Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices 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 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 

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 

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. 

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, 

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 


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Medicine (CVM) at cvmagdufa@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 741 of the FD&C Act (21 

U.S.C. 379j–21) establishes 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 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 

fee for a new JINAD file request or the 

first submission to an existing (prior to 

October 1, 2023) JINAD file is $50,000 

under section 741(c)(1)(C) of the FD&C 

Act. Therefore, the JINAD fees will 

generate a total of $3,000,000. 

Abbreviated application fees will have 

to generate a total of $2,000,000. 

To generate this amount, the fee for a 

generic new animal drug application 

will have to be $126,582 and for those 

applications that are subject to the 

criteria set forth in section 512(d)(4) of 

the FD&C Act, 50 percent of that 

amount, or $63,291. 

IV. Generic New Animal Drug Product 

Fee Calculations for FY 2024 

A. Product Fee Revenues and Numbers 

of Fee-Paying Products 

The generic new animal drug product 

fee must be paid annually by the person 

named as the applicant in an 

abbreviated application or supplemental 

abbreviated application for a generic 

new animal drug product submitted for 

listing under section 510 of the FD&C 

Act (21 U.S.C. 360), and who had an 

abbreviated application or supplemental 

abbreviated application for a generic 

new animal drug product pending at 

FDA after September 1, 2008 (see 21 

U.S.C. 379j–21(a)(2)). The term ‘‘generic 

new animal drug product’’ means each 

specific strength or potency of a 

particular active ingredient or 

ingredients in final dosage form 

marketed by a particular manufacturer 

or distributor, which is uniquely 

identified by the labeler code and 

product code portions of the National 

Drug Code, and for which an 

abbreviated application for a generic 

new animal drug or supplemental 

abbreviated application for a generic 

new animal drug has been approved (21 

U.S.C. 379j–21(k)(6)). The product fees 

are to be set so that they will generate 

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

To set generic new animal drug 

product fees to realize $10,000,000, FDA 

must make some assumptions about the 

number of products for which these fees 

will be paid in FY 2024. FDA gathered 

data on all generic new animal drug 

products that have been submitted for 

listing under section 510 of the FD&C 

Act and matched this to the list of all 

persons who FDA estimated would have 

a generic new animal drug application 

or supplemental abbreviated application 

pending after September 1, 2008. As of 

May 2023, FDA estimates that there is 

a total of 616 products submitted for 

listing by persons who had an 

abbreviated application for a generic 

new animal drug or supplemental 

abbreviated application for a generic 

new animal drug pending after 

September 1, 2008. Based on this, FDA 

believes that a total of 616 products will 

be subject to this fee in FY 2024. 

In estimating the fee revenue to be 

generated by generic new animal drug 

product fees in FY 2024, FDA is 

estimating that 1 percent of the products 

invoiced, or 6 products, will qualify for 

minor use/minor species fee waiver (see 

21 U.S.C. 379j–21(d)). FDA has made 

this estimate at 1 percent this year, 

based on historical data over the past 5 

completed fiscal years of the AGDUFA 

program. 

Accordingly, the Agency estimates 

that a total of 610 (616 minus 6) 

products will be subject to product fees 

in FY 2024. 

B. Product Fee Rates for FY 2024 

FDA must set the fee rates for FY 2024 

so that the estimated 610 products for 

which fees are paid will generate a total 

of $10,000,000. To generate this amount 

will require the fee for a generic new 

animal drug product, rounded to the 

nearest dollar, to be $16,393. 

V. Generic New Animal Drug Sponsor 

Fee Calculations for FY 2024 

A. Sponsor Fee Revenues and Numbers 

of Fee-Paying Sponsors 

The generic new animal drug sponsor 

fee must be paid annually by each 

person who: (1) is named as the 

applicant in an abbreviated application 

for a generic new animal drug, except 

for an approved application for which 

all subject products have been removed 

from listing under section 510 of the 

FD&C Act, or has submitted an 

investigational submission for a generic 

new animal drug that has not been 

terminated or otherwise rendered 

inactive and (2) had an abbreviated 

application for a generic new animal 

drug, supplemental abbreviated 

application for a generic new animal 

drug, or investigational submission for a 

generic new animal drug pending at 

FDA after September 1, 2008 (see 21 

U.S.C. 379j–21(k)(7) and 379j–21(a)(3)). 

A generic new animal drug sponsor is 

subject to only one such fee each fiscal 

year (see 21 U.S.C. 379j–21(a)(3)(C)). 

Applicants with more than 6 approved 

abbreviated applications will pay 100 

percent of the sponsor fee; applicants 

with more than 1 and fewer than 7 

approved abbreviated applications will 

pay 75 percent of the sponsor fee; and 

applicants with 1 or fewer approved 

abbreviated applications will pay 50 

percent of the sponsor fee (see 21 U.S.C. 

379j–21(a)(3)(C)). The sponsor fees are 

to be set so that they will generate 

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


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To set generic new animal drug 

sponsor fees to realize $10,000,000, FDA 

must make some assumptions about the 

number of sponsors who will pay these 

fees in FY 2024. FDA developed data on 

all generic new animal drug sponsors 

and matched this to the list of all 

sponsors who had pending submissions 

and applications after September 1, 

2008. As of May, 2023, FDA estimates 

that in FY 2024, 12 sponsors will pay 

100 percent fees, 18 sponsors will pay 

75 percent fees, and 28 sponsors will 

pay 50 percent fees. The total of these 

figures is the equivalent of 39.5 full 

sponsor fees (12 times 100 percent or 

12, plus 18 times 75 percent or 13.5 plus 

28 times 50 percent or 14). 

FDA estimates that about 2 percent of 

all of these sponsors, or 0.79, may 

qualify for a minor use/minor species 

fee waiver (see 21 U.S.C. 379j–21(d)). 

FDA has made the estimate of the 

percentage of sponsors that will not pay 

fees at 2 percent this year, based on 

historical data over the past 5 completed 

fiscal years of the AGDUFA program. 

Accordingly, the Agency estimates 

that the equivalent of 38.71 full sponsor 

fees (39.5 minus 0.79) are likely to be 

paid in FY 2024. 

B. Sponsor Fee Rates for FY 2024 

FDA must set the fee rates for FY 2024 

so that the estimated equivalent of 38.71 

full sponsor fees will generate a total of 

$10,000,000. To generate this amount 

will require the 100 percent fee for a 

generic new animal drug sponsor, 

rounded to the nearest dollar, to be 

$258,331. Accordingly, the fee for those 

paying 75 percent of the full sponsor fee 

will be $193,748, and the fee for those 

paying 50 percent of the full sponsor fee 

will be $129,166. 

VI. Fee Schedule for FY 2024 

The fee rates for FY 2024 are 

summarized in table 1. 

TABLE 1—FY 2024 FEE RATES

User fee category Fee rate for 

FY 2024 

Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) of the FD&C 

Act .................................................................................................................................................................................................... $126,582 

Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) of the FD&C Act ............... 63,291 

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 

1An animal drug sponsor is subject to only one fee each fiscal year. 

VII. Fee Waiver or Reduction; 

Exemption From Fees 

The types of fee waivers and 

reductions that applied last fiscal year 

still exist for FY 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices 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/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. 

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, 

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 


lotter on DSK11XQN23PROD with NOTICES1