Proposed Information Collection Activity; Tribal Maternal, Infant, and Early Childhood Home Visiting Program Implementation Plan Guidance for Development and Implementation and Implementation and Expansion Grantees, 7978-7979 [2023-02543]
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Federal Register / Vol. 88, No. 25 / Tuesday, February 7, 2023 / Notices
information on the quality of health care
services and prescription drug coverage
available to persons enrolled in a
Medicare health or prescription drug
plan under provisions in the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA).
Specifically, the MMA under Sec.
1860D–4 (Information to Facilitate
Enrollment) requires CMS to conduct
consumer satisfaction surveys regarding
Medicare prescription drug plans and
Medicare Advantage plans and report
this information to Medicare
beneficiaries prior to the Medicare
annual enrollment period. The Medicare
CAHPS survey meets the requirement of
collecting and publicly reporting
consumer satisfaction information. The
Balanced Budget Act of 1997 also
requires the collection of information
about fee-for-service plans.
The primary purpose of the Medicare
CAHPS surveys is to provide
information to Medicare beneficiaries to
help them make more informed choices
among health and prescription drug
plans available to them. Survey results
are reported by CMS in the Medicare &
You Handbook published each fall and
on the Medicare Plan Finder website.
Beneficiaries can compare CAHPS
scores for each health and drug plan as
well as compare MA and FFS scores
when making enrollment decisions. The
Medicare CAHPS also provides data to
help CMS and others monitor the
quality and performance of Medicare
health and prescription drug plans and
identify areas to improve the quality of
care and services provided to enrollees
of these plans. CAHPS data are included
in the Medicare Part C & D Star Ratings
and used to calculate MA Quality Bonus
Payments. Form Number: CMS–R–246
(OMB control number: 0938- 0732);
Frequency: Yearly; Affected Public:
Individuals and Households; Number of
Respondents: 794,500; Total Annual
Responses: 794,500; Total Annual
Hours: 192,265. (For policy questions
regarding this collection contact Lauren
Fuentes at 410–786–2290).
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Implementation
of the Medicare Prescription Drug Plan
(PDP) and Medicare Advantage (MA)
Plan Disenrollment Reasons Survey;
Use: The Balanced Budget Act of 1997
required that the CMS publicly report
two years of disenrollment rates on all
Medicare + Choice (M+C) organizations.
Disenrollment rates are a useful measure
of beneficiary dissatisfaction with a
plan; this information is even more
useful when reasons for disenrollment
are provided to consumers, insurers,
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18:52 Feb 06, 2023
Jkt 259001
and other stakeholders. Advocacy
organizations agree that CMS needs to
report disenrollment reasons so that
disenrollment rates can be interpreted
correctly.
Specifically, the MMA under Sec.
1860D–4 (Information to Facilitate
Enrollment) requires CMS to conduct
consumer satisfaction surveys regarding
the PDP and MA contracts pursuant to
section 1860D–4(d). Plan disenrollment
is generally believed to be a broad
indicator of beneficiary dissatisfaction
with some aspect of plan services, such
as access to care, customer service, cost
of the plan, services, benefits provided,
or quality of care.
The information generated from the
disenrollment survey supports CMS’
ongoing efforts to assess plan
performance and provide oversight to
the functioning of Medicare Advantage
(Part C) and PDP (Part D) plans, which
provide health care services to millions
of Medicare beneficiaries (i.e., 28
million for Part C coverage and 49
million for Part D coverage).
Beneficiary experiences of care (as
measured in the MCAHPS survey) and
dissatisfaction (as measured in the
disenrollment survey) with plan
performance are both important sources
of information for plan monitoring and
oversight. The disenrollment survey
assesses different aspects of
dissatisfaction (i.e., reasons why
beneficiaries voluntarily left a plan),
which can identify problems with plan
operations; performance areas evaluated
include access to care, customer service,
cost, coverage, benefits provided, and
quality of care. Understanding how well
plans perform on these dimensions of
care and service helps CMS understand
whether beneficiaries are satisfied with
the care they are receiving from
contracted plans. When and if plans are
found to be performing poorly against
an array of performance measures,
including beneficiary disenrollment,
CMS may take corrective action. Form
Number: CMS–10316 (OMB control
number: 0938–1113); Frequency: Yearly;
Affected Public: Individuals and
Households; Number of Respondents:
32,750; Total Annual Responses:
32,750; Total Annual Hours: 7,055. (For
policy questions regarding this
collection contact Beth Simons at 415–
744–3780).
Dated: February 2, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–02580 Filed 2–6–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Tribal Maternal, Infant, and
Early Childhood Home Visiting
Program Implementation Plan
Guidance for Development and
Implementation and Implementation
and Expansion Grantees
Office of Early Childhood
Development, 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), Office of
Early Childhood Development (ECD) is
requesting Office of Management and
Budget (OMB) approval of Tribal
Maternal, Infant, and Early Childhood
Home Visiting (MIECHV) Program
Implementation Plan Guidance for
Tribal Home Visiting Development and
Implementation Grants (DIG) and Tribal
Home Visiting Implementation and
Expansion Grants (IEG).
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act (PRA) 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
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Section 511(e)(8)(A) of
title V of the Social Security Act
requires that grantees under the Tribal
MIECHV program, in the first year of
their grants, submit an implementation
plan on how they will meet the
requirements of the program. Section
511(h)(2)(A) further states that the
requirements for the MIECHV grants to
tribes, tribal organizations, and urban
Indian organizations are to be
consistent, to the greatest extent
practicable, with the requirements for
grantees under the MIECHV program for
states and jurisdictions.
The ACF Office of Early Childhood
Development, in collaboration with the
Health Resources and Services
Administration, Maternal and Child
Health Bureau awarded grants for the
Tribal MIECHV Program to support
cooperative agreements to conduct
community needs assessments; plan for
SUMMARY:
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7979
Federal Register / Vol. 88, No. 25 / Tuesday, February 7, 2023 / Notices
and implement high-quality, culturally
relevant, evidence-based home visiting
programs in at-risk tribal communities;
establish, measure, and report on
progress toward meeting performance
measures in six legislatively mandated
benchmark areas; and conduct rigorous
evaluation activities to build the
knowledge base on home visiting among
Native populations.
During the first grant year, Tribal
Home Visiting grantees must comply
with the requirement to submit an
implementation plan that should feature
planned activities to be carried out
under the program in years 2–5 of their
cooperative agreements. To assist
grantees with meeting these
requirements, ACF created guidance for
grantees to use when writing their
plans. The DIG and IEG guidance
specify that grantees must provide a
plan to address the following areas:
• Community Needs and Readiness
Assessment
• Program Design
• Program Blueprint
• Plan for Data Collection, Management
and Performance Measurement
• Fidelity Monitoring and Quality
Assurance
Respondents: Tribal Home Visiting
Managers (information collection does
not include direct interaction with
individuals or families that receive the
services).
TOTAL BURDEN ESTIMATES
Total number
of respondents
Number of
responses per
respondent
Implementation Plan Guidance for Development and Implementation Grantees ................................................................................................................
Implementation Plan Guidance for Implementation and Expansion Grantees
13
35
1
1
1,000
1,000
13,000
35,000
Estimated Total Annual Burden Hours: ....................................................
........................
........................
........................
48,000
Instrument
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.
Authority: Title V of the Social
Security Act, sections 511(e)(8)(A) and
511(h)(2)(A).
John M. Sweet Jr,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–02543 Filed 2–6–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ddrumheller on DSK120RN23PROD with NOTICES
[Docket Nos. FDA–2019–E–5658 and FDA–
2019–E–5659]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; YUPELRI
Food and Drug Administration,
HHS.
ACTION:
Notice.
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Jkt 259001
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by April 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
August 7, 2023. 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
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 10, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
ADDRESSES:
Food and Drug Administration
AGENCY:
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for YUPELRI and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
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Average
burden hours
per response
Total burden
hours
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’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
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[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7978-7979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02543]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Tribal Maternal,
Infant, and Early Childhood Home Visiting Program Implementation Plan
Guidance for Development and Implementation and Implementation and
Expansion Grantees
AGENCY: Office of Early Childhood Development, 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), Office of
Early Childhood Development (ECD) is requesting Office of Management
and Budget (OMB) approval of Tribal Maternal, Infant, and Early
Childhood Home Visiting (MIECHV) Program Implementation Plan Guidance
for Tribal Home Visiting Development and Implementation Grants (DIG)
and Tribal Home Visiting Implementation and Expansion Grants (IEG).
DATES: Comments due within 60 days of publication. In compliance with
the requirements of the Paperwork Reduction Act (PRA) 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: Section 511(e)(8)(A) of title V of the Social Security
Act requires that grantees under the Tribal MIECHV program, in the
first year of their grants, submit an implementation plan on how they
will meet the requirements of the program. Section 511(h)(2)(A) further
states that the requirements for the MIECHV grants to tribes, tribal
organizations, and urban Indian organizations are to be consistent, to
the greatest extent practicable, with the requirements for grantees
under the MIECHV program for states and jurisdictions.
The ACF Office of Early Childhood Development, in collaboration
with the Health Resources and Services Administration, Maternal and
Child Health Bureau awarded grants for the Tribal MIECHV Program to
support cooperative agreements to conduct community needs assessments;
plan for
[[Page 7979]]
and implement high-quality, culturally relevant, evidence-based home
visiting programs in at-risk tribal communities; establish, measure,
and report on progress toward meeting performance measures in six
legislatively mandated benchmark areas; and conduct rigorous evaluation
activities to build the knowledge base on home visiting among Native
populations.
During the first grant year, Tribal Home Visiting grantees must
comply with the requirement to submit an implementation plan that
should feature planned activities to be carried out under the program
in years 2-5 of their cooperative agreements. To assist grantees with
meeting these requirements, ACF created guidance for grantees to use
when writing their plans. The DIG and IEG guidance specify that
grantees must provide a plan to address the following areas:
Community Needs and Readiness Assessment
Program Design
Program Blueprint
Plan for Data Collection, Management and Performance
Measurement
Fidelity Monitoring and Quality Assurance
Respondents: Tribal Home Visiting Managers (information collection
does not include direct interaction with individuals or families that
receive the services).
Total Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Total number responses per burden hours Total burden
of respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Implementation Plan Guidance for Development and 13 1 1,000 13,000
Implementation Grantees........................
Implementation Plan Guidance for Implementation 35 1 1,000 35,000
and Expansion Grantees.........................
---------------------------------------------------------------
Estimated Total Annual Burden Hours:........ .............. .............. .............. 48,000
----------------------------------------------------------------------------------------------------------------
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.
Authority: Title V of the Social Security Act, sections
511(e)(8)(A) and 511(h)(2)(A).
John M. Sweet Jr,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-02543 Filed 2-6-23; 8:45 am]
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