[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Pages 72767-72771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4468]


Animal Generic Drug User Fee Program Rates and Payment Procedures 
for Fiscal Year 2024

AGENCY: Food and Drug Administration, 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) 2024 generic 
new animal drug program user fees. The Federal Food, Drug, and Cosmetic 
Act (FD&C Act), as amended by the Animal Generic Drug User Fee 
Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for 
certain abbreviated applications for generic new animal drugs, for 
certain generic new animal drug products, for certain sponsors of such 
abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs, and for 
certain submissions related to generic investigational new animal drug 
(JINAD) files. This notice establishes the fee rates for FY 2024.

DATES: The application fee rates are effective for all abbreviated 
applications for a generic new animal drug submitted on or after 
October 1, 2023, and will remain in effect through September 30, 2024. 
The fee rates for requests to establish a JINAD file, and for certain 
submissions to JINAD files established prior to October 1, 2023, are 
effective on October 1, 2023, and will remain in effect through 
September 30, 2024.

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, [email protected], 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 72768]]

Medicine (CVM) at [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes four 
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; (3) annual fees for certain sponsors 
of abbreviated applications for generic new animal drugs and/or 
investigational submissions for generic new animal drugs; and (4) JINAD 
file fees (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 2024 through FY 2028, the FD&C Act establishes a base 
revenue amount for each fiscal year (21 U.S.C. 379j-21(b)(1)). Base 
revenue amounts established for fiscal years after FY 2024 are subject 
to adjustment for inflation and workload. Workload increases will be 
adjusted for excess collections after FY 2025 (21 U.S.C. 379j-21(c)). 
Fees are to be established each year by FDA so that the percentage 
allocations for each of the fee categories is as follows: 20 percent 
shall be derived from fees for abbreviated applications for a generic 
new animal drug and JINAD file fees; 40 percent shall be derived from 
fees for generic new animal drug products; and 40 percent shall be 
derived from fees for generic new animal drug sponsors (21 U.S.C. 379j-
21(b)). The target revenue amounts for each fee category for FY 2024, 
are as follows: for application and/or JINAD file fees, the target 
revenue amount is $5,000,000; for product fees, the target revenue 
amount is $10,000,000; and for sponsor fees, the target revenue amount 
is $10,000,000.
    For FY 2024, the AGDUFA rates are: $126,582 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)); $63,291 for each abbreviated application for a generic new 
animal drug subject to the criteria in section 512(d)(4) of the FD&C 
Act; $50,000 for each JINAD file request or certain submissions to 
established JINAD files; $16,393 for each generic new animal drug 
product; $258,331 for each generic new animal drug sponsor paying 100 
percent of the sponsor fee; $193,748 for each generic new animal drug 
sponsor paying 75 percent of the sponsor fee; and $129,166 for each 
generic new animal drug sponsor paying 50 percent of the sponsor fee. 
FDA will issue invoices for FY 2024 product and sponsor fees by 
December 31, 2023, and payment will be due by January 31, 2024. The 
application fee rates are effective for all abbreviated applications 
for a generic new animal drug submitted on or after October 1, 2023, 
and will remain in effect through September 30, 2024. The fee rate for 
requests to establish a JINAD file, and for certain submissions to 
JINAD files established prior to October 1, 2023, is effective on 
October 1, 2023, and will remain in effect through September 30, 2024.
    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. Similarly, a request to establish a JINAD file will not 
be accepted for action by FDA until FDA has received full payment of 
all fees owed under the AGDUFA program. (21 U.S.C. 379j-21(e)).

II. Revenue Amount for FY 2024

A. Statutory Fee Revenue Amount

    AGDUFA IV, Title III of Public Law 118-15, specifies that the 
aggregate base fee revenue amount for FY 2024 for all user fee 
categories is $25,000,000 (21 U.S.C. 379j-21(b)(1)).

B. Inflation Adjustment to Fee Revenue Amount

    AGDUFA IV specifies that the annual fee revenue amount is to be 
adjusted for inflation increases for FY 2025 and subsequent fiscal 
years. (21 U.S.C. 379j-21(c)(2)). Since AGDUFA IV does not adjust for 
inflation until FY 2025, there is no inflation adjustment for FY 2024.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in AGDUFA IV for FY 2025 and 
subsequent fiscal years are also subject to adjustment to account for 
changes in FDA's review workload (21 U.S.C. 379j-21(c)(3)(A)). Since 
AGDUFA IV does not adjust for workload until FY 2025, there is no 
workload adjustment for FY 2024.

D. FY 2024 Fee Revenue Amounts

    AGDUFA IV specifies that the revenue amount of $25,000,000 for FY 
2024 is to be divided as follows: 20 percent, or a total of $5,000,000, 
is to come from application and/or JINAD file fees; 40 percent, or a 
total of $10,000,000, is to come from product fees; and 40 percent, or 
a total of $10,000,000, is to come from sponsor fees (21 U.S.C. 379j-
21(b)).

III. Abbreviated Application Fee and JINAD File Fee Calculations for FY 
2024

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

    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. FDA will also assess fees 
related to JINAD files. FDA will assess a fee under section 
741(a)(4)(A)(i) of the FD&C Act when a person submits a request to 
establish a new JINAD file. FDA will assess a fee under section 
741(a)(4)(A)(ii) of the FD&C Act for a person's first submission, as 
described below, to a JINAD file on or after October 1, 2023, where the 
JINAD file had been established prior to that date. The JINAD file fee 
is set in accordance with section 741(c)(1)(C) of the FD&C Act at 
$50,000. FDA will set the abbreviated application fee so that such fees 
combined with the JINAD file fees will generate a combined total of 
$5,000,000 in fee revenue for FY 2024.
    To set fees for abbreviated applications for generic new animal 
drugs, FDA must first make some assumptions about the number of fee-
paying abbreviated applications it will receive during FY 2024, the 
number of requests to establish new JINAD files it will receive during 
FY 2024, and the number of existing (prior to October 1, 2023) JINAD 
files to which it will receive submissions during FY 2024.
    Regarding the fee for a person's first submission to an existing 
(prior to October 1, 2023) JINAD file on or after October 1, 2023, FDA 
intends to assess a fee only for the first data (or ``P'') submission 
to the Bioequivalence (BE) or Chemistry, Manufacturing, and Controls 
(CMC) technical sections of the JINAD file. The Agency has selected P 
submissions to the BE or CMC technical sections as the basis for 
assessing this fee because P submissions to these sections consistently 
entail the substantial use of FDA review hours during the phased review 
process.
    The Agency knows the numbers of applications and submissions that 
have been submitted in previous years. Those numbers fluctuate 
annually. In estimating the fee revenue to be generated by application 
and submission fees in FY 2024, FDA is assuming that the number of 
applications and submissions for which

[[Page 72769]]

fees will be paid in FY 2024 will equal the average number of 
applications and submissions over the 5 most recently completed fiscal 
years of the AGDUFA program (FY 2018 through FY 2022).
    Also, under AGDUFA IV an abbreviated application for a generic new 
animal 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 12.6 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 15.80 anticipated full fees.
    Based on the previous assumptions, FDA is estimating that it will 
receive a total of 15.80 fee-paying generic new animal drug 
applications in FY 2024 (12.6 original applications paying a full fee 
and 6.4 applications paying a half fee).
    For estimating the number of requests to establish a new JINAD file 
and the number of P submissions to the BE or CMC section of an existing 
(prior to October 1, 2023) JINAD file the Agency will receive in FY 
2024, FDA took the average annual number of new JINAD file requests and 
P submissions to the BE or CMC section of an existing JINAD file 
received over the last 5 completed fiscal years. The average annual 
number of requests to establish new JINAD files and P submissions to 
the BE or CMC section of existing JINAD files over the 5 most recently 
completed fiscal years is 60.
    Based on the previous assumptions, FDA is estimating that it will 
receive a total of 60 fee-paying JINAD file submissions in FY 2024 
(including both requests to establish new JINAD files and first P 
submissions to the BE or CMC section of existing (prior to October 1, 
2023) JINAD files).

B. Application Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 15.80 
abbreviated application fees and 60 JINAD file fees will generate a 
total of $5,000,000. The fee for a new JINAD file request or the first 
submission to an existing (prior to October 1, 2023) JINAD file is 
$50,000 under section 741(c)(1)(C) of the FD&C Act. Therefore, the 
JINAD fees will generate a total of $3,000,000. Abbreviated application 
fees will have to generate a total of $2,000,000.
    To generate this amount, the fee for a generic new animal drug 
application will have to be $126,582 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 $63,291.

IV. Generic New Animal Drug Product Fee Calculations for FY 2024

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 $10,000,000 
in fee revenue for FY 2024.
    To set generic new animal drug product fees to realize $10,000,000, 
FDA must make some assumptions about the number of products for which 
these fees will be paid in FY 2024. 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 FDA estimated would have a generic new animal drug application or 
supplemental abbreviated application pending after September 1, 2008. 
As of May 2023, FDA estimates that there is a total of 616 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 616 products will be subject to this fee 
in FY 2024.
    In estimating the fee revenue to be generated by generic new animal 
drug product fees in FY 2024, FDA is estimating that 1 percent of the 
products invoiced, or 6 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.
    Accordingly, the Agency estimates that a total of 610 (616 minus 6) 
products will be subject to product fees in FY 2024.

B. Product Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 610 
products for which fees are paid will generate a total of $10,000,000. 
To generate this amount will require the fee for a generic new animal 
drug product, rounded to the nearest dollar, to be $16,393.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2024

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)).
    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 $10,000,000 in 
fee revenue for FY 2024.

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    To set generic new animal drug sponsor fees to realize $10,000,000, 
FDA must make some assumptions about the number of sponsors who will 
pay these fees in FY 2024. FDA developed data on all generic new animal 
drug sponsors and matched this to the list of all sponsors who had 
pending submissions and applications after September 1, 2008. As of 
May, 2023, FDA estimates that in FY 2024, 12 sponsors will pay 100 
percent fees, 18 sponsors will pay 75 percent fees, and 28 sponsors 
will pay 50 percent fees. The total of these figures is 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 fiscal years 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 2024.

B. Sponsor Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 
equivalent of 38.71 full sponsor fees will generate a total of 
$10,000,000. To generate this amount will require the 100 percent fee 
for a generic new animal drug sponsor, rounded to the nearest dollar, 
to be $258,331. Accordingly, the fee for those paying 75 percent of the 
full sponsor fee will be $193,748, and the fee for those paying 50 
percent of the full sponsor fee will be $129,166.

VI. Fee Schedule for FY 2024

    The fee rates for FY 2024 are summarized in table 1.

                       Table 1--FY 2024 Fee Rates
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                                                           Fee rate for
                    User fee category                         FY 2024
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Abbreviated Application Fee for Generic New Animal Drug         $126,582
 except those subject to the criteria in section
 512(d)(4) of the FD&C Act..............................
Abbreviated Application Fee for Generic New Animal Drug           63,291
 subject to the criteria in section 512(d)(4) of the
 FD&C Act...............................................
JINAD File Fee..........................................          50,000
Generic New Animal Drug Product Fee.....................         $16,393
100% Generic New Animal Drug Sponsor Fee \1\............         258,331
75% Generic New Animal Drug Sponsor Fee \1\.............         193,748
50% Generic New Animal Drug Sponsor Fee \1\.............         129,166
------------------------------------------------------------------------
\1\ An 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 2024 (see 21 U.S.C. 379j-21(d)(1)). However, 
there is no longer an exemption for any person who 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)). This 
exemption was added in AGDUFA III, but is not a part of AGDUFA IV.

VIII. Procedures for Paying FY 2024 Fees

A. Abbreviated Application Fees, JINAD File Fees, and Payment 
Instructions

    The FY 2024 fees established in the new fee schedule must be paid 
for the following applications/submissions that are subject to fees 
under AGDUFA IV and submitted on or after October 1, 2023: a generic 
new animal drug application, a submission requesting to establish a 
JINAD file, or the first BE or CMC submission to a JINAD file that was 
established prior to October 1, 2023. 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 or JINAD file submission.
    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, 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: 
U.S. Bank, Attn: Government Lockbox 979033, 3180

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Rider Trail South, Earth City, MO 63045. (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 and JINAD File Submission 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'' 
and follow the directions. For security reasons, each firm submitting 
an application and/or a JINAD file submission 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 username 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 or JINAD 
file submission. 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 or JINAD file 
submission as described in section VIII.A.
    Step Four: Submit your application or JINAD file submission.

C. Product and Sponsor Fees

    By December 31, 2023, FDA will issue invoices and payment 
instructions for product and sponsor fees for FY 2024 using this fee 
schedule. Payment will be due by January 31, 2024. FDA will issue 
invoices in November 2024 for any products and sponsors subject to fees 
for FY 2024 that qualify for fees after the December 2023 billing.

    Dated: October 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23374 Filed 10-20-23; 8:45 am]
BILLING CODE 4164-01-P