Agency Information Collection Activities: Submission for OMB Review; Comment Request, 64466-64467 [2024-17411]
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64466
Federal Register / Vol. 89, No. 152 / Wednesday, August 7, 2024 / Notices
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collection contact Valerie Yingling at
667–290–8657.)
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
Request for Retirement Benefit
Information; Use: Medicare Premium
Part A is a voluntary program that is
financed from premium payments by
enrollees together with contributions
from funds appropriated by the Federal
Government. Form CMS–R–285,
‘‘Medicare Request for Retirement
Benefit Information,’’ is used to obtain
information regarding whether a
beneficiary currently purchasing
Medicare Premium Part A coverage is
receiving retirement payments based on
State or local government employment,
how long the claimant worked for the
State or local government employer, and
whether the former employer or pension
plan is subsidizing the individual’s Part
A premium.
Form CMS–R–285 provides the
necessary information regarding the
prior state or local government
employment to process the individual’s
request for premium Part A reduction
based on their employment by a state or
local government. The form is
completed by the state or local
government employer on behalf of the
individual seeking the Medicare
premium reduction. The SSA, CMS’
agent for processing Medicare
enrollments and premium amount
determinations, will use this
information to help determine whether
a beneficiary meets the requirements for
reduction of the Part A premium. The
form is owned by CMS but not
completed by CMS staff. Form Number:
CMS–R–285 (OMB control number:
0938–0769); Frequency: Once; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
500; Total Annual Responses: 500; Total
Annual Hours: 125. (For policy
questions regarding this collection
contact Candace Carter at 410–786–
8446.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–17468 Filed 8–6–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10695]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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 6, 2024.
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 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.
DATES:
PO 00000
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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
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: Extension of a currently
approved collection; Title of
Information Collection: Quality
Payment Program/Merit-Based Incentive
Payment System (MIPS) Surveys and
Feedback Collections; Use: The purpose
of this submission is to request approval
for generic clearance of a program of
survey and feedback collections
supporting the Quality Payment
Program which includes the MeritBased Incentive Payment System (MIPS)
and Advanced Alternative Payment
Models (AAPMs). MIPS is a program for
certain eligible clinicians that makes
Medicare payment adjustments based
on performance on quality, cost and
other measures and activities, and that
consolidates components of three
precursor programs—the Physician
Quality Reporting system (PQRS), the
Value Modifier (VM), and the Medicare
Electronic Health Record (EHR)
Incentive Program for eligible
professionals. AAPMs are a track of the
Quality Payment Program that offer
incentives for achieving threshold levels
of payments or patients in Advanced
APMs or Other Payer Advanced APMs.
Under the AAPM path, eligible
clinicians may become Qualifying APM
Participants (QPs) and are excluded
from MIPS. Partial Qualifying APM
Participants (Partial QPs) may opt to
report and be scored under MIPS.
This generic clearance will cover a
program of surveys and feedback
collections designed to strategically
obtain data and feedback from MIPS
SUPPLEMENTARY INFORMATION:
E:\FR\FM\07AUN1.SGM
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Federal Register / Vol. 89, No. 152 / Wednesday, August 7, 2024 / Notices
eligible clinicians, third-party
intermediaries, Medicare beneficiaries,
and any other audiences that would
support the Agency in improving MIPS
or the Quality Payment Program. The
specific collections we intend to
conduct are: Human Centered Design
(HCD) User Testing Volunteer Sign-Up
Survey; HCD User Satisfaction, Product
Usage, and Benchmarking Surveys; and
Physician Compare (and/or successor
website) User Testing. Form Number:
CMS–10695 (OMB control number:
0938–1399); Frequency: Occasionally;
Affected Public: Private Sector: Business
or other for-profits and Not-for-profit
institutions and Individuals; Number of
Respondents: 630,300; Total Annual
Responses: 630,300; Total Annual
Hours: 61,035. (For policy questions
regarding this collection, contact Renee
O’Neill at 410–786–8821.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–17411 Filed 8–6–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0001]
Enhancing Diversity in Therapeutics
Development for Pediatric Patients;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Enhancing Diversity
in Therapeutics Development for
Pediatric Patients.’’ The aim of the
public workshop is to explore strategies
to increase the enrollment of historically
underrepresented populations in
pediatric clinical trials and to help
improve the strength and
generalizability of the evidence for the
intended use population.
DATES: The public workshop will be
held on September 6, 2024, from 9 a.m.
to 5 p.m. Eastern Time. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the registered public
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SUMMARY:
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workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/about-fda/visitorinformation. The workshop will also be
streamed online.
FOR FURTHER INFORMATION CONTACT: Julie
Levin, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6481, Silver Spring,
MD 20993, 202–567–7565, or
ONDPublicMTGSupport@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical trials in children are essential
for obtaining data on the safety and
effectiveness of medical products in
children and to protect children from
the risks associated with exposure to
medical products that may be unsafe or
ineffective for their intended uses in
children. In some therapeutic areas,
participation in clinical trials may be an
important component of a participant’s
clinical care. Pediatric drug
development programs should consider
the clinical and demographic factors
that impact the generalizability of study
results with respect to the patient
population that will use the product
once it is approved.
II. Topics for Discussion at the Public
Workshop
FDA, in collaboration with the
University of Maryland Center of
Excellence in Regulatory Science and
Innovation, is convening a 1-day
workshop to explore strategies for
enrolling historically underrepresented
populations in pediatric clinical trials.
The specific topics to be covered
include, but are not limited to, the
following:
• Understanding the current state and
challenges of pediatric clinical trial
participation;
• Understanding metrics for assessing
representative clinical study enrollment,
including considerations of disease
prevalence and incidence across
subgroups of the pediatric population;
and
• Discussing key elements of a
strategy to include a more representative
population, including trial design and
methodological considerations,
community engagement, recruitment
and retention practices, and other
related topics.
website: https://www.fda.gov/drugs/
news-events-human-drugs/adept-9public-workshop-enhancing-diversitytherapeutics-development-pediatricpatients-09062024. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop in
person must register by August 23,
2024, at 5 p.m. Eastern Time; virtual
attendees may register by September 6,
2024, at 9 a.m. Eastern Time. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation when they have
been accepted. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8:15 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact Julie
Levin at 202–567–7565 or
ONDPublicMTGSupport@fda.hhs.gov
no later than August 16, 2024.
Streaming Webcast of the Public
Workshop: This public workshop will
also be streamed virtually via Zoom. A
link will be provided via email to
registered participants. If you have
never attended a Zoom event before, test
your connection at https://zoom.us/test.
Although FDA verified the website
addresses in this document, please note
that websites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible on the workshop website.
(Notice of this meeting is given
pursuant to 21 CFR 10.65.)
Dated: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16365 Filed 8–6–24; 8:45 am]
BILLING CODE 4164–01–P
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
PO 00000
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Agencies
[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Notices]
[Pages 64466-64467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10695]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by September 6, 2024.
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 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/PRA-Listing.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: 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 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: Extension of a currently
approved collection; Title of Information Collection: Quality Payment
Program/Merit-Based Incentive Payment System (MIPS) Surveys and
Feedback Collections; Use: The purpose of this submission is to request
approval for generic clearance of a program of survey and feedback
collections supporting the Quality Payment Program which includes the
Merit-Based Incentive Payment System (MIPS) and Advanced Alternative
Payment Models (AAPMs). MIPS is a program for certain eligible
clinicians that makes Medicare payment adjustments based on performance
on quality, cost and other measures and activities, and that
consolidates components of three precursor programs--the Physician
Quality Reporting system (PQRS), the Value Modifier (VM), and the
Medicare Electronic Health Record (EHR) Incentive Program for eligible
professionals. AAPMs are a track of the Quality Payment Program that
offer incentives for achieving threshold levels of payments or patients
in Advanced APMs or Other Payer Advanced APMs. Under the AAPM path,
eligible clinicians may become Qualifying APM Participants (QPs) and
are excluded from MIPS. Partial Qualifying APM Participants (Partial
QPs) may opt to report and be scored under MIPS.
This generic clearance will cover a program of surveys and feedback
collections designed to strategically obtain data and feedback from
MIPS
[[Page 64467]]
eligible clinicians, third-party intermediaries, Medicare
beneficiaries, and any other audiences that would support the Agency in
improving MIPS or the Quality Payment Program. The specific collections
we intend to conduct are: Human Centered Design (HCD) User Testing
Volunteer Sign-Up Survey; HCD User Satisfaction, Product Usage, and
Benchmarking Surveys; and Physician Compare (and/or successor website)
User Testing. Form Number: CMS-10695 (OMB control number: 0938-1399);
Frequency: Occasionally; Affected Public: Private Sector: Business or
other for-profits and Not-for-profit institutions and Individuals;
Number of Respondents: 630,300; Total Annual Responses: 630,300; Total
Annual Hours: 61,035. (For policy questions regarding this collection,
contact Renee O'Neill at 410-786-8821.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-17411 Filed 8-6-24; 8:45 am]
BILLING CODE 4120-01-P