Agency Information Collection Activities: Submission for OMB Review; Comment Request, 94731-94732 [2024-28077]
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khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
Semistandard Supplies; and FAR
52.216–4, Economic Price Adjustment—
Labor and Material. These clauses
require contractors on contracts that
provide for economic price adjustments
to promptly notify the contracting
officer of any increases or decreases to
established prices or labor rates
(including fringe) because of certain
contingencies, such as increases or
decreases to established catalog or
market prices or changes to cost indexes
for labor or materials.
The contracting officer uses the
information provided by the contractor
to negotiate price adjustments under the
contract due to the contingency
specified in the contract.
• FAR 52.216–5, Price
Redetermination-Prospective. Paragraph
(c) of this clause requires a contractor on
a fixed-price contract with prospective
price redetermination to submit to the
Government (within an agreed upon
timeframe) a statement of costs incurred
for the most recent period of
performance, the proposed prices for the
upcoming contract period, and any
supporting or relevant documentation.
Per paragraph (h) of this clause, during
periods where firm prices have not been
established, the contractor must also
submit quarterly statements that
includes a breakdown of total contract
prices, costs, and profit incurred and all
invoices accepted for delivered items or
services for which final prices have not
been established.
The contracting officer uses the
information to negotiate/redetermine
fair and reasonable prices for supplies
and services that may be delivered or
performed under the contract in the
period following the effective date of
price redetermination.
• FAR 52.216–6, Price
Redetermination—Retroactive.
Paragraph (c) of this clause requires a
contractor on a fixed-ceiling-price
contract with retroactive price
redetermination to submit to the
Government (within an agreed upon
timeframe after completion of the
contract) the proposed prices, all costs
incurred in performing the contract, and
any supporting or relevant
documentation. Per paragraph (g) of this
clause, until final price redetermination
has been completed, the contractor must
also submit a quarterly statement that
includes a breakdown of total contract
prices, costs, and interim profit incurred
and all invoices accepted for delivered
items.
The contracting officer uses the
information provided by the contractor
to negotiate/redetermine fair and
reasonable prices for supplies and
services that have already been
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21:22 Nov 27, 2024
Jkt 265001
delivered or performed under the
contract.
• FAR 52.216–16, Incentive Price
Revision—Firm Target; and FAR
52.216–17, Incentive Price Revision—
Successive Targets. These clauses
require contractors on fixed price
incentive (firm or successive target)
contracts to submit to the Government
on a quarterly basis a statement
regarding total contract prices, costs,
portions of interim profit, and amounts
of invoices or vouchers for completed
work that is cumulative from the
beginning of the contract (see 52.216–
16(g) and 52.216–17(i)). Upon final
delivery of supplies or completion of
services for covered line items, the
contractor is required to submit a
detailed statement of all costs incurred
up to the end of that month in
performing all work under the items; an
estimate of costs of further performance,
if any, that may be necessary to
complete performance of all work under
the items; a list of all residual inventory
and an estimate of its value; and any
other relevant data that the Contracting
Officer may reasonably require (see
52.216–16(c) and 52.216–17(e)).
Paragraph (c) of 52.216–17 also requires
submission of data for establishing the
firm fixed price or a final profit
adjustment formula.
The contracting officer uses the
information provided by the contractor
to evaluate the contractor’s performance
in meeting the incentive target and to
negotiate the final prices of incentiverelated items and services.
C. Annual Burden
Respondents: 2,710.
Total Annual Responses: 45,260.
Total Burden Hours: 71,192.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 9000–0067, Certain Federal
Acquisition Regulation Part 16 Contract
Pricing Requirements.
William Clark,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2024–28053 Filed 11–27–24; 8:45 am]
BILLING CODE 6820–EP–P
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94731
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–290 and
CMS–10443]
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 December 30, 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:
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94732
Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices
khammond on DSK9W7S144PROD with NOTICES
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: Reinstatement without change
of a previously approved collection;
Title: Medicare Program: Procedures for
Making National Coverage Decisions;
Use: This collection is required by a
notice (78 FR 48164–69) published on
August 7, 2013 which delineates the
process for making a national coverage
determination (NCD) including
information for external parties to
submit a formal request for a new NCD
or a reconsideration of an existing NCD.
An NCD is defined in 1862(l) of the
Social Security Act (the Act) as ‘‘a
determination by the Secretary with
respect to whether or not a particular
item or service is covered nationally
under this title.’’ This information
collection will assist us in obtaining the
information we require to make a
national coverage determination in a
timely manner and ensuring that the
Medicare program continues to meet the
needs of its beneficiaries. Form Number:
CMS–R–290 (OMB control number:
0938–0776); Frequency: Annual;
Affected Public: Private Sector: Business
or other for-profits; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours:
1,200. (For policy questions regarding
this collection contact Lori M. Ashby at
410–786–6322.)
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection:
Title of Information Collection:
Transcatheter Valve Therapy (TVT)
Registry; Use: The data collection is
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21:22 Nov 27, 2024
Jkt 265001
required by the Centers for Medicare
and Medicaid Services (CMS) National
Coverage Determination (NCD) entitled,
‘‘Transcatheter Aortic Valve
Replacement (TAVR)’’. The TAVR
device is only covered when specific
conditions are met including that the
heart team and hospital are submitting
data in a prospective, national, audited
registry. The data includes patient,
practitioner and facility level variables
that predict outcomes such as all cause
mortality and quality of life. CMS finds
that the Society of Thoracic Surgery/
American College of Cardiology
Transcatheter Valve Therapy (STS/ACC
TVT) Registry, one registry overseen by
the National Cardiovascular Data
Registry, meets the requirements
specified in the NCD on TAVR. The
TVT Registry will support a national
surveillance system to monitor the
safety and efficacy of the TAVR
technologies for the treatment of aortic
stenosis.
The data will also include the
variables on the eight item Kansas City
Cardiomyopathy Questionnaire (KCCQ–
10) to assess heath status, functioning
and quality of life. In the KCCQ, an
overall summary score can be derived
from the physical function, symptoms
(frequency and severity), social function
and quality of life domains. For each
domain, the validity, reproducibility,
responsiveness and interpretability have
been independently established. Scores
are transformed to a range of 0–100, in
which higher scores reflect better health
status.
The conduct of the STS/ACC TVT
Registry and the KCCQ–10 is in
accordance with Section 1142 of the
Social Security Act (the Act) that
describes the authority of the Agency for
Healthcare Research and Quality
(AHRQ). Under section 1142, research
may be conducted and supported on the
outcomes, effectiveness, and
appropriateness of health care services
and procedures to identify the manner
in which disease, disorders, and other
health conditions can be prevented,
diagnosed, treated, and managed
clinically. Section 1862(a)(1)(E) of the
Act allows Medicare to cover under
coverage with evidence development
(CED) certain items or services for
which the evidence is not adequate to
support coverage under section
1862(a)(1)(A) and where additional data
gathered in the context of a clinical
setting would further clarify the impact
of these items and services on the health
of beneficiaries.
The data collected and analyzed in
the TVT Registry will be used by CMS
to determine if the TAVR is reasonable
and necessary (e.g., improves health
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outcomes) for Medicare beneficiaries
under Section 1862(a)(1)(A) of the Act.
Furthermore, data from the Registry will
assist the medical device industry and
the Food and Drug Administration
(FDA) in surveillance of the quality,
safety and efficacy of new medical
devices to treat aortic stenosis. For
purposes of the TAVR NCD, the TVT
Registry has contracted with the Data
Analytic Centers to conduct the
analyses. In addition, data will be made
available for research purposes under
the terms of a data use agreement that
only provides de-identified datasets.
Form Number: CMS–10443 (OMB
control number: 0938–1202); Frequency:
Annual; Affected Public: Individuals,
Households and Private Sector; Number
of Respondents: 49,704; Total Annual
Responses: 198,816; Total Annual
Hours: 63,790. (For policy questions
regarding this collection contact Nina
Arya at 667–290–9456).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–28077 Filed 11–27–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; Centers for
Independent Living Program
Performance Report (0985–0061)
Administration for Community
Living, HHS.
AGENCY:
ACTION:
Notice.
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This proposed revision of a
currently approved information
collection request (ICR Rev) solicits
comments on the information collection
requirements related to the Centers for
Independent Living (CILs) under the
Rehabilitation Act of 1973, 29 U.S.C.
701, et seq. (the Act).
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94731-94732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28077]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-290 and CMS-10443]
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 December 30, 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 94732]]
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: Reinstatement without
change of a previously approved collection; Title: Medicare Program:
Procedures for Making National Coverage Decisions; Use: This collection
is required by a notice (78 FR 48164-69) published on August 7, 2013
which delineates the process for making a national coverage
determination (NCD) including information for external parties to
submit a formal request for a new NCD or a reconsideration of an
existing NCD. An NCD is defined in 1862(l) of the Social Security Act
(the Act) as ``a determination by the Secretary with respect to whether
or not a particular item or service is covered nationally under this
title.'' This information collection will assist us in obtaining the
information we require to make a national coverage determination in a
timely manner and ensuring that the Medicare program continues to meet
the needs of its beneficiaries. Form Number: CMS-R-290 (OMB control
number: 0938-0776); Frequency: Annual; Affected Public: Private Sector:
Business or other for-profits; Number of Respondents: 30; Total Annual
Responses: 30; Total Annual Hours: 1,200. (For policy questions
regarding this collection contact Lori M. Ashby at 410-786-6322.)
2. Type of Information Collection Request: Reinstatement without
change of a previously approved collection: Title of Information
Collection: Transcatheter Valve Therapy (TVT) Registry; Use: The data
collection is required by the Centers for Medicare and Medicaid
Services (CMS) National Coverage Determination (NCD) entitled,
``Transcatheter Aortic Valve Replacement (TAVR)''. The TAVR device is
only covered when specific conditions are met including that the heart
team and hospital are submitting data in a prospective, national,
audited registry. The data includes patient, practitioner and facility
level variables that predict outcomes such as all cause mortality and
quality of life. CMS finds that the Society of Thoracic Surgery/
American College of Cardiology Transcatheter Valve Therapy (STS/ACC
TVT) Registry, one registry overseen by the National Cardiovascular
Data Registry, meets the requirements specified in the NCD on TAVR. The
TVT Registry will support a national surveillance system to monitor the
safety and efficacy of the TAVR technologies for the treatment of
aortic stenosis.
The data will also include the variables on the eight item Kansas
City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status,
functioning and quality of life. In the KCCQ, an overall summary score
can be derived from the physical function, symptoms (frequency and
severity), social function and quality of life domains. For each
domain, the validity, reproducibility, responsiveness and
interpretability have been independently established. Scores are
transformed to a range of 0-100, in which higher scores reflect better
health status.
The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in
accordance with Section 1142 of the Social Security Act (the Act) that
describes the authority of the Agency for Healthcare Research and
Quality (AHRQ). Under section 1142, research may be conducted and
supported on the outcomes, effectiveness, and appropriateness of health
care services and procedures to identify the manner in which disease,
disorders, and other health conditions can be prevented, diagnosed,
treated, and managed clinically. Section 1862(a)(1)(E) of the Act
allows Medicare to cover under coverage with evidence development (CED)
certain items or services for which the evidence is not adequate to
support coverage under section 1862(a)(1)(A) and where additional data
gathered in the context of a clinical setting would further clarify the
impact of these items and services on the health of beneficiaries.
The data collected and analyzed in the TVT Registry will be used by
CMS to determine if the TAVR is reasonable and necessary (e.g.,
improves health outcomes) for Medicare beneficiaries under Section
1862(a)(1)(A) of the Act. Furthermore, data from the Registry will
assist the medical device industry and the Food and Drug Administration
(FDA) in surveillance of the quality, safety and efficacy of new
medical devices to treat aortic stenosis. For purposes of the TAVR NCD,
the TVT Registry has contracted with the Data Analytic Centers to
conduct the analyses. In addition, data will be made available for
research purposes under the terms of a data use agreement that only
provides de-identified datasets. Form Number: CMS-10443 (OMB control
number: 0938-1202); Frequency: Annual; Affected Public: Individuals,
Households and Private Sector; Number of Respondents: 49,704; Total
Annual Responses: 198,816; Total Annual Hours: 63,790. (For policy
questions regarding this collection contact Nina Arya at 667-290-9456).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-28077 Filed 11-27-24; 8:45 am]
BILLING CODE 4120-01-P
