40064 Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 

caused to be created for their DMAA 

shipments stated falsely that the 

substance in the shipments had been 

extracted from the geranium plant. 

Further, on or about December 8, 2011, 

Mr. Doyle’s coconspirator instructed a 

Chinese chemical seller via email to 

misbrand a shipment of nine different 

chemicals sent from China to USP Labs 

in Texas. One of those synthetic 

chemicals was called ‘‘aegeline.’’ The 

first aegeline-containing version of 

OxyElite Pro, which was called OxyElite 

‘‘New Formula,’’ went on sale in 

December 2012. In summer 2013, USP 

Labs reformulated the product again to 

contain aegeline and powder derived 

from a Chinese herb called cynanchum 

auriculatum. On or about June 15, 2013, 

Mr. Doyle’s coconspirator instructed a 

Chinese chemical seller to have two 

metric tons of ground cynanchum 

auriculatum root powder shipped 

internationally to SK Laboratories in 

California for inclusion in USP Labs’ 

products, using the false name 

‘‘cynanchum auriculatum root extract.’’ 

USP Labs sent false labels listing 

‘‘cynanchum auriculatum (root) extract’’ 

as an ingredient in its OxyElite Pro 

‘‘Advanced Formula’’ supplement, even 

though that ingredient was not present 

in the product. The conspirators 

collected millions in revenue that they 

would not have obtained, absent the 

conspiracy. 

As a result of this conviction FDA 

sent Mr. Doyle, by certified mail on 

March 4, 2021, a notice proposing to 

debar him for a period of 5 years from 

importing articles of food or offering 

such articles for import into the United 

States. The proposal was based on a 

finding under section 306(b)(1)(C) of the 

FD&C Act that Mr. Doyle’s felony 

conviction of conspiracy to introduce 

misbranded food into interstate 

commerce with an intent to defraud and 

mislead in violation of 18 U.S.C. 371 (21 

U.S.C. 331(a) and 21 U.S.C. 333(a)(2)), 

constitutes conduct relating to the 

importation into the United States of an 

article of food because the offense 

involved a conspiracy to import a 

variety of chemicals with false labeling 

in order to either use those chemicals in 

dietary supplements which would 

themselves also contain false labeling or 

to determine whether those chemicals 

could be used in new dietary 

supplements. 

The proposal was also based on a 

determination, after consideration of the 

relevant factors set forth in section 

306(c)(3) of the FD&C Act, that Mr. 

Doyle should be subject to a 5-year 

period of debarment. The proposal also 

offered Mr. Doyle an opportunity to 

request a hearing, providing Mr. Doyle 

30 days from the date of receipt of the 

letter in which to file the request, and 

advised Mr. Doyle that failure to request 

a hearing constituted a waiver of the 

opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Doyle failed to respond 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)(1)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Jonathan 

Doyle has been convicted of a felony 

count under Federal law for conduct 

relating to the importation into the 

United States of an article of food and 

that he is subject to a 5-year period of 

debarment. 

As a result of the foregoing finding, 

Mr. Doyle is debarred for a period of 5 

years from importing articles of food or 

offering such articles for import into the 

United States, effective July 26, 2021. 

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 an article of food by, with the 

assistance of, or at the direction of 

Jonathan Doyle is a prohibited act. 

Any application by Mr. Doyle for 

termination of debarment under section 

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

identified with Docket No. FDA–2020– 

N–2149 and sent to the Dockets 

Management Staff (ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20. 

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. 2021–15775 Filed 7–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: COVID–19 

Provider Relief Fund Reporting 

Activities, OMB No. 0906–XXXX New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than September 24, 

2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

COVID–19 Provider Relief Fund 

Reporting Activities, OMB No. 0906– 

XXXX New. 

Abstract: HRSA administers the 

Provider Relief Fund (PRF), which has 

disbursed funds to eligible health care 

providers to support health care-related 

expenses or lost revenues attributable to 

the COVID–19 pandemic. Providers who 

have accepted the Terms and 

Conditions regarding their PRF 

payment(s), including the requirement 

that the provider ‘‘shall submit reports 

as the Secretary determines are needed 

to ensure compliance with conditions 

that are imposed on this Payment, and 


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Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40065 

such reports shall be in such form, with 

such content, as specified by the 

Secretary in future program instructions 

directed to all Recipients,’’ will be using 

the PRF Reporting Portal to submit 

information about their use of PRF 

payments. HRSA is currently operating 

under the Paperwork Reduction Act 

Public Health Emergency (PHE) waiver 

that was approved by the Office of the 

Assistant Secretary for Planning and 

Evaluation on January 14, 2021. In 

anticipation of the PHE waiver expiring, 

HRSA is undergoing the OMB clearance 

process as the data will be collected 

beyond the PHE. 

Need and Proposed Use of the 

Information: Recipients of a PRF 

payment agreed to a set of Terms and 

Conditions, which, among other 

requirements, mandate compliance with 

certain reporting requirements that will 

facilitate appropriate oversight of 

recipients’ use of funds. 

Information collected will allow for 

(1) assessing whether recipients have 

met statutory and programmatic 

requirements, (2) conducting audits, (3) 

gathering data required to report on 

findings with respect to the 

disbursements of PRF payments, and (4) 

program evaluation. HRSA staff will 

also use information collected to 

identify and report on trends in health 

care metrics and expenditures before 

and during the allowable period for 

expending PRF payments. 

Likely Respondents: PRF recipients 

who have received more than $10,000 in 

aggregate PRF payments during one of 

the Payment Received Periods outlined 

below and that agreed to the associated 

Terms and Conditions are required to 

submit a report in the PRF Reporting 

Portal during the applicable Reporting 

Time Period. 

Reporting period 

Payment received period 

(payments exceeding $10,000 in 

aggregate received) 

Reporting time period 

Period 1 ....................................... April 10, 2020, to June 30, 2020 ...................................................... July 1, 2021, to September 30, 2021. 

Period 2 ....................................... July 1, 2020, to December 31, 2020 ................................................ January 1, 2022, to March 31, 2022. 

Period 3 ....................................... January 1, 2021, to June 30, 2021 .................................................. July 1, 2022, to September 30, 2022. 

Period 4 ....................................... July 1, 2021, to December 31, 2021 ................................................ January 1, 2023, to March 31, 2023. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

PRF Reporting Portal, Reporting Period 1 (Providers who 

received payments April 10, 2020, to June 30, 2020) ..... 126,831 1 126,831 5.6 710,254 

PRF Reporting Portal, Reporting Period 2 (Providers who 

received payments July 1, 2020, to December 31, 2020) 120,536 1 120,536 4.2 506,251 

PRF Reporting Portal, Reporting Period 3 (Providers who 

received payments January 1, 2021, to June 30, 2021) 19,962 1 19,962 5.6 111,787 

PRF Reporting Portal, Reporting Period 4 (Providers who 

received payments July 1, 2021, to December 31, 2021) 19,962 1 19,962 5.6 111,787 

Total .............................................................................. 287,291 ........................ 287,291 ........................ 1,440,079 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–15885 Filed 7–23–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Tick-Borne Disease 

Working Group 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As required by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the Tick-Borne Disease Working 

Group (TBDWG) will hold a virtual 

meeting. The meeting will be open to 

the public. For this meeting, TBDWG 

members will focus on plans to develop 

the next report due December 2022 on 

federal tick-borne activities and 

research, taking into consideration the 

2018 and 2020 reports. The 2022 report 

will address a wide range of topics 

related to tick-borne diseases, such as, 

surveillance, prevention, diagnosis, 

diagnostics, and treatment; identify 

advances made in research, as well as 

overlap and gaps in tick-borne disease 

research; and provide recommendations 

regarding any appropriate changes or 


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