Agency Information Collection Activities: Proposed Collection; Comment Request, 88622-88623 [2023-28292]
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Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices
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 January 22, 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:
ddrumheller on DSK120RN23PROD 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: Extension of a currently
approved collection; Title of
Information Collection: 1915(c) Home
and Community-Based Services (HCBS)
Waiver Application; Use: Although we
published a Federal Register notice on
September 11, 2023 (88 FR 62377) that
VerDate Sep<11>2014
18:10 Dec 21, 2023
Jkt 262001
set out revisions to what is active and
currently approved by OMB, this
December 2023 iteration is an extension
that does not propose any change. The
subsequent 30-day notice for the
September 11, 2023, revisions is
expected to publish in the Federal
Register in January/February 2024. We
use the application to review and
adjudicate individual waiver actions.
The application is also used by states to
submit and revise their waiver requests.
Form Number: CMS–8003 (OMB control
number 0938–0449); Frequency: Yearly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
47; Total Annual Responses: 71; Total
Annual Hours: 6,005. (For policy
questions regarding this collection
contact Ryan Shannahan at 410–786–
0295.)
Dated: December 19, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–28288 Filed 12–21–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10883, CMS–
R–64 and CMS–10396]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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 must be received by
February 20, 2024.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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.
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
Contents
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10883 American Dental
Association (ADA) Dental Claim Form
CMS–R–64 Indirect Medical Education
and Direct Graduate Medical
Education
CMS–10396 Medication Therapy
Management Program
Improvements—Standardized Format
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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
AGENCY:
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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22DEN1
Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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
requires Federal agencies to publish a
60-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.
Information Collection
1. Type of Information Collection
Request: New collection; Title of
Information Collection: American
Dental Association (ADA) Dental Claim
Form; Use: Medicare has traditionally
accepted the Professional (CMS–1500/
837P transaction) and Institutional
(UB04/837I transaction) claims forms to
provide payment for Medicare-covered
services. The Centers for Medicare &
Medicaid Services (CMS) now plans to
allow providers to submit Medicarecovered dental services on the dental
claim form, a similar information
collection as the already-approved
professional and institutional claim
forms. The ADA Dental Claim Form will
be used to deliver information from
dental providers to CMS for CMS to
reimburse for provided dental services.
Medicare Part B MACs will use the data
collected on the ADA dental form to
determine the proper amount of
reimbursement for Part B dental services
provided to Medicare beneficiaries.
Submission of information on the ADA
Dental Claim Form and associated
HIPAA-standard 837D transaction
format permits Medicare Part B MACs to
receive consistent data for proper
benefit payment. Form Number: CMS–
10883 (OMB control number: 0938New); Frequency: Occasionally;
Affected Public: Private sector,
Businesses and other for-profits;
Number of Respondents: 50,000; Total
Annual Responses: 50,000; Total
Annual Hours: 12,500. (For policy
questions regarding this collection
contact Charlene Parks at 410–786–
8684.)
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Indirect
Medical Education and Direct Graduate
Medical Education; Use: Section
1886(d)(5)(B) of the Social Security Act
requires additional payments to be
made under the Medicare Prospective
Payment System (PPS) for the indirect
medical educational costs a hospital
VerDate Sep<11>2014
18:10 Dec 21, 2023
Jkt 262001
incurs in connection with interns and
residents (IRs) in approved teaching
programs. In addition, title 42, part 413,
sections 75 through 83 implement
section 1886(d) of the Act by
establishing the methodology for
Medicare payment for the costs of direct
graduate medical educational activities.
The information collected on IRs is
used by Part-A Medicare Administrative
Contractors (MAC) to verify the number
of IRs FTE used in the calculation of
Medicare payments for IME and GME.
The IR data submitted by the hospitals
to the MACs is uploaded into CMS’
Intern and Resident Information System
(IRIS) database to identify duplicate
FTEs reported for any IR.
The MACs use the information
collected on IRs to ensure that all
program payments for IME and GME are
accurate and are in accordance with
Medicare regulations. The IR data
submitted by the hospitals to the MACs
are used to audit the Medicare cost
reports filed by the hospitals. Form
Number: CMS–R–64 (OMB control
number: 0938–0456); Frequency:
Monthly; Affected Public: Private sector
and Federal Government; Number of
Respondents: 1,245; Total Annual
Responses: 1,245; Total Annual Hours:
2,490. (For policy questions regarding
this collection contact Owen Osaghae at
410–786–7550.)
3. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medication
Therapy Management Program
Improvements—Standardized Format;
Use: Section 1860D–4(c)(2)(C)(i) of the
Act requires plan sponsors to offer MTM
services that include an annual CMR
with a written summary and action plan
provided in a standardized format
developed in consultation with
stakeholders. This requirement is
codified at § 423.153(d)(1)(vii)(D),
which requires that the standardized
action plan and summary comply with
requirements specified by CMS for the
standardized format. Components of the
CMR summary in Standardized Format
should include a cover letter,
personalized medication list, and action
plan if applicable.
Users include members in a Part D
sponsors’ plan who are eligible are
enrolled in the sponsors’ MTM program
and offered a CMR. The CMR is a
consultation between the MTM provider
(such as a pharmacist) with the
beneficiary to review their medications.
The MTM provider is either an
employee/contractor of the plan itself or
of a downstream entity contracted by
the plan to provide MTM services. After
a CMR is performed, the sponsor creates
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
88623
and sends a summary of the CMR to the
beneficiary that includes a medication
action plan and personal medication list
using the Standardized Format.
Information collected by Part D MTM
programs as required by the
Standardized Format for the CMR
summary is used by beneficiaries or
their authorized representatives,
caregivers, and their healthcare
providers to improve medication use
and achieve better healthcare outcomes.
Form Number: CMS–10396 (OMB
control number: 0938–1154); Frequency:
Yearly; Affected Public: Private Sector
and Business or other for-profits;
Number of Respondents: 842; Total
Annual Responses: 2,382,774; Total
Annual Hours: 1,588,595. (For policy
questions regarding this collection
contact Victoria Dang at 410–786–3991
or Victoria.dang@cms.hhs.gov.)
Dated: December 19, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–28292 Filed 12–21–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–5259]
Master Protocols for Drug and
Biological Product Development; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Master
Protocols for Drug and Biological
Product Development.’’ The draft
guidance addresses the design and
analysis of trials conducted under a
master protocol as well as the
submission of documentation to support
regulatory review. The primary focus is
on randomized umbrella and platform
trials that are intended to contribute to
a demonstration of safety and
substantial evidence of effectiveness.
The considerations in this guidance
apply to a range of therapeutic areas.
The draft guidance is intended to clarify
the Agency’s thinking on the use of
master protocols in drug and biological
product development, which was
previously addressed in FDA’s guidance
entitled ‘‘COVID–19: Master Protocols
Evaluating Drugs and Biological
SUMMARY:
E:\FR\FM\22DEN1.SGM
22DEN1
Agencies
[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88622-88623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28292]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10883, CMS-R-64 and CMS-10396]
Agency Information Collection Activities: Proposed Collection;
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 60 days for public comment on
the proposed action. Interested persons are invited to send comments
regarding our burden estimates 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 must be received by February 20, 2024.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
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 N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10883 American Dental Association (ADA) Dental Claim Form
CMS-R-64 Indirect Medical Education and Direct Graduate Medical
Education
CMS-10396 Medication Therapy Management Program Improvements--
Standardized Format
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. The term
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
[[Page 88623]]
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 requires Federal agencies
to publish a 60-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.
Information Collection
1. Type of Information Collection Request: New collection; Title of
Information Collection: American Dental Association (ADA) Dental Claim
Form; Use: Medicare has traditionally accepted the Professional (CMS-
1500/837P transaction) and Institutional (UB04/837I transaction) claims
forms to provide payment for Medicare-covered services. The Centers for
Medicare & Medicaid Services (CMS) now plans to allow providers to
submit Medicare-covered dental services on the dental claim form, a
similar information collection as the already-approved professional and
institutional claim forms. The ADA Dental Claim Form will be used to
deliver information from dental providers to CMS for CMS to reimburse
for provided dental services. Medicare Part B MACs will use the data
collected on the ADA dental form to determine the proper amount of
reimbursement for Part B dental services provided to Medicare
beneficiaries. Submission of information on the ADA Dental Claim Form
and associated HIPAA-standard 837D transaction format permits Medicare
Part B MACs to receive consistent data for proper benefit payment. Form
Number: CMS-10883 (OMB control number: 0938-New); Frequency:
Occasionally; Affected Public: Private sector, Businesses and other
for-profits; Number of Respondents: 50,000; Total Annual Responses:
50,000; Total Annual Hours: 12,500. (For policy questions regarding
this collection contact Charlene Parks at 410-786-8684.)
2. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Indirect Medical Education and Direct Graduate Medical
Education; Use: Section 1886(d)(5)(B) of the Social Security Act
requires additional payments to be made under the Medicare Prospective
Payment System (PPS) for the indirect medical educational costs a
hospital incurs in connection with interns and residents (IRs) in
approved teaching programs. In addition, title 42, part 413, sections
75 through 83 implement section 1886(d) of the Act by establishing the
methodology for Medicare payment for the costs of direct graduate
medical educational activities.
The information collected on IRs is used by Part-A Medicare
Administrative Contractors (MAC) to verify the number of IRs FTE used
in the calculation of Medicare payments for IME and GME. The IR data
submitted by the hospitals to the MACs is uploaded into CMS' Intern and
Resident Information System (IRIS) database to identify duplicate FTEs
reported for any IR.
The MACs use the information collected on IRs to ensure that all
program payments for IME and GME are accurate and are in accordance
with Medicare regulations. The IR data submitted by the hospitals to
the MACs are used to audit the Medicare cost reports filed by the
hospitals. Form Number: CMS-R-64 (OMB control number: 0938-0456);
Frequency: Monthly; Affected Public: Private sector and Federal
Government; Number of Respondents: 1,245; Total Annual Responses:
1,245; Total Annual Hours: 2,490. (For policy questions regarding this
collection contact Owen Osaghae at 410-786-7550.)
3. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Medication Therapy Management Program Improvements--Standardized
Format; Use: Section 1860D-4(c)(2)(C)(i) of the Act requires plan
sponsors to offer MTM services that include an annual CMR with a
written summary and action plan provided in a standardized format
developed in consultation with stakeholders. This requirement is
codified at Sec. 423.153(d)(1)(vii)(D), which requires that the
standardized action plan and summary comply with requirements specified
by CMS for the standardized format. Components of the CMR summary in
Standardized Format should include a cover letter, personalized
medication list, and action plan if applicable.
Users include members in a Part D sponsors' plan who are eligible
are enrolled in the sponsors' MTM program and offered a CMR. The CMR is
a consultation between the MTM provider (such as a pharmacist) with the
beneficiary to review their medications. The MTM provider is either an
employee/contractor of the plan itself or of a downstream entity
contracted by the plan to provide MTM services. After a CMR is
performed, the sponsor creates and sends a summary of the CMR to the
beneficiary that includes a medication action plan and personal
medication list using the Standardized Format.
Information collected by Part D MTM programs as required by the
Standardized Format for the CMR summary is used by beneficiaries or
their authorized representatives, caregivers, and their healthcare
providers to improve medication use and achieve better healthcare
outcomes. Form Number: CMS-10396 (OMB control number: 0938-1154);
Frequency: Yearly; Affected Public: Private Sector and Business or
other for-profits; Number of Respondents: 842; Total Annual Responses:
2,382,774; Total Annual Hours: 1,588,595. (For policy questions
regarding this collection contact Victoria Dang at 410-786-3991 or
[email protected].)
Dated: December 19, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-28292 Filed 12-21-23; 8:45 am]
BILLING CODE 4120-01-P