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, 40064-40065 [2021-15885]
Download as PDF
<![CDATA[
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:10 Jul 23, 2021
Jkt 253001
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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
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
ADDRESSES:
E:\FR\FM\26JYN1.SGM
26JYN1
40065
Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices
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
Payment received period
(payments exceeding $10,000 in
aggregate received)
Reporting period
Period
Period
Period
Period
1
2
3
4
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 time period
April 10, 2020, to June 30, 2020 ......................................................
July 1, 2020, to December 31, 2020 ................................................
January 1, 2021, to June 30, 2021 ..................................................
July 1, 2021, to December 31, 2021 ................................................
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
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
July 1, 2021, to September 30, 2021.
January 1, 2022, to March 31, 2022.
July 1, 2022, to September 30, 2022.
January 1, 2023, to March 31, 2023.
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
Number of
respondents
Form name
PRF Reporting Portal, Reporting Period 1 (Providers who
received payments April 10, 2020, to June 30, 2020) .....
PRF Reporting Portal, Reporting Period 2 (Providers who
received payments July 1, 2020, to December 31, 2020)
PRF Reporting Portal, Reporting Period 3 (Providers who
received payments January 1, 2021, to June 30, 2021)
PRF Reporting Portal, Reporting Period 4 (Providers who
received payments July 1, 2021, to December 31, 2021)
jbell on DSKJLSW7X2PROD with NOTICES
Total ..............................................................................
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.
[FR Doc. 2021–15885 Filed 7–23–21; 8:45 am]
BILLING CODE 4165–15–P
17:10 Jul 23, 2021
Jkt 253001
5.6
710,254
120,536
1
120,536
4.2
506,251
19,962
1
19,962
5.6
111,787
19,962
1
19,962
5.6
111,787
287,291
........................
287,291
........................
1,440,079
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
Notice.
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
Frm 00076
Total
burden hours
126,831
Meeting of the Tick-Borne Disease
Working Group
PO 00000
Average
burden per
response
(in hours)
1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Total
responses
126,831
SUMMARY:
Maria G. Button,
Director, Executive Secretariat.
VerDate Sep<11>2014
Number of
responses per
respondent
Fmt 4703
Sfmt 4703
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
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40064-40065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15885]
-----------------------------------------------------------------------
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 [email protected] 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 [email protected] 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
[[Page 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.
----------------------------------------------------------------------------------------------------------------
Payment received
period (payments
Reporting period exceeding $10,000 in Reporting time period
aggregate received)
----------------------------------------------------------------------------------------------------------------
Period 1.......................... April 10, 2020, to July 1, 2021, to September 30, 2021.
June 30, 2020.
Period 2.......................... July 1, 2020, to January 1, 2022, to March 31, 2022.
December 31, 2020.
Period 3.......................... January 1, 2021, to July 1, 2022, to September 30, 2022.
June 30, 2021.
Period 4.......................... July 1, 2021, to January 1, 2023, to March 31, 2023.
December 31, 2021.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
PRF Reporting Portal, Reporting 126,831 1 126,831 5.6 710,254
Period 1 (Providers who
received payments April 10,
2020, to June 30, 2020)........
PRF Reporting Portal, Reporting 120,536 1 120,536 4.2 506,251
Period 2 (Providers who
received payments July 1, 2020,
to December 31, 2020)..........
PRF Reporting Portal, Reporting 19,962 1 19,962 5.6 111,787
Period 3 (Providers who
received payments January 1,
2021, to June 30, 2021)........
PRF Reporting Portal, Reporting 19,962 1 19,962 5.6 111,787
Period 4 (Providers who
received payments July 1, 2021,
to December 31, 2021)..........
-------------------------------------------------------------------------------
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
