Agency Information Collection Activities: Submission for OMB Review; Comment Request, 24480-24481 [2024-07429]
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24480
Federal Register / Vol. 89, No. 68 / Monday, April 8, 2024 / Notices
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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by May 8, 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:
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: Medicaid Drug
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SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:37 Apr 05, 2024
Jkt 262001
Rebate Program State Reporting Forms;
Use: Form CMS 368 is a report of
contact for the State to name the
individuals involved in the Medicaid
Drug Rebate Program (MDRP) and is
required only in those instances where
a change to the originally submitted
data is necessary. The ability to require
the reporting of any changes to these
data is necessary to the efficient
operation of these programs. Form
CMS–R–144 is required from States
quarterly to report utilization for any
drugs paid for during that quarter. Form
Number: CMS–368 and –R–144 (OMB
control number: 0938–0582); Frequency:
Quarterly and on occasion; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 290; Total
Annual Hours: 13,669. (For policy
questions regarding this collection
contact Robert Giles at 667–290–8626.)
2. Type of Information Collection
Request: Extension of currently
approved collection; Title of
Information Collection: Identifying
Medicaid Payment for Physician
Administered Drugs; Use: States are
required to provide for the collection
and submission of utilization data for
certain physician-administered drugs in
order to receive Federal financial
participation for these drugs.
Physicians, serving as respondents to
states, submit National Drug Code
numbers and utilization information for
‘‘J’’ code physician-administered drugs
so that the states will have sufficient
information to collect drug rebate
dollars. Form Number: CMS–10215
(OMB control number: 0938–1026);
Frequency: Weekly; Affected Public:
Business or other for-profits and Notfor-profit institutions); Number of
Respondents: 26,000; Total Annual
Responses: 39,053,932; Total Annual
Hours: 162,074. (For policy questions
regarding this collection contact
Michael Forman at 410–786–2666.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–07393 Filed 4–5–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10887 and
CMS–10394]
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 May 8, 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:
E:\FR\FM\08APN1.SGM
08APN1
Federal Register / Vol. 89, No. 68 / Monday, April 8, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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: New collection (Request for a
new OMB control number); Title of
Information Collection: The Medicare
Advantage and Prescription Drug
Programs: Part C and Part D Medicare
Advantage Prescription Drug (MARx)
System Updates for the Medicare
Prescription Payment Plan Program;
Use: The IRA amended the Act by
adding section 1860D–2(b)(2)(E) which,
beginning January 1, 2025, establishes
the Medicare Prescription Payment Plan
program (hereinafter referred to as the
‘‘program’’). Under this program, MA
Organizations offering Part D coverage
and Part D sponsors (collectively ‘‘Part
D plans’’ or ‘‘Plans’’) are required to
offer enrollees the option to pay their
Part D cost sharing in monthly amounts
spread out over the plan year based on
the formulae described in section
1860D–2(b)(2)(E)(iv) of the Act.
To effectively monitor the program,
Part D plans will be required to report
data elements related to the program at
the beneficiary, contract, and Plan
Benefit Package (PBP)1 levels beginning
in Contract Year (CY) 2025. In this
information collection package, CMS
addresses the proposal to require Part D
plans to submit beneficiary-level data
elements into the MARx system via a
program-specific transaction (separate
from the enrollment file). In accordance
with the Plan Communication User
Guide (PCUG), plans may submit
multiple transaction files during any
CMS business day, Monday through
Friday. Plan transactions are processed
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16:37 Apr 05, 2024
Jkt 262001
as received; there is no minimum or
maximum limit to the number of files
that Plans may submit in a day. In
general, transaction and processing
occur throughout the Current Calendar
Month (CCM). For CY 2025, CMS will
not require independent data validation
for this new MARx reporting
requirement. Form Number: CMS–
10887 (OMB control number: 0938–
New); Frequency: Monthly; Affected
Public: Private, Federal Government,
Business or other for profits, Not-forprofits institutions; Number of
Respondents: 856; Total Annual
Responses: 3,200,856; Total Annual
Hours: 59,958. (For policy questions
regarding this collection contact
Michael Brown at (872) 287–1370 or
michael.brown3@cms.hhs.gov.)
2. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: Application to
be a Qualified Entity to Receive
Medicare Data for Performance
Measurement/Reapplication/Annual
Report Worksheet; Use: The Patient
Protection and Affordable Care Act
(ACA) was enacted on March 23, 2010
(Pub. L. 111–148). ACA amends section
1874 of the Social Security Act by
adding a new subsection (e) to make
standardized extracts of Medicare
claims data under Parts A, B, and D
available to QEs to evaluate the
performance of providers of services
and suppliers. This is the Application,
Reapplication, and ARW which
provides CMS with the information it
needs to determine whether an
organization earns approval and
continues as a QE.
CMS established the Qualified Entity
Certification Program (QECP) to
evaluate an organization’s eligibility
across three areas: (1) organizational and
governance capabilities, (2) addition of
claims data from other sources (as
required in the statute), and (3) data
privacy and security. QE certification
lasts for 3 years. Organizations that are
interested in remaining in the QE
program must submit a Reapplication
that is reviewed and approved by QECP.
In addition, each year QEs must submit
an annual report to QECP that provides
information required by statute. Form
Number: CMS–10394 (OMB control
number: 0938–1144); Frequency: Yearly;
Affected Public: Business or other forprofits; Number of Respondents: 40;
Total Annual Responses: 210; Total
Annual Hours: 17,400. (For policy
questions regarding this collection
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24481
contact Kari Gaare at kari.gaare@
cms.hhs.gov.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–07429 Filed 4–5–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 1009 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
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Genetics and Biology of von Willebrand
Disease.
Date: May 8, 2024.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Manoj Kumar
Valiyaveettil, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA,
National Heart, Lung, and Blood Institute,
National Institutes of Health, 6705 Rockledge
Drive, Room 208–R, Bethesda, MD 20817,
(301) 402–1616, manoj.valiyaveettil@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: April 3, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–07376 Filed 4–5–24; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 89, Number 68 (Monday, April 8, 2024)]
[Notices]
[Pages 24480-24481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07429]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10887 and CMS-10394]
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 May 8, 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.
[[Page 24481]]
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: New collection (Request
for a new OMB control number); Title of Information Collection: The
Medicare Advantage and Prescription Drug Programs: Part C and Part D
Medicare Advantage Prescription Drug (MARx) System Updates for the
Medicare Prescription Payment Plan Program; Use: The IRA amended the
Act by adding section 1860D-2(b)(2)(E) which, beginning January 1,
2025, establishes the Medicare Prescription Payment Plan program
(hereinafter referred to as the ``program''). Under this program, MA
Organizations offering Part D coverage and Part D sponsors
(collectively ``Part D plans'' or ``Plans'') are required to offer
enrollees the option to pay their Part D cost sharing in monthly
amounts spread out over the plan year based on the formulae described
in section 1860D-2(b)(2)(E)(iv) of the Act.
To effectively monitor the program, Part D plans will be required
to report data elements related to the program at the beneficiary,
contract, and Plan Benefit Package (PBP)1 levels beginning in Contract
Year (CY) 2025. In this information collection package, CMS addresses
the proposal to require Part D plans to submit beneficiary-level data
elements into the MARx system via a program-specific transaction
(separate from the enrollment file). In accordance with the Plan
Communication User Guide (PCUG), plans may submit multiple transaction
files during any CMS business day, Monday through Friday. Plan
transactions are processed as received; there is no minimum or maximum
limit to the number of files that Plans may submit in a day. In
general, transaction and processing occur throughout the Current
Calendar Month (CCM). For CY 2025, CMS will not require independent
data validation for this new MARx reporting requirement. Form Number:
CMS-10887 (OMB control number: 0938-New); Frequency: Monthly; Affected
Public: Private, Federal Government, Business or other for profits,
Not-for-profits institutions; Number of Respondents: 856; Total Annual
Responses: 3,200,856; Total Annual Hours: 59,958. (For policy questions
regarding this collection contact Michael Brown at (872) 287-1370 or
[email protected].)
2. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection:
Application to be a Qualified Entity to Receive Medicare Data for
Performance Measurement/Reapplication/Annual Report Worksheet; Use: The
Patient Protection and Affordable Care Act (ACA) was enacted on March
23, 2010 (Pub. L. 111-148). ACA amends section 1874 of the Social
Security Act by adding a new subsection (e) to make standardized
extracts of Medicare claims data under Parts A, B, and D available to
QEs to evaluate the performance of providers of services and suppliers.
This is the Application, Reapplication, and ARW which provides CMS with
the information it needs to determine whether an organization earns
approval and continues as a QE.
CMS established the Qualified Entity Certification Program (QECP)
to evaluate an organization's eligibility across three areas: (1)
organizational and governance capabilities, (2) addition of claims data
from other sources (as required in the statute), and (3) data privacy
and security. QE certification lasts for 3 years. Organizations that
are interested in remaining in the QE program must submit a
Reapplication that is reviewed and approved by QECP. In addition, each
year QEs must submit an annual report to QECP that provides information
required by statute. Form Number: CMS-10394 (OMB control number: 0938-
1144); Frequency: Yearly; Affected Public: Business or other for-
profits; Number of Respondents: 40; Total Annual Responses: 210; Total
Annual Hours: 17,400. (For policy questions regarding this collection
contact Kari Gaare at [email protected].)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-07429 Filed 4-5-24; 8:45 am]
BILLING CODE 4120-01-P
