Agency Information Collection Activities: Proposed Collection; Public Comment Request; Evaluation of the National Paralysis Resource Center (NPRC) and Performance Management Support, OMB Control Number 0985-New, 65209-65210 [2022-23484]
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Federal Register / Vol. 87, No. 208 / Friday, October 28, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
Health Options Program; Use: On March
23, 2010, the President signed into law
H.R. 3590, the Patient Protection and
Affordable Care Act, Public Law 111–
148, as amended by the Health Care and
Education Reconciliation Act of 2010,
Public Law 111–152. The Patient
Protection and Affordable Care Act
(PPACA) expands access to health
insurance coverage through
improvements to the Medicaid and
Children’s Health Insurance (CHIP)
programs, the establishment of
Affordable Insurance Exchanges
(Exchanges), and the coordination
between Medicaid, CHIP, and
Exchanges. Small business employers
may participate in and provide health
coverage through the Small Business
Health Options Program (SHOP), so long
as the small business employer obtains
a positive eligibility determination from
SHOP. Employers will work with
SHOP-registered agents/brokers or
Issuers offering Qualified Health Plans
(QHPs) and Qualified Dental Plans
(SADPs), to enroll in SHOP coverage
and to select coverage options to offer
their employees. SHOP Exchanges
became operational on October 1, 2013.
HHS has developed a single,
streamlined form that employers use to
obtain a SHOP eligibility determination,
which is included as an appendix to
this Information Collection Request. 45
CFR 155.731 provides more detail about
this ‘‘single employer application,’’
which is used to determine employer
eligibility. Since publication of the last
package, no updates have been made in
regulation concerning what information
should be collected on the single
employer application to determine
employer eligibility under 45 CFR
155.731. When an employer completes
the SHOP Eligibility Determination
Form, the form and its results are
retained by SHOP for future use, if
needed (e.g., reconciliation with issuer
records, SHOP employer appeals, etc.).
Form Number: CMS–10439 (OMB
control number 0938–1193); Frequency:
Annually; Affected Public: Private
Sector (business or other for-profits, notfor-profit institutions); Number of
Respondents: 2,100; Number of
Responses: 2,100; Total Annual Hours:
336. (For questions regarding this
collection contact Elliot Klein at 410–
786–0415).
Dated: October 25, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–23553 Filed 10–27–22; 8:45 am]
BILLING CODE 4120–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities: Proposed Collection; Public
Comment Request; Evaluation of the
National Paralysis Resource Center
(NPRC) and Performance Management
Support, OMB Control Number 0985–
New
Administration for Community
Living, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This information collection (IC)
request solicits comments on the
information collection requirements
relating to the Evaluation of the
National Paralysis Resource Center
(NPRC) and Performance Management
Support.
SUMMARY:
Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (EST) or
postmarked by December 27, 2022.
ADDRESSES: Submit electronic
comments on the collection of
information to: Amanda Cash, 202–795–
7369 Amanda.Cash@acl.hhs.gov.
Submit written comments on the
collection of information to
Administration for Community Living,
330 C Street SW, Washington, DC
20201, Attention: Amanda Cash.
FOR FURTHER INFORMATION CONTACT:
Amanda Cash, 202–795–7369,
Amanda.Cash@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
The PRA requires Federal agencies to
provide a 60-day notice in the Federal
DATES:
PO 00000
Frm 00025
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65209
Register concerning each proposed
collection of information, including
each proposed extension of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, ACL invites
comments on our burden estimates or
any other aspect of this collection of
information, including:
(1) whether the proposed collection of
information is necessary for the proper
performance of ACL’s functions,
including whether the information will
have practical utility.
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates.
(3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
The Administration for Community
Living (ACL) is conducting process and
outcome evaluations of the National
Paralysis Resource Center (NPRC) to
understand how and to what extent the
NPRC is meeting its goals. The NPRC
provides resources to people living with
paralysis, their caregivers, and their
support network. ACL is responsible for
oversight of the NPRC, which has been
administered by the Christopher and
Dana Reeve Foundation since its
authorization in 2009. This data
collection effort will be focused on
evaluating specific major activities of
the NPRC: (a) the Quality of Life (QOL)
Grants Program; (b) the Peer and Family
Support Program (PFSP); and (c) the
Promotional Activities, Outreach, and
Collaboration program. This evaluation
seeks to identify barriers and challenges
to operating the NPRC, document best
practices for other Resource Centers,
and recommend areas for improvement.
Specifically, this IC will help ACL to
understand how each major NPRC
activity aims to achieve the following
goals, and to what extent the activities
affect related outcomes:
a. Improving the health and quality of
life of individuals living with
paralysis of all ages, their families,
and their support network
b. Raising awareness of members of the
target populations about paralysis
E:\FR\FM\28OCN1.SGM
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65210
Federal Register / Vol. 87, No. 208 / Friday, October 28, 2022 / Notices
c. Increasing access of members of the
target populations to services relevant
to individuals with paralysis
d. Increasing the empowerment,
confidence, and independence of
individuals living with paralysis
e. Strengthening support networks for
individuals living with paralysis
f. Improving and increasing
opportunities for community living
for individuals living with paralysis
and their caretakers
To gain an in-depth understanding of
the perspectives of mentors and peers
participating in the PFSP, QOL program
subgrantees, and people who serve as
regional champions in the Promotional
Activities, Outreach, and Collaboration
program, eight focus groups will be
conducted with no more than eight
people per focus group. Additionally, a
web-based survey will be administered
to a maximum of 330 PFSP peers, 150
PFSP mentors, and 850 people served
by QOL subgrantees to understand
respondents’ experiences with the
NPRC.
This data will contribute to
documenting how each of the NPRC’s
major activities are delivered and the
extent to which they improve the
quality of life of people living with
paralysis, their caregivers, and their
support networks.
Findings can inform practice for the
NPRC and other Resource Centers. This
evaluation will also help to identify
how the NPRC can better meet the
stated goals of the Department of Health
and Human Services (HHS) to, ‘‘protect
and strengthen equitable access to high
quality and affordable healthcare,’’ and
to, ‘‘strengthen social well-being, equity,
and economic resilience.’’ 1
The proposed data collection tools
may be found on the ACL website for
review at: https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden: ACL
estimates the burden of this collection
of information as follows:
Number of
respondents
Respondent/data collection activity
The eight focus groups together will
include no more than 64 total
individuals representing three major
activities of the NPRC: the QOL Grants
Program; the PFSP; and the Promotional
Activities, Outreach, and Collaboration
program. The burden for their
participation is estimated at 1.5 hours
per participant, for a total of 96 hours.
A maximum of 150 PFSP mentors,
330 PFSP peers, and 850 people served
by QOL subgrantee programs are
expected to respond to the web-based
survey, for a total of 1,330 respondents.
The approximate burden for survey
completion is 15 minutes for the peer
mentor survey, and 10 minutes for the
peer survey and QOL end-user survey
per respondent.
This results in a total survey burden
estimate of 14,050 minutes (234.17
hours). The estimated survey
completion burden includes time to
review the instructions, read the
questions, and complete responses.
Responses
per
respondent
Hours per
response
Annual
burden
hours *
Focus groups ...................................................................................................
Survey—Peer Mentor ......................................................................................
Survey—Peers .................................................................................................
Survey—Quality of Life End-User ....................................................................
64
150
330
850
1
1
1
1
1.50
0.25
0.17
0.17
96.00
37.50
55.00
141.67
Total ..........................................................................................................
1,394
1
2.09
330.17
* Annual burden hours were calculated from total minutes for each activity divided by sixty.
Dated: October 24, 2022.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2022–23484 Filed 10–27–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1261]
Clostridioides difficile Infection:
Developing Drugs for Treatment,
Reduction of Recurrence, and
Prevention; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
lotter on DSK11XQN23PROD with NOTICES1
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
SUMMARY:
guidance for industry entitled
‘‘Clostridioides difficile Infection:
Developing Drugs for Treatment,
Reduction of Recurrence, and
Prevention.’’ The purpose of this draft
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of Clostridioides difficile
infection (CDI), reduction of recurrence,
or prevention of CDI.
DATES: Submit either electronic or
written comments on the draft guidance
by December 27, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
1 FY 2023 Evaluation Plan (p. 3). (2022). U.S.
Department of Health & Human Services. https://
aspe.hhs.gov/reports/fy-2023-hhs-evaluation-plan.
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]]>Agencies
[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65209-65210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23484]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities: Proposed Collection;
Public Comment Request; Evaluation of the National Paralysis Resource
Center (NPRC) and Performance Management Support, OMB Control Number
0985-New
AGENCY: Administration for Community Living, Department of Health and
Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
information listed above. Under the Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to publish a notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
information collection (IC) request solicits comments on the
information collection requirements relating to the Evaluation of the
National Paralysis Resource Center (NPRC) and Performance Management
Support.
DATES: Comments on the collection of information must be submitted
electronically by 11:59 p.m. (EST) or postmarked by December 27, 2022.
ADDRESSES: Submit electronic comments on the collection of information
to: Amanda Cash, 202-795-7369 [email protected]. Submit written
comments on the collection of information to Administration for
Community Living, 330 C Street SW, Washington, DC 20201, Attention:
Amanda Cash.
FOR FURTHER INFORMATION CONTACT: Amanda Cash, 202-795-7369,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. The PRA requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, ACL is publishing a notice
of the proposed collection of information set forth in this document.
With respect to the following collection of information, ACL
invites comments on our burden estimates or any other aspect of this
collection of information, including:
(1) whether the proposed collection of information is necessary for
the proper performance of ACL's functions, including whether the
information will have practical utility.
(2) the accuracy of ACL's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used to determine burden estimates.
(3) ways to enhance the quality, utility, and clarity of the
information to be collected; and
(4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques when appropriate, and other forms of information technology.
The Administration for Community Living (ACL) is conducting process
and outcome evaluations of the National Paralysis Resource Center
(NPRC) to understand how and to what extent the NPRC is meeting its
goals. The NPRC provides resources to people living with paralysis,
their caregivers, and their support network. ACL is responsible for
oversight of the NPRC, which has been administered by the Christopher
and Dana Reeve Foundation since its authorization in 2009. This data
collection effort will be focused on evaluating specific major
activities of the NPRC: (a) the Quality of Life (QOL) Grants Program;
(b) the Peer and Family Support Program (PFSP); and (c) the Promotional
Activities, Outreach, and Collaboration program. This evaluation seeks
to identify barriers and challenges to operating the NPRC, document
best practices for other Resource Centers, and recommend areas for
improvement.
Specifically, this IC will help ACL to understand how each major
NPRC activity aims to achieve the following goals, and to what extent
the activities affect related outcomes:
a. Improving the health and quality of life of individuals living with
paralysis of all ages, their families, and their support network
b. Raising awareness of members of the target populations about
paralysis
[[Page 65210]]
c. Increasing access of members of the target populations to services
relevant to individuals with paralysis
d. Increasing the empowerment, confidence, and independence of
individuals living with paralysis
e. Strengthening support networks for individuals living with paralysis
f. Improving and increasing opportunities for community living for
individuals living with paralysis and their caretakers
To gain an in-depth understanding of the perspectives of mentors
and peers participating in the PFSP, QOL program subgrantees, and
people who serve as regional champions in the Promotional Activities,
Outreach, and Collaboration program, eight focus groups will be
conducted with no more than eight people per focus group. Additionally,
a web-based survey will be administered to a maximum of 330 PFSP peers,
150 PFSP mentors, and 850 people served by QOL subgrantees to
understand respondents' experiences with the NPRC.
This data will contribute to documenting how each of the NPRC's
major activities are delivered and the extent to which they improve the
quality of life of people living with paralysis, their caregivers, and
their support networks.
Findings can inform practice for the NPRC and other Resource
Centers. This evaluation will also help to identify how the NPRC can
better meet the stated goals of the Department of Health and Human
Services (HHS) to, ``protect and strengthen equitable access to high
quality and affordable healthcare,'' and to, ``strengthen social well-
being, equity, and economic resilience.'' \1\
---------------------------------------------------------------------------
\1\ FY 2023 Evaluation Plan (p. 3). (2022). U.S. Department of
Health & Human Services. https://aspe.hhs.gov/reports/fy-2023-hhs-evaluation-plan.
---------------------------------------------------------------------------
The proposed data collection tools may be found on the ACL website
for review at: https://www.acl.gov/about-acl/public-input.
Estimated Program Burden: ACL estimates the burden of this
collection of information as follows:
The eight focus groups together will include no more than 64 total
individuals representing three major activities of the NPRC: the QOL
Grants Program; the PFSP; and the Promotional Activities, Outreach, and
Collaboration program. The burden for their participation is estimated
at 1.5 hours per participant, for a total of 96 hours.
A maximum of 150 PFSP mentors, 330 PFSP peers, and 850 people
served by QOL subgrantee programs are expected to respond to the web-
based survey, for a total of 1,330 respondents. The approximate burden
for survey completion is 15 minutes for the peer mentor survey, and 10
minutes for the peer survey and QOL end-user survey per respondent.
This results in a total survey burden estimate of 14,050 minutes
(234.17 hours). The estimated survey completion burden includes time to
review the instructions, read the questions, and complete responses.
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours *
----------------------------------------------------------------------------------------------------------------
Focus groups.................................... 64 1 1.50 96.00
Survey--Peer Mentor............................. 150 1 0.25 37.50
Survey--Peers................................... 330 1 0.17 55.00
Survey--Quality of Life End-User................ 850 1 0.17 141.67
---------------------------------------------------------------
Total....................................... 1,394 1 2.09 330.17
----------------------------------------------------------------------------------------------------------------
* Annual burden hours were calculated from total minutes for each activity divided by sixty.
Dated: October 24, 2022.
Alison Barkoff,
Acting Administrator and Assistant Secretary for Aging.
[FR Doc. 2022-23484 Filed 10-27-22; 8:45 am]
BILLING CODE 4154-01-P
