Federal Register / Vol. 88, No. 203 / Monday, October 23, 2023 / Notices 72763 

four years. CDC requests information 

from states regarding children’s cavity 

risk, one-year sealant retention rate, 

sealant program services delivered, and 

school sealant program cost and 

quantity of resources used at each 

school event. This data will allow CDC 

and states to monitor the performance 

and efficiency of their school sealant 

programs, which will improve and 

extend program delivery to more 

children. 

CDC requests OMB approval for a 

Reinstatement of a previously approved 

data collection. The total estimated 

annualized burden hours requested are 

1,388. There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

State Sealant Administrator .................................. Add Program and Add User ................................. 18 1 45/60 

SSP Local Administrator ....................................... Add User and Add School ................................... 162 1 43/60 

SSP Local Administrator ....................................... Program Options and Cost Options ..................... 162 1 46/60 

SSP Local Administrator ....................................... Add Event ............................................................. 162 20 21/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–23339 Filed 10–20–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4488] 

Animal Drug User Fee Rates and 

Payment Procedures for Fiscal Year 

2024 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the fee rates and payment 

procedures for fiscal year (FY) 2024 

animal drug user fees. The Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Animal Drug 

User Fee Amendments of 2023 (ADUFA 

V), authorizes FDA to collect user fees 

for certain animal drug applications and 

supplemental animal drug applications, 

for certain animal drug products, for 

certain establishments where such 

products are made, and for certain 

sponsors of such animal drug 

applications and/or investigational 

animal drug submissions. This notice 

establishes the fee rates for FY 2024. 

DATES: The application fee rates are 

effective for applications submitted on 

or after October 1, 2023, and will remain 

in effect through September 30, 2024. 

FOR FURTHER INFORMATION CONTACT: Visit 

FDA’s website at https://www.fda.gov/ 

ForIndustry/UserFees/AnimalDrug

UserFeeActADUFA/default.htm or 

contact Lisa Kable, Center for Veterinary 

Medicine (HFV–10), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–6888, 

Lisa.Kable@fda.hhs.gov. For general 

questions, you may also email FDA’s 

Center for Veterinary Medicine (CVM) 

at: cvmadufa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 740 of the FD&C Act (21 

U.S.C. 379j–12), as amended by ADUFA 

V, establishes four different types of 

user fees: (1) fees for certain types of 

animal drug applications and 

supplemental animal drug applications; 

(2) annual fees for certain animal drug 

products; (3) annual fees for certain 

establishments where such products are 

made; and (4) annual fees for certain 

sponsors of animal drug applications 

and/or investigational animal drug 

submissions (21 U.S.C. 379j–12(a)). 

When certain conditions are met, FDA 

will waive or reduce fees (21 U.S.C. 

379j–12(d)). 

For FYs 2024 through 2028, the FD&C 

Act establishes the base revenue amount 

for each fiscal year (21 U.S.C. 379j– 

12(b)(1)). Beginning in FY 2025, the 

base revenue amount is subject to 

adjustment for inflation and workload 

(21 U.S.C. 379j–12(c)(2) and (3)). Also 

beginning in FY 2025, ADUFA V 

provides for an operating reserve 

adjustment to allow FDA to adjust the 

fee revenue amount to maintain a 

specified operating reserve of carryover 

user fees (21 U.S.C. 379j–12(c)(4)). FDA 

may increase the fee revenue amount to 

maintain a 12-week minimum. If FDA 

has an excess operating reserve, FDA 

will decrease the fee revenue amount so 

that FDA has 22 weeks of operating 

reserve for FY 2025, 20 weeks for FY 

2026, 18 weeks for FY 2027, and 16 

weeks for FY 2028. 

Fees for applications, establishments, 

products, and sponsors are to be 

established each year by FDA so that the 

percentages of the total revenue that are 

derived from each type of user fee will 

be as follows: (1) revenue from 

application fees shall be 20 percent of 

total fee revenue; (2) revenue from 

product fees shall be 27 percent of total 

fee revenue; (3) revenue from 

establishment fees shall be 26 percent of 

total fee revenue; and (4) revenue from 

sponsor fees shall be 27 percent of total 

fee revenue (21 U.S.C. 

379jndash;12(b)(2)). The fee revenue 

amount for FY 2024 is $33,500,000 (21 

U.S.C. 379j–12(b)(1)). The target revenue 

amounts for each fee category for FY 

2024 are as follows: for application fees, 

the target revenue amount is $6,700,000; 

for product fees, the target revenue 

amount is $9,045,000; for establishment 

fees, the target revenue amount is 

$8,710,000; and for sponsor fees, the 

target revenue amount is $9,045,000. 

For FY 2024, the animal drug user fee 

rates are: $683,673 for an animal drug 

application; $341,837 for a 

supplemental animal drug application 

for which safety or effectiveness data are 

required, for an animal drug application 

subject to the criteria set forth in section 

512(d)(4) of the FD&C Act (21 U.S.C. 

360b(d)(4)), and for an application for 

conditional approval under section 571 

of the FD&C Act (21 U.S.C. 360ccc) for 

which an animal drug application 

submitted under section 512(b)(1) of the 

FD&C Act has been previously approved 

under section 512(d)(1) of the FD&C Act 

for another intended use; $12,459 for 

the annual product fee; $174,200 for the 

annual establishment fee; and $153,305 

for the annual sponsor fee. FDA will 

issue invoices for FY 2024 product, 

establishment, and sponsor fees by 

December 31, 2023, and payment will 

be due by January 31, 2024. The 

application fee rates are effective for 

applications submitted on or after 

October 1, 2023, and will remain in 

effect through September 30, 2024. 


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Applications will not be accepted for 

review until FDA has received full 

payment of application fees and any 

other animal drug user fees owed under 

the ADUFA program. 

II. Revenue Amount for FY 2024 

A. Statutory Fee Revenue Amounts 

ADUFA V, Title III of Public Law 

118–15, specifies that the aggregate base 

fee revenue amount for FY 2024 for all 

animal drug user fee categories is 

$33,500,000 (21 U.S.C. 379j–12(b)(1)). 

B. Inflation Adjustment to Fee Revenue 

Amount 

ADUFA V specifies that the annual 

fee revenue amount is to be adjusted for 

inflation increases for FY 2025 and 

subsequent fiscal years (21 U.S.C. 379j– 

12(c)(2)). Since ADUFA V does not 

adjust for inflation until FY 2025, there 

is no inflation adjustment for FY 2024. 

C. Workload Adjustment to Inflation 

Adjusted Fee Revenue Amount 

The fee revenue amounts established 

in ADUFA V for FY 2025 and 

subsequent fiscal years are also subject 

to adjustment to account for changes in 

FDA’s review workload (21 U.S.C. 379j– 

12(c)(3)). Since ADUFA V does not 

adjust for workload until FY 2025, there 

is no workload adjustment for FY 2024. 

D. Operating Reserve Adjustment 

For fiscal year 2025 and each 

subsequent fiscal year, after the fee 

revenue amount established under 

section 740(b) of the FD&C Act is 

adjusted for inflation and workload, the 

Secretary shall increase the fee revenue 

amount for such fiscal year, if necessary 

to provide an operating reserve of not 

less than 12 weeks. If the operating 

reserve is in excess of the number of 

weeks specified in section 740(c)(4)(C) 

of the FD&C Act for that fiscal year, the 

Secretary shall decrease the fee revenue 

amount to provide not more than the 

number of weeks specified for that fiscal 

year. Since ADUFA V does not adjust 

for the operating reserve until FY 2025, 

there is no adjustment for FY 2024. 

E. FY 2024 Fee Revenue Amounts 

The fee revenue amount for FY 2024 

is $33,500,000. ADUFA V specifies that 

this revenue amount is to be divided as 

follows: 20 percent, or a total of 

$6,700,000, is to come from application 

fees; 27 percent, or a total of $9,045,000, 

is to come from product fees; 26 

percent, or a total of $8,710,000 is to 

come from establishment fees; and 27 

percent, or a total of $9,045,000 is to 

come from sponsor fees (21 U.S.C. 379j– 

12(b)). 

III. Application Fee Calculations for FY 

2024 

A. Application Fee Revenues and 

Numbers of Fee-Paying Applications 

Each person that submits an animal 

drug application or a supplemental 

animal drug application shall be subject 

to an application fee, with limited 

exceptions (see 21 U.S.C. 379j–12(a)(1)). 

The term ‘‘animal drug application’’ 

means an application for approval of 

any new animal drug submitted under 

section 512(b)(1) of the FD&C Act or an 

application for conditional approval of 

a new animal drug submitted under 

section 571 of the FD&C Act (see section 

739(1) of the FD&C Act (21 U.S.C. 379j– 

11(1)). A ‘‘supplemental animal drug 

application’’ is defined as a request to 

FDA to approve a change in an 

approved animal drug application, or a 

request to FDA to approve a change to 

an application approved under section 

512(c)(2) of the FD&C Act for which 

data with respect to safety or 

effectiveness are required. Such 

applications are subject to ADUFA fees, 

except those fees may be waived if the 

application is intended solely to provide 

for a minor use or minor species 

(MUMS) indication (see 21 U.S.C. 379j– 

12(d)(1)(D)). 

Furthermore, ADUFA V continues to 

provide an exception from application 

fees for animal drug applications 

submitted under section 512(b)(1) of the 

FD&C Act by a sponsor who previously 

applied for conditional approval under 

section 571 of the FD&C Act for the 

same product and paid an application 

fee at the time they applied for 

conditional approval. The purpose of 

this exception is to prevent sponsors of 

conditionally approved products from 

having to pay a second application fee 

at the time they apply for full approval 

of their products under section 512(b)(1) 

of the FD&C Act, provided the sponsor’s 

application for full approval is filed 

consistent with the timeframes 

established in section 571(h) of the 

FD&C Act (see 21 U.S.C. 379j– 

12(a)(1)(C)(ii)). 

The application fees are to be set so 

that they will generate $6,700,000 in fee 

revenue for FY 2024. The fee for a 

supplemental animal drug application 

for which safety or effectiveness data are 

required, for an animal drug application 

subject to criteria set forth in section 

512(d)(4) of the FD&C Act, and for an 

application for conditional approval 

under section 571 of the FD&C Act of a 

new animal drug for which an animal 

drug application submitted under 

section 512(b)(1) of the FD&C Act has 

been previously approved under section 

512(d)(1) for another intended use is to 

be set at 50 percent of the animal drug 

application fee (21 U.S.C. 379j– 

12(a)(1)(A)(ii)). 

To set animal drug application fees 

and supplemental animal drug 

application fees to realize $6,700,000, 

FDA must first make some assumptions 

about the number of fee-paying 

applications and supplemental 

applications the Agency will receive in 

FY 2024. 

The Agency knows the number of 

applications that have been submitted 

in previous fiscal years. That number 

fluctuates annually. In estimating the 

fee revenue to be generated by animal 

drug application fees in FY 2024, FDA 

is assuming that the number of 

applications for which fees will be paid 

in FY 2024 will equal the average 

number of applications over the 5 most 

recently completed fiscal years of the 

ADUFA program (FY 2018 to FY 2022). 

Over the 5 most recently completed 

fiscal years, the average number of 

animal drug applications subject to the 

full fee was 5.20. Over this same period, 

the average number of supplemental 

applications for which safety or 

effectiveness data are required, 

applications subject to the criteria set 

forth in section 512(d)(4) of the FD&C 

Act, and applications for conditional 

approval of a new animal drug for 

which a section 512(b)(1) application 

has been previously approved for 

another intended use subject to half of 

the full fee was 9.20. 

Based on the previous assumptions, 

FDA is estimating that it will receive a 

total of 9.80 fee-paying animal drug 

applications in FY 2024 (5.20 

applications paying a full fee and 9.20 

applications paying a half fee). 

B. Application Fee Rates for FY 2024 

FDA must set the fee rates for FY 2024 

so that the estimated 9.80 applications 

that pay the fee will generate a total of 

$6,700,000. To generate this amount, the 

fee for an animal drug application, 

rounded to the nearest dollar, will have 

to be $683,673, and the fee for a 

supplemental animal drug application 

for which safety or effectiveness data are 

required, for applications subject to the 

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

the FD&C Act, and for an application for 

conditional approval under section 571 

of the FD&C Act of a new animal drug 

for which an animal drug application 

submitted under section 512(b)(1) of the 

FD&C Act has been previously approved 

under section 512(d)(1) for another 

intended use will have to be $341,837. 


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IV. Animal Drug Product Fee 

Calculations for FY 2024 

A. Product Fee Revenues and Numbers 

of Fee-Paying Products 

The animal drug product fee must be 

paid annually by the person named as 

the applicant in a new animal drug 

application or supplemental new animal 

drug application for an animal drug 

product submitted for listing under 

section 510 of the FD&C Act (21 U.S.C. 

360) and who had an animal drug 

application or supplemental animal 

drug application pending at FDA after 

September 1, 2003 (21 U.S.C. 379j– 

12(a)(2)). The term ‘‘animal drug 

product’’ means each specific strength 

or potency of a particular active 

ingredient or ingredients in final dosage 

form marketed by a particular 

manufacturer or distributor, which is 

uniquely identified by the labeler code 

and product code portions of the 

National Drug Code, and for which an 

animal drug application or a 

supplemental animal drug application 

has been approved (21 U.S.C. 379j– 

11(3)). The product fees are to be set so 

that they will generate $9,045,000 in fee 

revenue for FY 2024. 

To set animal drug product fees to 

realize $9,045,000, FDA must make 

some assumptions about the number of 

products for which these fees will be 

paid in FY 2024. FDA developed data 

on all animal drug products that have 

been submitted for listing under section 

510 of the FD&C Act and matched this 

to the list of all persons who had an 

animal drug application or 

supplemental animal drug application 

pending after September 1, 2003. As of 

May 2023, FDA estimates that there are 

733 products submitted for listing by 

persons who had an animal drug 

application or supplemental animal 

drug application pending after 

September 1, 2003. Based on this, FDA 

estimates that a total of 733 products 

will be subject to this fee in FY 2024. 

In estimating the fee revenue to be 

generated by animal drug product fees 

in FY 2024, FDA is assuming that 1 

percent of the products invoiced, or 

seven, will not pay fees in FY 2024, due 

to fee waivers and reductions. FDA has 

made this estimate at 1 percent this 

year, based on historical data over the 

past 5 completed fiscal years of the 

ADUFA program. 

Accordingly, the Agency estimates 

that a total of 726 (733 minus 7) 

products will be subject to product fees 

in FY 2024. 

B. Product Fee Rates for FY 2024 

FDA must set the fee rates for FY 2024 

so that the estimated 726 products for 

which fees are paid will generate a total 

of $9,045,000. To generate this amount 

will require the fee for an animal drug 

product, rounded to the nearest dollar, 

to be $12,459. 

V. Animal Establishment Fee 

Calculations for FY 2024 

A. Establishment Fee Revenues and 

Numbers of Fee-Paying Establishments 

The animal drug establishment fee 

must be paid annually by the person 

who: (1) owns or operates, directly or 

through an affiliate, an animal drug 

establishment; (2) is named as the 

applicant in an animal drug application 

or supplemental animal drug 

application for an animal drug product 

submitted for listing under section 510 

of the FD&C Act; (3) had an animal drug 

application or supplemental animal 

drug application pending at FDA after 

September 1, 2003; and (4) whose 

establishment engaged in the 

manufacture of the animal drug product 

during the fiscal year (see 21 U.S.C. 

379j–12(a)(3)). An establishment subject 

to animal drug establishment fees is 

assessed only one such fee per fiscal 

year. The term ‘‘animal drug 

establishment’’ is defined as a foreign or 

domestic place of business at one 

general physical location, consisting of 

one or more buildings, all of which are 

within 5 miles of each other, at which 

one or more animal drug products are 

manufactured in final dosage form (21 

U.S.C. 379j–11(4)). The establishment 

fees are to be set so that they will 

generate $8,710,000 in fee revenue for 

FY 2024. 

To set animal drug establishment fees 

to realize $8,710,000, FDA must make 

some assumptions about the number of 

establishments for which these fees will 

be paid in FY 2024. FDA developed data 

on all animal drug establishments and 

matched this to the list of all persons 

who had an animal drug application or 

supplemental animal drug application 

pending after September 1, 2003. As of 

May 2023, FDA estimates that there are 

a total of 53 establishments owned or 

operated by persons who had an animal 

drug application or supplemental 

animal drug application pending after 

September 1, 2003. Based on this, FDA 

believes that 53 establishments will be 

subject to this fee in FY 2024. 

In estimating the fee revenue to be 

generated by animal drug establishment 

fees in FY 2024, FDA is assuming that 

6 percent of the establishments 

invoiced, or three, will not pay fees in 

FY 2024 due to fee waivers and 

reductions. FDA has made this estimate 

at 6 percent this year, based on 

historical data over the past 5 completed 

fiscal years. 

Accordingly, the Agency estimates 

that a total of 50 establishments (53 

minus 3) will be subject to 

establishment fees in FY 2024. 

B. Establishment Fee Rates for FY 2024 

FDA must set the fee rates for FY 2024 

so that the fees paid for the estimated 50 

establishments will generate a total of 

$8,710,000. To generate this amount 

will require the fee for an animal drug 

establishment, rounded to the nearest 

dollar, to be $174,200. 

VI. Animal Drug Sponsor Fee 

Calculations for FY 2024 

A. Sponsor Fee Revenues and Numbers 

of Fee-Paying Sponsors 

The animal drug sponsor fee must be 

paid annually by each person who: (1) 

is named as the applicant in an animal 

drug application, except for an 

approved application for which all 

subject products have been removed 

from listing under section 510 of the 

FD&C Act, or has submitted an 

investigational animal drug submission 

that has not been terminated or 

otherwise rendered inactive and (2) had 

an animal drug application, 

supplemental animal drug application, 

or investigational animal drug 

submission pending at FDA after 

September 1, 2003 (see 21 U.S.C. 379j– 

11(6) and 379j–12(a)(4)). An animal 

drug sponsor is subject to only one such 

fee each fiscal year (see 21 U.S.C. 379j– 

12(a)(4)). The sponsor fees are to be set 

so that they will generate $9,045,000 in 

fee revenue for FY 2024. 

To set animal drug sponsor fees to 

realize $9,045,000, FDA must make 

some assumptions about the number of 

sponsors who will pay these fees in FY 

2024. FDA developed data on all animal 

drug sponsors and matched this to the 

list of all sponsors who had pending 

submissions and applications after 

September 1, 2003. As of May, 2023, 

FDA estimates that a total of 179 

sponsors will meet this definition in FY 

2024. 

In estimating the fee revenue to be 

generated by animal drug sponsor fees 

in FY 2024, FDA is assuming that 67 

percent of the sponsors invoiced, or 120, 

will not pay sponsor fees in FY 2024 

due to fee waivers and reductions. FDA 

has made this estimate at 67 percent this 

year, based on historical data over the 

past 5 completed fiscal years of the 

ADUFA program. 

Accordingly, the Agency estimates 

that a total of 59 sponsors (179 minus 

120) will be subject to and pay sponsor 

fees in FY 2024. 


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1CVM’s GFI #170 is located at: https://

www.fda.gov/downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/UCM052494.pdf. 

B. Sponsor Fee Rates for FY 2024 

FDA must set the fee rates for FY 2024 

so that the estimated 59 sponsors that 

pay fees will generate a total of 

$9,045,000. To generate this amount 

will require the fee for an animal drug 

sponsor, rounded to the nearest dollar, 

to be $153,305. 

VII. Fee Schedule for FY 2024 

The fee rates for FY 2024 are 

summarized in table 1. 

TABLE 1—FY 2024 FEE RATES

Animal drug user fee category Fee rate for 

FY 2024 

Animal Drug Application Fees: 

Animal Drug Application ............................................................................................................................................................... $683,673 

Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required, Animal Drug Application Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act, or Application for Conditional Approval Under Section 

571 of the FD&C Act for Which an Animal Drug Application Submitted Under Section 512(b)(1) of the FD&C Act Has 

Been Previously Approved Under Section 512(d)(1) for Another Intended Use ..................................................................... 341,837 

Animal Drug Product Fee .................................................................................................................................................................... 12,459 

Animal Drug Establishment Fee 1 ........................................................................................................................................................ 174,200 

Animal Drug Sponsor Fee 2 ................................................................................................................................................................. 153,305 

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

2An animal drug sponsor is subject to only one such fee each fiscal year. 

VIII. Fee Waiver or Reduction; 

Exemption From Fees 

The types of fee waivers, fee 

reductions, and exemptions from fees 

that applied during ADUFA IV still exist 

in ADUFA V, with one exception. No 

longer available is the exemption for a 

supplemental animal drug application 

relating to a new animal drug 

application approved under section 512 

of the FD&C Act, solely to add the 

application number to the labeling of 

the drug in the manner specified in 

section 503(w) of the FD&C Act (21 

U.S.C. 352(w)). 

Remaining waivers and reductions 

apply for the following: barriers to 

innovation; where fees will exceed the 

cost to review the animal drug 

application; if the application is related 

to certain free-choice medicated feeds; if 

the application is solely for a MUMS 

indication; or if the sponsor is a small 

business submitting its first animal drug 

application. See section 740(d)(1) of the 

FD&C Act. 

A. Barrier to Innovation Waivers or Fee 

Reductions 

Under section 740(d)(1)(A) of the 

FD&C Act, an animal drug applicant 

may qualify for a waiver or reduction of 

one or more ADUFA fees if the fee 

would present a significant barrier to 

innovation because of limited resources 

available to the applicant or other 

circumstances. CVM’s guidance for 

industry (GFI) #170, entitled ‘‘Animal 

Drug User Fees and Fee Waivers and 

Reductions,’’ 1 states that the Agency 

interprets this provision to mean that a 

waiver or reduction is appropriate 

when: (1) the product for which the 

waiver is being requested is innovative, 

or the requestor is otherwise pursuing 

innovative animal drug products or 

technology, and (2) the fee would be a 

significant barrier to the applicant’s 

ability to develop, manufacture, or 

market the innovative product or 

technology. Only those applicants that 

meet both of these criteria will qualify 

for a waiver or reduction in user fees 

under this provision (see GFI #170 at 

pp. 6–8). For purposes of determining 

whether the second criterion would be 

met on the basis of limited financial 

resources available to the applicant, 

FDA has determined an applicant with 

financial resources of less than 

$20,000,000 (including the financial 

resources of the applicant’s affiliates), 

adjusted annually for inflation, has 

limited resources available. Using the 

Consumer Price Index for urban 

consumers (U.S. city average; not 

seasonally adjusted; all items; annual 

index), the inflation-adjusted level for 

FY 2024 will be $22,796,000; this level 

represents the financial resource ceiling 

that will be used to determine if there 

are limited resources available to an 

applicant requesting a Barrier to 

Innovation waiver on financial grounds 

for FY 2024. Requests for a waiver need 

to be submitted to FDA each fiscal year 

not later than 180 days from when the 

fees are due. A waiver granted on 

Barrier to Innovation grounds (or any of 

the other grounds listed in section 

740(d)(1) of the FD&C Act) is only valid 

for 1 fiscal year. If a sponsor is not 

granted a waiver, they are liable for the 

fees. 

B. Exemption or Exception From Fees 

In addition to the waivers and fee 

reductions described above, one fee 

exemption and two exceptions still 

apply in ADUFA V. 

If an animal drug application, 

supplemental animal drug application, 

or investigational submission involves 

the intentional genomic alteration of an 

animal that is intended to produce a 

human medical product, any person 

who is the named applicant or sponsor 

of that application or submission will 

not be subject to sponsor, product, or 

establishment fees under ADUFA based 

solely on that application or submission 

(21 U.S.C. 379j–12(d)(4)). 

There is an exception from 

application fees for animal drug 

applications submitted under section 

512(b)(1) of the FD&C Act by a sponsor 

who previously applied for conditional 

approval under section 571 of the FD&C 

Act for the same product and paid an 

application fee at the time they applied 

for conditional approval, provided the 

sponsor has submitted the application 

under section 512(b)(1) of the FD&C Act 

within the timeframe specified in 

section 571(h) of the FD&C Act. There 

is also an exception from application 

fees for previously filed applications 

that were not approved or were 

withdrawn (without waiver or refund). 

Both exceptions are detailed in section 

740(a)(1)(C) of the FD&C Act. 

IX. Procedures for Paying the FY 2024 

Fees 

A. Application Fees and Payment 

Instructions 

The FY 2024 fee established in the 

new fee schedule must be paid for an 

animal drug application or supplement 

subject to fees under ADUFA V that is 

submitted on or after October 1, 2023. 

The payment must be made in U.S. 

currency from a U.S. bank by one of the 

following methods: wire transfer, 


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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 


lotter on DSK11XQN23PROD with NOTICES1