Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; COVID-19 Provider Relief Programs Single and Commercial Audits and Delinquent Audit Reporting Submission Activities-Revision, 65637-65638 [2024-17907]
Download as PDF
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
monotherapy in patients unable to
tolerate UDCA.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at the location
of the advisory committee meeting and
at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The meeting presentations will
also be heard, viewed, captioned, and
recorded through an online
teleconferencing and/or video
conferencing platform. The online
presentation of materials will include
slide presentations with audio and
video components in a manner that
most closely resembles an in-person
advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before August 29,
2024, will be provided to the
Committee. Oral presentations from the
public will be scheduled between
approximately 1:30 p.m. to 2:30 p.m.
Eastern Time. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, whether they would like to
present online or in-person, and an
indication of the approximate time
requested to make their presentation on
or before August 21, 2024. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. Similarly, room for
interested persons to participate inperson may be limited. If the number of
registrants requesting to speak in-person
during the open public hearing is
greater than can be reasonably
accommodated in the venue for the inperson portion of the advisory
committee meeting, FDA may conduct a
lottery to determine the speakers who
will be invited to participate in-person.
VerDate Sep<11>2014
17:30 Aug 09, 2024
Jkt 262001
The contact person will notify
interested persons regarding their
request to speak by August 22, 2024.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Jessica Seo
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform in conjunction with
the physical meeting room (see
location). This waiver is in the interest
of allowing greater transparency and
opportunities for public participation,
in addition to convenience for advisory
committee members, speakers, and
guest speakers. The conditions for
issuance of a waiver under 21 CFR 10.19
are met.
Dated: August 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17926 Filed 8–9–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
65637
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; COVID–19 Provider Relief
Programs Single and Commercial
Audits and Delinquent Audit Reporting
Submission Activities—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than September 11,
2024.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
COVID–19 Provider Relief Programs
Single and Commercial Audits and
Delinquent Audit Reporting Submission
Activities, OMB No. 0906–0083—
Revision
Abstract: The Coronavirus Aid, Relief,
and Economic Security Act (Pub. L.
116–136); the Paycheck Protection
Program and Health Care Enhancement
Act (Pub. L. 116–139); the Coronavirus
Response and Relief Supplemental
Appropriations Act (Pub. L. 116–260);
the Families First Coronavirus Response
ADDRESSES:
E:\FR\FM\12AUN1.SGM
12AUN1
65638
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
Act (Pub. L. 116–127); and the
American Rescue Plan Act of 2021 (Pub.
L. 117–2) provided the Department of
Health and Human Services the
authority to administer the Provider
Relief Programs (PRP) (i.e., Provider
Relief Fund; American Rescue Plan Act
Rural Distribution; COVID–19 Coverage
Assistance Fund; and COVID–19 Claims
Reimbursement to Health Care
Providers and Facilities for Testing,
Treatment, and Vaccine Administration
for the Uninsured). The Department of
Health and Human Services, through
HRSA, administered the PRP. The PRP
issued payments to eligible health care
providers for expenses or lost revenues
attributable to COVID–19 and claims
reimbursement for COVID–19 testing,
treatment, and vaccine administration
for uninsured individuals. Recipients of
these funds agreed to the Terms and
Conditions applicable to each Program,
which require, among other Terms,
compliance with reporting requirements
as specified by the Secretary of Health
and Human Services and the statues
listed above. Recipients are eligible
health care providers who include
public entities, Medicare or Medicaid
enrolled suppliers and providers, and
for-profit and non-profit entities that
provide diagnosis, testing, vaccination,
or care for individuals with possible or
actual cases of COVID–19. The Single
Audit Act requires entities that expend
$750,000 or more of federal assistance
during the entity’s fiscal year to conduct
an independent audit. Requirements for
these audits are set forth in regulations
at 45 CFR Subpart F. Requirements
differ for non-profit and commercial/forprofit entities, and non-profit entities
are required to submit their audits to the
Federal Audit Clearinghouse. HRSA has
established a Commercial Audit
Reporting Portal to collect audits from
commercial/for-profit organizations. In
late calendar year 2023, HRSA
developed a delinquent audit follow-up
process to ensure that all providers
required to submit an audit do so. The
delinquent audit follow-up process
includes educating PRP recipients on
the 45 CFR 75 Subpart F requirements
and following up on overdue audit
report submissions. In February 2024,
OMB approved HRSA’s emergency ICR
for the Commercial Audit Reporting
Portal and the delinquent audit followup process. Collectively, these activities
will help ensure the fiscal and program
integrity of the PRP.
A 60-day notice published in the
Federal Register on May 2, 2024, vol.
89, No. 86; pp. 35842–35843. There
were no public comments.
Need and Proposed Use of the
Information: HRSA will use the
collected information to ensure all PRP
recipients who expended over $750,000
in funding during the recipient’s fiscal
year submit an audit and resolve audit
findings, which may include recovery of
any funds used not in accordance with
the Terms and Conditions of the
programs.
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
Provider Relief Bureau Commercial Audit Reporting Portal
Commercial Audit Compliance Email ..................................
Delinquent Audit Follow-up General Email Blast and Attestation .................................................................................
Delinquent Audit Follow-up Targeted Email and Attestation
Questioned Cost Attestation ................................................
21,000
500
1
1
21,000
500
0.75
0.25
15,750
125
42,000
21,000
7,000
6
2
10
252,000
42,000
70,000
0.25
0.25
5.00
63,000
10,500
350,000
Total ..............................................................................
91,500
........................
385,500
........................
439,375
Maria G. Button,
Director, Executive Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–17907 Filed 8–9–24; 8:45 am]
BILLING CODE 4165–15–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Likely Respondents: PRP recipients
who expended over $750,000 in funding
during their fiscal year.
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.
The February 2024 emergency ICR
also included the Commercial Audit
Compliance and Delinquent Audit
Follow-up General and Targeted emails,
which will continue to be used. These
burden hours associated with these
emails were erroneously left out of
burden table in the 60-day notice and
have been added back into the 30-day
Federal Register notice. The Delinquent
Audit Follow-up General Email Blast
was also updated to include more
details regarding audit requirements for
PRP payments.
Total Estimated Annualized Burden
Hours:
Health Resources and Services
Administration
Notice of Supplemental Funding for
Regional Pediatric Pandemic Network
Award Recipients
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
VerDate Sep<11>2014
17:30 Aug 09, 2024
Jkt 262001
PO 00000
Notice of supplemental funding.
Frm 00058
Fmt 4703
Sfmt 4703
Per Congressional Report
language accompanying the Further
Consolidated Appropriations Act, 2024,
HRSA is awarding supplemental funds
in FY 2024 to two Regional Pediatric
Pandemic Network (RPPN) Program
recipients to increase activities to
coordinate among the Nation’s pediatric
hospitals and their communities to
prepare for and coordinate researchinformed responses to future
pandemics. The current RPPN program
period of performance ends on August
31, 2026.
SUMMARY:
E:\FR\FM\12AUN1.SGM
12AUN1
Agencies
[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65637-65638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17907]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; COVID-19 Provider Relief
Programs Single and Commercial Audits and Delinquent Audit Reporting
Submission Activities--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than September
11, 2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Joella Roland, the HRSA
Information Collection Clearance Officer, at [email protected] or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: COVID-19 Provider Relief
Programs Single and Commercial Audits and Delinquent Audit Reporting
Submission Activities, OMB No. 0906-0083--Revision
Abstract: The Coronavirus Aid, Relief, and Economic Security Act
(Pub. L. 116-136); the Paycheck Protection Program and Health Care
Enhancement Act (Pub. L. 116-139); the Coronavirus Response and Relief
Supplemental Appropriations Act (Pub. L. 116-260); the Families First
Coronavirus Response
[[Page 65638]]
Act (Pub. L. 116-127); and the American Rescue Plan Act of 2021 (Pub.
L. 117-2) provided the Department of Health and Human Services the
authority to administer the Provider Relief Programs (PRP) (i.e.,
Provider Relief Fund; American Rescue Plan Act Rural Distribution;
COVID-19 Coverage Assistance Fund; and COVID-19 Claims Reimbursement to
Health Care Providers and Facilities for Testing, Treatment, and
Vaccine Administration for the Uninsured). The Department of Health and
Human Services, through HRSA, administered the PRP. The PRP issued
payments to eligible health care providers for expenses or lost
revenues attributable to COVID-19 and claims reimbursement for COVID-19
testing, treatment, and vaccine administration for uninsured
individuals. Recipients of these funds agreed to the Terms and
Conditions applicable to each Program, which require, among other
Terms, compliance with reporting requirements as specified by the
Secretary of Health and Human Services and the statues listed above.
Recipients are eligible health care providers who include public
entities, Medicare or Medicaid enrolled suppliers and providers, and
for-profit and non-profit entities that provide diagnosis, testing,
vaccination, or care for individuals with possible or actual cases of
COVID-19. The Single Audit Act requires entities that expend $750,000
or more of federal assistance during the entity's fiscal year to
conduct an independent audit. Requirements for these audits are set
forth in regulations at 45 CFR Subpart F. Requirements differ for non-
profit and commercial/for-profit entities, and non-profit entities are
required to submit their audits to the Federal Audit Clearinghouse.
HRSA has established a Commercial Audit Reporting Portal to collect
audits from commercial/for-profit organizations. In late calendar year
2023, HRSA developed a delinquent audit follow-up process to ensure
that all providers required to submit an audit do so. The delinquent
audit follow-up process includes educating PRP recipients on the 45 CFR
75 Subpart F requirements and following up on overdue audit report
submissions. In February 2024, OMB approved HRSA's emergency ICR for
the Commercial Audit Reporting Portal and the delinquent audit follow-
up process. Collectively, these activities will help ensure the fiscal
and program integrity of the PRP.
A 60-day notice published in the Federal Register on May 2, 2024,
vol. 89, No. 86; pp. 35842-35843. There were no public comments.
Need and Proposed Use of the Information: HRSA will use the
collected information to ensure all PRP recipients who expended over
$750,000 in funding during the recipient's fiscal year submit an audit
and resolve audit findings, which may include recovery of any funds
used not in accordance with the Terms and Conditions of the programs.
Likely Respondents: PRP recipients who expended over $750,000 in
funding during their fiscal year.
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.
The February 2024 emergency ICR also included the Commercial Audit
Compliance and Delinquent Audit Follow-up General and Targeted emails,
which will continue to be used. These burden hours associated with
these emails were erroneously left out of burden table in the 60-day
notice and have been added back into the 30-day Federal Register
notice. The Delinquent Audit Follow-up General Email Blast was also
updated to include more details regarding audit requirements for PRP
payments.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Provider Relief Bureau 21,000 1 21,000 0.75 15,750
Commercial Audit Reporting
Portal.........................
Commercial Audit Compliance 500 1 500 0.25 125
Email..........................
Delinquent Audit Follow-up 42,000 6 252,000 0.25 63,000
General Email Blast and
Attestation....................
Delinquent Audit Follow-up 21,000 2 42,000 0.25 10,500
Targeted Email and Attestation.
Questioned Cost Attestation..... 7,000 10 70,000 5.00 350,000
-------------------------------------------------------------------------------
Total....................... 91,500 .............. 385,500 .............. 439,375
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-17907 Filed 8-9-24; 8:45 am]
BILLING CODE 4165-15-P