[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39028-39033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0703]


Animal Generic Drug User Fee Rates and Payment Procedures for 
Fiscal Year 2022

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the fee rates and payment procedures for fiscal year (FY) 2022 generic 
new animal drug user fees. The Federal Food, Drug, and Cosmetic Act 
(FD&C Act), as amended by the Animal Generic Drug User Fee Amendments 
of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain 
abbreviated applications for generic new animal drugs, for certain 
generic new animal drug products, and for certain sponsors of such 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs. This notice 
establishes the fee rates for FY 2022.

FOR FURTHER INFORMATION 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 or visit 
FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm. For general questions, 
you may also email the Center for Veterinary

[[Page 39029]]

Medicine (CVM) at cvmagdufa@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three 
different types of user fees: (1) Fees for certain types of abbreviated 
applications for generic new animal drugs; (2) annual fees for certain 
generic new animal drug products; and (3) annual fees for certain 
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C. 
379j-21(a)). When certain conditions are met, FDA will waive or reduce 
fees for generic new animal drugs intended solely to provide for a 
minor use or minor species indication (21 U.S.C. 379j-21(d)).
    For FY 2019 through FY 2023, the FD&C Act establishes a yearly base 
revenue amount and percentages for each of these fee categories (21 
U.S.C. 379j-21(b)). Base revenue amounts are subject to adjustment for 
inflation and workload (21 U.S.C. 379j-21(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 (21 U.S.C. 379j-21(c)(3)(B)). The target revenue 
amounts for each fee category for FY 2022, are as follows: For 
application fees, the target revenue amount is $6,199,500; for product 
fees, the target revenue amount is $9,299,250; and for sponsor fees, 
the target revenue amount is $9,299,250.
    For FY 2022, the generic new animal drug user fee rates are: 
$548,628 for each abbreviated application for a generic new animal drug 
other than those subject to the criteria in section 512(d)(4) of the 
FD&C Act (21 U.S.C. 360b(d)(4)); $274,314 for each abbreviated 
application for a generic new animal drug subject to the criteria in 
section 512(d)(4) of the FD&C Act; $17,513 for each generic new animal 
drug product; $234,297 for each generic new animal drug sponsor paying 
100 percent of the sponsor fee; $175,723 for each generic new animal 
drug sponsor paying 75 percent of the sponsor fee; and $117,149 for 
each generic new animal drug sponsor paying 50 percent of the sponsor 
fee. FDA will issue invoices for FY 2022 product and sponsor fees by 
December 31, 2021. These fees will be due by January 31, 2022. The 
application fee rates are effective for all abbreviated applications 
for a generic new animal drug 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 
related application fees and any other fees owed under the Animal 
Generic Drug User Fee program (AGDUFA program).

II. Revenue Amount for FY 2022

A. Statutory Fee Revenue Amounts

    AGDUFA III, Title II of Public Law 115-234, specifies that the 
aggregate base fee revenue amount for FY 2022 for all generic new 
animal drug user fee categories is $18,336,340 (21 U.S.C. 379j-
21(b)(1)).

B. Inflation Adjustment to Fee Revenue Amount

    AGDUFA III 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 (see 21 U.S.C. 379j-
21(c)(2)). The component of the inflation adjustment for payroll costs 
shall be one plus the average annual percent change in the cost of all 
PC&B paid per full-time equivalent position (FTE) at FDA for the first 
3 of the 4 preceding fiscal years of available data, multiplied by the 
average proportion of PC&B costs to total FDA costs for the first 3 of 
the 4 preceding fiscal years of available data. The data on total PC&B 
paid and numbers of FTE paid, from which the average cost per FTE can 
be derived, are published in FDA's Justification of Estimates for 
Appropriations Committees.
    Table 1 summarizes the actual cost and FTE data for the specified 
fiscal years, 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 Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                                                                                        3-year
                Fiscal year                        2018               2019               2020          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 Year.........             4.2206            -3.3120             7.3063       2.7383
----------------------------------------------------------------------------------------------------------------

    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 
FYs.

                                Table 2--PC&B as a Percent of Total Costs at FDA
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             Fiscal year                     2018               2019               2020          3-year average
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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 cost 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

[[Page 39030]]

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 
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 index, less food and energy, in 
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 is shown in table 3.
---------------------------------------------------------------------------

    \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
----------------------------------------------------------------------------------------------------------------
                      Year                             2018            2019            2020       3-year average
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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-47.9915 percent = 52.0085 percent). The non-payroll 
adjustment 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.
    AGDUFA III provides for the inflation adjustment to be compounded 
each fiscal year after FY 2020 (see 21 U.S.C. 379j-21(c)(2)). 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 46647 to 46651), which equals 1.057121 (rounded) 
(1.020538 x 1.035847) for FY 2022. We then multiply the base revenue 
amount for FY 2022 ($18,336,340) by 1.057121, yielding an inflation 
adjusted amount of $19,383,730.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in AGDUFA III 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-21(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 
four types of applications and submissions specified in the workload 
adjustment provision (abbreviated applications for generic new animal 
drugs, manufacturing supplemental abbreviated applications for generic 
new animal drugs, investigational generic new animal drug study 
submissions, and investigational generic new 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, reflecting how much of the total FDA generic 
new animal drug review workload was accounted for by each type of 
application or submission in the table during the most recent 5 years. 
Column 5 is the weighted percent change in each category of workload, 
and was derived by multiplying the weighting factor in each line in 
column 4 by the percent change from the base years in column 3. At the 
bottom right of the table the sum of the values in column 5 is 
calculated, reflecting a total change in workload of 49.0190 percent 
for FY 2022. This is the workload adjuster for FY 2022.

                                     Table 4--Workload Adjuster Calculation
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                                     Column 1        Column 2        Column 3        Column 4        Column 5
                                 -------------------------------------------------------------------------------
        Application type          5-year average   Latest 5-year                     Weighting       Weighted
                                   (base years)       average     Percent change      factor      percent change
----------------------------------------------------------------------------------------------------------------
Abbreviated Application for a               24.0            26.6         10.8333          0.1745          1.8904
 Generic New Animal Drug
 (ANADAs).......................
Manufacturing Supplements ANADAs           169.4           198.2         17.0012          0.2601          4.4212
Generic Investigational Study               69.2           122.8         77.4566          0.4121         31.9161
 Submissions....................
Generic Investigational Protocol            34.4           58.64         70.3488          0.1534         10.7913
 Submissions....................
                                 -------------------------------------------------------------------------------
    FY 2022 AGDUFA III Workload   ..............  ..............  ..............  ..............         49.0190
     Adjuster...................
----------------------------------------------------------------------------------------------------------------


[[Page 39031]]

    The statutory revenue amount after the inflation adjustment 
($19,383,730) must now be increased by 49.0190 percent to reflect the 
changes in review workload (workload adjustment), for a workload and 
inflation-adjusted amount of $28,885,441.

D. Reduction of Workload-Based Increase by Amount of Certain Excess 
Collections

    Under section 741(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. The workload and 
inflation-adjusted amount ($28,885,441) is subtracted by the inflation 
adjusted amount ($19,383,730) to get the workload adjustment amount 
($9,501,711). Then the excess fees collected from FY 2020 as of May 31, 
2021 ($4,087,114) are subtracted from the workload adjustment amount 
($9,501,711) to get a reduced workload adjustment amount of $5,414,597. 
Next, the reduced workload adjustment amount ($5,414,597) is added to 
the inflation-adjusted revenue amount ($19,383,730), for a total fee 
revenue target of $24,798,000 (rounded to the nearest thousand 
dollars).

E. FY 2022 Fee Revenue Amounts

    AGDUFA III specifies that the revenue amount of $24,798,000 for FY 
2022 is to be divided as follows: 25 percent, or a total of $6,199,500, 
is to come from application fees; 37.5 percent, or a total of 
$9,299,250, is to come from product fees; and 37.5 percent, or a total 
of $9,299,250, is to come from sponsor fees (21 U.S.C. 379j-21(b)).

III. Abbreviated Application Fee Calculations for FY 2022

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    Each person who submits an abbreviated application for a generic 
new animal drug shall be subject to an application fee, with limited 
exceptions (21 U.S.C. 379j-21(a)(1)). The term ``abbreviated 
application for a generic new animal drug'' means an abbreviated 
application for the approval of any generic new animal drug submitted 
under section 512(b)(2) of the FD&C Act (21 U.S.C. 379j-21(k)(1)). The 
application fees are to be set so that they will generate $6,199,500 in 
fee revenue for FY 2022.
    To set fees for abbreviated applications for generic new animal 
drugs to realize $6,199,500 FDA must first make some assumptions about 
the number of fee-paying abbreviated applications it will receive 
during FY 2022.
    The Agency knows the number of applications that have been 
submitted in previous years. That number fluctuates annually. In 
estimating the fee revenue to be generated by generic new animal drug 
applications 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 recently completed fiscal 
years of the AGDUFA program (FY 2016-FY 2020).
    Also, under AGDUFA III, an abbreviated application for an animal 
generic drug subject to the criteria in section 512(d)(4) of the FD&C 
Act and submitted on or after October 1, 2013, shall be subject to 50 
percent of the fee applicable to all other abbreviated applications for 
a generic new animal drug (21 U.S.C. 379j-21(a)(1)(C)(ii)).
    The average number of original submissions of abbreviated 
applications for generic new animal drugs over the 5 most recently 
completed fiscal years is 8.2 applications not subject to the criteria 
in section 512(d)(4) of the FD&C Act and 6.2 submissions subject to the 
criteria in section 512(d)(4). Each of the submissions described under 
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by 
the other applications and will be counted as one half of a fee. Adding 
all of the applications not subject to the criteria in section 
512(d)(4) of the FD&C Act and 50 percent of the number that are subject 
to such criteria results in a total of 11.30 anticipated full fees.
    Based on the previous assumptions, FDA is estimating that it will 
receive a total of 11.30 fee-paying generic new animal drug 
applications in FY 2022 (8.2 original applications paying a full fee 
and 6.2 applications paying a half fee).

B. Application Fee Rates for FY 2022

    FDA must set the fee rates for FY 2022 so that the estimated 11.30 
abbreviated applications that pay the fee will generate a total of 
$6,199,500. To generate this amount, the fee for a generic new animal 
drug application will have to be $548,628 and for those applications 
that are subject to the criteria set forth in section 512(d)(4) of the 
FD&C Act, 50 percent of that amount, or $274,314.

IV. Generic New Animal Drug Product Fee Calculations for FY 2022

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The generic new animal drug product fee must be paid annually by 
the person named as the applicant in an abbreviated application or 
supplemental abbreviated application for a generic new animal drug 
product submitted for listing under section 510 of the FD&C Act (21 
U.S.C. 360), and who had an abbreviated application or supplemental 
abbreviated application for a generic new animal drug product pending 
at FDA after September 1, 2008 (see 21 U.S.C. 379j-21(a)(2)). The term 
``generic new 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 abbreviated application for a 
generic new animal drug or supplemental abbreviated application for a 
generic new animal drug has been approved (21 U.S.C. 379j-21(k)(6)). 
The product fees are to be set so that they will generate $9,299,250 in 
fee revenue for FY 2022.
    To set generic new animal drug product fees to realize $9,299,250, 
FDA must make some assumptions about the number of products for which 
these fees will be paid in FY 2022. FDA gathered data on all generic 
new animal drug products that have been submitted for listing under 
section 510 of the FD&C Act and matched this to the list of all persons 
who had a generic new animal drug application or supplemental 
abbreviated application pending after September 1, 2008. As of May 
2021, FDA estimates a total of 536 products submitted for listing by 
persons who had an abbreviated application for a generic new animal 
drug or supplemental abbreviated application for a generic new animal 
drug pending after September 1, 2008. Based on this, FDA believes that 
a total of 536 products will be subject to this fee in FY 2022.
    In estimating the fee revenue to be generated by generic new animal 
drug product fees in FY 2022, FDA is estimating that 1 percent of the 
products invoiced, or 5 products, will qualify for minor use/minor 
species fee waiver (see 21 U.S.C. 379j-21(d)). FDA has made this 
estimate at 1 percent this year, based on historical data over the past 
5 completed fiscal years of the AGDUFA program.

[[Page 39032]]

    Accordingly, the Agency estimates that a total of 531 (536 minus 5) 
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 531 
products that pay fees will generate a total of $9,299,250. To generate 
this amount will require the fee for a generic new animal drug product, 
rounded to the nearest dollar, to be $17,513.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2022

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The generic new animal drug sponsor fee must be paid annually by 
each person who: (1) Is named as the applicant in an abbreviated 
application for a generic new animal drug, except for an approved 
application for which all subject products have been removed from 
listing under section 510 of the FD&C Act, or has submitted an 
investigational submission for a generic new animal drug that has not 
been terminated or otherwise rendered inactive and (2) had an 
abbreviated application for a generic new animal drug, supplemental 
abbreviated application for a generic new animal drug, or 
investigational submission for a generic new animal drug pending at FDA 
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-21(a)(3), 
respectively). A generic new animal drug sponsor is subject to only one 
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants 
with more than 6 approved abbreviated applications will pay 100 percent 
of the sponsor fee; applicants with more than 1 and fewer than 7 
approved abbreviated applications will pay 75 percent of the sponsor 
fee; and applicants with 1 or fewer approved abbreviated applications 
will pay 50 percent of the sponsor fee (see 21 U.S.C. 379j-
21(a)(3)(C)). The sponsor fees are to be set so that they will generate 
$9,299,250 in fee revenue for FY 2022.
    To set generic new animal drug sponsor fees to realize $9,299,250, 
FDA must make some assumptions about the number of sponsors who will 
pay these fees in FY 2022. FDA estimates that in FY 2022, 12 sponsors 
will pay 100 percent fees, 18 sponsors will pay 75 percent fees, and 30 
sponsors will pay 50 percent fees. That totals the equivalent of 40.5 
full sponsor fees (12 x 100 percent or 12, plus 18 x 75 percent or 
13.5, plus 30 x 50 percent or 15).
    FDA estimates that about 2 percent of all of these sponsors, or 
0.81, may qualify for a minor use/minor species fee waiver (see 21 
U.S.C. 379j-21(d)). FDA has made the estimate of the percentage of 
sponsors that will not pay fees at 2 percent this year, based on 
historical data over the past 5 completed fiscal years of the AGDUFA 
program.
    Accordingly, the Agency estimates that the equivalent of 39.69 full 
sponsor fees (40.5-0.81) are likely to be paid in FY 2022.

B. Sponsor Fee Rates for FY 2022

    FDA must set the fee rates for FY 2022 so that the estimated 
equivalent of 39.69 full sponsor fees will generate a total of 
$9,299,250. To generate this amount will require the 100 percent fee 
for a generic new animal drug sponsor, rounded to the nearest dollar, 
to be $234,297. Accordingly, the fee for those paying 75 percent of the 
full sponsor fee will be $175,723, and the fee for those paying 50 
percent of the full sponsor fee will be $117,149.

VI. Fee Schedule for FY 2022

    The fee rates for FY 2022 are summarized in table 5.

                       Table 5--FY 2022 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
        Generic new animal drug user fee category             FY 2022
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug         $548,628
 except those subject to the criteria in section
 512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug          274,314
 subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee.....................          17,513
100% Generic New Animal Drug Sponsor Fee.1..............         234,297
75% Generic New Animal Drug Sponsor Fee.1...............         175,723
50% Generic New Animal Drug Sponsor Fee.1...............         117,149
------------------------------------------------------------------------
1An animal drug sponsor is subject to only one fee each fiscal year.

VII. Fee Waiver or Reduction; Exemption From Fees

    The types of fee waivers and reductions that applied last fiscal 
year still exist for FY 2022. In AGDUFA III a new exemption from fees 
was established, as follows:
    Fees will not apply to any person who not later than September 30, 
2023, submits to CVM a supplemental abbreviated application relating to 
a generic new animal drug approved under section 512 of the FD&C Act, 
solely to add the application number to the labeling of the drug in the 
manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C. 
352(w)(3)), if that person otherwise would be subject to user fees 
under AGDUFA based only on the submission of the supplemental 
abbreviated application (21 U.S.C. 379j-21(d)(2)).

VIII. Procedures for Paying FY 2022 Generic New Animal Drug User Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2022 fee established in the new fee schedule must be paid 
for a generic new animal drug application subject to fees under AGDUFA 
III that is submitted on or after October 1, 2021. The payment must be 
made in U.S. currency from a U.S. bank by one of the following methods: 
Wire transfer, electronically, check, bank draft, or U.S. postal money 
order made payable to the Food and Drug Administration. The preferred 
payment method is online using an 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 have found your 
invoice, select ``Pay Now'' to be redirected to Pay.gov. Electronic 
payment options are based on the balance due. Payment by credit card is 
available only for balances 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.

[[Page 39033]]

    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 ``AG'', on the upper right-hand 
corner of your completed Animal Generic Drug User Fee Cover Sheet. Also 
write FDA's post office box number (P.O. Box 979033) and PIN on the 
enclosed check, bank draft, or money order. Mail the payment and a copy 
of the completed Animal Generic Drug User Fee Cover Sheet to: Food and 
Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000. Note: 
In no case should the payment for the fee be submitted to FDA with the 
application.
    When paying by wire transfer, it is required that the invoice 
number or PIN is 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 wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 
Liberty St., New York, NY 10045, Account Name: Food and Drug 
Administration, Account No.: 75060099, Routing No.: 021030004, SWIFT 
No.: 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 phone number is only for questions about courier 
delivery.)
    It is important that the fee arrives at the bank at least a day or 
two before the abbreviated application arrives at FDA's CVM. FDA 
records the official abbreviated 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. Department of the Treasury notifies FDA 
of payment. U.S. Bank and the United States 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 onto the AGDUFA 
website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the 
page until you find the link ``Create AGDUFA User Fee Cover Sheet.'' 
Select that link and follow the directions. 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 Generic 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 Generic Drug User Fee Cover Sheet. One cover sheet is needed 
for each abbreviated application for a generic new animal drug. Once 
you are satisfied that the data on the cover sheet is accurate and you 
have finalized the cover sheet, you will be able to transmit it 
electronically to FDA and you will be able to print a copy of your 
cover sheet showing your unique PIN.
    Step Three--Send the payment for your application as described in 
section VIII.A.
    Step Four--Please submit your application and a copy of the 
completed Animal Generic 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 and Sponsor Fees

    By December 31, 2021, FDA will issue invoices and payment 
instructions for product and sponsor fees for FY 2022 using this fee 
schedule. Fees will be due by January 31, 2022. FDA will issue invoices 
in November 2022 for any products and sponsors subject to fees for FY 
2022 that qualify for fees after the December 2021 billing.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15642 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


