U.S. Bank notifies FDA
that your payment in the full amount has been received, or when the
U.S. Treasury notifies FDA of receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S. 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
user name 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--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.
C. Product, Establishment, and Sponsor Fees
By December 31, 2021, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2022
using this fee schedule. Payment will be due by January 31, 2022. FDA
will issue invoices in November 2022 for any products, establishments,
and sponsors subject to fees for FY 2022 that qualify for fees after
the December 2021 billing.
Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16043 Filed 7-27-21; 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>Indexed from Federal Register on July 28, 2021.
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.