40582 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

supported FTE hourly rate excluding 

travel, $256/hour, to calculate the 

portion of the user fee attributable to 

those activities: $256/hour × (8 hours) = 

$2,048. For the portion of the fee 

covering onsite evaluation of a domestic 

VQIP importer, we use the fully 

supported FTE hourly rate for work 

requiring domestic travel, $277/hour, to 

calculate the portion of the user fee 

attributable to those activities: $277/ 

hour × 8 hours (i.e., one fully supported 

FTE × (1 day onsite × 8 hours)) = $2,216. 

Therefore, the total cost of conducting 

the domestic performance evaluation of 

a VQIP importer is determined to be 

$2,216 + $2,048 = $4,264. 

Coordination of the onsite 

performance evaluation of a foreign 

VQIP importer is estimated to take place 

at an FTE’s worksite, so we use the fully 

supported FTE hourly rate excluding 

travel, $256/hour, to calculate the 

portion of the user fee attributable to 

those activities: $256/hour × (10 hours) 

= $2,560. For the portion of the fee 

covering onsite evaluation of a foreign 

VQIP importer, we use the fully 

supported FTE hourly rate for work 

requiring foreign travel, $330/hour, to 

calculate the portion of the user fee 

attributable to those activities: $330/ 

hour × 24 hours (i.e., one fully 

supported FTE × ((2 travel days × 8 

hours) + (1 day onsite × 8 hours))) = 

$7,920. Therefore, the total cost of 

conducting the foreign performance 

evaluation of a VQIP importer is 

determined to be $2,560 + $7,920 = 

$10,480. 

Therefore, the estimated average cost 

of the work FDA performs in total for 

approving an application for a VQIP 

importer in FY22 based on these figures 

would be $7,000 + ($9,984 × 0.25) + 

($7,168 × 0.75) + ($4,264 × 0.25) = 

$15,938 

IV. How must the fee be paid? 

An invoice will be sent to VQIP 

importers approved to participate in the 

program. Payment must be made prior 

to October 1, 2021, to be eligible for 

VQIP participation for the benefit year 

beginning October 1, 2021. FDA will not 

refund the VQIP user fee for any reason. 

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. (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. 

When paying by check, bank draft, or 

U.S. postal money order, please include 

the invoice number in the check stub. 

Also write the FDA post office box 

number (P.O. Box 979108) on the 

enclosed check, bank draft, or money 

order. Mail the payment including the 

invoice number on the check stub to: 

Food and Drug Administration, P.O. 

Box 979108, St. Louis, MO 63197–9000. 

When paying by wire transfer, it is 

required that the invoice number is 

included; without the invoice number 

the payment may not be applied. 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. For 

international wire transfers, please 

inquire with the financial institutions 

prior to submitting the payment. 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 to: U.S. Bank, Attn: 

Government Lockbox 979108, 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.) 

The tax identification number of FDA 

is 53–0196965. (Note: Invoice copies do 

not need to be submitted to FDA with 

the payments.) 

V. What are the consequences of not 

paying this fee? 

The consequences of not paying these 

fees are outlined in Section J of ‘‘FDA’s 

Voluntary Qualified Importer Program; 

Guidance for Industry’’ document 

(available at https://www.fda.gov/ 

media/92196/download). If the user fee 

is not paid before October 1, a VQIP 

importer will not be eligible to 

participate in VQIP. For the first year a 

VQIP application is approved, if the 

user fee is not paid before October 1, 

2021, you are not eligible to participate 

in VQIP. If you subsequently pay the 

user fee, FDA will begin your benefits 

after we receive the full payment. The 

user fee may not be paid after December 

31, 2021. For a subsequent year, if you 

do not pay the user fee before October 

1, FDA will send a Notice of Intent to 

Revoke your participation in VQIP. If 

you do not pay the user fee within 30 

days of the date of the Notice of Intent 

to Revoke, we will revoke your 

participation in VQIP. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16053 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–0661] 

Generic Drug User Fee Rates for Fiscal 

Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Federal Food, Drug, and 

Cosmetic Act (FD&C Act or statute), as 

amended by the Generic Drug User Fee 

Amendments of 2017 (GDUFA II), 

authorizes the Food and Drug 

Administration (FDA, Agency, or we) to 

assess and collect fees for abbreviated 

new drug applications (ANDAs); drug 

master files (DMFs); generic drug active 

pharmaceutical ingredient (API) 

facilities, finished dosage form (FDF) 

facilities, and contract manufacturing 

organization (CMO) facilities; and 

generic drug applicant program user 

fees. In this document, FDA is 

announcing fiscal year (FY) 2022 rates 

for GDUFA II fees. 

FOR FURTHER INFORMATION CONTACT: Lola 

Olajide, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61077B, Beltsville, MD 20705– 

4304, 240–402–4244. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 744A and 744B of the FD&C 

Act (21 U.S.C. 379j–41 and 379j–42) 

establish fees associated with human 

generic drug products. Fees are assessed 

on: (1) Certain types of applications for 


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1The Bureau of Labor Statistics’ announcement of 

the geographical revision can be viewed at https:// 

www.bls.gov/cpi/additional-resources/geographicrevision-2018.htm. 

human generic drug products; (2) 

certain facilities where APIs and FDFs 

are produced; (3) certain DMFs 

associated with human generic drug 

products; and (4) generic drug 

applicants who have approved ANDAs 

(the program fee) (see section 744B(a)(2) 

through (5) of the FD&C Act). 

GDUFA II provides that user fees 

should total $493,600,000 annually 

adjusted each year for inflation. For FY 

2022, the generic drug fee rates are: 

ANDA ($225,712), DMF ($74,952), 

domestic API facility ($42,557) foreign 

API facility ($57,557), domestic FDF 

facility ($195,012), foreign FDF facility 

($210,012), domestic CMO facility 

($65,004), foreign CMO facility 

($80,004), large size operation generic 

drug applicant program ($1,536,856), 

medium size operation generic drug 

applicant program ($614,742), and small 

business generic drug applicant program 

($153,686). These fees are effective on 

October 1, 2021, and will remain in 

effect through September 30, 2022. 

II. Fee Revenue Amount for FY 2022 

GDUFA II directs FDA to use the 

yearly revenue amount determined 

under the statute as a starting point to 

set the fee rates for each fee type. The 

base revenue amount for FY 2022 is 

$520,208,640. This is the amount 

calculated for the prior fiscal year, FY 

2021, pursuant to the statute (see 

section 744B(b)(1) of the FD&C Act). For 

more information about GDUFA II, 

please refer to the FDA website (https:// 

www.fda.gov/gdufa). The ANDA, DMF, 

API facility, FDF facility, CMO facility, 

and generic drug applicant program fee 

(GDUFA program fee) calculations for 

FY 2022 are described in this document. 

A. Inflation Adjustment 

The base revenue amount for FY 2022 

is $520,208,640. This is the amount 

calculated for the prior fiscal year, FY 

2021, pursuant to the statute (see 

section 744B(b)(1) of the FD&C Act). 

GDUFA II specifies that the 

$520,208,640 is to be adjusted for 

inflation increases for FY 2022 using 

two separate adjustments—one for 

personnel compensation and benefits 

(PC&B) and one for non-PC&B costs (see 

sections 744B(c)(1)(B) and (C) of the 

FD&C Act). 

The component of the inflation 

adjustment for PC&B 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, 

multiplied by the proportion of PC&B 

costs to total FDA costs of human 

generic drug activities for the first 3 of 

the preceding 4 fiscal years (see section 

744B(c)(1)(B) of the FD&C Act). 

Table 1 summarizes the actual cost 

and total FTEs 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 FTEs ........................................................................................... 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 expended for 

human generic drug activities for the 

first 3 of the preceding 4 fiscal years. 

Table 2 shows the amount of PC&B and 

the total amount obligated for human 

generic drug activities from FY 2018 

through FY 2020. 

TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS OF HUMAN GENERIC DRUG APPLICATIONS

OVER THE LAST 3 YEARS

Fiscal year 2018 2019 2020 3-Year 

average 

PC&B ............................................................................................................... $332,617,643 $356,874,114 $397,392,785 ........................

Non-PC&B ....................................................................................................... $276,911,265 $290,439,277 $300,692,399 ........................

Total Costs ....................................................................................................... $609,528,908 $647,313,391 $698,085,185 ........................

PC&B Percent .................................................................................................. 54.5696 55.1316 56.9261 55.5424 

Non-PC&B Percent .......................................................................................... 45.4304 44.8684 43.0739 44.4576 

The payroll adjustment is 2.7383 

percent multiplied by 55.5424 percent 

(or 1.5209 percent). 

The statute specifies that the portion 

of the inflation adjustment for nonPC&B costs for FY 2022 is the average 

annual percent change that occurred in 

the Consumer Price Index (CPI) for 

urban consumers (WashingtonBaltimore, DC–MD–VA–WV; not 

seasonally adjusted; all items; annual 

index) for the first 3 of the preceding 4 

years of available data multiplied by the 

proportion of all costs other than PC&B 

costs to total costs of human generic 

drug activities (see section 744B(c)(1)(C) 

of the FD&C Act). As a result of a 

geographical revision made by the 

Bureau of Labor and Statistics in 

January 2018,1 the WashingtonBaltimore, DC–MD–VA–WV index was 

discontinued and replaced with two 

separate indices (i.e., WashingtonArlington-Alexandria, DC–VA–MD–WV 

and Baltimore-Columbia-Towson, 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, the Washington-ArlingtonAlexandria index will be used in 

calculating the relevant adjustment 

factors for FY 2022 and subsequent 

years. Table 3 provides the summary 

data for the percent change in the 

specified CPI. The data are published by 


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the Bureau of Labor Statistics and can 

be found on its website at: https://

data.bls.gov/pdq/ 

SurveyOutputServlet?data_

tool=dropmap&series_

id=CUURS35ASA0,CUUSS35ASA0. 

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

Year 2018 2019 2020 3-Year 

average 

Annual CPI ....................................................................................................... 261.445 264.777 267.157 ........................

Annual Percent Change .................................................................................. 2.0389 1.2745 0.8989 1.4041 

To calculate the inflation adjustment 

for non-pay costs, we multiply the 3- 

year average percent change in the CPI 

(1.4041 percent) by the proportion of all 

costs other than PC&B to total costs of 

human generic drug activities obligated. 

Because 55.5424 percent was obligated 

for PC&B as shown in table 2, 44.4576 

percent is the portion of costs other than 

PC&B. The non-pay adjustment is 

1.4041 percent times 44.4576 percent, or 

0.6242 percent. 

To complete the inflation adjustment 

for FY 2022, we add the PC&B 

component (1.5209 percent) to the nonPC&B component (0.6242 percent) for a 

total inflation adjustment of 2.1451 

percent (rounded), and then add 1, 

making an inflation adjustment multiple 

of 1.021451. We then multiply the base 

revenue amount for FY 2022 

($520,208,640) by 1.021451, yielding an 

inflation-adjusted amount of 

$531,367,636. 

B. Final Year Adjustment 

For FY 2022, FDA may, in addition to 

the inflation adjustment, further 

increase the fee revenue and fees 

established if such an adjustment is 

necessary to provide for not more than 

3 months of operating reserves of 

carryover user fees for human generic 

drug activities for the first 3 months of 

FY 2023. To determine whether a final 

year adjustment applies, FDA calculates 

operating reserves of carryover and its 

estimated balance as of the beginning of 

FY 2023. 

After running analyses on the 

projected collections and obligations for 

FY 2021 and FY 2022, FDA estimates 

available carryover balance will be 

$63,131,283 as of the beginning of FY 

2023. FDA estimates the cost of 

operations per week is $10,202,769; 

thus, the projected available carryover 

balance of $63,131,283 at the beginning 

of FY 2023 represents approximately 6 

weeks of operating reserves. Per the 

statute, FDA could raise the fee revenue 

by $59,301,948 (12 weeks × $10,202,769 

minus projected carryover of 

$63,131,283) for the final year 

adjustment. FDA recognizes that adding 

$59,301,948 to the fee revenue in FY 

2022 may pose as a burden to the 

regulated industry. In light of this, and 

in light of the fact that the legislative 

language authorizing the final year 

adjustment allows FDA discretion in 

whether to make this adjustment for a 

full 3 months of operating reserves or 

for a shorter period, FDA has decided to 

make the final year adjustment to allow 

for only 7 weeks of operating reserves. 

Accordingly, the final year adjustment 

will be $8,288,102 (7 × $10,202,769 less 

projected carryover of $63,131,283). 

Adding this amount to the inflation 

adjusted amount of $531,367,636 results 

in a total revenue target of $539,656,000 

(rounded to the nearest thousand 

dollars). 

III. ANDA Filing Fee 

Under GDUFA II, the FY 2022 ANDA 

filing fee is owed by each applicant that 

submits an ANDA on or after October 1, 

2021. This fee is due on the submission 

date of the ANDA. Section 744B(b)(2)(B) 

of the FD&C Act specifies that the 

ANDA fee will make up 33 percent of 

the $539,656,000, which is 

$178,086,480. 

To calculate the ANDA fee, FDA 

estimated the number of full application 

equivalents (FAEs) that will be 

submitted in FY 2022. The submissions 

are broken down into three categories: 

New originals (submissions that have 

not been received by FDA previously); 

submissions that FDA refused to receive 

(RTR) for reasons other than failure to 

pay fees; and applications that are 

resubmitted after an RTR decision for 

reasons other than failure to pay fees. 

An ANDA counts as one FAE; however, 

75 percent of the fee paid for an ANDA 

that has been RTR shall be refunded 

according to GDUFA II if: (1) The ANDA 

is refused for a cause other than failure 

to pay fees or (2) the ANDA has been 

withdrawn prior to receipt (section 

744B(a)(3)(D)(i) of the FD&C Act). 

Therefore, an ANDA that is considered 

not to have been received by FDA due 

to reasons other than failure to pay fees 

or withdrawn prior to receipt counts as 

one-fourth of an FAE. After an ANDA 

has been RTR, the applicant has the 

option of resubmitting. For user fee 

purposes, these resubmissions are 

equivalent to new original 

submissions—ANDA resubmissions are 

charged the full amount for an 

application (one FAE). 

FDA utilized data from ANDAs 

submitted from October 1, 2019, to 

April 30, 2021, to estimate the number 

of new original ANDAs that will incur 

filing fees in FY 2022. For FY 2022, the 

Agency estimates that approximately 

788 new original ANDAs will be 

submitted and incur filing fees. Not all 

of the new original ANDAs will be 

received by the Agency and some of 

those not received will be resubmitted 

in the same fiscal year. Therefore, the 

Agency expects that the FAE count for 

ANDAs will be 789 for FY 2022. 

The FY 2022 application fee is 

estimated by dividing the number of 

FAEs that will pay the fee in FY 2022 

(789) into the fee revenue amount to be 

derived from ANDA application fees in 

FY 2022 ($178,086,480). The result, 

rounded to the nearest dollar, is a fee of 

$225,712 per ANDA. 

The statute provides that those 

ANDAs that include information about 

the production of active pharmaceutical 

ingredients other than by reference to a 

DMF will pay an additional fee that is 

based on the number of such active 

pharmaceutical ingredients and the 

number of facilities proposed to 

produce those ingredients (see section 

744B(a)(3)(F) of the FD&C Act). FDA 

anticipates that this additional fee is 

unlikely to be assessed often; therefore, 

FDA has not included projections 

concerning the amount of this fee in 

calculating the fees for ANDAs. 

IV. DMF Fee 

Under GDUFA II, the DMF fee is 

owed by each person that owns a type 

II API DMF that is referenced, on or 

after October 1, 2012, in a generic drug 

submission by an initial letter of 

authorization. This is a one-time fee for 

each DMF. This fee is due on the earlier 

of the date on which the first generic 

drug submission is submitted that 

references the associated DMF or the 

date on which the DMF holder requests 

the initial completeness assessment. 

Under section 744B(a)(2)(D)(iii) of the 

FD&C Act, if a DMF has successfully 

undergone an initial completeness 


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assessment and the fee is paid, the DMF 

will be placed on a publicly available 

list documenting DMFs available for 

reference. 

To calculate the DMF fee, FDA 

assessed the volume of DMF 

submissions over time. The Agency 

assessed DMFs from October 1, 2019, to 

April 30, 2021, and concluded that 

averaging the number of fee-paying 

DMFs provided the most accurate model 

for predicting fee-paying DMFs for FY 

2022. The monthly average of paid DMF 

submissions the Agency received in FY 

2020 and FY 2021 is 30. To determine 

the FY 2022 projected number of feepaying DMFs, the average of 30 DMF 

submissions is multiplied by 12 months, 

which results in 360 estimated FY 2022 

fee-paying DMFs. FDA is estimating 360 

fee-paying DMFs for FY 2022. 

The FY 2022 DMF fee is determined 

by dividing the DMF target revenue by 

the estimated number of fee-paying 

DMFs in FY 2022. Section 744B(b)(2)(A) 

of the FD&C Act specifies that the DMF 

fees will make up 5 percent of the 

$539,656,000, which is $26,982,800. 

Dividing the DMF revenue amount 

($26,982,800) by the estimated feepaying DMFs (360), and rounding to the 

nearest dollar, yields a DMF fee of 

$74,952 for FY 2022. 

V. Foreign Facility Fee Differential 

Under GDUFA II, the fee for a facility 

located outside the United States and its 

territories and possessions shall be 

$15,000 higher than the amount of the 

fee for a facility located in the United 

States and its territories and 

possessions. The basis for this 

differential is the extra cost incurred by 

conducting an inspection outside the 

United States and its territories and 

possessions. 

VI. FDF and CMO Facility Fees 

Under GDUFA II, the annual FDF 

facility fee is owed by each person who 

owns an FDF facility that is identified 

in at least one approved generic drug 

submission owned by that person or its 

affiliates. The CMO facility fee is owed 

by each person who owns an FDF 

facility that is identified in at least one 

approved ANDA but is not identified in 

an approved ANDA held by the owner 

of that facility or its affiliates. These fees 

are due no later than the first business 

day on or after October 1 of each such 

year. Section 744B(b)(2)(C) of the FD&C 

Act specifies that the FDF and CMO 

facility fee revenue will make up 20 

percent of the $539,656,000, which is 

$107,931,200. 

To calculate the fees, data from FDA’s 

Integrity Services (IS) were utilized as 

the primary source of facility 

information for determining the 

denominators of each facility fee type. 

IS is the master data steward for all 

facility information provided in generic 

drug submissions received by FDA. A 

facility’s reference status in an approved 

generic drug submission is extracted 

directly from submission data rather 

than relying on data from selfidentification. This information 

provided the number of facilities 

referenced as FDF manufacturers in at 

least one approved generic drug 

submission. Based on FDA’s IS data, the 

FDF and CMO facility denominators are 

181 FDF domestic, 279 FDF foreign, 88 

CMO domestic, and 104 CMO foreign 

facilities for FY 2022. 

GDUFA II specifies that the CMO 

facility fee is to be equal to one-third the 

amount of the FDF facility fee. 

Therefore, to generate the target 

collection revenue amount from FDF 

and CMO facility fees ($107,931,200), 

FDA must weight a CMO facility as onethird of an FDF facility. FDA set fees 

based on the estimate of 181 FDF 

domestic, 279 FDF foreign, 29.33 CMO 

domestic (88 multiplied by one-third), 

and 34.67 CMO foreign facilities (104 

multiplied by one-third), which equals 

524 total weighted FDF and CMO 

facilities for FY 2022. 

To calculate the fee for domestic 

facilities, FDA first determines the total 

fee revenue that will result from the 

foreign facility differential by 

subtracting the fee revenue resulting 

from the foreign facility fee differential 

from the target collection revenue 

amount ($107,931,200) as follows. The 

foreign facility fee differential revenue 

equals the foreign facility fee differential 

($15,000) multiplied by the number of 

FDF foreign facilities (279) plus the 

foreign facility fee differential ($15,000) 

multiplied by the number of CMO 

foreign facilities (104), totaling 

$5,745,000. This results in foreign fee 

differential revenue of $5,745,000 from 

the total FDF and CMO facility fee target 

collection revenue. Subtracting the 

foreign facility differential fee revenue 

($5,745,000) from the total FDF and 

CMO facility target collection revenue 

($107,931,200) results in a remaining 

facility fee revenue balance of 

$102,186,200. To determine the 

domestic FDF facility fee, FDA divides 

the $102,186,200 by the total weighted 

number of FDF and CMO facilities 

(524), which results in a domestic FDF 

facility fee of $195,012. The foreign FDF 

facility fee is $15,000 more than the 

domestic FDF facility fee, or $210,012. 

According to GDUFA II, the domestic 

CMO fee is calculated as one-third the 

amount of the domestic FDF facility fee. 

Therefore, the domestic CMO fee is 

$65,004, rounded to the nearest dollar. 

The foreign CMO fee is calculated as the 

domestic CMO fee plus the foreign fee 

differential of $15,000. Therefore, the 

foreign CMO fee is $80,004. 

VII. API Facility Fee 

Under GDUFA II, the annual API 

facility fee is owed by each person who 

owns a facility that is identified in: (1) 

At least one approved generic drug 

submission or (2) in a Type II API DMF 

referenced in at least one approved 

generic drug submission. These fees are 

due no later than the first business day 

on or after October 1 of each such year. 

Section 744B(b)(2)(D) of the FD&C Act 

specifies the API facility fee will make 

up 7 percent of $539,656,000 in fee 

revenue, which is $37,775,920. 

To calculate the API facility fee, data 

from FDA’s IS were utilized as the 

primary source of facility information 

for determining the denominator. As 

stated above, IS is the master data 

steward for all facility information 

provided in generic drug submissions 

received by FDA. A facility’s reference 

status in an approved generic drug 

submission is extracted directly from 

submission data rather than relying on 

data from self-identification. This 

information provided the number of 

facilities referenced as API 

manufacturers in at least one approved 

generic drug submission. 

The total number of API facilities 

identified was 679; of that number, 87 

were domestic and 592 were foreign 

facilities. The foreign facility differential 

is $15,000. To calculate the fee for 

domestic facilities, FDA must first 

subtract the fee revenue that will result 

from the foreign facility fee differential. 

FDA takes the foreign facility 

differential ($15,000) and multiplies it 

by the number of foreign facilities (592) 

to determine the total fee revenue that 

will result from the foreign facility 

differential. As a result of that 

calculation, the foreign fee differential 

revenue will make up $8,880,000 of the 

total API fee revenue. Subtracting the 

foreign facility differential fee revenue 

($8,880,000) from the total API facility 

target revenue ($37,775,920) results in a 

remaining balance of $28,895,920. To 

determine the domestic API facility fee, 

we divide the $28,895,920 by the total 

number of facilities (679), which gives 

us a domestic API facility fee of 

$42,557. The foreign API facility fee is 

$15,000 more than the domestic API 

facility fee, or $57,557. 

VIII. Generic Drug Applicant Program 

Fee 

Under GDUFA II, if a person and its 

affiliates own at least one but not more 


khammond on DSKJM1Z7X2PROD with NOTICES
40586 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

than five approved ANDAs on October 

1, 2021, the person and its affiliates 

shall owe a small business GDUFA 

program fee. If a person and its affiliates 

own at least 6 but not more than 19 

approved ANDAs, the person and its 

affiliates shall owe a medium size 

operation GDUFA program fee. If a 

person and its affiliates own at least 20 

approved ANDAs, the person and its 

affiliates shall owe a large size operation 

GDUFA program fee. These fees are due 

no later than the first business day on 

or after October 1 of each such year. 

Section 744B(b)(2)(E) of the FD&C Act 

specifies the GDUFA program fee will 

make up 35 percent of $539,656,000 in 

fee revenue, which is $188,879,600. 

To determine the appropriate number 

of parent companies for each tier, the 

Agency asked companies to claim their 

ANDAs and affiliates in the Center for 

Drug Evaluation and Research (CDER) 

NextGen Portal. The companies were 

able to confirm relationships currently 

present in the Agency’s records, while 

also reporting newly approved ANDAs, 

newly acquired ANDAs, and new 

affiliations. 

In determining the appropriate 

number of approved ANDAs, the 

Agency has factored in a number of 

variables that could affect the collection 

of the target revenue: (1) Inactive 

ANDAs—applicants who have not 

submitted an annual report for one or 

more of their approved applications 

within the past 2 years; (2) Program Fee 

Arrears List—parent companies that are 

on the arrears list for any fiscal year; (3) 

Center for Biologics Evaluation and 

Research (CBER) approved ANDAs— 

applicants and their affiliates with 

CBER-approved ANDAs in addition to 

CDER’s approved ANDAs; and (4) 

withdrawals of approved ANDAs by 

April 1st—applicants who have 

submitted a written request for 

withdrawal of approval by April 1st of 

the previous fiscal year. The list of 

original approved ANDAs from the 

Generic Drug Review Platform as of 

April 30, 2021, shows 291 applicants in 

the small business tier, 76 applicants in 

the medium size tier, and 76 applicants 

in the large size tier. Factoring in all the 

variables for the fourth year of GDUFA 

II, the Agency estimates there will be 

203 applicants in the small business 

tier, 69 applicants in the medium size 

tier, and 75 applicants in the large size 

tier for FY 2022. 

To calculate the GDUFA program fee, 

GDUFA II provides that large size 

operation generic drug applicants pay 

the full fee, medium size operation 

applicants pay two-fifths of the full fee, 

and small business applicants pay onetenth of the full fee. To generate the 

target collection revenue amount from 

GDUFA program fees ($188,879,600), 

we must weigh medium and small 

tiered applicants as a subset of a large 

size operation generic drug applicant. 

FDA will set fees based on the weighted 

estimate of 20.30 applicants in the small 

business tier (203 multiplied by 10 

percent), 27.6 applicants in the medium 

size tier (69 multiplied by 40 percent), 

and 75 applicants in the large size tier, 

arriving at 122.90 total weighted 

applicants for FY 2022. 

To generate the large size operation 

GDUFA program fee, FDA divides the 

target revenue amount of $188,879,600 

by 122.90, which equals $1,536,856. 

The medium size operation GDUFA 

program fee is 40 percent of the full fee 

($614,742), and the small business 

operation GDUFA program fee is 10 

percent of the full fee ($153,686). 

IX. Fee Schedule for FY 2022 

The fee rates for FY 2022 are set out 

in table 4. 

TABLE 4—FEE SCHEDULE FOR FY 

2022 

Fee category Fees rates for 

FY 2022 

Applications: 

Abbreviated New Drug Application (ANDA) ............ $225,712 

Drug Master File (DMF) .... 74,952 

Facilities: 

Active Pharmaceutical Ingredient (API)—Domestic ................................... 42,557 

API—Foreign ..................... 57,557 

Finished Dosage Form 

(FDF)—Domestic ........... 195,012 

FDF—Foreign ................... 210,012 

Contract Manufacturing 

Organization (CMO)— 

Domestic ........................ 65,004 

CMO—Foreign .................. 80,004 

GDUFA Program: 

Large size operation generic drug applicant ... 1,536,856 

Medium size operation 

generic drug applicant 614,742 

Small business operation generic drug applicant ......................... 153,686 

X. Fee Payment Options and 

Procedures 

The new fee rates are effective 

October 1, 2021. To pay the ANDA, 

DMF, API facility, FDF facility, CMO 

facility, and GDUFA program fees, a 

Generic Drug User Fee Cover Sheet must 

be completed, available at https://

www.fda.gov/gdufa and http://

userfees.fda.gov/OA_HTML/ 

gdufaCAcdLogin.jsp, and a user fee 

identification (ID) number must be 

generated. Payment must be made in 

U.S. currency drawn on a U.S. bank by 

electronic check, check, bank draft, U.S. 

postal money order, credit card, or wire 

transfer. 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). FDA has partnered with the 

U.S. Department of the Treasury to 

utilize Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA website after 

completing the Generic Drug User Fee 

Cover Sheet and generating the user fee 

ID number. 

Secure electronic payments can be 

submitted using the User Fees Payment 

Portal at https://userfees.fda.gov/pay. 

(Note: only full payments are accepted; 

no partial payments can be made 

online.) Once an invoice is located, 

‘‘Pay Now’’ should be selected to be 

redirected to Pay.gov. Electronic 

payment options are based on the 

balance due. Payment by credit card is 

available 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. 

The user fee ID number must be 

included on the check, bank draft, or 

postal money order and must be made 

payable to the order of the Food and 

Drug Administration. Payments can be 

mailed to: Food and Drug 

Administration, P.O. Box 979108, St. 

Louis, MO 63197–9000. If checks are to 

be sent by a courier that requests a street 

address, the courier can deliver checks 

to: U.S. Bank, Attention: Government 

Lockbox 979108, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. For questions concerning courier 

delivery, U.S. Bank can be contacted at 

314–418–4013. This telephone number 

is only for questions about courier 

delivery.) The FDA post office box 

number (P.O. Box 979108) must be 

written on the check, bank draft, or 

postal money order. 

For payments made by wire transfer, 

the unique user fee ID number must be 

referenced. Without the unique user fee 

ID number, the payment may not be 

applied. If the payment amount is not 

applied, the invoice amount will be 

referred to collections. The originating 

financial institution may charge a wire 

transfer fee. Applicable wire transfer 

fees must be included with payment to 

ensure fees are fully paid. Questions 

about wire transfer fees should be 

addressed to the financial institution. 

The following account information 

should be used to send payments by 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40587 

1See 79 FR 22501 (April 22, 2014). 

wire transfer: U.S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, account number: 

75060099, routing number: 021030004, 

SWIFT: FRNYUS33. FDA’s tax 

identification number is 53–0196965. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16039 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–0649] 

Determination That CECLOR CD 

(Cefaclor Extended-Release Tablets) 

375 Milligrams and 500 Milligrams 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness, 

Except the Indication of Secondary 

Bacterial Infections of Acute 

Bronchitis, Which Was Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that CECLOR CD 

(cefaclor extended-release tablets) 375 

milligrams (mg) and 500 mg were not 

withdrawn from sale for reasons of 

safety or effectiveness, except with 

respect to the indication of secondary 

bacterial infections of acute bronchitis 

(SBIAB) that was withdrawn for reasons 

of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to suspend approval of 

any abbreviated new drug application 

(ANDA) that refers to this drug product 

and has removed the indication for 

SBIAB. This determination also will 

allow FDA to continue to approve 

ANDAs that refer to these drug products 

as long as they meet relevant legal and 

regulatory requirements. However, the 

Agency will not accept or approve 

ANDAs for CECLOR CD (cefaclor 

extended-release tablets) 375 mg and 

500 mg that include SBIAB as an 

indication. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) Has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and, with certain exceptions, 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

Under § 314.161(a)(2), the Agency 

must also determine whether a listed 

drug was withdrawn from sale for 

reasons of safety or effectiveness if 

ANDAs that referred to the listed drug 

have already been approved prior to its 

market withdrawal. If the Agency 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, and there are 

approved ANDAs that reference that 

listed drug, FDA will initiate a 

proceeding to determine whether the 

suspension of the ANDAs is also 

required (21 CFR 314.161(d)). 

CECLOR CD (cefaclor extendedrelease tablets) 375 mg and 500 mg are 

the subject of NDA 050673 held by Eli 

Lilly and Co., and initially approved on 

June 28, 1996. CECLOR CD (cefaclor 

extended-release tablets) is indicated for 

the treatment of patients with the 

following mild to moderate infections 

when caused by susceptible strains of 

the designated microorganisms: 

• Acute bacterial exacerbations of 

chronic bronchitis due to Haemophilus 

influenzae (non-b-lactamase-producing 

strains only), Moraxella catarrhalis 

(including b-lactamase-producing 

strains) or Streptococcus pneumoniae. 

• Secondary bacterial infections of 

acute bronchitis due to H. influenzae 

(non-b-lactamase-producing strains 

only), M. catarrhalis (including blactamase-producing strains), or S. 

pneumoniae. 

• Pharyngitis and tonsillitis due to 

Streptococcus pyogenes. 

• Uncomplicated skin and skin 

structure infections due to 

Staphylococcus aureus (methicillinsusceptible). 

On June 13, 2005, Eli Lilly and Co. 

submitted a request to the Agency to 

withdraw approval of NDA 050673, 

CECLOR CD (cefaclor extended-release 

tablets), 375 mg and 500 mg, under 21 

CFR 314.150(c). The Agency published 

a Federal Register notice on April 22, 

2014, withdrawing approval of NDA 

050673, effective May 22, 2014.1

After reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that CECLOR CD (cefaclor 

extended-release tablets), 375 mg and 

500 mg, were not withdrawn from sale 

for reasons of safety or effectiveness, 

except with respect to the indication for 

SBIAB. 

Based on a review of relevant 

information, FDA has concluded that 

the SBIAB indication is not appropriate 

because most cases of SBIAB are 

considered to be viral or noninfectious. 

As an antibacterial drug, CECLOR CD 

(cefaclor extended-release tablets) is not 

considered to be effective to treat 

SBIAB. Such use of CECLOR CD 

(cefaclor extended-release tablets) 

would likely result in inappropriate 

antibacterial drug use. Accordingly, for 

the treatment of SBIAB, the benefit-risk 

profile of CECLOR CD (cefaclor 

extended-release tablets) is unfavorable 

and does not support approval of these 

products (or ANDAs referencing them) 

for this indication. For the remaining 

indications, the Agency has determined 

that CECLOR CD (cefaclor extendedrelease tablets) continues to have a 

favorable benefit-risk profile. 

Accordingly, the Agency will 

continue to list CECLOR CD (cefaclor 

extended-release tablets), 375 mg and 

500 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The approved ANDA has 


khammond on DSKJM1Z7X2PROD with NOTICES