Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2024, 72763-72767 [2023-23373]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Pages 72763-72767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23373]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4488]


Animal Drug User Fee 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 animal 
drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as 
amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), 
authorizes FDA to collect user fees for certain animal drug 
applications and supplemental animal drug applications, for certain 
animal drug products, for certain establishments where such products 
are made, and for certain sponsors of such animal drug applications 
and/or investigational animal drug submissions. This notice establishes 
the fee rates for FY 2024.

DATES: The application fee rates are effective for applications 
submitted on or after October 1, 2023, and will remain in effect 
through September 30, 2024.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 740 of the FD&C Act (21 U.S.C. 379j-12), as amended by 
ADUFA V, establishes four different types of user fees: (1) fees for 
certain types of animal drug applications and supplemental animal drug 
applications; (2) annual fees for certain animal drug products; (3) 
annual fees for certain establishments where such products are made; 
and (4) annual fees for certain sponsors of animal drug applications 
and/or investigational animal drug submissions (21 U.S.C. 379j-12(a)). 
When certain conditions are met, FDA will waive or reduce fees (21 
U.S.C. 379j-12(d)).
    For FYs 2024 through 2028, the FD&C Act establishes the base 
revenue amount for each fiscal year (21 U.S.C. 379j-12(b)(1)). 
Beginning in FY 2025, the base revenue amount is subject to adjustment 
for inflation and workload (21 U.S.C. 379j-12(c)(2) and (3)). Also 
beginning in FY 2025, ADUFA V provides for an operating reserve 
adjustment to allow FDA to adjust the fee revenue amount to maintain a 
specified operating reserve of carryover user fees (21 U.S.C. 379j-
12(c)(4)). FDA may increase the fee revenue amount to maintain a 12-
week minimum. If FDA has an excess operating reserve, FDA will decrease 
the fee revenue amount so that FDA has 22 weeks of operating reserve 
for FY 2025, 20 weeks for FY 2026, 18 weeks for FY 2027, and 16 weeks 
for FY 2028.
    Fees for applications, establishments, products, and sponsors are 
to be established each year by FDA so that the percentages of the total 
revenue that are derived from each type of user fee will be as follows: 
(1) revenue from application fees shall be 20 percent of total fee 
revenue; (2) revenue from product fees shall be 27 percent of total fee 
revenue; (3) revenue from establishment fees shall be 26 percent of 
total fee revenue; and (4) revenue from sponsor fees shall be 27 
percent of total fee revenue (21 U.S.C. 379jndash;12(b)(2)). The fee 
revenue amount for FY 2024 is $33,500,000 (21 U.S.C. 379j-12(b)(1)). 
The target revenue amounts for each fee category for FY 2024 are as 
follows: for application fees, the target revenue amount is $6,700,000; 
for product fees, the target revenue amount is $9,045,000; for 
establishment fees, the target revenue amount is $8,710,000; and for 
sponsor fees, the target revenue amount is $9,045,000.
    For FY 2024, the animal drug user fee rates are: $683,673 for an 
animal drug application; $341,837 for a supplemental animal drug 
application for which safety or effectiveness data are required, for an 
animal drug application subject to the criteria set forth in section 
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)), and for an 
application for conditional approval under section 571 of the FD&C Act 
(21 U.S.C. 360ccc) for which an animal drug application submitted under 
section 512(b)(1) of the FD&C Act has been previously approved under 
section 512(d)(1) of the FD&C Act for another intended use; $12,459 for 
the annual product fee; $174,200 for the annual establishment fee; and 
$153,305 for the annual sponsor fee. FDA will issue invoices for FY 
2024 product, establishment, and sponsor fees by December 31, 2023, and 
payment will be due by January 31, 2024. The application fee rates are 
effective for applications submitted on or after October 1, 2023, and 
will remain in effect through September 30, 2024.

[[Page 72764]]

Applications will not be accepted for review until FDA has received 
full payment of application fees and any other animal drug user fees 
owed under the ADUFA program.

II. Revenue Amount for FY 2024

A. Statutory Fee Revenue Amounts

    ADUFA V, Title III of Public Law 118-15, specifies that the 
aggregate base fee revenue amount for FY 2024 for all animal drug user 
fee categories is $33,500,000 (21 U.S.C. 379j-12(b)(1)).

B. Inflation Adjustment to Fee Revenue Amount

    ADUFA V 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-12(c)(2)). Since ADUFA V 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 ADUFA V 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-12(c)(3)). Since ADUFA 
V does not adjust for workload until FY 2025, there is no workload 
adjustment for FY 2024.

D. Operating Reserve Adjustment

    For fiscal year 2025 and each subsequent fiscal year, after the fee 
revenue amount established under section 740(b) of the FD&C Act is 
adjusted for inflation and workload, the Secretary shall increase the 
fee revenue amount for such fiscal year, if necessary to provide an 
operating reserve of not less than 12 weeks. If the operating reserve 
is in excess of the number of weeks specified in section 740(c)(4)(C) 
of the FD&C Act for that fiscal year, the Secretary shall decrease the 
fee revenue amount to provide not more than the number of weeks 
specified for that fiscal year. Since ADUFA V does not adjust for the 
operating reserve until FY 2025, there is no adjustment for FY 2024.

E. FY 2024 Fee Revenue Amounts

    The fee revenue amount for FY 2024 is $33,500,000. ADUFA V 
specifies that this revenue amount is to be divided as follows: 20 
percent, or a total of $6,700,000, is to come from application fees; 27 
percent, or a total of $9,045,000, is to come from product fees; 26 
percent, or a total of $8,710,000 is to come from establishment fees; 
and 27 percent, or a total of $9,045,000 is to come from sponsor fees 
(21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY 2024

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

    Each person that submits an animal drug application or a 
supplemental animal drug application shall be subject to an application 
fee, with limited exceptions (see 21 U.S.C. 379j-12(a)(1)). The term 
``animal drug application'' means an application for approval of any 
new animal drug submitted under section 512(b)(1) of the FD&C Act or an 
application for conditional approval of a new animal drug submitted 
under section 571 of the FD&C Act (see section 739(1) of the FD&C Act 
(21 U.S.C. 379j-11(1)). A ``supplemental animal drug application'' is 
defined as a request to FDA to approve a change in an approved animal 
drug application, or a request to FDA to approve a change to an 
application approved under section 512(c)(2) of the FD&C Act for which 
data with respect to safety or effectiveness are required. Such 
applications are subject to ADUFA fees, except those fees may be waived 
if the application is intended solely to provide for a minor use or 
minor species (MUMS) indication (see 21 U.S.C. 379j-12(d)(1)(D)).
    Furthermore, ADUFA V continues to provide an exception from 
application fees for animal drug applications submitted under section 
512(b)(1) of the FD&C Act by a sponsor who previously applied for 
conditional approval under section 571 of the FD&C Act for the same 
product and paid an application fee at the time they applied for 
conditional approval. The purpose of this exception is to prevent 
sponsors of conditionally approved products from having to pay a second 
application fee at the time they apply for full approval of their 
products under section 512(b)(1) of the FD&C Act, provided the 
sponsor's application for full approval is filed consistent with the 
timeframes established in section 571(h) of the FD&C Act (see 21 U.S.C. 
379j-12(a)(1)(C)(ii)).
    The application fees are to be set so that they will generate 
$6,700,000 in fee revenue for FY 2024. The fee for a supplemental 
animal drug application for which safety or effectiveness data are 
required, for an animal drug application subject to criteria set forth 
in section 512(d)(4) of the FD&C Act, and for an application for 
conditional approval under section 571 of the FD&C Act of a new animal 
drug for which an animal drug application submitted under section 
512(b)(1) of the FD&C Act has been previously approved under section 
512(d)(1) for another intended use is to be set at 50 percent of the 
animal drug application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)).
    To set animal drug application fees and supplemental animal drug 
application fees to realize $6,700,000, FDA must first make some 
assumptions about the number of fee-paying applications and 
supplemental applications the Agency will receive in FY 2024.
    The Agency knows the number of applications that have been 
submitted in previous fiscal years. That number fluctuates annually. In 
estimating the fee revenue to be generated by animal drug application 
fees in FY 2024, FDA is assuming that the number of applications for 
which fees will be paid in FY 2024 will equal the average number of 
applications over the 5 most recently completed fiscal years of the 
ADUFA program (FY 2018 to FY 2022).
    Over the 5 most recently completed fiscal years, the average number 
of animal drug applications subject to the full fee was 5.20. Over this 
same period, the average number of supplemental applications for which 
safety or effectiveness data are required, applications subject to the 
criteria set forth in section 512(d)(4) of the FD&C Act, and 
applications for conditional approval of a new animal drug for which a 
section 512(b)(1) application has been previously approved for another 
intended use subject to half of the full fee was 9.20.
    Based on the previous assumptions, FDA is estimating that it will 
receive a total of 9.80 fee-paying animal drug applications in FY 2024 
(5.20 applications paying a full fee and 9.20 applications paying a 
half fee).

B. Application Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 9.80 
applications that pay the fee will generate a total of $6,700,000. To 
generate this amount, the fee for an animal drug application, rounded 
to the nearest dollar, will have to be $683,673, and the fee for a 
supplemental animal drug application for which safety or effectiveness 
data are required, for applications subject to the criteria set forth 
in section 512(d)(4) of the FD&C Act, and for an application for 
conditional approval under section 571 of the FD&C Act of a new animal 
drug for which an animal drug application submitted under section 
512(b)(1) of the FD&C Act has been previously approved under section 
512(d)(1) for another intended use will have to be $341,837.

[[Page 72765]]

IV. Animal Drug Product Fee Calculations for FY 2024

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

    The animal drug product fee must be paid annually by the person 
named as the applicant in a new animal drug application or supplemental 
new animal drug application for an animal drug product submitted for 
listing under section 510 of the FD&C Act (21 U.S.C. 360) and who had 
an animal drug application or supplemental animal drug application 
pending at FDA after September 1, 2003 (21 U.S.C. 379j-12(a)(2)). The 
term ``animal drug product'' means each specific strength or potency of 
a particular active ingredient or ingredients in final dosage form 
marketed by a particular manufacturer or distributor, which is uniquely 
identified by the labeler code and product code portions of the 
National Drug Code, and for which an animal drug application or a 
supplemental animal drug application has been approved (21 U.S.C. 379j-
11(3)). The product fees are to be set so that they will generate 
$9,045,000 in fee revenue for FY 2024.
    To set animal drug product fees to realize $9,045,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2024. FDA developed data on all animal drug products 
that have been submitted for listing under section 510 of the FD&C Act 
and matched this to the list of all persons who had an animal drug 
application or supplemental animal drug application pending after 
September 1, 2003. As of May 2023, FDA estimates that there are 733 
products submitted for listing by persons who had an animal drug 
application or supplemental animal drug application pending after 
September 1, 2003. Based on this, FDA estimates that a total of 733 
products will be subject to this fee in FY 2024.
    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2024, FDA is assuming that 1 percent of the products 
invoiced, or seven, will not pay fees in FY 2024, due to fee waivers 
and reductions. FDA has made this estimate at 1 percent this year, 
based on historical data over the past 5 completed fiscal years of the 
ADUFA program.
    Accordingly, the Agency estimates that a total of 726 (733 minus 7) 
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 726 
products for which fees are paid will generate a total of $9,045,000. 
To generate this amount will require the fee for an animal drug 
product, rounded to the nearest dollar, to be $12,459.

V. Animal Establishment Fee Calculations for FY 2024

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

    The animal drug establishment fee must be paid annually by the 
person who: (1) owns or operates, directly or through an affiliate, an 
animal drug establishment; (2) is named as the applicant in an animal 
drug application or supplemental animal drug application for an animal 
drug product submitted for listing under section 510 of the FD&C Act; 
(3) had an animal drug application or supplemental animal drug 
application pending at FDA after September 1, 2003; and (4) whose 
establishment engaged in the manufacture of the animal drug product 
during the fiscal year (see 21 U.S.C. 379j-12(a)(3)). An establishment 
subject to animal drug establishment fees is assessed only one such fee 
per fiscal year. The term ``animal drug establishment'' is defined as a 
foreign or domestic place of business at one general physical location, 
consisting of one or more buildings, all of which are within 5 miles of 
each other, at which one or more animal drug products are manufactured 
in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are 
to be set so that they will generate $8,710,000 in fee revenue for FY 
2024.
    To set animal drug establishment fees to realize $8,710,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2024. FDA developed data on all animal 
drug establishments and matched this to the list of all persons who had 
an animal drug application or supplemental animal drug application 
pending after September 1, 2003. As of May 2023, FDA estimates that 
there are a total of 53 establishments owned or operated by persons who 
had an animal drug application or supplemental animal drug application 
pending after September 1, 2003. Based on this, FDA believes that 53 
establishments will be subject to this fee in FY 2024.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2024, FDA is assuming that 6 percent of the 
establishments invoiced, or three, will not pay fees in FY 2024 due to 
fee waivers and reductions. FDA has made this estimate at 6 percent 
this year, based on historical data over the past 5 completed fiscal 
years.
    Accordingly, the Agency estimates that a total of 50 establishments 
(53 minus 3) will be subject to establishment fees in FY 2024.

B. Establishment Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the fees paid for 
the estimated 50 establishments will generate a total of $8,710,000. To 
generate this amount will require the fee for an animal drug 
establishment, rounded to the nearest dollar, to be $174,200.

VI. Animal Drug Sponsor Fee Calculations for FY 2024

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

    The animal drug sponsor fee must be paid annually by each person 
who: (1) is named as the applicant in an animal drug application, 
except for an approved application for which all subject products have 
been removed from listing under section 510 of the FD&C Act, or has 
submitted an investigational animal drug submission that has not been 
terminated or otherwise rendered inactive and (2) had an animal drug 
application, supplemental animal drug application, or investigational 
animal drug submission pending at FDA after September 1, 2003 (see 21 
U.S.C. 379j-11(6) and 379j-12(a)(4)). An animal drug sponsor is subject 
to only one such fee each fiscal year (see 21 U.S.C. 379j-12(a)(4)). 
The sponsor fees are to be set so that they will generate $9,045,000 in 
fee revenue for FY 2024.
    To set animal drug sponsor fees to realize $9,045,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2024. FDA developed data on all animal drug sponsors and 
matched this to the list of all sponsors who had pending submissions 
and applications after September 1, 2003. As of May, 2023, FDA 
estimates that a total of 179 sponsors will meet this definition in FY 
2024.
    In estimating the fee revenue to be generated by animal drug 
sponsor fees in FY 2024, FDA is assuming that 67 percent of the 
sponsors invoiced, or 120, will not pay sponsor fees in FY 2024 due to 
fee waivers and reductions. FDA has made this estimate at 67 percent 
this year, based on historical data over the past 5 completed fiscal 
years of the ADUFA program.
    Accordingly, the Agency estimates that a total of 59 sponsors (179 
minus 120) will be subject to and pay sponsor fees in FY 2024.

[[Page 72766]]

B. Sponsor Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 59 
sponsors that pay fees will generate a total of $9,045,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest dollar, to be $153,305.

VII. 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
              Animal drug user fee category                   FY 2024
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Animal Drug Application Fees:
    Animal Drug Application.............................        $683,673
    Supplemental Animal Drug Application for Which               341,837
     Safety or Effectiveness Data are Required, Animal
     Drug Application Subject to the Criteria Set Forth
     in Section 512(d)(4) of the FD&C Act, or
     Application for Conditional Approval Under Section
     571 of the FD&C Act for Which an Animal Drug
     Application Submitted Under Section 512(b)(1) of
     the FD&C Act Has Been Previously Approved Under
     Section 512(d)(1) for Another Intended Use.........
Animal Drug Product Fee.................................          12,459
Animal Drug Establishment Fee \1\.......................         174,200
Animal Drug Sponsor Fee \2\.............................         153,305
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\1\ An animal drug establishment is subject to only one such fee each
  fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

VIII. Fee Waiver or Reduction; Exemption From Fees

    The types of fee waivers, fee reductions, and exemptions from fees 
that applied during ADUFA IV still exist in ADUFA V, with one 
exception. No longer available is the exemption for a supplemental 
animal drug application relating to a new animal drug application 
approved under section 512 of the FD&C Act, solely to add the 
application number to the labeling of the drug in the manner specified 
in section 503(w) of the FD&C Act (21 U.S.C. 352(w)).
    Remaining waivers and reductions apply for the following: barriers 
to innovation; where fees will exceed the cost to review the animal 
drug application; if the application is related to certain free-choice 
medicated feeds; if the application is solely for a MUMS indication; or 
if the sponsor is a small business submitting its first animal drug 
application. See section 740(d)(1) of the FD&C Act.

A. Barrier to Innovation Waivers or Fee Reductions

    Under section 740(d)(1)(A) of the FD&C Act, an animal drug 
applicant may qualify for a waiver or reduction of one or more ADUFA 
fees if the fee would present a significant barrier to innovation 
because of limited resources available to the applicant or other 
circumstances. CVM's guidance for industry (GFI) #170, entitled 
``Animal Drug User Fees and Fee Waivers and Reductions,'' \1\ states 
that the Agency interprets this provision to mean that a waiver or 
reduction is appropriate when: (1) the product for which the waiver is 
being requested is innovative, or the requestor is otherwise pursuing 
innovative animal drug products or technology, and (2) the fee would be 
a significant barrier to the applicant's ability to develop, 
manufacture, or market the innovative product or technology. Only those 
applicants that meet both of these criteria will qualify for a waiver 
or reduction in user fees under this provision (see GFI #170 at pp. 6-
8). For purposes of determining whether the second criterion would be 
met on the basis of limited financial resources available to the 
applicant, FDA has determined an applicant with financial resources of 
less than $20,000,000 (including the financial resources of the 
applicant's affiliates), adjusted annually for inflation, has limited 
resources available. Using the Consumer Price Index for urban consumers 
(U.S. city average; not seasonally adjusted; all items; annual index), 
the inflation-adjusted level for FY 2024 will be $22,796,000; this 
level represents the financial resource ceiling that will be used to 
determine if there are limited resources available to an applicant 
requesting a Barrier to Innovation waiver on financial grounds for FY 
2024. Requests for a waiver need to be submitted to FDA each fiscal 
year not later than 180 days from when the fees are due. A waiver 
granted on Barrier to Innovation grounds (or any of the other grounds 
listed in section 740(d)(1) of the FD&C Act) is only valid for 1 fiscal 
year. If a sponsor is not granted a waiver, they are liable for the 
fees.
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    \1\ CVM's GFI #170 is located at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
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B. Exemption or Exception From Fees

    In addition to the waivers and fee reductions described above, one 
fee exemption and two exceptions still apply in ADUFA V.
    If an animal drug application, supplemental animal drug 
application, or investigational submission involves the intentional 
genomic alteration of an animal that is intended to produce a human 
medical product, any person who is the named applicant or sponsor of 
that application or submission will not be subject to sponsor, product, 
or establishment fees under ADUFA based solely on that application or 
submission (21 U.S.C. 379j-12(d)(4)).
    There is an exception from application fees for animal drug 
applications submitted under section 512(b)(1) of the FD&C Act by a 
sponsor who previously applied for conditional approval under section 
571 of the FD&C Act for the same product and paid an application fee at 
the time they applied for conditional approval, provided the sponsor 
has submitted the application under section 512(b)(1) of the FD&C Act 
within the timeframe specified in section 571(h) of the FD&C Act. There 
is also an exception from application fees for previously filed 
applications that were not approved or were withdrawn (without waiver 
or refund). Both exceptions are detailed in section 740(a)(1)(C) of the 
FD&C Act.

IX. Procedures for Paying the FY 2024 Fees

A. Application Fees and Payment Instructions

    The FY 2024 fee established in the new fee schedule must be paid 
for an animal drug application or supplement subject to fees under 
ADUFA V that is submitted on or after 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,

[[Page 72767]]

electronically, check, bank draft, or U.S. postal money order made 
payable to the Food and Drug Administration. The preferred payment 
method is online using electronic check (Automated Clearing House (ACH) 
also known as eCheck) or credit card (Discover, VISA, MasterCard, 
American Express). Secure electronic payments can be submitted using 
the User Fees Payment Portal at https://userfees.fda.gov/pay, or the 
Pay.gov payment option is available to you after you submit a cover 
sheet. (Note: Only full payments are accepted. No partial payments can 
be made online.) Once you search for and find your invoice, select 
``Pay Now'' to be redirected to www.pay.gov. Electronic payment options 
are based on the balance due. Payment by credit card is available only 
for balances that are less than $25,000. If the balance exceeds this 
amount, only the ACH option is available. Payments must be made using 
U.S. bank accounts as well as U.S. credit cards.
    When paying by check, bank draft, or U.S. postal money order, 
please write your application's unique Payment Identification Number 
(PIN), beginning with the letters AD, on the upper right-hand corner of 
your completed Animal Drug User Fee Cover Sheet. Also write the FDA'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 Drug User Fee Cover Sheet to: Food and Drug 
Administration, P.O. Box 979033, St. Louis, MO 63197-9000. Note: In no 
case should the payment for the fee be submitted to FDA with the 
application.
    When paying by wire transfer, the invoice number or PIN needs to be 
included. Without the invoice number or PIN, the payment may not be 
applied, and the invoice amount would be referred to collections. The 
originating financial institution may charge a wire transfer fee. If 
the financial institution charges a wire transfer fee, it is required 
to add that amount to the payment to ensure that the invoice is paid in 
full.
    Use the following account information when sending a payment by 
wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty 
St., New York, NY 10045, 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 Rider Trail S., 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 application arrives at FDA's CVM. FDA records the 
official application receipt date as the later of the following: the 
date the application was received by 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 receipt of an 
electronic or wire transfer 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 on to the ADUFA 
website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet and, under Application Submission 
Information, click on ``Create ADUFA User Fee Cover Sheet.'' For 
security reasons, each firm submitting an application will be assigned 
an organization identification number, and each user will also be 
required to set up a user account and password the first time you use 
this site. Online instructions will walk you through this process.
    Step Two: Create an Animal Drug User Fee Cover Sheet, transmit it 
to FDA, and print a copy. After logging into your account with your 
username and password, complete the steps required to create an Animal 
Drug User Fee Cover Sheet. One cover sheet is needed for each animal 
drug application or supplement. Once you are satisfied that the data on 
the cover sheet are accurate and you have finalized the cover sheet, 
you will be able to transmit it electronically to FDA and you will be 
able to print a copy of your cover sheet showing your unique PIN.
    Step Three: Send the payment for your application as described in 
section IX.A.
    Step Four: Submit your application.

C. Product, Establishment, and Sponsor Fees

    By December 31, 2023, FDA will issue invoices and payment 
instructions for product, establishment, 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, establishments, 
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. 2023-23373 Filed 10-20-23; 8:45 am]
BILLING CODE 4164-01-P