Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 41043 

District of Texas-Dallas Division, when 

the court accepted Mr. Hebert’s plea of 

guilty and entered judgment against him 

for the offense of introduction of 

misbranded food into interstate 

commerce with intent to defraud and 

mislead, in violation of sections 301(a) 

and 303(a)(2) of the FD&C Act (21 U.S.C. 

331(a) and 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 

superseding indictment, filed on 

January 5, 2016, Mr. Hebert was a coowner of USP Labs with primarily 

responsibilities over product packaging 

design. As contained in the factual 

re ́sume ́ submitted as part of Mr. Hebert’s 

plea agreement on March 11, 2019, and 

the factual resumes submitted as part of 

plea agreements with his codefendants, 

one of Mr. Hebert’s codefendants 

instructed a Chinese company to have 2 

metric tons of ground cynanchum 

auriculatum root powder shipped 

internationally to S.K. Laboratories in 

California for inclusion in USP Labs’ 

dietary supplement products, using the 

false name ‘‘cynanchum auriculatum 

root extract.’’ USP Labs sent false labels 

to retailers and wholesalers listing 

‘‘cynanchum auriculatum (root) extract’’ 

as an ingredient in OxyElite Pro 

‘‘Advanced Formula’’ (which went on 

sale in or around August 2013), even 

though that ingredient was not present 

in the product. Beginning in or around 

August 2013, Mr. Hebert, USP Labs, and 

others working at USP Labs and S.K. 

Laboratories, did knowingly, and with 

the intent to defraud and mislead, cause 

the shipment of a misbranded food, 

namely the OxyElite Pro ‘‘Advanced 

Formula’’ dietary supplement, in 

interstate commerce. Specifically, on or 

about October 4, 2013, with intent to 

defraud and mislead, Mr. Hebert caused 

the shipment of misbranded OxyElite 

Pro ‘‘Advanced Formula’’ in interstate 

commerce. The labeling for OxyElite Pro 

‘‘Advanced Formula’’ falsely declared 

cynanchum auriculatum (root) extract as 

an ingredient, when in fact OxyElite Pro 

‘‘Advanced Formula’’ contained 

imported cynanchum auriculatum 

powder but no cynanchum auriculatum 

(root) extract. 

As a result of this conviction, FDA 

sent Mr. Hebert, by certified mail on 

March 29, 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. Hebert’s felony 

conviction of ‘‘introduction of 

misbranded food into interstate 

commerce with intent to defraud and 

mislead’’ in violation of sections 301(a) 

and 303(a)(2) of the FD&C Act 

constitutes conduct relating to the 

importation into the United States of an 

article of food because Mr. Hebert 

caused the shipment of a misbranded 

food in interstate commerce, and the 

food was misbranded because its 

labeling falsely declared cynanchum 

auriculatum (root) extract as an 

ingredient, when in fact the imported 

ingredient was cynanchum auriculatum 

powder, not cynanchum auriculatum 

root extract. 

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. 

Hebert should be subject to a 5-year 

period of debarment. The proposal also 

offered Mr. Hebert an opportunity to 

request a hearing, providing Mr. Hebert 

30 days from the date of receipt of the 

letter in which to file the request, and 

advised Mr. Hebert that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Hebert 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. Matthew 

Hebert 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. Hebert is debarred for a period of 5 

years from importing articles of food or 

offering such articles for import into the 

United States, effective (see DATES). 

Pursuant to section 301(cc) of the FD&C 

Act, 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 Matthew Hebert is a 

prohibited act. 

Any application by Mr. Hebert for 

termination of debarment under section 

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

identified with Docket No. FDA–2020– 

N–2340 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 23, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16211 Filed 7–29–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of a Supplemental Award to the 

University of Arkansas System 

Telehealth Focused Rural Health 

Research Center 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA announces a 

supplemental award in the amount of 

$100,000 annually through fiscal year 

2024. This funding will support the 

University of Arkansas Telehealth 

Focused Rural Health Research Center 

(TF RHRC), a current HRSA-funded 

cooperative agreement. The 

supplemental request is for the 

remaining period of performance of the 

current cooperative agreement, subject 

to the availability of funds and 

successful performance of the activities 

in a given budget year. 

FOR FURTHER INFORMATION CONTACT: For 

further information regarding this 

request, please contact Nicole Hewitt, 

(nhewitt@hrsa.gov), (301) 443–3893. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of Award: 

University of Arkansas System. 

Amount of Award Increase NonCompetitive Award: $100,000 annually. 

Period of Supplemental Funding: 9/1/ 

2021–08/31/2024. 

CFDA Number: 93.155. 

Authority: Section 711(b)(5) of the 

Social Security Act (42 U.S.C. 

912(b)(5)). 

Justification: The TF RHRC program is 

authorized by Section 711(b)(5) of the 

Social Security Act (42 U.S.C. 

912(b)(5)), as amended. This program is 

within HRSA’s Federal Office of Rural 

Health Policy’s (FORHP) Office for the 

Advancement of Telehealth (OAT), 

which administers grants, cooperative 


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41044 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices 

1Consolidated Appropriations Act, 2021. https:// 

docs.house.gov/billsthisweek/20201221/BILLS116HR133SA-RCP-116-68.pdf (pages 2102–2106). 

agreements, and contracts to provide 

technical assistance and other activities 

as necessary to support activities related 

to improving health care in rural areas. 

Such activities include the evaluation of 

telehealth programs in rural and 

underserved areas. 

Under the TF RHRC Program, one of 

the two research centers was selected to 

receive supplemental funding to 

evaluate all of OAT’s programs. The 

University of Arkansas was awarded a 

cooperative agreement on September 1, 

2020, to conduct evaluation-focused 

research and maintain a thorough and 

comprehensive evaluation of 

nationwide telehealth investments in 

rural areas and populations. 

The University of Arkansas is 

presently in the first year of evaluating 

OAT’s programs, and the current 

research is evaluating the impact of 

investments in telehealth services 

funded by the FORHP. In Year 1 of the 

grant, they have been working on 

evaluating OAT’s Licensure and 

Portability Program and the Telehealth 

Resource Centers. All program 

evaluation research falls under the 

jurisdiction of the University of 

Arkansas. 

Consistent with fiscal year 2021 

Departmental appropriations language, 

HRSA’s FORHP has funded telehealth 

research that impacts rural areas and 

underserved rural populations. In 

addition, per the Consolidated 

Appropriations Act, 2021 (Pub. L. 116– 

260), the HHS Secretary is required to 

develop a strategic plan to research and 

evaluate the evidence for such 

technology-enabled collaborative 

learning and capacity building models.1

As part of that directive, FORHP 

intends to work in consultation with the 

University of Arkansas who can 

evaluate the Telehealth Technology 

Enabled Learning Program (TTELP). 

TTELP connects specialists at academic 

medical centers with primary care 

providers in rural, frontier, and 

underserved populations providing 

evidence-based training and support to 

help them treat patients with complex 

conditions in their communities. TTELP 

is also tasked with developing 

appropriate methodologies to evaluate 

and identify outcomes associated with 

learning community model initiatives. 

The proposed activities for the 

supplemental funding are within the 

scope of the University of Arkansas’ 

current TF RHRC cooperative 

agreement. This funding will allow 

HRSA to demonstrate whether or not 

this congressionally mandated program 

was effective. The University of 

Arkansas will be asked to submit a 

Request for Information and include a 

work plan, budget and budget narrative 

for the funding increase that 

incorporates this new TTELP evaluation 

project. 

The supplemental funds are being 

requested for the remaining years of the 

cooperative agreement, subject to the 

availability of funds. The supplemental 

funds will be awarded prior to the end 

of the current fiscal year. The 

cooperative agreement ends on August 

31, 2024. 

Grantee/organization name Grant number State 

FY 2021 

authorized 

funding level 

FY 2021 

estimated 

supplemental 

funding 

University of Arkansas for Medical Sciences .................................................. U3GRH40001 AR $950,000 $100,000 

Grantee/organization name Grant number State 

FY 2022 

authorized 

funding level 

FY 2022 

estimated 

supplemental 

funding 

University of Arkansas for Medical Sciences .................................................. U3GRH40001 AR $950,000 $100,000 

Grantee/organization name Grant number State 

FY 2023 

authorized 

funding level 

FY 2023 

estimated 

supplemental 

funding 

University of Arkansas for Medical Sciences .................................................. U3GRH40001 AR $950,000 $100,000 

Diana Espinosa, 

Acting Administrator. 

[FR Doc. 2021–16255 Filed 7–29–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Community Health Aide Program: 

Tribal Planning & Implementation 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2021–IHS–TPI–0001. 

Assistance Listing (Catalog of Federal 

Domestic Assistance or CFDA) Number: 

93.382. 

Key Dates 

Application Deadline Date: 

September 1, 2021. 

Earliest Anticipated Start Date: 

September 30, 2021. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) is 

accepting applications for grants for the 

Community Health Aide Program 

(CHAP) Tribal Planning and 

Implementation (TPI) program. The 

CHAP is authorized under the Snyder 

Act, 25 U.S.C. 13; the Transfer Act, 42 

U.S.C. 2001(a); and the Indian Health 

Care Improvement Act, 25 U.S.C. 16161. 

This grant program is described in the 

Assistance Listings located at https://

beta.sam.gov (formerly known as 

Catalog of Federal Domestic Assistance) 

under 93.382. 

Background 

The national CHAP will provide a 

network of health aides trained to 

support licensed health professionals 

while providing direct health care, 


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