Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40579 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
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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