Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Rural Health Clinic COVID-19 Testing Program Data Collection, OMB No. 0906-0056-Extension, 11304-11305 [2021-03749]
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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
HDE Records—814.126(b)(2) ..............................................
62
1
62
2
124
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Notification of emergency use—814.124(a) ........................
22
1
22
1
22
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
khammond on DSKJM1Z7X2PROD with NOTICES
The number of respondents in tables
1, 2, and 3 are an average based on data
for the previous 3 years, i.e., fiscal years
2017 through 2019. The number of
respondents has been adjusted to reflect
updated respondent data. This has
resulted in an overall increase of 5,803
hours to the total estimated burden. The
number of annual reports submitted
under § 814.126(b)(1) in table 1 reflects
50 respondents with approved HUD
applications. Based on further review,
the estimated number of recordkeepers
has been adjusted from 65 respondents
to 62 respondents in table 2 to reflect
the most current data available.
Therefore, under § 814.126(b)(2) in table
2, the estimated number of
recordkeepers is 62.
We have also updated the burden
estimate consistent with new provisions
in § 814.104(b)(4)(i) regarding ‘‘Human
Subject Protection; Acceptance of Data
from Clinical Investigations for Medical
Devices’’ (83 FR 7366; February 21,
2018) (approved under OMB control
number 0910–0741). Section 814.104 is
being amended to address submission of
data from clinical investigations in an
HDE. To the extent the applicant
includes data from clinical
investigations, the applicant will be
required to include the information and
statements as described in
§ 814.104(b)(4)(i). Consistent with our
estimate in OMB control number 0910–
0741, this revision increases our burden
estimate for an HDE by 8 hours per
submission.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03746 Filed 2–23–21; 8:45 am]
BILLING CODE 4164–01–P
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17:21 Feb 23, 2021
Jkt 253001
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; Information Collection
Request Title: Rural Health Clinic
COVID–19 Testing Program Data
Collection, OMB No. 0906–0056—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has 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 March 26, 2021.
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 Lisa
Wright-Solomon, the HRSA Information
SUMMARY:
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Health Clinic COVID–19 Testing
Program Data Collection, OMB No.
0906–0056—Extension.
Abstract: This ICR is for continued
approval of the Rural Health Clinic
(RHC) COVID–19 Testing Program Data
Collection. HRSA is proposing to
continue this data collection with no
changes. The current performance
measures are collected electronically in
the RHC COVID–19 Testing Report
(CTR), which funded providers access
via rhccovidreporting.com. RHC
COVID–19 Testing Program Data
Collection supports the HRSA
requirement to monitor and report on
funds distributed under the Paycheck
Protection Program and Health Care
Enhancement Act. Signed into law on
April 24, 2020, the Paycheck Protection
Program and Health Care Enhancement
Act appropriated $225 million to RHCs
to support COVID–19 testing efforts,
expand access to testing in rural
communities, and other related
expenses. On May 20, 2020, HRSA
issued funding as one-time payments to
2,406 RHC organizations based on the
number of certified clinic sites they
operate, providing $49,461.42 per clinic
site (4,549 RHC clinic sites total across
the country).
The RHC CTR collects monthly,
aggregate data from funded
organizations. Funded organizations
provide basic identifying information,
report on the number of and location of
testing sites, indicate how they used the
funds, and report the total number of
patients tested and the number of tests
with a positive result.
Funded organizations must report the
number of patients tested and the
number of positive tests on a monthly
E:\FR\FM\24FEN1.SGM
24FEN1
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
basis for the duration of the reporting
period. HRSA will use this information
to evaluate the effectiveness of COVID–
19 Testing Program at an aggregate level,
assist HRSA in understanding how RHC
COVID–19 Testing Program funding is
being used to support RHC
organizations and patients, and ensure
that HRSA is compliant with federal
reporting requirements.
A 60-day notice published in the
Federal Register on December 10, 2020,
vol. 85, No. 238; p. 79492. There were
no public comments.
Need and Proposed Use of the
Information: The RHC CTR is designed
to collect information from funded
providers who use RHC COVID–19
Testing Program funding to support
COVID–19 testing efforts, expand access
to testing in rural communities, and
other related expenses. These data are
critical to meet HRSA requirements to
monitor and report on how federal
funding is being used and to measure
the effectiveness of RHC CTR.
Specifically, these data will be used to
assess the following:
• Whether program funds are being
spent for their intended purposes;
• Where COVID–19 testing supported
by these funds is occurring;
• Number of patients tested for
COVID–19; and
• Results of provided COVID–19
tests.
Likely Respondents: Respondents are
RHC organizations who received
funding for COVID–19 testing and
related expenses.
11305
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
Form name
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
RHC COVID–19 Testing Report ..........................................
2,406
12
28,872
.25
7,218
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. 2021–03749 Filed 2–23–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Small Health
Care Provider Quality Improvement
Program, OMB No. 0915–0387—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
VerDate Sep<11>2014
17:21 Feb 23, 2021
Jkt 253001
In compliance with the
requirement for opportunity for public
comment on the proposed data
collection projects of the Paperwork
Reduction Act of 1995, HRSA 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 April 26, 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:
Small Health Care Provider Quality
Improvement Program, OMB No. 0915–
0387—Extension.
Abstract: This program is authorized
by Title III, Public Health Service Act,
SUMMARY:
PO 00000
Frm 00089
Fmt 4703
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Section 330A(g) (42 U.S.C. 254c(g)), as
amended. This authority authorizes
HRSA’s Federal Office of Rural Health
Policy to issue grants that expand access
to, coordinate, contain the cost of, and
improve the quality of essential health
care services, including preventive and
emergency services, through the
development of health care networks in
rural and frontier areas and regions.
Across these various programs, the
authority allows HRSA to provide funds
to rural communities to support the
direct delivery of health care and related
services, expand existing services, or
enhance health service delivery through
education, promotion, and prevention
programs.
The purpose of the Small Health Care
Provider Quality Improvement Grant
(Rural Quality) Program is to provide
support to rural primary care providers
for implementation of quality
improvement activities. The goal of the
program is to promote the development
of an evidence-based culture and
delivery of coordinated care in the
primary care setting. Additional
objectives of the program include
improved health outcomes for patients,
enhanced chronic disease management,
and better engagement of patients and
their caregivers. Organizations
participating in the program are
required to use an evidence-based
quality improvement model, perform
tests of change focused on
improvement, and use health
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]]>Agencies
[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11304-11305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03749]
-----------------------------------------------------------------------
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; Information Collection
Request Title: Rural Health Clinic COVID-19 Testing Program Data
Collection, OMB No. 0906-0056--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has 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 March 26,
2021.
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 Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Rural Health Clinic COVID-19
Testing Program Data Collection, OMB No. 0906-0056--Extension.
Abstract: This ICR is for continued approval of the Rural Health
Clinic (RHC) COVID-19 Testing Program Data Collection. HRSA is
proposing to continue this data collection with no changes. The current
performance measures are collected electronically in the RHC COVID-19
Testing Report (CTR), which funded providers access via
rhccovidreporting.com. RHC COVID-19 Testing Program Data Collection
supports the HRSA requirement to monitor and report on funds
distributed under the Paycheck Protection Program and Health Care
Enhancement Act. Signed into law on April 24, 2020, the Paycheck
Protection Program and Health Care Enhancement Act appropriated $225
million to RHCs to support COVID-19 testing efforts, expand access to
testing in rural communities, and other related expenses. On May 20,
2020, HRSA issued funding as one-time payments to 2,406 RHC
organizations based on the number of certified clinic sites they
operate, providing $49,461.42 per clinic site (4,549 RHC clinic sites
total across the country).
The RHC CTR collects monthly, aggregate data from funded
organizations. Funded organizations provide basic identifying
information, report on the number of and location of testing sites,
indicate how they used the funds, and report the total number of
patients tested and the number of tests with a positive result.
Funded organizations must report the number of patients tested and
the number of positive tests on a monthly
[[Page 11305]]
basis for the duration of the reporting period. HRSA will use this
information to evaluate the effectiveness of COVID-19 Testing Program
at an aggregate level, assist HRSA in understanding how RHC COVID-19
Testing Program funding is being used to support RHC organizations and
patients, and ensure that HRSA is compliant with federal reporting
requirements.
A 60-day notice published in the Federal Register on December 10,
2020, vol. 85, No. 238; p. 79492. There were no public comments.
Need and Proposed Use of the Information: The RHC CTR is designed
to collect information from funded providers who use RHC COVID-19
Testing Program funding to support COVID-19 testing efforts, expand
access to testing in rural communities, and other related expenses.
These data are critical to meet HRSA requirements to monitor and report
on how federal funding is being used and to measure the effectiveness
of RHC CTR. Specifically, these data will be used to assess the
following:
Whether program funds are being spent for their intended
purposes;
Where COVID-19 testing supported by these funds is
occurring;
Number of patients tested for COVID-19; and
Results of provided COVID-19 tests.
Likely Respondents: Respondents are RHC organizations who received
funding for COVID-19 testing and related expenses.
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 responses per response Total burden
respondents respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
RHC COVID-19 Testing Report........................................ 2,406 12 28,872 .25 7,218
--------------------------------------------------------------------------------------------------------------------------------------------------------
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. 2021-03749 Filed 2-23-21; 8:45 am]
BILLING CODE 4165-15-P
