Agency Information Collection Activities: Proposed Collection; Comment Request, 67944-67945 [2024-18866]
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ddrumheller on DSK120RN23PROD with NOTICES1
67944
Federal Register / Vol. 89, No. 163 / Thursday, August 22, 2024 / Notices
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.
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 of Information Collection: Patient
Access through Application
Programming Interfaces (API); Use: This
final rule is the first phase of policies
centrally focused on advancing
interoperability and patient access to
health information using the authority
available to the Centers for Medicare &
Medicaid Services (CMS). We believe
this is an important step in advancing
interoperability, putting patients at the
center of their health care, and ensuring
they have electronic access to their
health information. We are committed
to working with stakeholders to solve
the issue of interoperability and getting
patients access to information about
their health care, and we are taking an
active approach to move participants in
the health care market toward
interoperability and the secure and
timely exchange of electronic health
information by adopting policies for the
Medicare and Medicaid programs, the
Children’s Health Insurance Program
VerDate Sep<11>2014
17:28 Aug 21, 2024
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(CHIP), and qualified health plan (QHP)
issuers on the individual market
Federally-facilitated Exchanges (FFEs).
For purposes of this rule, references to
QHP issuers on the FFEs excludes
issuers offering only stand-alone dental
plans (SADPs). Likewise, we are also
excluding QHP issuers only offering
QHPs in the Federally-facilitated Small
Business Health Options Program
Exchanges (FF–SHOPs) from the
provisions of this rule. This rule
requires these impacted payers to
maintain and use standards-based APIs
to make certain information available to
enrollees. CMS regulations at 42 CFR
417.414, 417.416, 422.112(a)(1)(i), and
422.114(a)(3)(ii) require that all
Medicare Advantage organizations
(MAOs) offering coordinated care plans,
network-based private fee-for-service
(PFFS) plans, and as well as section
1876 cost organizations, maintain a
network of appropriate providers that is
sufficient to provide adequate access to
covered services to meet the needs of
the population served. To enforce this
requirement, CMS regulations at
§ 422.116 outline network adequacy
criteria which set forth the minimum
number of providers and maximum
travel time and distance from enrollees
to providers, for required provider
specialty types in each county in the
United States and its territories.
Organizations must be in compliance
with the current CMS network adequacy
criteria guidance, which is updated and
published annually on CMS’s website.
This collection of information is
essential to appropriate and timely
compliance monitoring by CMS, in
order to ensure that all active contracts
offering network-based plans maintain
an adequate network. Form Number:
CMS–10767 (OMB control number:
0938–1412); Frequency: Occasionally;
Affected Public: Private sector; Number
of Respondents: 345; Number of
Responses: 345; Total Annual Hours:
589,950. (For policy questions regarding
this collection contact Lorraine Doo at
410–786–6597.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–18868 Filed 8–21–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10653]
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
October 21, 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.
SUMMARY:
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 89, No. 163 / Thursday, August 22, 2024 / Notices
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:
ddrumheller on DSK120RN23PROD with NOTICES1
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–10653 Coverage of Certain
Preventive Services Under the
Affordable Care Act
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 Collections
1. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Coverage of
Certain Preventive Services Under the
Affordable Care Act; Use: Section 2713
of the PHS Act requires nongrandfathered group health plans and
health insurance issuers offering nongrandfathered group or individual
health insurance coverage to provide
benefits for certain preventive services
without cost sharing, including benefits
for certain women’s preventive health
services as provided for in
comprehensive guidelines supported by
the Health Resources and Services
Administration (HRSA). The 2018 final
regulations titled ‘‘Religious Exemptions
VerDate Sep<11>2014
17:28 Aug 21, 2024
Jkt 262001
and Accommodations for Coverage of
Certain Preventive Services Under the
Affordable Care Act’’ (83 FR 57536) and
‘‘Moral Exemptions and
Accommodations for Coverage of
Certain Preventive Services Under the
Affordable Care Act’’ (83 FR 57592)
finalized interim final rules that
expanded exemptions for religious
beliefs and established an exemption for
moral convictions for certain entities or
individuals whose health plans may
otherwise be subject to the mandate of
contraceptive coverage. The final
regulations extended the exemption to
health insurance issuers that hold
religious or moral objections in certain
circumstances, as well as to additional
categories of group health plan
sponsors.
The 2018 final regulations also left in
place, from previous rulemaking, an
accommodation process for objecting
entities who wish to use it to avoid
contracting, arranging, paying, or
referring for contraceptive coverage, but
made use of the accommodation
optional for such entities. An
organization seeking to be treated as an
eligible organization may self-certify (by
using EBSA Form 700), prior to the
beginning of the first plan year to which
an accommodation is to apply, that it
meets the definition of an eligible
organization. The eligible organization
must provide a copy of its selfcertification to each health insurance
issuer that would otherwise provide
such coverage in connection with the
health plan (for insured group health
plans or student health insurance
coverage). The issuer that receives the
self-certification must provide separate
payments for contraceptive services for
plan participants and beneficiaries (or
students and dependents). For a selfinsured group health plan, the selfcertification must be provided to its
third party administrator, which must
provide or arrange separate payments
for contraceptive services. An eligible
organization may submit a notification
to the Department of Health and Human
Services (HHS) as an alternative to
submitting EBSA Form 700 to the
eligible organization’s health insurance
issuer or third party administrator. A
health insurance issuer or third party
administrator providing or arranging
payments for contraceptive services for
participants and beneficiaries in plans
(or student enrollees and covered
dependents in student health insurance
coverage) of eligible organizations must
provide a written notice to such plan
participants and beneficiaries (or such
student enrollees and covered
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67945
dependents) informing them of the
availability of such payments.
Under the 2018 final regulations,
eligible organizations can revoke the
accommodation process if participants
and beneficiaries (or student enrollees
and covered dependents) receive
written notice of such revocation from
the issuer or third party administrator,
and such revocation will be effective on
the first day of the first plan year that
begins on or after thirty days after the
date of revocation. The Centers for
Medicare & Medicaid Services is
requesting an extension of OMB
approval for the data collections
included in this information collection
request. HHS will only implement the
information collections to the extent
they are consistent with regulations that
are in effect. Form Number: CMS–10653
(OMB control number: 0938–1344);
Frequency: Occasionally; Affected
Public: Private Sector; Number of
Respondents: 60; Total Annual
Responses: 595,312; Total Annual
Hours: 72. (For policy questions
regarding this collection contact Russell
Tipps at 301–869–3502).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–18866 Filed 8–21–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–2338]
Predetermined Change Control Plans
for Medical Devices; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Predetermined
Change Control Plans for Medical
Devices.’’ A predetermined change
control plan (PCCP) is the
documentation describing what
modifications will be made to a device
and how the modifications will be
assessed. This draft guidance provides
FDA’s current thinking on a policy for
PCCPs and recommendations on the
information to include in a PCCP in a
marketing submission for a device. This
draft guidance is not final nor is it for
implementation at this time.
SUMMARY:
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Agencies
[Federal Register Volume 89, Number 163 (Thursday, August 22, 2024)]
[Notices]
[Pages 67944-67945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18866]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10653]
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 October 21, 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.
[[Page 67945]]
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-10653 Coverage of Certain Preventive Services Under the Affordable
Care Act
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 Collections
1. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Coverage of Certain Preventive Services Under the Affordable Care Act;
Use: Section 2713 of the PHS Act requires non-grandfathered group
health plans and health insurance issuers offering non-grandfathered
group or individual health insurance coverage to provide benefits for
certain preventive services without cost sharing, including benefits
for certain women's preventive health services as provided for in
comprehensive guidelines supported by the Health Resources and Services
Administration (HRSA). The 2018 final regulations titled ``Religious
Exemptions and Accommodations for Coverage of Certain Preventive
Services Under the Affordable Care Act'' (83 FR 57536) and ``Moral
Exemptions and Accommodations for Coverage of Certain Preventive
Services Under the Affordable Care Act'' (83 FR 57592) finalized
interim final rules that expanded exemptions for religious beliefs and
established an exemption for moral convictions for certain entities or
individuals whose health plans may otherwise be subject to the mandate
of contraceptive coverage. The final regulations extended the exemption
to health insurance issuers that hold religious or moral objections in
certain circumstances, as well as to additional categories of group
health plan sponsors.
The 2018 final regulations also left in place, from previous
rulemaking, an accommodation process for objecting entities who wish to
use it to avoid contracting, arranging, paying, or referring for
contraceptive coverage, but made use of the accommodation optional for
such entities. An organization seeking to be treated as an eligible
organization may self-certify (by using EBSA Form 700), prior to the
beginning of the first plan year to which an accommodation is to apply,
that it meets the definition of an eligible organization. The eligible
organization must provide a copy of its self-certification to each
health insurance issuer that would otherwise provide such coverage in
connection with the health plan (for insured group health plans or
student health insurance coverage). The issuer that receives the self-
certification must provide separate payments for contraceptive services
for plan participants and beneficiaries (or students and dependents).
For a self-insured group health plan, the self-certification must be
provided to its third party administrator, which must provide or
arrange separate payments for contraceptive services. An eligible
organization may submit a notification to the Department of Health and
Human Services (HHS) as an alternative to submitting EBSA Form 700 to
the eligible organization's health insurance issuer or third party
administrator. A health insurance issuer or third party administrator
providing or arranging payments for contraceptive services for
participants and beneficiaries in plans (or student enrollees and
covered dependents in student health insurance coverage) of eligible
organizations must provide a written notice to such plan participants
and beneficiaries (or such student enrollees and covered dependents)
informing them of the availability of such payments.
Under the 2018 final regulations, eligible organizations can revoke
the accommodation process if participants and beneficiaries (or student
enrollees and covered dependents) receive written notice of such
revocation from the issuer or third party administrator, and such
revocation will be effective on the first day of the first plan year
that begins on or after thirty days after the date of revocation. The
Centers for Medicare & Medicaid Services is requesting an extension of
OMB approval for the data collections included in this information
collection request. HHS will only implement the information collections
to the extent they are consistent with regulations that are in effect.
Form Number: CMS-10653 (OMB control number: 0938-1344); Frequency:
Occasionally; Affected Public: Private Sector; Number of Respondents:
60; Total Annual Responses: 595,312; Total Annual Hours: 72. (For
policy questions regarding this collection contact Russell Tipps at
301-869-3502).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-18866 Filed 8-21-24; 8:45 am]
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