Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024, 72767-72771 [2023-23374]
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Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices
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 righthand 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
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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/animaldrug-user-fee-act-adufa/animal-druguser-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
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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
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.
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,
Lisa.Kable@fda.hhs.gov, or visit FDA’s
website at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/default.htm.
For general questions, you may also
email the Center for Veterinary
SUMMARY:
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Medicine (CVM) at cvmagdufa@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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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
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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)).
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III. Abbreviated Application Fee and
JINAD File Fee Calculations for FY
2024
A. Fee Revenues and Numbers of FeePaying 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 feepaying 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
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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
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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
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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
Fee rate for
FY 2024
User fee category
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) of the FD&C
Act ....................................................................................................................................................................................................
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) of the FD&C Act ...............
JINAD File Fee ....................................................................................................................................................................................
Generic New Animal Drug Product Fee ..............................................................................................................................................
100% Generic New Animal Drug Sponsor Fee 1 ................................................................................................................................
75% Generic New Animal Drug Sponsor Fee 1 ..................................................................................................................................
50% Generic New Animal Drug Sponsor Fee 1 ..................................................................................................................................
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
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$126,582
63,291
50,000
$16,393
258,331
193,748
129,166
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
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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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23OCN1.SGM
23OCN1
Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
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/AnimalGeneric
DrugUserFeeActAGDUFA/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.
VerDate Sep<11>2014
17:24 Oct 20, 2023
Jkt 262001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cardiovascular Sciences.
Date: November 16, 2023.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Margaret Chandler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4126,
MSC 7814, Bethesda, MD 20892, (301) 435–
1743, margaret.chandler@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Infection Immunology,
Immune Tolerance, and Transplantation.
Date: November 20, 2023.
Time: 12:00 p.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Xinrui Li, Ph.D., Scientific
Review Officer, Center for Scientific Review,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
72771
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 594–2084,
xinrui.li@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Nephrology and Urology.
Date: December 7, 2023.
Time: 9:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Stacey Nicole Williams,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 867–5309, stacey.williams@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR:
Countermeasures Against Chemical Threats
Exploratory/Developmental and Full
Projects.
Date: December 7–8, 2023.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jodie Michelle Fleming,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 812R,
Bethesda, MD 20892, (301) 867–5309,
flemingjm@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 17, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–23325 Filed 10–20–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 72770]]
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
------------------------------------------------------------------------
Fee rate for
User fee category FY 2024
------------------------------------------------------------------------
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
[[Page 72771]]
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
