[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40595-40601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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, Lisa.Kable@fda.hhs.gov. For general questions, you may also 
email FDA's Center for Veterinary Medicine (CVM) at: 
cvmadufa@fda.hhs.gov.

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\ https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

[[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: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
---------------------------------------------------------------------------

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 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

[[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 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, 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


