Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40063 

Gowns, Other Apparel, and Gloves 

During the Coronavirus Disease 

(COVID–19) Public Health Emergency; 

Guidance for Industry and Food and 

Drug Administration Staff’’ (Ref. 8). 

V. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

1. *Centers for Disease Control. ‘‘Perspectives 

in Disease Prevention and Health 

Promotion Update: Universal 

Precautions for Prevention of 

Transmission of Human 

Immunodeficiency Virus, Hepatitis B 

Virus, and Other Bloodborne Pathogens 

in Health-Care Settings.’’ Morbidity and 

Mortality Weekly Report 1988; 

37(25):377–388. 

2. World Health Organization. Glove Use 

Information Leaflet. 2009. https://

www.who.int/gpsc/5may/Glove_Use_

Information_Leaflet.pdf. 

3. *Collins, A.S. ‘‘Preventing Health CareAssociated Infections.’’ In: Hughes, R.G., 

editor. Patient Safety and Quality: An 

Evidence-Based Handbook for Nurses. 

Rockville (MD): Agency for Healthcare 

Research and Quality (US); 2008 April. 

Chapter 41. https://

www.ncbi.nlm.nih.gov/books/NBK2683/ 

pdf/Bookshelf_NBK2683.pdf. 

4. Alexander, J. Wesley, Joseph S. Solomkin, 

and Michael J. Edwards (2011). 

‘‘Updated Recommendations for Control 

of Surgical Site Infections,’’ Annals of 

Surgery, 253(6):1082–1093. 

5. Sugarbaker, P.H. (2018). ‘‘Increased Safety 

of Surgical Glove Application: The 

Under/Over Method’’ Annals of the 

Royal College of Surgeons of England, 

100(4):339–340. 

6. Landeck, L., E. Gonzalez, and O.M. Koch. 

‘‘Handling Chemotherapy Drugs—Do 

Medical Gloves Really Protect?’’ 

International Journal of Cancer. 2015 

October 15;137(8):1800–5. doi: 10.1002/ 

ijc.29058. Epub 2014 July 22. PMID: 

24978061 

7. Nalin, M., G. Hug, E. Boeckmans, C. 

Machon, et al. ‘‘Permeation 

Measurement of 27 Chemotherapy Drugs 

After Simulated Dynamic Testing on 15 

Surgical And Examination Gloves: A 

Knowledge Update.’’ Journal of 

Oncology Pharmacy Practice. 2020 Aug 

26:1078155220950423. doi: 10.1177/ 

1078155220950423. Epub ahead of print. 

PMID: 32847481. 

8. *FDA Guidance, ‘‘Enforcement Policy for 

Gown, Other Apparel, and Gloves During 

the Coronavirus Disease (COVID–19) 

Public Health Emergency, Guidance for 

Industry and Food and Drug 

Administration Staff,’’ March 25, 2020, 

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

regulatory-information/search-fdaguidance-documents/enforcementpolicy-gowns-other-apparel-and-glovesduring-coronavirus-disease-covid-19- 

public-health. 

Dated: July 12, 2021. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

Dated: July 21, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–15891 Filed 7–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2149] 

Jonathan Doyle: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

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 

Jonathan Doyle for a period of 5 years 

from importing articles of food or 

offering such articles for importation 

into the United States. FDA bases this 

order on a finding that Mr. Doyle was 

convicted of a felony count under 

Federal law for conduct relating to the 

importation into the United States of an 

article of food. Mr. Doyle was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. As of April 8, 2021 (30 days 

after receipt of the notice), Mr. Doyle 

has not responded. Mr. Doyle’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 26, 

2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, 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, 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)(C) of the FD&C Act 

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

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) 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 food. 

On October 15, 2020, Mr. Doyle was 

convicted as defined in section 

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

District Court for the Northern District 

of Texas-Dallas Division, when the court 

accepted Mr. Doyle’s plea of guilty and 

entered judgment against him for the 

offense 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)). 

FDA’s finding that the debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: As contained in the factual 

re ́sume ́, dated February 15, 2019, in Mr. 

Doyle’s case, he was the President of 

USPlabs, LLC (USP Labs), and owned 45 

percent of the company. USP Labs sold 

dietary supplements. Beginning in or 

around October 2008 and continuing 

until at least in or around August 2014, 

Mr. Doyle engaged in a conspiracy with 

others to import and ship in interstate 

commerce a variety of chemicals for use 

and prospective use in dietary 

supplements with false labeling. To 

further this conspiracy, Mr. Doyle’s 

coconspirators ordered chemicals from 

Chinese chemical sellers to be used as 

ingredients in dietary supplements and 

had them labeled falsely as other food 

substances. USP Labs sold dietary 

supplements called Jack3d and OxyElite 

Pro, both of which originally contained 

a substance called 1,3- 

dimethylamylamine (DMAA), which is 

also known as methylhexaneamine. USP 

Labs imported numerous substances 

intended for human consumption, 

including DMAA, using false and 

fraudulent Certificates of Analysis 

(COA) and other false and fraudulent 

documentation and labeling. At least 

some of the false COAs that USP Labs 


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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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