Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Health Center Program: COVID-19 Data Collection Tools, OMB No. 0906-0062-Revision, 21756-21757 [2021-08454]
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21756
Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
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
Nutrient labeling; 107.10(a) and 107.20 ..............................
5
13
65
8
520
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
We estimate compliance with our
infant formula labeling requirements in
21 CFR 107.10(a) and 107.20 requires
520 hours annually.
Dated: April 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08470 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Health Center
Program: COVID–19 Data Collection
Tools, OMB No. 0906–0062—Revision
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 June 22, 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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Health Center Program: COVID–19 Data
Collection Tools, OMB No. 0906–0062—
Revision.
Abstract: This information collection
request was previously approved by
OMB on June 11, 2020, as an emergency
clearance (OMB No.: 0906–0062). HRSA
is currently undertaking the standard
Paperwork Reduction Act process for
normal OMB approval.
During the COVID–19 public health
emergency, HRSA-supported health
centers and Federally Qualified Health
Center Look-Alikes (look-alikes) have
played a key role in providing testing
and care for those affected by the virus.
HRSA awarded billions of dollars in
new funding to support health center
awardees and look-alikes in the
detection, prevention, diagnosis, and
treatment of COVID–19. This funding
has enabled health centers to maintain
or increase their staffing levels, conduct
training, provide COVID–19 treatment,
and administer millions of tests for both
existing and new patients. In addition,
HRSA, in collaboration with Centers for
Disease Control and Prevention,
launched the Health Center COVID–19
Vaccine program as part of a White
House initiative focused on health
equity. This occurred in February 2021
to directly allocate COVID–19 vaccines
to HRSA-supported health centers.
This ICR to support the
implementation of COVID–19 relief
funding and response activities includes
forms previously submitted in the
emergency information collection
request clearance: (1) Health Center
COVID–19 Data Collection Survey Tool,
(2) Addendum to COVID–19 Data
Collection Survey Tool, and (3) the
Health Center COVID–19 Vaccine
Program Readiness Assessment Tool.
This revised information collection
request includes two newly added
forms: (1) Primary Care Association
(PCA) COVID–19 Data Collection
Survey Tool 1 and (2) the Health Center
SUPPLEMENTARY INFORMATION:
1 The bi-weekly COVID–19 PCA Survey Tool
(comprised of six questions) is currently approved
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
COVID–19 Vaccine Program Conditions
of Participation Agreement.
Need and Proposed Use of the
Information: HRSA uses the data
collected to optimize COVID–19 testing
and vaccination; track health center
capacity and the impact of COVID–19
on operations, patients, and staff; and
better understand training and technical
assistance, funding, and other health
center resource needs. The data allow
HRSA to assess health center capacity
prior to program enrollment, supporting
successful vaccine allocation strategies
while providing HRSA with information
on the effectiveness of vaccine
distribution through this program. In
addition, the data inform HRSA in
resource allocation and technical
assistance to health centers.
The readiness assessment supports
HRSA’s analysis of health center ability
to successfully participate in the Health
Center COVID–19 Vaccine Program.
These data are critical to determine
health center capacity to implement the
vaccination program as well as comply
with program requirements. These data
are used to assess program readiness
including:
• Ability to safely store the vaccine
• Availability of trained and
credentialed staff and other staff
capacity
• Reporting capacity
• Sufficient Personal Protective
Equipment
• Plan for vaccine transport
The health center weekly survey and
addendum support HRSA’s ability to
monitor progress towards the
development and delivery of COVID–19
prevention, preparedness, and/or
response activities and ensure
appropriate vaccine administration as
well as better understand training and
technical assistance, funding, and other
health center resource needs.
The Conditions of Participation
Agreement governs all COVID–19
vaccination activities at all health center
sites that receive COVID–19 vaccine
through the HRSA Health Center
under the HHS Secretary’s Public Health
Emergency Authority to waive the requirements of
the Paperwork Reduction Act during the Public
Health Emergency for reporting on a voluntary
basis.
E:\FR\FM\23APN1.SGM
23APN1
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
COVID–19 Vaccine Program. Health
Centers that sign the agreement agree to
adhere to each of the stated
requirements.
The PCA weekly survey increases
information sharing between health
centers, PCAs, and HRSA in order to
better support COVID–19 emergency
response efforts inclusive of testing and
vaccination activities. Data collected
from the survey tool is used to track and
monitor issues/challenges to program
implementation and assess the need for
the delivery/dissemination of targeted
training and technical assistance.
Likely Respondents: HRSA-supported
health centers, look-alikes, and PCAs.
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
respondents
Condition of Participation Agreement (one-time
completion for vaccine program participants
only).
Readiness Assessment Tool (one-time completion for vaccine program participants only).
1,467 (Total health centers, including lookalikes, in 2019).
1,467 (Total health centers, including lookalikes, in 2019).
1,389 (Total health centers in 2019).
Health Center COVID–19 Data Collection Survey
Tool (weekly completion of existing 20 questions).
Addendum to COVID–19 Data Collection Survey
Tool (weekly completion for vaccine program
participants only).
PCA COVID–19 Data Collection Survey Tool (biweekly completion of existing six questions).
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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–08454 Filed 4–22–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses
to form per
respondent
Form name
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
Total
responses
Total
burden
hours
1
1,467
.25
366.75
1
1,467
.50
733.5
48
66,672
1.00
66,672
1,389 (Total health centers in 2019).
48
66,672
.50
33,336
52 ..................................
6
312
.75
234
5,764 .............................
........................
136,590
........................
101,342.25
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development Initial
Review Group Obstetrics and Maternal-Fetal
Biology Subcommittee.
Date: June 25, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NICHD/NIH, 6710B Rockledge
Drive, Bethesda, MD 20892 (Video-Assisted
Meeting).
Contact Person: Luis E. Dettin, Ph.D.,
Scientific Review Officer, Eunice Kennedy
Shriver National Institute of Child Health
and Human Development, 6710B Rockledge
Drive, Room 2131B, Bethesda, MD 20892,
301–827–8231, luis.dettin@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
PO 00000
Average
burden per
response
(in hours)
Frm 00075
Fmt 4703
Sfmt 4703
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: April 20, 2021.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–08475 Filed 4–22–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
E:\FR\FM\23APN1.SGM
23APN1
]]>Agencies
[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21756-21757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08454]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: Health
Center Program: COVID-19 Data Collection Tools, OMB No. 0906-0062--
Revision
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 June 22,
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: Health Center Program: COVID-
19 Data Collection Tools, OMB No. 0906-0062--Revision.
Abstract: This information collection request was previously
approved by OMB on June 11, 2020, as an emergency clearance (OMB No.:
0906-0062). HRSA is currently undertaking the standard Paperwork
Reduction Act process for normal OMB approval.
During the COVID-19 public health emergency, HRSA-supported health
centers and Federally Qualified Health Center Look-Alikes (look-alikes)
have played a key role in providing testing and care for those affected
by the virus. HRSA awarded billions of dollars in new funding to
support health center awardees and look-alikes in the detection,
prevention, diagnosis, and treatment of COVID-19. This funding has
enabled health centers to maintain or increase their staffing levels,
conduct training, provide COVID-19 treatment, and administer millions
of tests for both existing and new patients. In addition, HRSA, in
collaboration with Centers for Disease Control and Prevention, launched
the Health Center COVID-19 Vaccine program as part of a White House
initiative focused on health equity. This occurred in February 2021 to
directly allocate COVID-19 vaccines to HRSA-supported health centers.
This ICR to support the implementation of COVID-19 relief funding
and response activities includes forms previously submitted in the
emergency information collection request clearance: (1) Health Center
COVID-19 Data Collection Survey Tool, (2) Addendum to COVID-19 Data
Collection Survey Tool, and (3) the Health Center COVID-19 Vaccine
Program Readiness Assessment Tool. This revised information collection
request includes two newly added forms: (1) Primary Care Association
(PCA) COVID-19 Data Collection Survey Tool \1\ and (2) the Health
Center COVID-19 Vaccine Program Conditions of Participation Agreement.
---------------------------------------------------------------------------
\1\ The bi-weekly COVID-19 PCA Survey Tool (comprised of six
questions) is currently approved under the HHS Secretary's Public
Health Emergency Authority to waive the requirements of the
Paperwork Reduction Act during the Public Health Emergency for
reporting on a voluntary basis.
---------------------------------------------------------------------------
Need and Proposed Use of the Information: HRSA uses the data
collected to optimize COVID-19 testing and vaccination; track health
center capacity and the impact of COVID-19 on operations, patients, and
staff; and better understand training and technical assistance,
funding, and other health center resource needs. The data allow HRSA to
assess health center capacity prior to program enrollment, supporting
successful vaccine allocation strategies while providing HRSA with
information on the effectiveness of vaccine distribution through this
program. In addition, the data inform HRSA in resource allocation and
technical assistance to health centers.
The readiness assessment supports HRSA's analysis of health center
ability to successfully participate in the Health Center COVID-19
Vaccine Program. These data are critical to determine health center
capacity to implement the vaccination program as well as comply with
program requirements. These data are used to assess program readiness
including:
Ability to safely store the vaccine
Availability of trained and credentialed staff and other staff
capacity
Reporting capacity
Sufficient Personal Protective Equipment
Plan for vaccine transport
The health center weekly survey and addendum support HRSA's ability
to monitor progress towards the development and delivery of COVID-19
prevention, preparedness, and/or response activities and ensure
appropriate vaccine administration as well as better understand
training and technical assistance, funding, and other health center
resource needs.
The Conditions of Participation Agreement governs all COVID-19
vaccination activities at all health center sites that receive COVID-19
vaccine through the HRSA Health Center
[[Page 21757]]
COVID-19 Vaccine Program. Health Centers that sign the agreement agree
to adhere to each of the stated requirements.
The PCA weekly survey increases information sharing between health
centers, PCAs, and HRSA in order to better support COVID-19 emergency
response efforts inclusive of testing and vaccination activities. Data
collected from the survey tool is used to track and monitor issues/
challenges to program implementation and assess the need for the
delivery/dissemination of targeted training and technical assistance.
Likely Respondents: HRSA-supported health centers, look-alikes, and
PCAs.
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
Number of responses to Total Average burden Total burden
Form name respondents form per responses per response hours
respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Condition of Participation 1,467 (Total 1 1,467 .25 366.75
Agreement (one-time health centers,
completion for vaccine including look-
program participants only). alikes, in
2019).
Readiness Assessment Tool (one- 1,467 (Total 1 1,467 .50 733.5
time completion for vaccine health centers,
program participants only). including look-
alikes, in
2019).
Health Center COVID-19 Data 1,389 (Total 48 66,672 1.00 66,672
Collection Survey Tool health centers
(weekly completion of in 2019).
existing 20 questions).
Addendum to COVID-19 Data 1,389 (Total 48 66,672 .50 33,336
Collection Survey Tool health centers
(weekly completion for in 2019).
vaccine program participants
only).
PCA COVID-19 Data Collection 52.............. 6 312 .75 234
Survey Tool (bi-weekly
completion of existing six
questions).
---------------------------------------------------------------------------------
Total..................... 5,764........... .............. 136,590 .............. 101,342.25
----------------------------------------------------------------------------------------------------------------
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. 2021-08454 Filed 4-22-21; 8:45 am]
BILLING CODE 4165-15-P
