[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46635-46641]
[FR Doc No: 2020-16839]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0806]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2021

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for fiscal year (FY) 2021 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
supplements, 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 2021.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-
402-6888<EMAIL_ADDRESS>For general questions, you may also
email the Center for Veterinary Medicine (CVM) at:
<EMAIL_ADDRESS>
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 supplements; (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

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 2021, the animal drug user fee rates are: $574,810 for an
animal drug application; $287,405 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)); $12,230 for an annual
product fee; $166,695 for an annual establishment fee; and $142,881 for
an annual sponsor fee. FDA will issue invoices for FY 2021 product,
establishment, and sponsor fees by December 31, 2020, and payment will
be due by January 31, 2021. The application fee rates are effective for
applications submitted on or after October 1, 2020, and will remain in
effect through September 30, 2021. 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 2021

A. Statutory Fee Revenue Amounts

    ADUFA IV, Title I of Public Law 115-234, specifies that the
aggregate base fee revenue amount for FY 2021 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 2021. The 3-year average is 1.2644 percent.

                                 Table 1--FDA PC&B Each Year and Percent Change
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             Fiscal year                     2017               2018               2019          3-Year average
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Total PC&B..........................     $2,581,551,000     $2,690,678,000     $2,620,052,000  .................
Total FTE...........................             17,022             17,023             17,144  .................
PC&B per FTE........................           $151,660           $158,061           $152,826  .................
Percent Change from Previous Year...            2.8845%            4.2206%           -3.3120%            1.2644%
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    The statute specifies that this 1.2644 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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             Fiscal year                     2017               2018               2019          3-Year average
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Total PC&B..........................     $2,581,551,000     $2,690,678,000     $2,620,052,000  .................
Total Costs.........................     $5,104,580,000     $5,370,935,000     $5,663,389,000  .................
PC&B Percent........................           50.5732%           50.0970%           46.2630%           48.9777%
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    The portion of the inflation adjustment relating to payroll costs
is 1.2644 percent multiplied by 48.9777 percent, or 0.6193 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''). In
order to continue applying a CPI which best reflects the geographic
region in which FDA is headquartered and which 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\ https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

   Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI Less Food and
                                                     Energy
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                Year                         2017               2018               2019          3-Year average
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Annual CPI..........................            266.897            272.414            275.841  .................
Annual Percent Change...............            0.5894%            2.0671%            1.2580%            1.3048%
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    To calculate the inflation adjustment for non-payroll costs, we
multiply 1.3048 percent by the proportion of all costs other than PC&B
to total FDA costs. Since 48.9777 percent was obligated for PC&B as
shown in table 2, 51.0223 percent is the portion of costs other than
PC&B (100 percent-48.9777 percent = 51.0223 percent). The portion of
the inflation adjustment relating to non-payroll costs is 1.3048
percent times 51.0223 percent, or 0.6657 percent.
    Next, we add the payroll component (0.6193 percent) to the non-
payroll component (0.6657 percent), for an inflation adjustment of
1.2850 percent for FY 2021.
    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 2021 (1.2850 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2020 (2.2705 percent), as published in the Federal Register on
August 2, 2019 (84 FR 37896 to 37901), which equals 1.035847 (rounded)
(1.012850 x 1.022705) for FY 2021. We then multiply the base revenue
amount for FY 2021 ($29,931,240) by 1.035847, yielding an inflation
adjusted amount of $31,004,185.

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, 2020.
    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, 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 added, reflecting a
total change in workload of 2.2092 percent for FY 2021. This is the
workload adjuster for FY 2021.

                                     Table 4--Workload Adjuster Calculation
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                                    Column 1 5-      Column 2                        Column 4        Column 5
        Application type           Year average    latest 5-year     Column 3        weighting       weighted
                                   (base years)       average     percent change      factor      percent change
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New Animal Drug Applications                16.4            16.8         2.4390%          0.0414         0.1011%
 (NADAs)........................
Supplemental NADAs with Safety              11.6             8.6       -25.8621%          0.0192        -0.4963%
 or Efficacy Data...............
Manufacturing Supplements.......           353.2           366.4         3.7373%          0.1662         0.6210%
Investigational Study                      183.2           175.0        -4.4760%          0.5615        -2.5131%
 Submissions....................
Investigational Protocol                   236.4           286.6        21.2352%          0.2117         4.4964%
 Submissions....................
FY 2021 ADUFA IV Workload         ..............  ..............  ..............  ..............         2.2092%
 Adjuster.......................
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    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)). The statutory
revenue amount after the inflation adjustment ($31,004,185) must now be
increased by 2.2092 percent to reflect the changes in review workload
(workload adjustment), for a workload and inflation-adjusted amount of
$31,689,129.

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. In FY 2019, the total
revenue amount was $30,331,000 and the total collections as of May 31,
2020, were $28,680,823. Because the total amount of fees collected did
not exceed the total revenue amount, there were no excess collections
for FY 2019 that can be applied to reduce the workload-based increase
for FY 2021.

E. Recovery of Collection Shortfalls

    Under section 740(g)(5)(A) of the FD&C Act, for FY 2021, the amount
of fees otherwise authorized to be collected shall be increased by the
amount, if any, by which the amount collected and appropriated for FY
2019

falls below the amount of fees authorized for FY 2019.
    In FY 2019, the total revenue amount was $30,331,000 and the total
amount of fees collected as of May 31, 2020, was $28,680,823. Because
the amount of fees collected is less than the total revenue amount,
there was a collection shortfall in FY 2019 in the amount of $1,650,177
($30,331,000-$28,680,823). In accordance with section 740(g)(5)(A) of
the FD&C Act, the amount of the collection shortfall in FY 2019
($1,650,177) is to be recovered by adjusting the fee revenue amount for
FY 2021. To make this adjustment, the collection shortfall amount
($1,650,177) is added to the workload and inflation-adjusted fee
revenue amount ($31,689,129), resulting in a fee revenue amount of
$33,339,000 (rounded to the nearest thousand dollars).

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 did not have
excess collections in FY 2019, there will be no reduction of the
shortfall-based fee increase for FY 2021.

G. FY 2021 Fee Revenue Amounts

    ADUFA IV specifies that the revenue amount of $33,339,000 (rounded
to the nearest thousand dollars) for FY 2021 is to be divided as
follows: 20 percent, or a total of $6,667,800, is to come from
application fees; 27 percent, or a total of $9,001,530, is to come from
product fees; 26 percent, or a total of $8,668,140, is to come from
establishment fees; and 27 percent, or a total of $9,001,530, is to
come from sponsor fees (21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY 2021

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 $6,667,800 in
fee revenue for FY 2021. 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 $6,667,800, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2021.
    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
2021, FDA is assuming that the number of applications for which fees
will be paid in FY 2021 will equal the average number of submissions
over the 5 most recent completed fiscal years of the ADUFA program (FY
2015 to FY 2019).
    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 6.8. 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
9.6.

B. Application Fee Rates for FY 2021

    FDA must set the fee rates for FY 2021 so that the estimated 6.8
applications for which the full fee will be paid and the estimated 9.6
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 $6,667,800. To generate this amount, the fee
for an animal drug application, rounded to the nearest dollar, will
have to be $574,810, 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 $287,405.

IV. Product Fee Calculations for FY 2021

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 $9,001,530 in fee revenue for
FY 2021.
    To set animal drug product fees to realize $9,001,530, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2021. 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 supplement pending after September 1, 2003. As of June
2020, FDA estimates that there are a total of 751 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 751 products will be
subject to this fee in FY 2021.
    In estimating the fee revenue to be generated by animal drug
product fees in FY 2021, FDA is assuming that 2 percent of the products
invoiced, or 15, will not pay fees in FY 2021 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 736 (751 minus
15) products will be subject to product fees in FY 2021.

B. Product Fee Rates for FY 2021

    FDA must set the fee rates for FY 2021 so that the estimated 736
products that pay fees will generate a total of $9,001,530. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest dollar, to be $12,230.

V. Establishment Fee Calculations for FY 2021

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 $8,668,140 in fee revenue for FY
2021.
    To set animal drug establishment fees to realize $8,668,140, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2021. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplement pending after September 1,
2003. As of June 2020, FDA estimates that there are a total of 57
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 57 establishments
will be subject to this fee in FY 2021.
    In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2021, FDA is assuming that 8 percent of the
establishments invoiced, or 5, will not pay fees in FY 2021 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 52 establishments
(57 minus 5) will be subject to establishment fees in FY 2021.

B. Establishment Fee Rates for FY 2021

    FDA must set the fee rates for FY 2021 so that the fees paid for
the estimated 52 establishments will generate a total of $8,668,140. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $166,695.

VI. Sponsor Fee Calculations for FY 2021

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 $9,001,530 in
fee revenue for FY 2021.
    To set animal drug sponsor fees to realize $9,001,530, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2021. FDA estimates that a total of 192 sponsors will meet
this definition in FY 2021.
    In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2021, FDA is assuming that 67 percent of the
sponsors invoiced, or 129, will not pay sponsor fees in FY 2021 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 63 sponsors (192
129) will be subject to and pay sponsor fees in FY 2021.

B. Sponsor Fee Rates for FY 2021

    FDA must set the fee rates for FY 2021 so that the estimated 63
sponsors that pay fees will generate a total of $9,001,530. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest dollar, to be $142,881.

VII. Fee Schedule for FY 2021

    The fee rates for FY 2021 are summarized in table 5.

                       Table 5--FY 2021 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                   FY 2021
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................        $574,810
Supplemental Animal Drug Application for Which Safety or         287,405
 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.................................          12,230
Animal Drug Establishment Fee\1\........................         166,695
Animal Drug Sponsor Fee \2\.............................         142,881
------------------------------------------------------------------------
\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. FDA CVM's guidance for industry (GFI) #170, entitled
``Animal Drug User Fees and Fee Waivers and Reductions \2\,'' states
that the agency interprets this provision to mean that a waiver or
reduction is appropriate when: (1) The product for which the waiver is
being requested is innovative, or the requestor is otherwise pursuing
innovative animal drug products or technology and (2) the fee would be
a significant barrier to the applicant's ability to develop,
manufacture, or market the innovative product or technology. Only
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 2021 will be $21,607,020; 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
2021.
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    \2\ CVM's GFI #170 is located at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
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B. Exemptions From Fees

    The types of fee waivers and reductions that applied during ADUFA
III still exist for FY 2021. 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 2021 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, 2020. 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 https://userfees.fda.gov/pay, or the Pay.gov 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 https://www.pay.gov/. 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 needs to be
included; without the invoice number, 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<PHONE_NUMBER>. 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 FDA's 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 https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet 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, 2020, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2021
using this fee schedule. Payment will be due by January 31, 2021. FDA
will issue invoices in November 2021 for any products, establishments,
and sponsors subject to fees for FY 2021 that qualify for fees after
the December 2020 billing.

    Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2020-16839 Filed 7-30-20; 11:15 am]
BILLING CODE 4164-01-P