39028 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Reduction of Issuer Burden Through 

Technology Grant 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice of funding opportunity. 

SUMMARY: This notice announces the 

issuance of the March 10, 2021 (and 

amended on April 29, 2021) singlesource funding opportunity titled 

‘‘Reduction of Issuer Burden Through 

Technology Grant’’ (hereafter referred to 

as the ‘‘RIBTT Grant’’) available solely 

to the National Association of Insurance 

Commissioners (NAIC) to build a 

connection between the State Electronic 

Rate and Form Filing (SERFF) system, 

owned and operated by the NAIC, and 

the Health Insurance Oversight System 

(HIOS), which is operated by the 

Centers for Medicare and Medicaid 

Services (CMS). This connection will 

enable health insurance issuers to enter 

rate justification data into the SERFF 

system and then have this rate 

justification data automatically transfer 

to HIOS. Currently, health insurance 

issuers have to enter duplicate data into 

both the SERFF system and HIOS in 

order to maintain compliance with 

federal and state law in 49 states and the 

District of Columbia. 

DATES: The project period of the award, 

in the amount of $250,000 to the NAIC, 

will be 24 months from the date of 

award. The tentative award date is July 

29, 2021. 

FOR FURTHER INFORMATION CONTACT: Jim 

Taing, (301) 492–4182. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Reduction of Issuer Burden 

Through Technology Grant (RIBTT 

Grant) provides a funding source to 

build a connection between the SERFF 

system and the Unified Rate Review 

(URR) module of HIOS. Forty-nine 

states and the District of Columbia 

currently use the SERFF system to 

collect and review rate data. Building a 

connection between SERFF and HIOS 

will reduce burden on health insurance 

issuers and decrease the potential for 

data mismatches between the two 

systems. It will enable health insurance 

issuers to enter rate justification data 

into the SERFF system and the rate 

justification data will automatically 

transfer to HIOS. Currently, health 

insurance issuers have to enter 

duplicate data into both the SERFF 

system and HIOS in order to maintain 

compliance with applicable federal and 

state law. Funding under the RIBTT 

Grant is available to the NAIC to 

complete their portion of the technical 

changes needed in order to build such 

a connection between the SERFF system 

and HIOS. 

II. Provisions of the Notice 

CMS is anticipating approximately a 

total of $250,000 will be available for 

the RIBTT Grant, pending availability of 

funds, to the NAIC to complete their 

portion of the technical changes needed 

in order to build such a connection 

between the SERFF system and HIOS 

for the transfer of rate filing information. 

The NAIC may use grant funds for a 

variety of planning, development, 

testing, and implementation objectives 

related to the technical changes needed 

to build the connection between the 

SERFF system and HIOS. This includes, 

but is not limited to, hiring or 

contracting with information technology 

professionals or firms to complete the 

work. Pending an acceptable application 

and budget, the CMS will recommend 

awarding a single source grant to the 

NAIC who is uniquely qualified to 

complete the work requested. The NAIC 

is uniquely positioned to perform this 

work as they are the only applicant 

under this funding opportunity to meet 

the objectives of this funding 

opportunity as they own, operate, and 

maintain the SERFF system and the 

SERFF system is what is utilized by 

health insurance issuers to submit rate 

filing justification data in 49 states and 

the District of Columbia. The NAIC has 

built previous IT connections between 

their SERFF system and HIOS for the 

submission of Qualified Health Plan 

certification data between SERFF and 

the Plan Management module of HIOS. 

Funds enable NAIC to establish this 

new IT connection between the SERFF 

system and the URR module of HIOS 

based on the prior system architecture. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: July 19, 2021. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2021–15656 Filed 7–22–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Submission for OMB 

Review; Public Comment Request; 

State Developmental Disabilities 

Council—Annual Program 

Performance Report (PPR) (OMB 

Control Number 0985–0033) 

Correction 

In notice document 2021–15025, 

appearing on page 37337 in the issue of 

Thursday, July 15, 2021 make the 

following correction: 

On page 37337, in the first column, in 

the DATES section, on the second and 

third lines, ‘‘August 30, 2021’’ should 

read, ‘‘August 16, 2021’’. 

[FR Doc. C1–2021–15025 Filed 7–22–21; 8:45 am] 

BILLING CODE 0099–10–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0703] 

Animal Generic Drug User Fee Rates 

and Payment Procedures for Fiscal 

Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (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 

generic new animal drug user fees. The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), as amended by the Animal 

Generic Drug User Fee Amendments of 

2018 (AGDUFA III), authorizes FDA to 

collect user fees for certain abbreviated 

applications for generic new animal 

drugs, for certain generic new animal 

drug products, and for certain sponsors 

of such abbreviated applications for 

generic new animal drugs and/or 

investigational submissions for generic 

new animal drugs. This notice 

establishes the fee rates for FY 2022. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39029 

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 three 

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; and (3) annual fees for certain 

sponsors of abbreviated applications for 

generic new animal drugs and/or 

investigational submissions for generic 

new animal drugs (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 FY 2019 through FY 2023, the 

FD&C Act establishes a yearly base 

revenue amount and percentages for 

each of these fee categories (21 U.S.C. 

379j–21(b)). Base revenue amounts are 

subject to adjustment for inflation and 

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

379j–21(c)(3)(B)). The target revenue 

amounts for each fee category for FY 

2022, are as follows: For application 

fees, the target revenue amount is 

$6,199,500; for product fees, the target 

revenue amount is $9,299,250; and for 

sponsor fees, the target revenue amount 

is $9,299,250. 

For FY 2022, the generic new animal 

drug user fee rates are: $548,628 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)); $274,314 for each 

abbreviated application for a generic 

new animal drug subject to the criteria 

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

$17,513 for each generic new animal 

drug product; $234,297 for each generic 

new animal drug sponsor paying 100 

percent of the sponsor fee; $175,723 for 

each generic new animal drug sponsor 

paying 75 percent of the sponsor fee; 

and $117,149 for each generic new 

animal drug sponsor paying 50 percent 

of the sponsor fee. FDA will issue 

invoices for FY 2022 product and 

sponsor fees by December 31, 2021. 

These fees will be due by January 31, 

2022. The application fee rates are 

effective for all abbreviated applications 

for a generic new animal drug 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 related application fees and 

any other fees owed under the Animal 

Generic Drug User Fee program 

(AGDUFA program). 

II. Revenue Amount for FY 2022 

A. Statutory Fee Revenue Amounts 

AGDUFA III, Title II of Public Law 

115–234, specifies that the aggregate 

base fee revenue amount for FY 2022 for 

all generic new animal drug user fee 

categories is $18,336,340 (21 U.S.C. 

379j–21(b)(1)). 

B. Inflation Adjustment to Fee Revenue 

Amount 

AGDUFA III 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 (see 21 U.S.C. 

379j–21(c)(2)). 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 of 

available data. 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 the 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 PERSONNEL COMPENSATION AND BENEFITS (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 FYs. 

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 cost 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 


khammond on DSKJM1Z7X2PROD with NOTICES
39030 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

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

geographic-revision-2018.htm. 

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’’). In order 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 Washington-ArlingtonAlexandria index, less food and energy, 

in 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 WashingtonArlington-Alexandria area. The data 

from the Bureau of Labor Statistics is 

shown in table 3. 

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¥47.9915 

percent = 52.0085 percent). The nonpayroll adjustment 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. 

AGDUFA III provides for the inflation 

adjustment to be compounded each 

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

379j–21(c)(2)). 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 

46647 to 46651), which equals 1.057121 

(rounded) (1.020538 × 1.035847) for FY 

2022. We then multiply the base 

revenue amount for FY 2022 

($18,336,340) by 1.057121, yielding an 

inflation adjusted amount of 

$19,383,730. 

C. Workload Adjustment to Inflation 

Adjusted Fee Revenue Amount 

The fee revenue amounts established 

in AGDUFA III 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–21(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 four types 

of applications and submissions 

specified in the workload adjustment 

provision (abbreviated applications for 

generic new animal drugs, 

manufacturing supplemental 

abbreviated applications for generic new 

animal drugs, investigational generic 

new animal drug study submissions, 

and investigational generic new 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, 

reflecting how much of the total FDA 

generic new 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, 

and 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 calculated, reflecting a total 

change in workload of 49.0190 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 

Abbreviated Application for a Generic New Animal Drug 

(ANADAs) ......................................................................... 24.0 26.6 10.8333 0.1745 1.8904 

Manufacturing Supplements ANADAs ................................. 169.4 198.2 17.0012 0.2601 4.4212 

Generic Investigational Study Submissions ........................ 69.2 122.8 77.4566 0.4121 31.9161 

Generic Investigational Protocol Submissions .................... 34.4 58.64 70.3488 0.1534 10.7913 

FY 2022 AGDUFA III Workload Adjuster ..................... ........................ ........................ ........................ ........................ 49.0190 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39031 

The statutory revenue amount after 

the inflation adjustment ($19,383,730) 

must now be increased by 49.0190 

percent to reflect the changes in review 

workload (workload adjustment), for a 

workload and inflation-adjusted amount 

of $28,885,441. 

D. Reduction of Workload-Based 

Increase by Amount of Certain Excess 

Collections 

Under section 741(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. 

The workload and inflation-adjusted 

amount ($28,885,441) is subtracted by 

the inflation adjusted amount 

($19,383,730) to get the workload 

adjustment amount ($9,501,711). Then 

the excess fees collected from FY 2020 

as of May 31, 2021 ($4,087,114) are 

subtracted from the workload 

adjustment amount ($9,501,711) to get a 

reduced workload adjustment amount of 

$5,414,597. Next, the reduced workload 

adjustment amount ($5,414,597) is 

added to the inflation-adjusted revenue 

amount ($19,383,730), for a total fee 

revenue target of $24,798,000 (rounded 

to the nearest thousand dollars). 

E. FY 2022 Fee Revenue Amounts 

AGDUFA III specifies that the revenue 

amount of $24,798,000 for FY 2022 is to 

be divided as follows: 25 percent, or a 

total of $6,199,500, is to come from 

application fees; 37.5 percent, or a total 

of $9,299,250, is to come from product 

fees; and 37.5 percent, or a total of 

$9,299,250, is to come from sponsor fees 

(21 U.S.C. 379j–21(b)). 

III. Abbreviated Application Fee 

Calculations for FY 2022 

A. Application Fee Revenues and 

Numbers of Fee-Paying Applications 

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 

(21 U.S.C. 379j–21(k)(1)). The 

application fees are to be set so that they 

will generate $6,199,500 in fee revenue 

for FY 2022. 

To set fees for abbreviated 

applications for generic new animal 

drugs to realize $6,199,500 FDA must 

first make some assumptions about the 

number of fee-paying abbreviated 

applications it will receive during FY 

2022. 

The Agency knows the number of 

applications that have been submitted 

in previous years. That number 

fluctuates annually. In estimating the 

fee revenue to be generated by generic 

new animal drug applications 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 

recently completed fiscal years of the 

AGDUFA program (FY 2016–FY 2020). 

Also, under AGDUFA III, an 

abbreviated application for an animal 

generic 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 

8.2 applications not subject to the 

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

Act and 6.2 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 11.30 anticipated full fees. 

Based on the previous assumptions, 

FDA is estimating that it will receive a 

total of 11.30 fee-paying generic new 

animal drug applications in FY 2022 

(8.2 original applications paying a full 

fee and 6.2 applications paying a half 

fee). 

B. Application Fee Rates for FY 2022 

FDA must set the fee rates for FY 2022 

so that the estimated 11.30 abbreviated 

applications that pay the fee will 

generate a total of $6,199,500. To 

generate this amount, the fee for a 

generic new animal drug application 

will have to be $548,628 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 $274,314. 

IV. Generic New Animal Drug Product 

Fee Calculations for FY 2022 

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 

$9,299,250 in fee revenue for FY 2022. 

To set generic new animal drug 

product fees to realize $9,299,250, FDA 

must make some assumptions about the 

number of products for which these fees 

will be paid in FY 2022. 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 had a generic new animal 

drug application or supplemental 

abbreviated application pending after 

September 1, 2008. As of May 2021, 

FDA estimates a total of 536 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 536 

products will be subject to this fee in FY 

2022. 

In estimating the fee revenue to be 

generated by generic new animal drug 

product fees in FY 2022, FDA is 

estimating that 1 percent of the products 

invoiced, or 5 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
39032 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

Accordingly, the Agency estimates 

that a total of 531 (536 minus 5) 

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 531 products that 

pay fees will generate a total of 

$9,299,250. To generate this amount 

will require the fee for a generic new 

animal drug product, rounded to the 

nearest dollar, to be $17,513. 

V. Generic New Animal Drug Sponsor 

Fee Calculations for FY 2022 

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), 

respectively). 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 $9,299,250 

in fee revenue for FY 2022. 

To set generic new animal drug 

sponsor fees to realize $9,299,250, FDA 

must make some assumptions about the 

number of sponsors who will pay these 

fees in FY 2022. FDA estimates that in 

FY 2022, 12 sponsors will pay 100 

percent fees, 18 sponsors will pay 75 

percent fees, and 30 sponsors will pay 

50 percent fees. That totals the 

equivalent of 40.5 full sponsor fees (12 

× 100 percent or 12, plus 18 × 75 percent 

or 13.5, plus 30 × 50 percent or 15). 

FDA estimates that about 2 percent of 

all of these sponsors, or 0.81, 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 39.69 full sponsor 

fees (40.5¥0.81) are likely to be paid in 

FY 2022. 

B. Sponsor Fee Rates for FY 2022 

FDA must set the fee rates for FY 2022 

so that the estimated equivalent of 39.69 

full sponsor fees will generate a total of 

$9,299,250. To generate this amount 

will require the 100 percent fee for a 

generic new animal drug sponsor, 

rounded to the nearest dollar, to be 

$234,297. Accordingly, the fee for those 

paying 75 percent of the full sponsor fee 

will be $175,723, and the fee for those 

paying 50 percent of the full sponsor fee 

will be $117,149. 

VI. Fee Schedule for FY 2022 

The fee rates for FY 2022 are 

summarized in table 5. 

TABLE 5—FY 2022 FEE RATES

Generic new animal drug user fee category Fee rate 

for FY 2022 

Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) ..................... $548,628 

Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) ........................................... 274,314 

Generic New Animal Drug Product Fee .............................................................................................................................................. 17,513 

100% Generic New Animal Drug Sponsor Fee.1 ................................................................................................................................ 234,297 

75% Generic New Animal Drug Sponsor Fee.1 .................................................................................................................................. 175,723 

50% Generic New Animal Drug Sponsor Fee.1 .................................................................................................................................. 117,149 

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 2022. In AGDUFA III 

a new exemption from fees was 

established, as follows: 

Fees will not apply to any person who 

not later than September 30, 2023, 

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)), if that 

person otherwise would be subject to 

user fees under AGDUFA based only on 

the submission of the supplemental 

abbreviated application (21 U.S.C. 379j– 

21(d)(2)). 

VIII. Procedures for Paying FY 2022 

Generic New Animal Drug User Fees 

A. Abbreviated Application Fees and 

Payment Instructions 

The FY 2022 fee established in the 

new fee schedule must be paid for a 

generic new animal drug application 

subject to fees under AGDUFA III that 

is submitted on or after October 1, 2021. 

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 an 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 have found 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 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39033 

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. 

When paying by wire transfer, it is 

required that the invoice number or PIN 

is 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 wire transfer: U.S. 

Department of the Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Account Name: Food and Drug 

Administration, Account No.: 75060099, 

Routing No.: 021030004, SWIFT No.: 

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 phone 

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 United 

States 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 onto the AGDUFA 

website at https://www.fda.gov/ 

ForIndustry/UserFees/AnimalGeneric

DrugUserFeeActAGDUFA/ 

ucm137049.htm and scroll down the 

page until you find the link ‘‘Create 

AGDUFA User Fee Cover Sheet.’’ Select 

that link and follow the directions. 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 Generic 

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 Generic 

Drug User Fee Cover Sheet. One cover 

sheet is needed for each abbreviated 

application for a generic new animal 

drug. 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 as described in section 

VIII.A. 

Step Four—Please submit your 

application and a copy of the completed 

Animal Generic 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 and Sponsor Fees 

By December 31, 2021, FDA will issue 

invoices and payment instructions for 

product and sponsor fees for FY 2022 

using this fee schedule. Fees will be due 

by January 31, 2022. FDA will issue 

invoices in November 2022 for any 

products and sponsors subject to fees for 

FY 2022 that qualify for fees after the 

December 2021 billing. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15642 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0363] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prescription Drug 

Advertising 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by August 23, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0686. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St. North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Prescription Drug Advertising—21 CFR 

Part 202 

OMB Control Number 0910–0686— 

Extension 

This information collection supports 

Agency regulations and associated 

guidance. FDA protects the public 

health by assuring the safety, 

effectiveness, and security of a wide 

range of products. We also help 

consumers get accurate, science-based 

information they need to use medicines 

appropriately and improve their health. 


khammond on DSKJM1Z7X2PROD with NOTICES