Proposed Information Collection Activity; Formative Data Collections for ACF Research and Evaluation (Office of Management and Budget #0970-0356), 54614-54615 [2023-17205]
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54614
Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by September 11,
2023.
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 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (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. The term ‘‘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. Section
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SUPPLEMENTARY INFORMATION:
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16:59 Aug 10, 2023
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3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Part C
and Part D Data Validation; Use:
Sections 1857(e) and 1860D–12 of the
Social Security Act (‘‘the Act’’)
authorize CMS to establish information
collection requirements with respect to
MAOs and Part D sponsors. Section
1857(e)(1) of the Act requires MAOs to
provide the Secretary of the Department
of Health and Human Services (DHHS)
with such information as the Secretary
may find necessary and appropriate.
Section 1857(e)(1) of the Act applies to
Prescription Drug Plans (PDPs) as
indicated in section 1860D–12. Pursuant
to statutory authority, CMS codified
these information collection
requirements in regulation at
§§ 422.516(g) Validation of Part C
Reporting Requirements, and 423.514(j)
Validation of Part D Reporting
Requirements, respectively.
Data collected via Medicare Part C
and Part D reporting requirements are
an integral resource for oversight,
monitoring, compliance and auditing
activities necessary to ensure quality
provision of Medicare benefits to
beneficiaries. CMS uses the findings
collected through the data validation
process to substantiate the data reported
via Medicare Part C and Part D reporting
requirements. Data validation provides
CMS with assurance that plan-reported
data are credible and consistently
collected and reported by Part C and D
SOs. CMS uses validated data to
respond to inquiries from Congress,
oversight agencies, and the public about
Part C and D SOs. The validated data
also allows CMS to effectively monitor
and compare the performance of SOs
over time. Validated plan-reported data
may be used for Star Ratings, Display
measures and other performance
measures. Additionally, SOs can take
advantage of the DV process to
effectively assess their own performance
and make improvements to their
internal operations and reporting
processes. Form Number: CMS–10305
(OMB control number: 0938–1115);
Frequency: Yearly; Affected Public:
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State, local, or Tribal governments;
Number of Respondents: 809; Total
Annual Responses: 809; Total Annual
Hours: 10,500. For policy questions
regarding this collection contact
Chanelle Jones at 410–786–8008.
Dated: August 2, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–16804 Filed 8–10–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Formative Data Collections
for ACF Research and Evaluation
(Office of Management and Budget
#0970–0356)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families (ACF) proposes
to extend data collection under the
existing overarching generic clearance
for Formative Data Collections for ACF
Research and Evaluation (Office of
Management and Budget (OMB) #0970–
0356). There are no changes proposed.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF programs promote
the economic and social well-being of
families, children, individuals, and
communities. The Office of Planning,
Research, and Evaluation (OPRE)
studies ACF programs, and the
populations they serve, through rigorous
research and evaluation projects. These
include evaluations of existing
programs, evaluations of innovative
approaches to helping low-income
children and families, research
syntheses, and descriptive and
exploratory studies. OPRE’s research
SUMMARY:
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54615
Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
offers further understanding of current
programs and service populations,
explores options for program
improvement, and assesses alternative
policy and program designs. OPRE
anticipates undertaking a variety of new
research projects related to welfare,
employment and self-sufficiency, Head
Start, child care, healthy marriage and
responsible fatherhood, family and
youth services, home visiting, child
welfare, trafficking, community
services, and other areas of interest to
ACF. Some ACF program offices
conduct their own research and
evaluation projects and may utilize this
generic.
Under this generic clearance, ACF
engages in a variety of formative data
collections with researchers,
practitioners, technical assistance
providers, service providers, and
potential participants throughout the
field to fulfill the following goals: (1)
inform the development of ACF
research, (2) maintain a research agenda
that is rigorous and relevant, (3) ensure
that research products are as current as
possible, and (4) inform the provision of
technical assistance and supports
around research and evaluation. ACF
envisions using a variety of techniques
including semi-structured discussions,
focus groups, surveys, and telephone or
in-person interviews, in order to reach
these goals. Information collected under
this overarching generic is meant to
inform ACF research activities and may
be incorporated into documents or
presentations that are made public.
The following are some examples of
ways in which we may share
information resulting from these data
collections: research design documents
or reports; research or technical
assistance plans; background materials
for technical workgroups; concept maps,
process maps, or conceptual
frameworks; contextualization of
research findings from a follow-up data
collection that has full PRA approval;
informational reports to TA providers;
or project specific reports, or other
documents relevant to the field, such as
federal leadership and staff, grantees,
local implementing agencies.
Following standard OMB
requirements, ACF has and will
continue to submit to OMB information
about individual information collection
activities proposed under the generic
clearance. ACF will provide OMB with
a copy of the individual instruments or
questionnaires, as well as other
materials describing the project. ACF
requests OMB’s review within 10 days
of submission of individual requests
under this generic.
Respondents: Respondents could
include key groups involved in ACF
projects and programs, state or local
government officials, service providers,
participants in ACF programs or similar
comparison groups, experts in fields
pertaining to ACF research and
programs, or others involved in
conducting ACF research or evaluation
projects.
Annual Burden Estimates
Find currently approved information
collections here: https://
www.reginfo.gov/public/do/PRAOMB
History?ombControlNumber=0970-0356.
The request to OMB will include an
extension request for approved
information collections that are planned
to continue beyond November 2023.
ANNUAL BURDEN ESTIMATES—NEW REQUESTS
Instrument
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Number of
responses per
respondent
(total over
request
period)
Number of
respondents
(total over
request
period)
Average
burden per
response
(in hours)
Total burden
(in hours)
Semi-Structured Discussions and Focus Groups ............................................
Interviews .........................................................................................................
Questionnaires/Surveys ...................................................................................
3,000
1,500
1,125
1
1
1
2
1
.5
6,000
1,500
563
Total ..........................................................................................................
........................
........................
........................
8,063
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–17205 Filed 8–10–23; 8:45 am]
BILLING CODE 4184–79–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–E–1865]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Vercise Genus Deep Brain
Stimulation System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for VERCISE GENUS DEEP BRAIN
STIMULATION SYSTEM (VERCISE
GENUS DBS SYSTEM) and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
SUMMARY:
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the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 10, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 7, 2024. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
ADDRESSES:
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Agencies
[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54614-54615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17205]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Formative Data
Collections for ACF Research and Evaluation (Office of Management and
Budget #0970-0356)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, U.S. Department of Health and Human
Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) proposes to
extend data collection under the existing overarching generic clearance
for Formative Data Collections for ACF Research and Evaluation (Office
of Management and Budget (OMB) #0970-0356). There are no changes
proposed.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of the Paperwork Reduction Act of 1995, ACF is
soliciting public comment on the specific aspects of the information
collection described above.
ADDRESSES: You can obtain copies of the proposed collection of
information and submit comments by emailing
[email protected]. Identify all requests by the title of
the information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF programs promote the economic and social well-
being of families, children, individuals, and communities. The Office
of Planning, Research, and Evaluation (OPRE) studies ACF programs, and
the populations they serve, through rigorous research and evaluation
projects. These include evaluations of existing programs, evaluations
of innovative approaches to helping low-income children and families,
research syntheses, and descriptive and exploratory studies. OPRE's
research
[[Page 54615]]
offers further understanding of current programs and service
populations, explores options for program improvement, and assesses
alternative policy and program designs. OPRE anticipates undertaking a
variety of new research projects related to welfare, employment and
self-sufficiency, Head Start, child care, healthy marriage and
responsible fatherhood, family and youth services, home visiting, child
welfare, trafficking, community services, and other areas of interest
to ACF. Some ACF program offices conduct their own research and
evaluation projects and may utilize this generic.
Under this generic clearance, ACF engages in a variety of formative
data collections with researchers, practitioners, technical assistance
providers, service providers, and potential participants throughout the
field to fulfill the following goals: (1) inform the development of ACF
research, (2) maintain a research agenda that is rigorous and relevant,
(3) ensure that research products are as current as possible, and (4)
inform the provision of technical assistance and supports around
research and evaluation. ACF envisions using a variety of techniques
including semi-structured discussions, focus groups, surveys, and
telephone or in-person interviews, in order to reach these goals.
Information collected under this overarching generic is meant to inform
ACF research activities and may be incorporated into documents or
presentations that are made public.
The following are some examples of ways in which we may share
information resulting from these data collections: research design
documents or reports; research or technical assistance plans;
background materials for technical workgroups; concept maps, process
maps, or conceptual frameworks; contextualization of research findings
from a follow-up data collection that has full PRA approval;
informational reports to TA providers; or project specific reports, or
other documents relevant to the field, such as federal leadership and
staff, grantees, local implementing agencies.
Following standard OMB requirements, ACF has and will continue to
submit to OMB information about individual information collection
activities proposed under the generic clearance. ACF will provide OMB
with a copy of the individual instruments or questionnaires, as well as
other materials describing the project. ACF requests OMB's review
within 10 days of submission of individual requests under this generic.
Respondents: Respondents could include key groups involved in ACF
projects and programs, state or local government officials, service
providers, participants in ACF programs or similar comparison groups,
experts in fields pertaining to ACF research and programs, or others
involved in conducting ACF research or evaluation projects.
Annual Burden Estimates
Find currently approved information collections here: https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0970-0356. The
request to OMB will include an extension request for approved
information collections that are planned to continue beyond November
2023.
Annual Burden Estimates--New Requests
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per
respondents respondent Average burden Total burden
Instrument (total over (total over per response (in hours)
request request (in hours)
period) period)
----------------------------------------------------------------------------------------------------------------
Semi-Structured Discussions and Focus Groups.... 3,000 1 2 6,000
Interviews...................................... 1,500 1 1 1,500
Questionnaires/Surveys.......................... 1,125 1 .5 563
---------------------------------------------------------------
Total....................................... .............. .............. .............. 8,063
----------------------------------------------------------------------------------------------------------------
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-17205 Filed 8-10-23; 8:45 am]
BILLING CODE 4184-79-P