Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40575 

1For the reasons explained in the third-party 

certification final rule (80 FR 74570 at 74578– 

74579, November 27, 2015), and for consistency 

with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11, 

and 16, this notice uses the term ‘‘third-party 

certification body’’ rather than the term ‘‘third-party 

auditor’’ used in section 808(a)(3) of the FD&C Act. 

FOR FURTHER INFORMATION CONTACT: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398 and/or 

PSG-Questions@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

draft guidance on a generic olodaterol 

hydrochloride; tiotropium bromide 

inhalation spray. 

FDA initially approved new drug 

application (NDA) 206756 for STIOLTO 

RESPIMAT (olodaterol hydrochloride; 

tiotropium bromide inhalation spray) in 

May 2015. We are now issuing draft 

guidance for industry on BE 

recommendations for generic olodaterol 

hydrochloride; tiotropium bromide 

inhalation spray (‘‘Draft Guidance for 

Olodaterol Hydrochloride; Tiotropium 

Bromide’’). 

In October 2012, Boehringer 

Ingelheim, manufacturer of the 

reference listed drug SPIRIVA 

HANDIHALER, NDA 21395, submitted a 

citizen petition requesting, among other 

things, that FDA adopt and apply 

certain requirements in its review of any 

proposed generic and follow-on 

versions of SPIRIVA HANDIHALER or 

any other Boehringer Ingelheim oral 

inhalation product containing the active 

ingredient tiotropium bromide under 

section 505(j) and (b)(2), respectively, of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(j) and (b)(2)) (Docket 

No. FDA–2012–P–1072). Boehringer 

Ingelheim submitted a supplement to 

the citizen petition in January 2021 

further expanding on its initial petition 

requests. FDA is reviewing the issues 

raised in the petition and supplement 

and will consider any comments on the 

draft guidance entitled ‘‘Draft Guidance 

for Olodaterol Hydrochloride; 

Tiotropium Bromide’’ before responding 

to Boehringer’s citizen petition. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the information and data to 

demonstrate BE to support ANDAs for 

tiotropium bromide inhalation spray. It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16046 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–0702] 

Food Safety Modernization Act ThirdParty Certification Program User Fee 

Rate for Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2022 annual fee rate for 

recognized accreditation bodies and 

accredited certification bodies, and the 

initial and renewal fee rate for 

accreditation bodies applying to be 

recognized in the third-party 

certification program that is authorized 

by the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as amended 

by the FDA Food Safety Modernization 

Act (FSMA). We are also announcing 

the fee rate for certification bodies that 

are applying to be directly accredited by 

FDA. 

DATES: This fee is effective October 1, 

2021. 

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 307 of FSMA (Pub. L. 111– 

353), Accreditation of Third-Party 

Auditors, amended the FD&C Act to 

create a new provision, section 808, 

under the same name. Section 808 of the 

FD&C Act (21 U.S.C. 384d) directs FDA 

to establish a program for accreditation 

of third-party certification bodies 1

conducting food safety audits and 

issuing food and facility certifications to 

eligible foreign entities (including 

registered foreign food facilities) that 

meet our applicable requirements. 

Under this provision, we established a 

system for FDA to recognize 

accreditation bodies to accredit 

certification bodies, except for limited 

circumstances in which we may directly 

accredit certification bodies to 

participate in the third-party 

certification program. 

Section 808(c)(8) of the FD&C Act 

directs FDA to establish a 

reimbursement (user fee) program by 

which we assess fees and require 

reimbursement for the work FDA 

performs to establish and administer the 

third-party certification program under 

section 808 of the FD&C Act. The user 

fee program for the third-party 

certification program was established by 

a final rule entitled ‘‘Amendments to 

Accreditation of Third-Party 

Certification Bodies To Conduct Food 

Safety Audits and To Issue 

Certifications To Provide for the User 

Fee Program’’ (81 FR 90186, December 

14, 2016). 

The FSMA FY 2022 third-party 

certification program user fee rate 

announced in this notice is effective on 

October 1, 2021 and will remain in 

effect through September 30, 2022. 


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II. Estimating the Average Cost of a 

Supported Direct FDA Work Hour for 

FY 2022 

FDA must estimate 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 the remaining funds (operating 

funds) available to FDA are used to 

support FDA employees for paying rent, 

travel, utility, information technology, 

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, information 

technology, general and administrative 

overhead—is $101,625; and rent, 

including cost allocation analysis and 

adjustments for other rent and rentrelated 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 

third-party certification user fees for FY 

2022 prior to including 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 

26.5 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 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 2021 and 2.2013 percent 

for FY 2022, and FDA intends to use 

this inflation rate 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 

1.35803 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 third-party certification program 

fees for FY 2022 prior to including 

travel costs as applicable for the 

activity. For the purpose of estimating 

the fee, we are using the travel cost rate 

for foreign travel because we anticipate 

that the vast majority of onsite 

assessments made by FDA under this 

program will require foreign travel. In 

FY 2020, the Office of Regulatory Affairs 

spent a total of $1,449,058 on 171 

foreign inspection trips related to FDA’s 

Center for Food Safety and Applied 

Nutrition and Center for Veterinary 

Medicine 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 

factor mentioned previously in this 

document (1.035803 or 3.5803 percent), 

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 

this rate in charging fees in FY 2022 

when travel is required for the thirdparty certification program. 

TABLE 2—FSMA FEE SCHEDULE FOR

FY 2022 

Fee category Fee rates for 

FY 2022 

Hourly rate without travel ..... $256 

Hourly rate if travel is required ................................ 330 

III. Fees for Accreditation Bodies and 

Certification Bodies in the Third-Party 

Certification Program Under Section 

808(c)(8) of the FD&C Act 

The third-party certification program 

assesses application fees and annual 

fees. In FY 2022, the only fees that 

could be collected by FDA under 

section 808(c)(8) of the FD&C Act are 

the initial application fee for 

accreditation bodies seeking 

recognition, the annual fee for 

recognized accreditation bodies, the 

annual fee for certification bodies 

accredited by a recognized accreditation 

body, the initial application fee for a 

certification body seeking direct 

accreditation from FDA, and the 

renewal fee for recognized accreditation 

bodies. Table 3 provides an overview of 

the fees for FY 2022. 


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TABLE 3—FSMA THIRD-PARTY CERTIFICATION PROGRAM USER FEE

SCHEDULE FOR FY 2022 

Fee category Fee rates for 

FY 2022 

Initial Application Fee for Accreditation Body Seeking 

Recognition ....................... $44,512 

Annual Fee for Recognized 

Accreditation Body ............ 2,064 

Annual Fee for Accredited 

Certification Body .............. 2,580 

Initial Application Fee for a 

Certification Body Seeking 

Direct Accreditation From 

FDA ................................... 44,512 

Renewal Application Fee for 

Recognized Accreditation 

Body .................................. 27,120 

A. Application Fee for Accreditation 

Bodies Applying for Recognition in the 

Third-Party Certification Program Under 

Section 808(c)(8) of the FD&C Act 

Section 1.705(a)(1) (21 CFR 

1.705(a)(1)) establishes an application 

fee for accreditation bodies applying for 

initial recognition that represents the 

estimated average cost of the work FDA 

performs in reviewing and evaluating 

initial applications for recognition of 

accreditation bodies. 

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 continue to 

reconsider the estimated hours. Based 

on data we have acquired since starting 

the program, we estimate that it would 

take, on average, 80 person-hours to 

review an accreditation body’s 

submitted application, 48 person-hours 

for an onsite performance evaluation of 

the applicant (including travel and other 

steps necessary for a fully supported 

FTE to complete an onsite assessment), 

and 32 person-hours to prepare a 

written report documenting the onsite 

assessment. 

FDA employees review applications 

and prepare reports 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 × (80 hours (application review) + 

32 hours (written report)) = $28,672. 

FDA employees will likely travel to 

foreign countries for the onsite 

performance evaluations because most 

accreditation bodies are anticipated to 

be located in foreign countries. For this 

portion of the fee we use the fully 

supported FTE hourly rate for work 

requiring travel, $330/hour, to calculate 

the portion of the user fee attributable 

to those activities: $330/hour × 48 hours 

(i.e., two fully supported FTEs × ((2 

travel days × 8 hours) + (1 day onsite × 

8 hours))) = $15,840. The estimated 

average cost of the work FDA performs 

in total for reviewing an initial 

application for recognition for an 

accreditation body based on these 

figures would be $28,672 + $15,840 = 

$44,512. Therefore, the application fee 

for accreditation bodies applying for 

recognition in FY 2022 will be $44,512. 

B. Annual Fee for Accreditation Bodies 

Participating in the Third-Party 

Certification Program Under Section 

808(c)(8) of the FD&C Act 

To calculate the annual fee for each 

recognized accreditation body, FDA 

takes the estimated average cost of work 

FDA performs to monitor performance 

of a single recognized accreditation 

body and annualizes that over the 

average term of recognition. At this 

time, we assume an average term of 

recognition of 5 years. We also assume 

that FDA will monitor 10 percent of 

recognized accreditation bodies onsite. 

As the program proceeds, we will adjust 

the term of recognition as appropriate. 

We estimate that for one performance 

evaluation of a recognized accreditation 

body, it would take, on average (taking 

into account that not all recognized 

accreditation bodies would be 

monitored onsite), 22 hours for FDA to 

conduct records review, 8 hours to 

prepare a report detailing the records 

review and onsite performance 

evaluation, and 8 hours of onsite 

performance evaluation. Using the fully 

supported FTE hourly rates in table 2, 

the estimated average cost of the work 

FDA performs to monitor performance 

of a single recognized accreditation 

body would be $7,680 ($256/hour × (22 

hours (records review) + 8 hours 

(written report))) plus $2,640 ($330/ 

hour × 8 hours (onsite evaluation)), 

which is $10,320. Annualizing this 

amount over 5 years would lead to an 

annual fee for recognized accreditation 

bodies of $2,064 for FY 2022. 

C. Annual Fee for Certification Bodies 

Accredited by a Recognized 

Accreditation Body in the Third-Party 

Certification Program Under Section 

808(c)(8) of the FD&C Act 

To calculate the annual fee for a 

certification body accredited by a 

recognized accreditation body, FDA 

takes the estimated average cost of work 

FDA performs to monitor performance 

of a single certification body accredited 

by a recognized accreditation body and 

annualizes that over the average term of 

accreditation. At this time, we assume 

an average term of accreditation of 4 

years. This 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. We estimate that FDA would 

conduct, on average, the same activities, 

for the same amount of time to monitor 

certification bodies accredited by a 

recognized accreditation body as we 

would to monitor an accreditation body 

recognized by FDA. Using the fully 

supported FTE hourly rates in Table 2, 

the estimated average cost of the work 

FDA performs to monitor performance 

of a single accredited certification body 

would be $7,680 ($256/hour × (22 hours 

(records review) + 8 hours (written 

report))) plus $2,640 ($330/hour × 8 

hours (onsite evaluation)), which is 

$10,320. Annualizing this amount over 

4 years would lead to an annual fee for 

accredited certification bodies of $2,580 

for FY 2022. 

D. Initial Application Fee for 

Certification Bodies Seeking Direct 

Accreditation From FDA in the ThirdParty Certification Program Under 

Section 808(c)(8) of the FD&C Act 

Section 1.705(a)(3) establishes an 

application fee for certification bodies 

applying for direct accreditation from 

FDA that represents the estimated 

average cost of the work FDA performs 

in reviewing and evaluating initial 

applications for direct accreditation of 

certification bodies. 

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, 80 person-hours 

to review a certification body’s 

submitted application, 48 person-hours 

for an onsite performance evaluation of 

the applicant (including travel and other 

steps necessary for a fully supported 

FTE to complete an onsite assessment), 

and 32 person-hours to prepare a 

written report documenting the onsite 

assessment. 

FDA employees are likely to review 

applications and prepare reports 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 × (80 hours 

(application review) + 32 hours (written 

report)) = $28,672. FDA employees will 

likely travel to foreign countries for the 

onsite performance evaluations because 

most certification bodies are anticipated 

to be located in foreign countries. For 


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this portion of the fee we use the fully 

supported FTE hourly rate for work 

requiring travel, $330/hour, to calculate 

the portion of the user fee attributable 

to those activities: $330/hour × 48 hours 

(i.e., two fully supported FTEs × ((2 

travel days × 8 hours) + (1 day onsite × 

8 hours))) = $15,840. The estimated 

average cost of the work FDA performs 

in total for reviewing an initial 

application for direct accreditation of a 

certification body based on these figures 

would be $28,672 + $15,840 = $44,512. 

Therefore, the application fee for 

certification bodies applying for direct 

accreditation from FDA in FY 2022 will 

be $44,512. 

E. Renewal Fee for Accreditation Bodies 

Participating in the Third-Party 

Certification Program Under Section 

808(c)(8) of the FD&C Act 

Section 1.705(a)(2) establishes a 

renewal application fee for recognized 

accreditation bodies that represents the 

estimated average cost of the work FDA 

performs in reviewing and evaluating 

renewal applications for recognition of 

accreditation bodies. 

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, 43 person-hours 

to review an accreditation body’s 

submitted renewal application, 24 

person-hours for an onsite performance 

evaluation of the applicant (including 

travel and other steps necessary for a 

fully supported FTE to complete an 

onsite assessment), and 32 person-hours 

to prepare a written report documenting 

the onsite assessment. 

FDA employees are likely to review 

renewal applications and prepare 

reports 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 × (43 

hours (application review) + 32 hours 

(written report)) = $19,200. FDA 

employees will likely travel to foreign 

countries for the onsite performance 

evaluations because most certification 

bodies are anticipated to be located in 

foreign countries. For this portion of the 

fee we use the fully supported FTE 

hourly rate for work requiring travel, 

$330/hour, to calculate the portion of 

the user fee attributable to those 

activities: $330/hour × 24 hours (i.e., 

fully supported FTE × ((2 travel days × 

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

$7,920. The estimated average cost of 

the work FDA performs in total for 

reviewing a renewal application for 

recognition of an accreditation body 

based on these figures would be $19,200 

+ $7,920 = $27,120. Therefore, the 

renewal application fee for recognized 

accreditation bodies in FY 2022 will be 

$27,120. 

IV. Estimated Fees for Accreditation 

Bodies and Certification Bodies in 

Other Fee Categories for FY 2022 

Section 1.705(a) also establishes 

application fees for certification bodies 

applying for renewal of direct 

accreditation. Section 1.705(b) also 

establishes annual fees for certification 

bodies directly accredited by FDA. 

Although we will not be collecting 

these other fees in FY 2022, for 

transparency and planning purposes, we 

have provided an estimate of what these 

fees would be for FY 2022 based on the 

fully supported FTE hourly rates for FY 

2022 and estimates of the number of 

hours it would take FDA to perform 

relevant activities as outlined in the 

Final Regulatory Impact Analysis for the 

Third-Party Certification Regulation. 

Table 4 provides an overview of the 

estimated fees for other fee categories. 

TABLE 4—ESTIMATED FEE RATES FOR

OTHER FEE CATEGORIES UNDER

THE FSMA THIRD-PARTY CERTIFICATION PROGRAM

Fee category 

Estimated fee 

rates for FY 

2022 

Renewal application fee for 

directly accredited certification body ........................ $27,120 

Annual fee for certification 

body directly accredited by 

FDA ................................... 21,392 

V. How must the fee be paid? 

Accreditation bodies seeking initial 

recognition must submit the application 

fee with the application. For recognized 

accreditation bodies and accredited 

certification bodies, an invoice will be 

sent annually. Payment must be made 

within 30 days of the receipt invoice 

date. 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. 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.) 

VI. What are the consequences of not 

paying this fee? 

The consequences of not paying these 

fees are outlined in 21 CFR 1.725. If 

FDA does not receive an application fee 

with an application for recognition, the 

application will be considered 

incomplete and FDA will not review the 

application. If a recognized 

accreditation body fails to submit its 

annual user fee within 30 days of the 

due date, we will suspend its 

recognition. If the recognized 


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accreditation body fails to submit its 

annual user fee within 90 days of the 

due date, we will revoke its recognition. 

If an accredited certification body fails 

to pay its annual fee within 30 days of 

the due date, we will suspend its 

accreditation. If the accredited 

certification body fails to pay its annual 

fee within 90 days of the due date, we 

will withdraw its accreditation. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16062 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–2020–N–2366] 

Justin Ash: Final Debarment Order 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

Justin Ash for a period of 5 years from 

importing or offering for import any 

drug into the United States. FDA bases 

this order on a finding that Mr. Ash was 

convicted of one felony count under 

Federal law for conspiracy to commit 

offenses against the United States. The 

factual basis supporting Mr. Ash’s 

conviction, as described below, is 

conduct relating to the importation into 

the United States of a drug or controlled 

substance. Mr. Ash was given notice of 

the proposed debarment and was given 

an opportunity to request a hearing to 

show why he should not be debarred. 

As of April 4, 2021 (30 days after receipt 

of the notice), Mr. Ash had not 

responded. Mr. Ash’s failure to respond 

and request a hearing constitutes a 

waiver of his right to a hearing 

concerning this matter. 

DATES: This order is applicable July 28, 

2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

240–402–7500, or at https://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa (ELEM–4029), Division 

of Enforcement (ELEM–4029), Office of 

Strategic Planning and Operational 

Policy, Office of Regulatory Affairs, 

Food and Drug Administration, 12420 

Parklawn Dr., Rockville, MD 20857, 

240–402–8743, or at debarments@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(D) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(D)) permits 

debarment of an individual from 

importing or offering for import any 

drug into the United States if FDA finds, 

as required by section 306(b)(3)(C) of the 

FD&C Act, that the individual has been 

convicted of a felony for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance. 

On November 24, 2020, Mr. Ash was 

convicted, as defined in section 

306(l)(1) of FD&C Act, in the U. S. 

District Court for the Western District of 

Pennsylvania, when the court entered 

judgment against him for the offense of 

conspiracy to commit offenses against 

the United States, in violation of 18 

U.S.C. 371. 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: As contained in the information 

in Mr. Ash’s case, filed December 10, 

2019, to which he plead guilty, from on 

or about January 1, 2016, and 

continuing until May 8, 2018, he 

controlled an internet-based business 

entity known as both DRC and Domestic 

RCS (hereinafter DRC). During this time, 

Mr. Ash obtained bulk supplies of 

clonazolam, diclazepam, 

flubromazolam, and etizolam (none of 

which have been approved for use by 

FDA in the United States) from overseas 

sources, including from suppliers in 

China. Mr. Ash caused his overseas 

suppliers to ship these drugs in smaller 

quantities to multiple addresses in the 

United States he controlled to draw less 

government scrutiny. After receiving 

these bulk drugs, Mr. Ash caused his 

employees to press them into pills and 

package them. Mr. Ash caused the pill 

packaging to include disclaimers stating 

that the drugs were for research 

purposes only, in part to evade 

detection by regulatory authorities, 

including FDA. Mr. Ash then had the 

packages shipped to customers 

throughout the United States who 

ordered the drugs through a website he 

operated. 

As a result of this conviction, FDA 

sent Mr. Ash, by certified mail, on 

February 26, 2021, a notice proposing to 

debar him for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Mr. Ash’s felony conviction under 

Federal law for conspiracy to commit 

offenses against the United States, in 

violation of 18 U.S.C. 371, was for 

conduct relating to the importation into 

the United States of any drug or 

controlled substance because he 

illegally imported, manufactured, 

repackaged, and then introduced 

unapproved clonazolam, diclazepam, 

flubromazolam, and etizolam drug 

products into interstate commerce. 

In proposing a debarment period, 

FDA weighed the considerations set 

forth in section 306(c)(3) of the FD&C 

Act that it considered applicable to Mr. 

Ash’s offense, and concluded that the 

offense warranted the imposition of a 5- 

year period of debarment. 

The proposal informed Mr. Ash of the 

proposed debarment and offered him an 

opportunity to request a hearing, 

providing him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Ash received the proposal and notice of 

opportunity for a hearing on March 5, 

2021. Mr. Ash failed to request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

his opportunity for a hearing and 

waived any contentions concerning his 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Justin Ash 

has been convicted of a felony under 

Federal law for conduct relating to the 

importation into the United States of 

any drug or controlled substance. FDA 

finds that the offense should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Ash is debarred for a period of 5 

years from importing or offering for 

import any drug into the United States, 

effective (see DATES). Pursuant to section 

301(cc) of the FD&C Act (21 U.S.C. 

331(cc)), the importing or offering for 

import into the United States of any 

drug or controlled substance by, with 

the assistance of, or at the direction of 

Mr. Ash is a prohibited act. 

Any application by Mr. Ash for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 


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