[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45323-45328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16174]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1620]


Animal Generic Drug User Fee Rates and Payment Procedures for 
Fiscal Year 2023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the fee rates and payment procedures for fiscal year (FY) 
2023 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 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs. This notice 
establishes the fee rates for FY 2023.

DATES: The application fee rates are effective for all abbreviated 
applications for a generic new animal drug submitted on or after 
October 1, 2022, and will remain in effect through September 30, 2023.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/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 protected]. For general questions, you 
may also email FDA's Center for Veterinary Medicine (CVM) at: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) as amended by 
AGDUFA III, 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 FYs 2019 through 2023, the FD&C Act establishes the base 
revenue amount for each fiscal year (21 U.S.C. 379j-21(b)(1)). 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)). Fees for applications, 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) 25 percent shall be derived from fees for abbreviated applications 
for a generic new animal drug; (2) 37.5 percent shall be derived from 
fees for generic new animal drug products; and (3) 37.5 percent shall 
be derived from fees for generic new animal drug sponsors (21 U.S.C. 
379j-

[[Page 45324]]

21(b)(2)). The target revenue amounts for each fee category for FY 
2023, are as follows: for application fees, the target revenue amount 
is $7,325,750; for product fees, the target revenue amount is 
$10,988,625; and for sponsor fees, the target revenue amount is 
$10,988,625.
    For FY 2023, the generic new animal drug user fee rates are: 
$494,983 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)); $247,492 for each abbreviated 
application for a generic new animal drug subject to the criteria in 
section 512(d)(4) of the FD&C Act; $18,881 for each generic new animal 
drug product; $283,870 for each generic new animal drug sponsor paying 
100 percent of the sponsor fee; $212,903 for each generic new animal 
drug sponsor paying 75 percent of the sponsor fee; and $141,935 for 
each generic new animal drug sponsor paying 50 percent of the sponsor 
fee. FDA will issue invoices for FY 2023 product and sponsor fees by 
December 31, 2022, and payment will be due by January 31, 2023. The 
application fee rates are effective for all abbreviated applications 
for a generic new animal drug submitted on or after October 1, 2022, 
and will remain in effect through September 30, 2023. Applications will 
not be accepted for review until FDA has received full payment of 
application fees and any other fees owed under the AGDUFA program.

II. Revenue Amount for FY 2023

A. Statutory Fee Revenue Amount

    AGDUFA III, Title II of Public Law 115-234, specifies that the 
aggregate base fee revenue amount for FY 2023 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, provides the percent change from the previous fiscal 
year, and provides the average percent change over the first 3 of the 4 
fiscal years preceding FY 2023. The 3-year average is 1.3918 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                                                                                      3-year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,620,052,000    $2,875,592,000    $3,039,513,000  ..............
Total FTE.................................             17144             17535             18501  ..............
PC&B per FTE..............................          $152,826          $163,992          $164,829  ..............
Percent Change From Previous Year.........          -3.3120%           7.3063%           0.1811%         1.3918%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.3918 percent should be multiplied 
by the proportion of PC&B costs to total FDA costs. Table 2 shows the 
amount of PC&B and the total amount obligated by FDA for the same 3 
FYs.

                                Table 2--PC&B as a Percent of Total Costs at FDA
----------------------------------------------------------------------------------------------------------------
                                                                                                      3-year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,620,052,000    $2,875,592,000    $3,039,513,000  ..............
Total Costs...............................    $5,663,389,000    $6,039,321,000    $6,049,798,000  ..............
PC&B Percent..............................          46.2630%          47.6145%          50.2416%        48.0397%
----------------------------------------------------------------------------------------------------------------

    The portion of the inflation adjustment relating to payroll costs 
is 1.3918 percent multiplied by 48.0397 percent, or 0.6686 percent.
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs is the average annual percent change that 
occurred in the Consumer Price Index (CPI) for urban consumers 
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items 
less food and energy; annual index) for the first 3 of the preceding 4 
years of available data multiplied by the average proportion of all 
costs other than PC&B costs to total FDA costs for the first 3 of the 4 
preceding fiscal years. As a result of a geographical revision made by 
the Bureau of Labor 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 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 are shown in table 3.
---------------------------------------------------------------------------

    \1\ Available at: https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

[[Page 45325]]



  Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI, Less Food and
                                                     Energy
----------------------------------------------------------------------------------------------------------------
                                                                                                      3-Year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................            275.84            278.44            287.14  ..............
Annual Percent Change.....................           1.2580%           0.9411%           3.1271%         1.7754%
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-payroll costs, we 
multiply 1.7754 percent by the proportion of all costs other than PC&B 
to total FDA costs. Since 48.0397 percent was obligated for PC&B as 
shown in table 2, 51.9603 percent is the portion of costs other than 
PC&B (100 percent minus 48.0397 percent equals 51.9603 percent). The 
portion of the inflation adjustment relating to non-payroll costs is 
1.7754 percent times 51.9603 percent, or 0.9225 percent.
    Next, we add the payroll component (0.6686 percent) to the non-
payroll component (0.9225 percent), for an inflation adjustment of 
1.5911 percent for FY 2023.
    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 2023 (1.5911 percent) is compounded by 
adding 1 and then multiplying by 1 plus the inflation adjustment factor 
for FY 2022 (5.7121 percent), as published in the Federal Register on 
July 23, 2021 (86 FR 39028), which equals 1.0739 (rounded) (1.0159 
times 1.0571) for FY 2023. We then multiply the base revenue amount for 
FY 2023 ($18,336,340) by 1.073941, yielding an inflation adjusted 
amount of $19,692,147.

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, 2022.
    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 77.5221 percent 
for FY 2023. This is the workload adjuster for FY 2023.

                                     Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
                                     Column 1        Column 2        Column 3        Column 4        Column 5
                                 -------------------------------------------------------------------------------
        Application type              5-year
                                  average  (base   Latest 5-year  Percent change     Weighting       Weighted
                                      years)          average                         factor      percent change
----------------------------------------------------------------------------------------------------------------
Abbreviated Application for a              24.00           27.00         12.5000            0.15          1.8953
 Generic New Animal Drug
 (ANADAs).......................
Manufacturing Supplements ANADAs          169.40          219.60         29.6340            0.24          7.2536
Generic Investigational Study              69.20          155.40        124.5665            0.46         57.2176
 Submissions....................
Generic Investigational Protocol           34.40           61.00         77.3256            0.14         11.1556
 Submissions....................
                                 -------------------------------------------------------------------------------
    FY 2023 AGDUFA III Workload   ..............  ..............  ..............  ..............        77.52221
     Adjuster...................
----------------------------------------------------------------------------------------------------------------

    The statutory revenue amount after the inflation adjustment 
($19,692,147) must now be increased by 77.5221 percent to reflect the 
changes in review workload (workload adjustment), for a workload and 
inflation-adjusted amount of $34,957,913.

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 ($34,957,913) is subtracted by the inflation 
adjusted amount ($19,692,147) to get the workload adjustment amount 
($15,265,766). Then the excess fees collected from FY 2021 as of May 
31, 2022 ($5,655,218) are subtracted from the workload adjustment 
amount ($15,265,766) to get a reduced workload adjustment amount of 
$9,610,548. Next, the reduced workload adjustment amount ($9,610,548) 
is added to the inflation-adjusted revenue amount ($19,692,147), for a 
total fee revenue target of $29,303,000 (rounded to the nearest 
thousand dollars).

E. Final Year Adjustment

    For FY 2023, FDA may, in addition to other adjustments under 
section 741(c) of the FD&C Act, further increase the fees, if such an 
adjustment is necessary, to provide for up to 3 months of

[[Page 45326]]

operating reserves of carryover user fees for the process for the 
review of generic animal drug applications for the first 3 months of FY 
2024. If FDA has carryover balances for the process for the review of 
generic new animal drug applications in excess of 3 months of such 
operating reserves, then this adjustment will not be made (see 21 
U.S.C. 379j-21(c)(4)). Since FDA currently has an excess of 3 months of 
such operating reserves, this adjustment will not be made for FY 2023.

F. FY 2023 Fee Revenue Amounts

    AGDUFA III specifies that the revenue amount of $29,303,000 for FY 
2023 is to be divided as follows: 25 percent, or a total of $7,325,750, 
is to come from application fees; 37.5 percent, or a total of 
$10,988,625, is to come from product fees; and 37.5 percent, or a total 
of $10,988,625, is to come from sponsor fees (21 U.S.C. 379j-21(b)).

III. Abbreviated Application Fee Calculations for FY 2023

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 $7,325,750 in 
fee revenue for FY 2023.
    To set fees for abbreviated applications for generic new animal 
drugs to realize $7,325,750, FDA must first make some assumptions about 
the number of fee-paying abbreviated applications it will receive 
during FY 2023.
    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 2023, FDA is assuming that the number of 
applications for which fees will be paid in FY 2023 will equal the 
average number of applications over the 5 most recently completed 
fiscal years of the AGDUFA program (FY 2017-FY 2021).
    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 11.6 applications not subject to the criteria 
in section 512(d)(4) of the FD&C Act and 6.4 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 14.80 anticipated full fees.
    Based on the previous assumptions, FDA is estimating that it will 
receive a total of 14.80 fee-paying generic new animal drug 
applications in FY 2023 (11.6 original applications paying a full fee 
and 6.4 applications paying a half fee).

B. Application Fee Rates for FY 2023

    FDA must set the fee rates for FY 2023 so that the estimated 14.80 
abbreviated applications that pay the fee will generate a total of 
$7,325,750. To generate this amount, the fee for a generic new animal 
drug application will have to be $494,983 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 $247,492.

IV. Generic New Animal Drug Product Fee Calculations for FY 2023

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 $10,988,625 
in fee revenue for FY 2023.
    To set generic new animal drug product fees to realize $10,988,625, 
FDA must make some assumptions about the number of products for which 
these fees will be paid in FY 2023. FDA gathered data on all 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 
2022, FDA estimates that there is a total of 588 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 588 products will be subject to this fee in FY 
2023.
    In estimating the fee revenue to be generated by generic new animal 
drug product fees in FY 2023, FDA is estimating that 1 percent of the 
products invoiced, or 6 products, will qualify for a 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.
    Accordingly, the Agency estimates that a total of 582 (588 minus 6) 
products will be subject to product fees in FY 2023.

B. Product Fee Rates for FY 2023

    FDA must set the fee rates for FY 2023 so that the estimated 582 
products for which fees are paid will generate a total of $10,988,625. 
To generate this amount will require the fee for a generic new animal 
drug product, rounded to the nearest dollar, to be $18,881.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2023

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

[[Page 45327]]

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)). 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 six approved abbreviated applications will pay 100 
percent of the sponsor fee; applicants with more than one and fewer 
than seven approved abbreviated applications will pay 75 percent of the 
sponsor fee; and applicants with one 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 $10,988,625 in fee revenue for FY 2023.
    To set generic new animal drug sponsor fees to realize $10,988,625, 
FDA must make some assumptions about the number of sponsors who will 
pay these fees in FY 2023. FDA estimates that in FY 2023, 12 sponsors 
will pay 100 percent fees, 18 sponsors will pay 75 percent fees, and 28 
sponsors will pay 50 percent fees. That results in the equivalent of 
39.5 full sponsor fees (12 times 100 percent or 12, plus 18 times 75 
percent or 13.5, plus 28 times 50 percent or 14).
    FDA estimates that about 2 percent of all of these sponsors, or 
0.79, 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 FYs of the AGDUFA program.
    Accordingly, the Agency estimates that the equivalent of 38.71 full 
sponsor fees (39.5 minus 0.79) are likely to be paid in FY 2023.

B. Sponsor Fee Rates for FY 2023

    FDA must set the fee rates for FY 2023 so that the estimated 
equivalent of 38.71 full sponsor fees will generate a total of 
$10,988,625. To generate this amount will require the 100 percent fee 
for a generic new animal drug sponsor, rounded to the nearest dollar, 
to be $283,870. Accordingly, the fee for those paying 75 percent of the 
full sponsor fee will be $212,903, and the fee for those paying 50 
percent of the full sponsor fee will be $141,935.

VI. Fee Schedule for FY 2023

    The fee rates for FY 2023 are summarized in table 5.

                       Table 5--FY 2023 Fee Rates
------------------------------------------------------------------------
                                                         Fee rate for FY
       Generic new animal drug user fee category              2023
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal              $494,983
 Drug except those subject to the criteria in section
 512(d)(4)............................................
Abbreviated Application Fee for Generic New Animal               247,492
 Drug subject to the criteria in section 512(d)(4)....
Generic New Animal Drug Product Fee...................            18,881
100% Generic New Animal Drug Sponsor Fee \1\..........           283,870
75% Generic New Animal Drug Sponsor Fee \1\...........           212,903
50% Generic New Animal Drug Sponsor Fee \1\...........           141,935
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one such 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 2023. 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 2023 Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2023 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, 2022. The payment must be 
made in U.S. currency from a U.S. bank by one of the following methods: 
wire transfer, electronically, check, bank draft, or U.S. postal money 
order made payable to the Food and Drug Administration. The preferred 
payment method is online using electronic check (Automated Clearing 
House (ACH), also known as eCheck) or credit card (Discover, VISA, 
MasterCard, American Express). Secure electronic payments can be 
submitted using the User Fees Payment Portal at 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 find 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 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 ``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, 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

[[Page 45328]]

transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., 
New York, NY 10045, Account Name: Food and Drug Administration, Account 
Number: 75060099, U.S. Department of the Treasury routing/transit 
number: 021030004, SWIFT Number: FRNYUS33.
    To send a check by a courier such as FedEx, the courier must 
deliver the check and printed copy of the cover sheet to: U.S. Bank, 
Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 
63101. (Note: This address is for courier delivery only. If you have 
any questions concerning courier delivery, contact U.S. Bank at 314-
418-4013. This telephone number is only for questions about courier 
delivery.)
    It is important that the fee arrives at the bank at least a day or 
two before the 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 U.S. Department of the Treasury are 
required to notify FDA within 1 working day, using the PIN described 
previously.
    The tax identification number of FDA is 53-0196965.

B. Application Cover Sheet Procedures

    Step One: Create a user account and password. Log onto the AGDUFA 
website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and, under Application 
Submission Information, click on ``Create AGDUFA 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 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 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 VIII.A.
    Step Four: Submit your application.

C. Product and Sponsor Fees

    By December 31, 2022, FDA will issue invoices and payment 
instructions for product and sponsor fees for FY 2023 using this fee 
schedule. Payment will be due by January 31, 2023. FDA will issue 
invoices in November 2023 for any products and sponsors subject to fees 
for FY 2023 that qualify for fees after the December 2022 billing.

    Dated: July 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16174 Filed 7-27-22; 8:45 am]
BILLING CODE 4164-01-P


