Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40595 

reflect an increase in annual submissions, as reflected in table 1, row 

6. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

MDR Procedures—803.17 ................................................... 1,799 1 1,799 3.3 5,937 

MDR Files—803.18 .............................................................. 1,799 1 1,799 1.5 2,699 

Total .............................................................................. ........................ ........................ ........................ ........................ 8,636 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The number of respondents in table 2 

is based on the MDRs reported to FDA’s 

internal databases recently. We believe 

that the majority of respondents 

(manufacturers, user facilities, and 

importers) have already established 

written procedures and MDR files to 

document complaints and information 

to meet the MDR requirements as part 

of their internal quality control system. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 2

Importer Reporting, Death and Serious Injury—803.40 and 

803.42.

112 25 2,800 0.35 (21 minutes).980 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Number has been rounded. 

The number of respondents for each 

CFR section in table 3 was identified 

from the MDRs reported to FDA’s 

internal databases during the period 

recently. 

Since the publication of the 60 day 

notice we have adjusted our burden 

estimate. Our estimated burden for the 

information collection reflects an 

increase of 155,360 total burden hours 

and a corresponding increase of 

1,566,458 total annual responses. This 

increase corresponds with data obtained 

from our database. 

Dated: July 21, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16034 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0706] 

Animal Drug User Fee Rates and 

Payment Procedures for Fiscal Year 

2022 

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) 2022 

animal drug user fees. The Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Animal Drug 

User Fee Amendments of 2018 (ADUFA 

IV), 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 2022. 

FOR FURTHER INFORMATION CONTACT: Visit 

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

ForIndustry/UserFees/ 

AnimalDrugUserFeeActADUFA/ 

default.htm or contact Lisa Kable, 

Center for Veterinary Medicine (HFV– 

10), Food and Drug Administration, 

7500 Standish Pl., Rockville, MD 20855, 

240–402–6888, 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) 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 2019 through 2023, the FD&C 

Act establishes aggregate yearly base 

revenue amounts for each fiscal year (21 

U.S.C. 379j–12(b)(1)). Base revenue 

amounts are subject to adjustment for 

inflation and workload (21 U.S.C. 379j– 

12(c)(2) and (3)). Beginning with FY 

2021, the annual fee revenue amounts 

are also subject to adjustment to reduce 

workload-based increases by the amount 

of certain excess collections or to 

account for certain collection shortfalls 

(21 U.S.C. 379j–12(c)(3) and (g)(5)). 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 


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1https://www.bls.gov/cpi/additional-resources/ 

geographic-revision-2018.htm. 

total fee revenue; and (4) revenue from 

sponsor fees shall be 27 percent of total 

fee revenue (21 U.S.C. 379j–12(b)(2)). 

For FY 2022, the animal drug user fee 

rates are: $580,569 for an animal drug 

application; $290,284 for a 

supplemental animal drug application 

for which safety or effectiveness data are 

required and 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)); $10,787 for 

an annual product fee; $155,220 for an 

annual establishment fee; and $137,791 

for an annual sponsor fee. FDA will 

issue invoices for FY 2022 product, 

establishment, and sponsor fees by 

December 31, 2021, and payment will 

be due by January 31, 2022. The 

application fee rates are effective for 

applications submitted on or after 

October 1, 2021, and will remain in 

effect through September 30, 2022. 

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 Animal Drug User Fee Act program 

(ADUFA program). 

II. Revenue Amount for FY 2022 

A. Statutory Fee Revenue Amounts 

ADUFA IV, Title I of Public Law 115– 

234, specifies that the aggregate base fee 

revenue amount for FY 2022 for all 

animal drug user fee categories is 

$29,931,240 (21 U.S.C. 379j– 

12(b)(1)(B)). 

B. Inflation Adjustment to Fee Revenue 

Amount 

ADUFA IV specifies that the annual 

fee revenue amount is to be adjusted for 

inflation increases for FY 2020 and 

subsequent fiscal years, using two 

separate adjustments—one for personnel 

compensation and benefits (PC&B) and 

one for non-PC&B costs (21 U.S.C. 379j– 

12(c)(2)(A)(ii) and (iii)). The component 

of the inflation adjustment for payroll 

costs shall be one plus the average 

annual percent change in the cost of all 

PC&B paid per full-time equivalent 

position (FTE) at FDA for the first 3 of 

the 4 preceding fiscal years of available 

data, multiplied by the average 

proportion of PC&B costs to total FDA 

costs for the first 3 of the 4 preceding 

fiscal years. The data on total PC&B paid 

and numbers of FTE paid, from which 

the average cost per FTE can be derived, 

are published in FDA’s Justification of 

Estimates for Appropriations 

Committees. 

Table 1 summarizes that actual cost 

and FTE data for the specified fiscal 

years, and provides the percent change 

from the previous fiscal year and the 

average percent change over the first 3 

of the 4 fiscal years preceding FY 2022. 

The 3-year average is 2.7383 percent. 

TABLE 1—FDA PC&B EACH YEAR AND PERCENT CHANGE

Fiscal year 2018 2019 2020 3-Year average 

Total PC&B ...................................................................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ................................

Total FTE ......................................................................... 17,023 17,144 17,535 ................................

PC&B per FTE ................................................................. $158,061 $152,826 $163,992 ................................

Percent Change from Previous Year .............................. 4.2206% ¥3.3120% 7.3063% 2.7383% 

The statute specifies that this 2.7383 

percent should be multiplied by the 

proportion of PC&B costs to total FDA 

costs. Table 2 shows the amount of 

PC&B and the total amount obligated by 

FDA for the same 3 fiscal years. 

TABLE 2—PC&B AS A PERCENT OF TOTAL COSTS AT FDA 

Fiscal year 2018 2019 2020 3-Year average 

Total PC&B ...................................................................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ................................

Total Costs ....................................................................... $5,370,935,000 $5,663,389,000 $6,039,321,000 ................................

PC&B Percent .................................................................. 50.0970% 46.2630% 47.6145% 47.9915% 

The portion of the inflation 

adjustment relating to payroll costs is 

2.7383 percent multiplied by 47.9915 

percent, or 1.3142 percent. 

The statute specifies that the portion 

of the inflation adjustment for nonpayroll costs is the average annual 

percent change that occurred in the 

Consumer Price Index (CPI) for urban 

consumers (Washington-Baltimore, DCMD-VA-WV; not seasonally adjusted; all 

items less food and energy; annual 

index) for the first 3 of the preceding 4 

years of available data multiplied by the 

average proportion of all costs other 

than PC&B costs to total FDA costs for 

the first 3 of the 4 preceding fiscal years. 

As a result of a geographical revision 

made by the Bureau of Labor and 

Statistics in January 2018,1 the 

‘‘Washington-Baltimore, DC-MD-VAWV’’ index was discontinued and 

replaced with two separate indices (i.e., 

‘‘Washington-Arlington-Alexandria, DCVA-MD-WV’’ and ‘‘Baltimore-ColumbiaTowson, MD’’). To continue applying a 

CPI that best reflects the geographic 

region in which FDA is headquartered 

and that provides the most current data 

available, FDA is using the WashingtonArlington-Alexandria less food and 

energy index when calculating the 

relevant adjustment factors for FY 2020 

and subsequent years. Table 3 provides 

the summary data for the percent 

change in the specified CPI for the 

Washington-Arlington-Alexandria area. 

The data from the Bureau of Labor 

Statistics are shown in table 3. 


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2CVM increases the fee revenue amount 

established for the fiscal year to reflect changes in 

workload only if the workload adjuster is equal to 

or greater than 1 percent. 

TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN WASHINGTON-ARLINGTON-ALEXANDRIA AREA CPI LESS

FOOD AND ENERGY

Year 2018 2019 2020 3-Year 

average 

Annual CPI ....................................................................................................... 272.414 275.841 278.437 ........................

Annual Percent Change .................................................................................. 2.0671% 1.2580% 0.9411% 1.4221% 

To calculate the inflation adjustment 

for non-payroll costs, we multiply 

1.4221 percent by the proportion of all 

costs other than PC&B to total FDA 

costs. Since 47.9915 percent was 

obligated for PC&B as shown in table 2, 

52.0085 percent is the portion of costs 

other than PC&B (100 percent minus 

47.9915 percent equals 52.0085 

percent). The portion of the inflation 

adjustment relating to non-payroll costs 

is 1.4221 percent times 52.0085 percent, 

or 0.7396 percent. 

Next, we add the payroll component 

(1.3142 percent) to the non-payroll 

component (0.7396 percent), for an 

inflation adjustment of 2.0538 percent 

for FY 2022. 

ADUFA IV provides for the inflation 

adjustment to be compounded each 

fiscal year after FY 2020 (see 21 U.S.C. 

379j–12(c)(2)(B)). The inflation 

adjustment for FY 2022 (2.0538 percent) 

is compounded by adding 1 and then 

multiplying by 1 plus the inflation 

adjustment factor for FY 2021 (3.5847 

percent), as published in the Federal 

Register on August 3, 2020 (85 FR 

46635), which equals 1.057121 

(rounded) (1.020538 × 1.035847) for FY 

2022. We then multiply the base 

revenue amount for FY 2022 

($29,931,240) by 1.057121, yielding an 

inflation adjusted amount of 

$31,640,942. 

C. Workload Adjustment to Inflation 

Adjusted Fee Revenue Amount 

The fee revenue amounts established 

in ADUFA IV for FY 2020 and 

subsequent fiscal years are also subject 

to adjustment to account for changes in 

FDA’s review workload. A workload 

adjustment will be applied to the 

inflation adjusted fee revenue amount 

(21 U.S.C. 379j–12(c)(3)). 

To determine whether a workload 

adjustment applies, FDA calculates the 

weighted average of the change in the 

total number of each of the five types of 

applications and submissions specified 

in the workload adjustment provision 

(animal drug applications, supplemental 

animal drug applications for which data 

with respect to safety or efficacy are 

required, manufacturing supplemental 

animal drug applications, 

investigational animal drug study 

submissions, and investigational animal 

drug protocol submissions) received 

over the 5-year period that ended on 

September 30, 2018 (the base years), and 

the average number of each of these 

types of applications and submissions 

over the most recent 5-year period that 

ended May 31, 2021. 

The results of these calculations are 

presented in the first two columns of 

table 4. Column 3 reflects the percent 

change in workload over the two 5-year 

periods. Column 4 shows the weighting 

factor for each type of application/ 

submissions, reflecting how much of the 

total FDA animal drug review workload 

was accounted for by each type of 

application or submission in the table 

during the most recent 5 years. Column 

5 is the weighted percent change in each 

category of workload, which was 

derived by multiplying the weighting 

factor in each line in column 4 by the 

percent change from the base years in 

column 3. At the bottom right of the 

table the sum of the values in column 

5 is added, reflecting a total change in 

workload of 0.6187 percent for FY 2022. 

This is the workload adjuster for FY 

2022. 

TABLE 4—WORKLOAD ADJUSTER CALCULATION

Application type 

Column 1 Column 2 Column 3 Column 4 Column 5 

5-Year 

average 

(base years) 

Latest 5-year 

average 

Percent 

change 

(%) 

Weighting 

factor 

Weighted 

percent 

change 

(%) 

New Animal Drug Applications (NADAs) ............................. 16.4 14.6 ¥10.9756 0.0442 ¥0.4852 

Supplemental NADAs with Safety or Efficacy Data ............ 11.6 9.0 ¥22.4138 0.0241 ¥0.5392 

Manufacturing Supplements ................................................ 353.2 382.4 8.2673 0.1826 1.5093 

Investigational Study Submissions ...................................... 183.2 175.2 ¥4.3668 0.5544 ¥2.4208 

Investigational Protocol Submissions .................................. 236.4 267.4 13.1134 0.1948 2.5547 

FY 2022 ADUFA IV Workload Adjuster ............................... ........................ ........................ ........................ ........................ 0.6187 

Under no circumstances will the 

workload adjustment result in fee 

revenues that are less than the base fee 

revenues for that fiscal year as adjusted 

for inflation (21 U.S.C. 379j–12(c)(3)). 

FDA will not adjust the FY 2022 fee 

revenue amount for workload changes 

because the workload adjuster was less 

than 1 percent.2

D. Reduction of Workload-Based 

Increase by Amount of Certain Excess 

Collections 

Under section 740(c)(3)(B) of the 

FD&C Act, for FYs 2021 through 2023, 

if application of the workload 

adjustment increases the amount of fee 

revenues established for the fiscal year, 

as adjusted for inflation, the fee revenue 

increase will be reduced by the amount 

of any excess collections for the second 

preceding fiscal year, up to the amount 

of the fee revenue increase for workload. 

Because there is no workload-based 

increase in FY 2022, this provision does 

not apply. 

E. Recovery of Collection Shortfalls 

Under section 740(g)(5)(A) of the 

FD&C Act, for FY 2022, the amount of 

fees otherwise authorized to be 


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collected shall be increased by the 

amount, if any, by which the amount 

collected and appropriated for FY 2020 

falls below the amount of fees 

authorized for FY 2020. 

In FY 2020, the total revenue amount 

was $30,611,000 and the total amount of 

fees collected as of May 31, 2021, was 

$31,261,667. Because the amount of fees 

collected exceeded the total revenue 

amount, there was no collection 

shortfall in FY 2020 and therefore no 

increase in fees will be made under 

section 740(g)(5)(A). 

F. Reduction of Shortfall-Based Fee 

Increase by Prior Year Excess 

Collections 

Under section 740(g)(5)(B) of the 

FD&C Act, where FDA’s calculations 

under section 740(g)(5)(A) result in a fee 

increase for that fiscal year to recover a 

collection shortfall, FDA must reduce 

the increase by the amount of any 

excess collections for preceding fiscal 

years (after FY 2018) that have not 

already been applied for purposes of 

reducing workload-based fee increases. 

Because FDA’s calculations under 

section 740(g)(5)(A) do not result in a 

fee increase for FY 2022 to recover a 

collection shortfall, there will be no 

reduction of a shortfall-based increase 

under section 740(g)(5)(B). 

G. FY 2022 Fee Revenue Amounts 

The fee revenue amount for FY 2022, 

after considering the possible 

adjustments under sections 740(c) and 

(g)(5) of the FD&C Act, is $31,641,000 

(rounded to the nearest thousand 

dollars). ADUFA IV specifies that this 

revenue amount is to be divided as 

follows: 20 Percent, or a total of 

$6,328,200, is to come from application 

fees; 27 percent, or a total of $8,543,070, 

is to come from product fees; 26 

percent, or a total of $8,226,660 is to 

come from establishment fees; and 27 

percent, or a total of $8,543,070 is to 

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

12(b)). 

III. Application Fee Calculations for FY 

2022 

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 (21 U.S.C. 

360ccc) (see section 739(1) of the FD&C 

Act (21 U.S.C. 379j–11(1))). As the 

expanded definition of ‘‘animal drug 

application’’ includes applications for 

conditional approval submitted under 

section 571 of the FD&C Act, such 

applications are now subject to ADUFA 

fees, except that fees may be waived if 

the drug is intended solely to provide 

for a minor use or minor species 

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

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

Prior to ADUFA IV, FDA only had 

authority to grant conditional approval 

for drugs intended for a MUMS 

indication. Under amendments made to 

section 571 of the FD&C Act by ADUFA 

IV, FDA retains authority to grant 

conditional approval for drugs intended 

for MUMS indications but also will be 

able to grant conditional approval for 

certain drugs not intended for a MUMS 

indication provided certain criteria are 

met. Beginning with FY 2019, ADUFA 

IV provides 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. 

A ‘‘supplemental animal drug 

application’’ is defined as a request to 

the Secretary of Health and Human 

Services (Secretary) to approve a change 

in an animal drug application that has 

been approved, or a request to the 

Secretary 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 (21 U.S.C. 

379j–11(2)). The application fees are to 

be set so that they will generate 

$6,328,200 in fee revenue for FY 2022. 

The fee for a supplemental animal drug 

application for which safety or 

effectiveness data are required and for 

an animal drug application subject to 

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

the FD&C Act 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 $6,328,200, 

FDA must first make some assumptions 

about the number of fee-paying 

applications and supplemental 

applications the Agency will receive in 

FY 2022. 

The Agency knows the number of 

applications that have been submitted 

in previous years, which fluctuates 

annually. In estimating the fee revenue 

to be generated by animal drug 

application fees in FY 2022, FDA is 

assuming that the number of 

applications for which fees will be paid 

in FY 2022 will equal the average 

number of submissions over the 5 most 

recent completed fiscal years of the 

ADUFA program (FY 2016 to FY 2020). 

Over the 5 most recent completed 

fiscal years, the average number of 

animal drug applications that would 

have been subject to the full fee was 6.4. 

Over this same period, the average 

number of supplemental applications 

for which safety or effectiveness data are 

required and applications subject to the 

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

the FD&C Act that would have been 

subject to half of the full fee was 9.0. 

B. Application Fee Rates for FY 2022 

FDA must set the fee rates for FY 2022 

so that the estimated 6.4 applications for 

which the full fee will be paid and the 

estimated 9.0 supplemental applications 

for which safety or effectiveness data are 

required and applications subject to the 

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

the FD&C Act for which half of the full 

fee will be paid will generate a total of 

$6,328,200. To generate this amount, the 

fee for an animal drug application, 

rounded to the nearest dollar, will have 

to be $580,569, and the fee for a 

supplemental animal drug application 

for which safety or effectiveness data are 

required and for applications subject to 

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

of the FD&C Act will have to be 

$290,284. 

IV. Product Fee Calculations for FY 

2022 

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 


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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 $8,543,070 in fee 

revenue for FY 2022. 

To set animal drug product fees to 

realize $8,543,070, FDA must make 

some assumptions about the number of 

products for which these fees will be 

paid in FY 2022. 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 2021, FDA estimates that there are 

a total of 808 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 808 products 

will be subject to this fee in FY 2022. 

In estimating the fee revenue to be 

generated by animal drug product fees 

in FY 2022, FDA is assuming that 2 

percent of the products invoiced, or 16, 

will not pay fees in FY 2022 due to fee 

waivers and reductions. FDA has made 

this estimate at 2 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 792 (808 minus 16) 

products will be subject to product fees 

in FY 2022. 

B. Product Fee Rates for FY 2022 

FDA must set the fee rates for FY 2022 

so that the estimated 792 products for 

which fees are paid will generate a total 

of $8,543,070. To generate this amount 

will require the fee for an animal drug 

product, rounded to the nearest dollar, 

to be $10,787. 

V. Establishment Fee Calculations for 

FY 2022 

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 $8,226,660 in fee revenue for 

FY 2022. 

To set animal drug establishment fees 

to realize $8,226,660, FDA must make 

some assumptions about the number of 

establishments for which these fees will 

be paid in FY 2022. 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 2021, FDA estimates that there are 

a total of 58 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 58 establishments will be 

subject to this fee in FY 2022. 

In estimating the fee revenue to be 

generated by animal drug establishment 

fees in FY 2022, FDA is assuming that 

8 percent of the establishments 

invoiced, or five, will not pay fees in FY 

2022 due to fee waivers and reductions. 

FDA has made this estimate at 8 percent 

this year, based on historical data over 

the past 5 completed fiscal years. 

Accordingly, the Agency estimates 

that a total of 53 establishments (58 

minus 5) will be subject to 

establishment fees in FY 2022. 

B. Establishment Fee Rates for FY 2022 

FDA must set the fee rates for FY 2022 

so that the fees paid for the estimated 53 

establishments will generate a total of 

$8,226,660. To generate this amount 

will require the fee for an animal drug 

establishment, rounded to the nearest 

dollar, to be $155,220. 

VI. Sponsor Fee Calculations for FY 

2022 

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 $8,543,070 in 

fee revenue for FY 2022. 

To set animal drug sponsor fees to 

realize $8,543,070, FDA must make 

some assumptions about the number of 

sponsors who will pay these fees in FY 

2022. FDA estimates that a total of 187 

sponsors will meet this definition in FY 

2022. 

In estimating the fee revenue to be 

generated by animal drug sponsor fees 

in FY 2022, FDA is assuming that 67 

percent of the sponsors invoiced, or 125, 

will not pay sponsor fees in FY 2022 

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 62 sponsors (187 minus 

125) will be subject to and pay sponsor 

fees in FY 2022. 

B. Sponsor Fee Rates for FY 2022 

FDA must set the fee rates for FY 2022 

so that the estimated 62 sponsors that 

pay fees will generate a total of 

$8,543,070. To generate this amount 

will require the fee for an animal drug 

sponsor, rounded to the nearest dollar, 

to be $137,791. 

VII. Fee Schedule for FY 2022 

The fee rates for FY 2022 are 

summarized in table 5. 


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3CVM’s GFI #170 is located at: https://

www.fda.gov/downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/UCM052494.pdf. 

TABLE 5—FY 2022 FEE RATES

Animal drug user fee category Fee rate for 

FY 2022 

Animal Drug Application Fees: 

Animal Drug Application ............................................................................................................................................................... $580,569 

Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required or Animal Drug Application 

Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act .................................................................................. 290,284 

Animal Drug Product Fee .................................................................................................................................................................... 10,787 

Animal Drug Establishment Fee 1 ........................................................................................................................................................ 155,220 

Animal Drug Sponsor Fee 2 ................................................................................................................................................................. 137,791 

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 

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,’’3 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 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 CPI for urban 

consumers (U.S. city average; not 

seasonally adjusted; all items; annual 

index), the inflation-adjusted level for 

FY 2022 will be $21,896,240; 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 2022. 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 one fiscal year. If a sponsor is not 

granted a waiver, they are liable for the 

fees. 

B. Exemptions From Fees 

The types of fee waivers and 

reductions that applied during ADUFA 

III still exist for FY 2022. In addition, 

ADUFA IV established two new 

exemptions and one new exception 

from fees, as described below: 

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)(B)). 

Fees will not apply to any person who 

not later than September 30, 2023, 

submits to CVM 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 502(w)(3) of the 

FD&C Act (21 U.S.C. 352(w)(3)), if that 

person otherwise would be subject to 

user fees under ADUFA based only on 

the submission of the supplemental 

application (21 U.S.C. 379j–12(d)(4)(A)). 

There is also 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 (21 

U.S.C. 379j–12(a)(1)(C)(ii)). 

IX. Procedures for Paying the FY 2022 

Fees 

A. Application Fees and Payment 

Instructions 

The appropriate application fee 

established in the new fee schedule 

must be paid for an animal drug 

application or supplement subject to 

fees under ADUFA IV that is submitted 

on or after October 1, 2021. The 

payment must be made in U.S. currency 

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 search for and find your invoice, 

select ‘‘Pay Now’’ to be redirected to 

https://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 post office box number (P.O. 

Box 979033) and PIN on the enclosed 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40601 

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, FDA Deposit 

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 

Federal Express, the courier must 

deliver the check and printed copy of 

the cover sheet to: U.S. Bank, Attn: 

Government Lockbox 979033, 1005 

Convention Plaza, St. Louis, MO 63101. 

(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 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. Treasury 

notifies FDA of receipt of an electronic 

or wire transfer payment. U.S. Bank and 

the U.S. 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 user name 

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—Please submit your 

application and a copy of the completed 

Animal Drug User Fee Cover Sheet to 

the following address: Food and Drug 

Administration, Center for Veterinary 

Medicine, Document Control Unit 

(HFV–199), 7500 Standish Pl., 

Rockville, MD 20855. 

C. Product, Establishment, and Sponsor 

Fees 

By December 31, 2021, FDA will issue 

invoices and payment instructions for 

product, establishment, and sponsor 

fees for FY 2022 using this fee schedule. 

Payment will be due by January 31, 

2022. FDA will issue invoices in 

November 2022 for any products, 

establishments, and sponsors subject to 

fees for FY 2022 that qualify for fees 

after the December 2021 billing. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16043 Filed 7–27–21; 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 Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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; Small 

Business: Biomedical Sensing, Measurement 

and Instrumentation. 

Date: August 12, 2021. 

Time: 1:00 p.m. to 7:00 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: Yordan V. Kostov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20817, 301–867–5309, kostovyv@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: July 22, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–15990 Filed 7–27–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council on Alcohol Abuse and 

Alcoholism. The meeting will be open 

to the public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. The open 

session will be videocast and can be 

accessed from the NIH Videocasting and 

Podcasting website (http://

videocast.nih.gov/). 

A portion of the meeting 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, 


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