Notice of a Supplemental Award to the University of Arkansas System Telehealth Focused Rural Health Research Center, 41043-41044 [2021-16255]
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices
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
VerDate Sep<11>2014
17:24 Jul 29, 2021
Jkt 253001
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
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41043
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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
SUMMARY:
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41044
Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices
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
Grantee/organization name
Grant number
University of Arkansas for Medical Sciences ..................................................
U3GRH40001
Grantee/organization name
Grant number
University of Arkansas for Medical Sciences ..................................................
U3GRH40001
Grantee/organization name
Grant number
University of Arkansas for Medical Sciences ..................................................
U3GRH40001
Diana Espinosa,
Acting Administrator.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.382.
[FR Doc. 2021–16255 Filed 7–29–21; 8:45 am]
BILLING CODE 4165–15–P
Key Dates
Application Deadline Date:
September 1, 2021.
Earliest Anticipated Start Date:
September 30, 2021.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
lotter on DSK11XQN23PROD with NOTICES1
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
Indian Health Service
I. Funding Opportunity Description
Community Health Aide Program:
Tribal Planning & Implementation
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for grants for the
Community Health Aide Program
(CHAP) Tribal Planning and
Announcement Type: New.
Funding Announcement Number:
HHS–2021–IHS–TPI–0001.
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.
FY 2021
authorized
funding level
State
AR
FY 2022
authorized
funding level
State
AR
17:24 Jul 29, 2021
Jkt 253001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
$950,000
FY 2023
authorized
funding level
State
AR
$950,000
$100,000
FY 2022
estimated
supplemental
funding
$100,000
FY 2023
estimated
supplemental
funding
$100,000
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,
1 Consolidated Appropriations Act, 2021. https://
docs.house.gov/billsthisweek/20201221/BILLS116HR133SA-RCP-116-68.pdf (pages 2102–2106).
VerDate Sep<11>2014
$950,000
FY 2021
estimated
supplemental
funding
E:\FR\FM\30JYN1.SGM
30JYN1
]]>Agencies
[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41043-41044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16255]
-----------------------------------------------------------------------
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, ([email protected]), (301) 443-
3893.
SUPPLEMENTARY INFORMATION:
Intended Recipient of Award: University of Arkansas System.
Amount of Award Increase Non-Competitive 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
[[Page 41044]]
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\
---------------------------------------------------------------------------
\1\ Consolidated Appropriations Act, 2021. https://docs.house.gov/billsthisweek/20201221/BILLS-116HR133SA-RCP-116-68.pdf (pages 2102-2106).
---------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
FY 2021
FY 2021 estimated
Grantee/organization name Grant number State authorized supplemental
funding level funding
----------------------------------------------------------------------------------------------------------------
University of Arkansas for Medical Sciences..... U3GRH40001 AR $950,000 $100,000
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
FY 2022
FY 2022 estimated
Grantee/organization name Grant number State authorized supplemental
funding level funding
----------------------------------------------------------------------------------------------------------------
University of Arkansas for Medical Sciences..... U3GRH40001 AR $950,000 $100,000
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
FY 2023
FY 2023 estimated
Grantee/organization name Grant number State authorized supplemental
funding level 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
