40580 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

identified with Docket No. FDA–2020– 

N–2366 and sent to the Dockets 

Management Staff (see ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20(j). 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: July 19, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16044 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–0704] 

Food Safety Modernization Act 

Voluntary Qualified Importer Program 

User Fee Rate for Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2022 annual fee rate for 

importers approved to participate in the 

Voluntary Qualified Importer Program 

(VQIP) that is authorized by the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the FDA Food 

Safety Modernization Act (FSMA). This 

fee is effective August 1, 2021, and will 

remain in effect through September 30, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Donald Prater, Office of Food Policy and 

Response, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3202, Silver Spring, 

MD 20993, 301–348–3007. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 302 of FSMA, Voluntary 

Qualified Importer Program, amended 

the FD&C Act to create a new provision, 

section 806, under the same name. 

Section 806 of the FD&C Act (21 U.S.C. 

384b) directs FDA to establish a 

program to provide for the expedited 

review and importation of food offered 

for importation by importers who have 

voluntarily agreed to participate in such 

program, and a process, consistent with 

section 808 of the FD&C Act (21 U.S.C. 

384d), for the issuance of a facility 

certification to accompany a food 

offered for importation by importers 

participating in the VQIP. 

Section 743 of the FD&C Act (21 

U.S.C. 379j–31) authorizes FDA to 

assess and collect fees from each 

importer participating in VQIP to cover 

FDA’s costs of administering the 

program. Each fiscal year, fees are to be 

established based on an estimate of 100 

percent of the costs for the year. The fee 

rates must be published in a Federal 

Register notice not later than 60 days 

before the start of each fiscal year 

(section 743(b)(1) of the FD&C Act). 

After FDA approves a VQIP application, 

the user fee must be paid before October 

1, the start of the VQIP fiscal year, to 

begin receiving benefits for that VQIP 

fiscal year. 

The FY 2022 VQIP user fee will 

support benefits from October 1, 2021, 

through September 30, 2022. 

II. Estimating the Average Cost of a 

Supported Direct FDA Work Hour for 

FY 2022 

FDA is required to estimate 100 

percent of its costs for each activity in 

order to establish fee rates for FY 2022. 

In each year, the costs of salary (or 

personnel compensation) and benefits 

for FDA employees account for between 

50 and 60 percent of the funds available 

to, and used by, FDA. Almost all of the 

remaining funds (operating funds) 

available to FDA are used to support 

FDA employees for paying rent, travel, 

utility, information technology (IT), and 

other operating costs. 

A. Estimating the Full Cost per Direct 

Work Hour in FY 2022 

Full-time Equivalent (FTE) reflects the 

total number of regular straight-time 

hours—not including overtime or 

holiday hours—worked by employees, 

divided by the number of compensable 

hours applicable to each fiscal year. 

Annual leave, sick leave, compensatory 

time off, and other approved leave 

categories are considered ‘‘hours 

worked’’ for purposes of defining FTE 

employment. 

In general, the starting point for 

estimating the full cost per direct work 

hour is to estimate the cost of an FTE 

or paid staff year. Calculating an 

Agency-wide total cost per FTE requires 

three primary cost elements: payroll, 

non-payroll, and rent. 

We have used an average of past year 

cost elements to predict the FY 2022 

cost. The FY 2022 FDA-wide average 

cost for payroll (salaries and benefits) is 

$171,228; non-payroll—including 

equipment, supplies, IT, general and 

administrative overhead—is $101,625; 

and rent, including cost allocation 

analysis and adjustments for other rent 

and rent-related costs, is $23,597 per 

paid staff year, excluding travel costs. 

Summing the average cost of an FTE 

for payroll, non-payroll, and rent, brings 

the FY 2022 average fully supported 

cost to $296,450 per FTE, excluding 

travel costs. FDA will use this base unit 

fee in determining the hourly fee rate for 

VQIP fees for FY 2022 prior to including 

domestic or foreign travel costs as 

applicable for the activity. 

To calculate an hourly rate, FDA must 

divide the FY 2022 average fully 

supported cost of $296,450 per FTE by 

the average number of supported direct 

FDA work hours in FY 2020—the last 

FY for which data are available. See 

table 1. 

TABLE 1—SUPPORTED DIRECT FDA 

WORK HOURS IN A PAID STAFF

YEAR IN FY 2020 

Total number of hours in a paid staff 

year ................................................. 2,080 

Less: 

10 paid holidays .............................. ¥80 

20 days of annual leave ................. ¥160 

10 days of sick leave ...................... ¥80 

12.5 days of training ....................... ¥100 

23 days of general administration .. ¥184 

26.5 days of travel .......................... ¥212 

2 hours of meetings per week ........ ¥104 

Net Supported Direct FDA Work 

Hours Available for Assignments 1,160 

Dividing the average fully supported 

FTE cost in FY 2022 ($296,450) by the 

total number of supported direct work 

hours available for assignment in FY 

2020 (1,160) results in an average fully 

supported cost of $256 (rounded to the 

nearest dollar), excluding inspection 

travel costs, per supported direct work 

hour in FY 2022. 

B. Adjusting FY 2020 Travel Costs for 

Inflation To Estimate FY 2022 Travel 

Costs 

To adjust the hourly rate for FY 2022, 

FDA must estimate the cost of inflation 

in each year for FY 2021 and FY 2022. 

FDA uses the method prescribed for 

estimating inflationary costs under the 

Prescription Drug User Fee Act 

(PDUFA) provisions of the FD&C Act 

(section 736(c)(1) (21 U.S.C. 379h(c)(1)), 

the statutory method for inflation 

adjustment in the FD&C Act that FDA 

has used consistently. FDA previously 

determined the FY 2021 inflation rate to 

be 1.3493 percent; this rate was 

published in the FY 2021 PDUFA user 

fee rates notice in the Federal Register 

(August 3, 2020, 85 FR 46651). Utilizing 

the method set forth in section 736(c)(1) 

of the FD&C Act, FDA has calculated an 

inflation rate of 1.3493 percent for FY 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40581 

2021 and 2.2013 percent for FY 2022, 

and FDA intends to use these inflation 

rates to make inflation adjustments for 

FY 2022; the derivation of this rate will 

be published in the Federal Register in 

the FY 2022 notice for the PDUFA user 

fee rates. The compounded inflation rate 

for FYs 2021 and 2022, therefore, is 

1.035803 (or 3.5803 percent) (calculated 

as 1 plus 1.3493 percent times 1 plus 

2.2013 percent). 

The average fully supported cost per 

supported direct FDA work hour, 

excluding travel costs, of $256 already 

takes into account inflation as the 

calculation above is based on FY 2022 

predicted costs. FDA will use this base 

unit fee in determining the hourly fee 

rate for VQIP fees for FY 2022 prior to 

including domestic or foreign travel 

costs as applicable for the activity. 

In FY 2020, FDA’s Office of 

Regulatory Affairs (ORA) spent a total of 

$3,831,758 for domestic regulatory 

inspection travel costs and General 

Services Administration Vehicle costs 

related to FDA’s Center for Food Safety 

and Applied Nutrition (CFSAN) and 

Center for Veterinary Medicine (CVM) 

field activities programs. The total ORA 

domestic travel costs spent is then 

divided by the 4,399 CFSAN and CVM 

domestic inspections, which averages a 

total of $871 per inspection. These 

inspections average 42.65 hours per 

inspection. Dividing $871 per 

inspection by 42.65 hours per 

inspection results in a total and an 

additional cost of $20 (rounded to the 

nearest dollar) per hour spent for 

domestic inspection travel costs in FY 

2020. To adjust for the $20 per hour 

additional domestic cost inflation 

increases for FY 2021 and FY 2022, FDA 

must multiply the FY 2021 PDUFA 

inflation rate adjustor (1.013493) by the 

FY 2022 PDUFA inflation rate adjustor 

(1.022013) times the $20 additional 

domestic cost, which results in an 

estimated cost of $21 (rounded to the 

nearest dollar) per paid hour in addition 

to $256 for a total of $277 per paid hour 

($256 plus $21) for each direct hour of 

work requiring domestic inspection 

travel. FDA will use these rates in 

charging fees in FY 2022 when domestic 

travel is required. 

In FY 2020, ORA spent a total of 

$1,449,058 on 171 foreign inspection 

trips related to FDA’s CFSAN and CVM 

field activities programs, which 

averaged a total of $8,474 per foreign 

inspection trip. These trips averaged 3 

weeks (or 120 paid hours) per trip. 

Dividing $8,474 per trip by 120 hours 

per trip results in a total and an 

additional cost of $71 (rounded to the 

nearest dollar) per paid hour spent for 

foreign inspection travel costs in FY 

2020. To adjust $71 for inflationary 

increases in FY 2021 and FY 2022, FDA 

must multiply it by the same inflation 

factors mentioned previously in this 

document (1.013493 and 1.022013), 

which results in an estimated cost of 

$74 (rounded to the nearest dollar) per 

paid hour in addition to $256 for a total 

of $330 per paid hour ($256 plus $74) 

for each direct hour of work requiring 

foreign inspection travel. FDA will use 

these rates in charging fees in FY 2022 

when foreign travel is required. 

TABLE 2—FSMA FEE SCHEDULE FOR

FY 2022 

Hourly rate without travel ................... $256 

Hourly rate if domestic travel is required .............................................. 277 

Hourly rate if foreign travel is required 330 

III. Fees for Importers Approved To 

Participate in the Voluntary Qualified 

Importer Program Under Section 743 of 

the FD&C Act 

FDA assesses fees for VQIP annually. 

Table 3 provides an overview of the fees 

for FY 2022. 

TABLE 3—FSMA VQIP USER FEE

SCHEDULE FOR FY 2022 

Fee category Fee rates for 

FY 2022 

VQIP User Fee ..................... $15,938 

Section 743 of the FD&C Act requires 

that each importer participating in VQIP 

pay a fee to cover FDA’s costs of 

administering the program. This fee 

represents the estimated average cost of 

the work FDA performs in reviewing 

and evaluating a VQIP importer. At this 

time, FDA is not offering an adjusted fee 

for small businesses. As required by 

section 743(b)(2)(B)(iii) of the FD&C Act, 

FDA previously published a set of 

guidelines in consideration of the 

burden of the VQIP fee on small 

businesses and provided for a period of 

public comment on the guidelines (80 

FR 32136, June 5, 2015). While we did 

receive some comments in response, 

they did not address the questions 

posed, i.e., how a small business fee 

reduction should be structured, what 

percentage of fee reduction would be 

appropriate, or what alternative 

structures FDA might consider to 

indirectly reduce fees for small 

businesses by charging different fee 

amounts to different VQIP participants. 

We plan on monitoring costs and 

collecting data to determine if, in future 

fiscal years, we will provide for a small 

business fee reduction. Consistent with 

section 743(b)(2)(B)(iii) of the FD&C Act, 

we will adjust the fee schedule for small 

businesses only through notice and 

comment rulemaking. 

The fee is based on the fully 

supported FTE hourly rates and 

estimates of the number of hours it 

would take FDA to perform relevant 

activities. These estimates represent 

FDA’s current thinking, and as the 

program evolves, FDA will reconsider 

the estimated hours. We estimate that it 

would take, on average, 39 person-hours 

to review a new VQIP application 

(including communication provided 

through the VQIP Importer’s Help Desk), 

28 person-hours to review a returning 

VQIP application (including 

communication provided through the 

VQIP Importer’s Help Desk), 16 personhours for an onsite performance 

evaluation of a domestic VQIP importer 

(including travel and other steps 

necessary for a fully supported FTE to 

complete and document an onsite 

assessment), and 34 person-hours for an 

onsite performance evaluation of a 

foreign VQIP importer (including travel 

and other steps necessary for a fully 

supported FTE to complete and 

document an onsite assessment). 

Additional costs include maintenance 

and support costs of information 

technology of administering benefits of 

the program. These costs are estimated 

to be $7,000 per VQIP importer. 

Based on updated data, FDA 

anticipates that there may be up to three 

returning VQIP applicants and up to one 

new applicant this fiscal year. FDA 

employees are likely to review new 

VQIP applications from their worksites, 

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 × (39 hours) = $9,984. FDA 

employees are likely to review returning 

VQIP applications from their worksites, 

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 × (28 hours) = $7,168. 

FDA employees will conduct a VQIP 

inspection to verify the eligibility 

criteria and full implementation of the 

food safety and food defense systems 

established in the Quality Assurance 

Program. A VQIP importer may be 

located inside or outside of the United 

States. However, this fiscal year, all 

VQIP importers will be located inside 

the United States. One new applicant 

may have an associated VQIP 

inspection. 

FDA employees are likely to prepare 

for and report on the performance 

evaluation of a domestic VQIP importer 

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


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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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