Agency Information Collection Activities: Proposed Collection; Comment Request, 21523-21524 [2024-06645]
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Federal Register / Vol. 89, No. 61 / Thursday, March 28, 2024 / Notices
21523
STUDY ELIGIBILITY CRITERIA BASED ON POPULATION, INTERVENTION, COMPARATOR, OUTCOME (PICO), AND OTHER
ELEMENTS—Continued
Element
Inclusion criteria
Timing ..................................
• Minimum duration of intervention: 2 weeks.
• In cross-over studies, any change in outcome measure must exclude data from the first week after end
of any prior treatments. This may be accomplished
by a washout period of at least 1 week.
• General population.
• English language.
• Published in peer-reviewed journals.
Setting ..................................
Publication ............................
Dated: March 18, 2024.
Marquita Cullom,
Associate Director.
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–38 and
CMS–10400]
Agency Information Collection
Activities: Proposed Collection;
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
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
May 28, 2024.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
20:27 Mar 27, 2024
None.
• Hospital or other acute care settings.
• Non-English language text.
• Conference abstracts and other non-peer-reviewed
data.
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:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
[FR Doc. 2024–06595 Filed 3–27–24; 8:45 am]
VerDate Sep<11>2014
Exclusion criteria
Jkt 262001
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–R–38 Conditions for
Certification for Rural Health Clinics
and Conditions for Coverage for
Federally Qualified Health Centers in
42 CFR 491
CMS–10400 Establishment of
Qualified Health Plans and American
Health Benefit Exchanges
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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
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: Reinstatement of a previously
approved collection; Title of
Information Collection: Conditions for
Certification for Rural Health Clinics
and Conditions for Coverage for
Federally Qualified Health Centers in 42
CFR 491; Use: The Conditions for
Medicare Certification (CfCs) for Rural
Health Clinics (RHCs) are based on
criteria prescribed in law and designed
to ensure that each RHC has properly
trained staff to provide appropriate care
and to assure a safe physical
environment for patients. The
information collection requirements
described herein are needed to
implement the Medicare and Medicaid
CfCs for a total of 5,349 RHCs. These
requirements are similar in intent to
standards developed by industry
organizations such as the Joint
Commission on Accreditation of
Hospitals, and the National League of
Nursing/American Public Association,
and merely reflect accepted standards of
management and care to which rural
health clinics must adhere.
E:\FR\FM\28MRN1.SGM
28MRN1
ddrumheller on DSK120RN23PROD with NOTICES1
21524
Federal Register / Vol. 89, No. 61 / Thursday, March 28, 2024 / Notices
Federally Qualified Health Centers
(FQHCs) are also subject to Conditions
for Certification to participate in the
Medicare and Medicaid programs.
These health and safety standards are
the foundation for improving quality
and protecting the health and safety of
Medicare and Medicaid beneficiaries.
The information collection requirements
described herein affect approximately
11,252 FQHCs. The current information
collection requirements at 42 CFR
491.9(b) and 491.11 are applicable to
both RHCs and FQHCs. Form Number:
CMS–R–38 (OMB control number:
0938–0334); Frequency: Recordkeeping
and Reporting—Annually; Affected
Public: Business or other for-profits;
Number of Respondents: 17,663; Total
Annual Responses: 17,663; Total
Annual Hours: 104,245. (For policy
questions regarding this collection
contact Claudia Molinar at 410–786–
8445.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Establishment of
Qualified Health Plans and American
Health Benefit Exchanges; Use: On
March 23, 2010, the Patient Protection
and Affordable Care Act (PPACA; Pub.
L. 111–148) was signed into law, and on
March 30, 2010, the Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–152) was signed into law.
The two laws implement various health
insurance policies. Section 1303 of the
PPACA, as implemented in 45 CFR
156.280, specifies standards for issuers
of qualified health plans (QHPs) through
the Exchanges that cover abortion
services for which public funding is
prohibited (also referred to as non-Hyde
abortion services or non-excepted
abortion services). In the Patient
Protection and Affordable Care Act;
Establishment of Exchanges and
Qualified Health Plans; Exchange
Standards for Employers (2012
Exchange Establishment Rule) (77 FR
18310), we codified the statutory
provisions of section 1303 of the PPACA
in regulation at 45 CFR 156.280. Under
45 CFR 156.280(e)(5)(ii), each QHP
issuer that offers coverage of abortion
services for which public funding is
prohibited must submit to the State
Insurance Commissioner a segregation
plan describing how the QHP issuer
establishes and maintains separate
allocation accounts for any QHP
covering abortion services for which
public funding is prohibited, and
pursuant to § 156.280(e)(5)(iii), each
QHP issuer must annually attest to
compliance with PPACA section 1303
and applicable regulations. This
VerDate Sep<11>2014
20:27 Mar 27, 2024
Jkt 262001
segregation plan is used to verify that
the QHP issuer’s financial and other
systems fully conform to the segregation
requirements required by the PPACA.
The Centers for Medicare and
Medicaid Services (CMS) is renewing
this information collection request (ICR)
in connection with the segregation plan
requirement under 45 CFR
156.280(e)(5)(ii). The burden estimates
for this collection of information
renewal reflect the time and effort for
QHP issuers to submit a segregation
plan that demonstrates how the QHP
issuer segregates QHP funds in
accordance with applicable provisions
of generally accepted accounting
requirements, circulars on funds
management of the Office of
Management and Budget (OMB) and
guidance on accounting of the
Government Accountability Office. CMS
is also renewing the ICR in connection
with the annual attestation requirement
under 45 CFR 156.280(e)(5)(iii). The
burden estimate for this ICR reflects the
time and effort associated with QHP
issuers submitting an annual attestation
to the State Insurance Commissioner
attesting to compliance with section
1303 of the PPACA. Form Number:
CMS–10400 (OMB control number:
0938–1156); Frequency: Annually);
Affected Public: Private Sector (business
or other for-profits, not-for-profits
institutions); Number of Respondents:
1,617; Number of Responses: 1,617;
Total Annual Hours: 5,508.75. (For
questions regarding this collection,
contact Agata Pelka at 667–290–9979).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–06645 Filed 3–27–24; 8:45 am]
BILLING CODE 4120–01–P
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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by April 29, 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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10593]
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
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28MRN1.SGM
28MRN1
Agencies
[Federal Register Volume 89, Number 61 (Thursday, March 28, 2024)]
[Notices]
[Pages 21523-21524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06645]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-38 and CMS-10400]
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 May 28, 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-R-38 Conditions for Certification for Rural Health Clinics and
Conditions for Coverage for Federally Qualified Health Centers in 42
CFR 491
CMS-10400 Establishment of Qualified Health Plans and American Health
Benefit Exchanges
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
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: Reinstatement of a
previously approved collection; Title of Information Collection:
Conditions for Certification for Rural Health Clinics and Conditions
for Coverage for Federally Qualified Health Centers in 42 CFR 491; Use:
The Conditions for Medicare Certification (CfCs) for Rural Health
Clinics (RHCs) are based on criteria prescribed in law and designed to
ensure that each RHC has properly trained staff to provide appropriate
care and to assure a safe physical environment for patients. The
information collection requirements described herein are needed to
implement the Medicare and Medicaid CfCs for a total of 5,349 RHCs.
These requirements are similar in intent to standards developed by
industry organizations such as the Joint Commission on Accreditation of
Hospitals, and the National League of Nursing/American Public
Association, and merely reflect accepted standards of management and
care to which rural health clinics must adhere.
[[Page 21524]]
Federally Qualified Health Centers (FQHCs) are also subject to
Conditions for Certification to participate in the Medicare and
Medicaid programs. These health and safety standards are the foundation
for improving quality and protecting the health and safety of Medicare
and Medicaid beneficiaries. The information collection requirements
described herein affect approximately 11,252 FQHCs. The current
information collection requirements at 42 CFR 491.9(b) and 491.11 are
applicable to both RHCs and FQHCs. Form Number: CMS-R-38 (OMB control
number: 0938-0334); Frequency: Recordkeeping and Reporting--Annually;
Affected Public: Business or other for-profits; Number of Respondents:
17,663; Total Annual Responses: 17,663; Total Annual Hours: 104,245.
(For policy questions regarding this collection contact Claudia Molinar
at 410-786-8445.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Establishment of
Qualified Health Plans and American Health Benefit Exchanges; Use: On
March 23, 2010, the Patient Protection and Affordable Care Act (PPACA;
Pub. L. 111-148) was signed into law, and on March 30, 2010, the Health
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) was
signed into law. The two laws implement various health insurance
policies. Section 1303 of the PPACA, as implemented in 45 CFR 156.280,
specifies standards for issuers of qualified health plans (QHPs)
through the Exchanges that cover abortion services for which public
funding is prohibited (also referred to as non-Hyde abortion services
or non-excepted abortion services). In the Patient Protection and
Affordable Care Act; Establishment of Exchanges and Qualified Health
Plans; Exchange Standards for Employers (2012 Exchange Establishment
Rule) (77 FR 18310), we codified the statutory provisions of section
1303 of the PPACA in regulation at 45 CFR 156.280. Under 45 CFR
156.280(e)(5)(ii), each QHP issuer that offers coverage of abortion
services for which public funding is prohibited must submit to the
State Insurance Commissioner a segregation plan describing how the QHP
issuer establishes and maintains separate allocation accounts for any
QHP covering abortion services for which public funding is prohibited,
and pursuant to Sec. 156.280(e)(5)(iii), each QHP issuer must annually
attest to compliance with PPACA section 1303 and applicable
regulations. This segregation plan is used to verify that the QHP
issuer's financial and other systems fully conform to the segregation
requirements required by the PPACA.
The Centers for Medicare and Medicaid Services (CMS) is renewing
this information collection request (ICR) in connection with the
segregation plan requirement under 45 CFR 156.280(e)(5)(ii). The burden
estimates for this collection of information renewal reflect the time
and effort for QHP issuers to submit a segregation plan that
demonstrates how the QHP issuer segregates QHP funds in accordance with
applicable provisions of generally accepted accounting requirements,
circulars on funds management of the Office of Management and Budget
(OMB) and guidance on accounting of the Government Accountability
Office. CMS is also renewing the ICR in connection with the annual
attestation requirement under 45 CFR 156.280(e)(5)(iii). The burden
estimate for this ICR reflects the time and effort associated with QHP
issuers submitting an annual attestation to the State Insurance
Commissioner attesting to compliance with section 1303 of the PPACA.
Form Number: CMS-10400 (OMB control number: 0938-1156); Frequency:
Annually); Affected Public: Private Sector (business or other for-
profits, not-for-profits institutions); Number of Respondents: 1,617;
Number of Responses: 1,617; Total Annual Hours: 5,508.75. (For
questions regarding this collection, contact Agata Pelka at 667-290-
9979).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-06645 Filed 3-27-24; 8:45 am]
BILLING CODE 4120-01-P