Agency Information Collection Activities: Submission for OMB Review; Comment Request, 79613-79614 [2024-22345]
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Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
data collections include online and
onsite training session evaluations.
CMS uses information from the data
collection activities to determine the
extent to which the goals of each
training and support session were
achieved and to help CMS make
improvements for future training and
support sessions. The collected data
helps CMS address its Government
Performance and Results Act (GPRA)
requirements, as well as CMS and HHS
goals for support for, and open dialogue
with, stakeholders.
The Affordable Care Act (ACA) was
enacted to assist millions of Americans
in obtaining affordable health care
services and to allow more employers to
offer insurance coverage to their
employees in a cost-effective manner.
Since the implementation of ACA in
2014, individuals and small businesses
have been able to purchase private
health insurance through competitive
marketplaces called the ‘‘Health
Insurance Marketplace’’ (Marketplace).
CMS issued regulations for the
establishment and practices of
Marketplaces in States. The cooperation
and coordination of States, health
insurance issuers, the Federal
Government and other key stakeholders
is essential to the continued success of
the Marketplace.
The Consolidated Appropriations Act
(CAA) of 2021 became law on December
27, 2020. It is a $1.4 trillion omnibus
spending agreement that encompasses
many different provisions. Two (2) acts
within the law apply to the Centers for
Medicare and Medicaid Services (CMS)
Center for Consumer Information and
Insurance Oversight (CCIIO): Title I,
‘‘No Surprises Act’’ and Title II,
‘‘Transparency’’ (NST). Beginning in
2022, new protections through the No
Surprises Act are in place to shield
millions of consumers from surprise
medical bills.
CMS is strongly committed to
providing training, outreach, and
technical assistance to stakeholders
participating in the Marketplace and/or
programs mandated by the ACA or NST.
In addition, CMS recognizes that the
success of Marketplaces and associated
programs relies on the cooperation and
coordination of States, issuers,
Assisters, self-insured health plans,
third-party administrators (TPA) of selfinsured health plans, agents and
brokers, Providers/Facilities, and other
stakeholders. Therefore, CMS expects to
design and conduct various consumer
satisfaction and feedback surveys,
usability tests, and focus groups for
these respondents to complete. Form
Number: CMS–10598 (OMB Control
Number: 0938–1331); Frequency:
VerDate Sep<11>2014
17:51 Sep 27, 2024
Jkt 262001
Annually; Affected Public: Individuals
and Households, Private Sector, State,
Local, and Tribal Governments, Federal
Government, Business or other forprofit, and not-for-profit institutions;
Number of Respondents: 9,588; Number
of Responses: 9,588 Total Annual
Hours: 2,397 hours. (For policy
questions regarding this collection
contact Sonia Henderson at 301–492–
4320.)
2. Type of Information Collection
Request: Extension without change of a
previously approved collection; Title of
Information Collection: Federally
Qualified Health Center Cost Report
Form; Use: The Form CMS–224–14 cost
report is needed to determine a
provider’s reasonable cost incurred in
furnishing medical services to Medicare
beneficiaries and to calculate the FQHC
settlement amount. These providers,
paid under the FQHC prospective
payment system (PPS), may receive
reimbursement outside of the PPS for
Medicare reimbursable bad debts,
pneumococcal, influenza, and COVID–
19 vaccines, and monoclonal antibody
products. CMS uses the Form CMS–
224–14 for rate setting; payment
refinement activities, including
developing a FQHC market basket;
Medicare Trust Fund projections; and to
support program operations.
Additionally, the Medicare Payment
Advisory Commission (MedPAC) uses
the FQHC Medicare cost report data to
calculate Medicare margins; to
formulate recommendations to Congress
regarding the FQHC PPS; and to
conduct additional analysis of the
FQHC PPS. Form Number: CMS–224–14
(OMB control number: 0938–1298);
Frequency: Yearly; Affected Public:
Private Sector, State, Local, or Tribal
Governments, Federal Government,
Business or other for-profits, Not-forProfit Institutions; Number of
Respondents: 2,967; Total Annual
Responses: 2,967; Total Annual Hours:
172,086. (For policy questions regarding
this collection contact LuAnn Piccione
at 410–786–5423.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–22355 Filed 9–27–24; 8:45 am]
BILLING CODE 4120–01–P
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79613
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10516]
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 October 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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79614
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
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. Title of Information Collection:
Program Integrity II; Type of
Information Collection Request:
Extension without change of a currently
approved collection; 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. On June 19, 2013,
the Department of Health and Human
Services (HHS) published proposed rule
CMS–9957–P: Program Integrity:
Exchanges, SHOP, Premium
Stabilization Programs, and Market
Standards (78 FR 37302) (Program
Integrity Proposed Rule) which, among
other things, contained third party
disclosure requirements and data
collections that supported the oversight
of premium stabilization programs,
State Exchanges, and qualified health
plan (QHP) issuers in Federallyfacilitated Exchanges (FFEs). Parts of the
proposed rule were finalized as Patient
Protection and Affordable Care Act;
Program Integrity: Exchange, Premium
Stabilization Programs, and Market
Standards; Amendments to the HHS
Notice of Benefit and Payment
Parameters for 2014; Final Rule
(Program Integrity Final Rule II), 78 FR
25326 (October 24, 2013). This
information collection request relates to
a portion of the information collection
requirements set forth in the final rule.
Form Number: CMS–10516 (OMB
VerDate Sep<11>2014
17:51 Sep 27, 2024
Jkt 262001
control number: 0938–1277); Frequency:
Annually; Affected Public: Private
Sector, State, Local, or Tribal
Governments; Business or other forprofits, and Not-for Profits; Number of
Respondents: 457; Number of
Responses: 457; Total Annual Hours:
42,771. (For questions regarding this
collection, contact Andrea Honig at
(301) 492–4147.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–22345 Filed 9–27–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–0598]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Studies
To Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
Genotoxicity Testing (Revision 2);
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
revised guidance for industry (GFI) #116
(VICH GL23) entitled ‘‘Studies to
Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
Genotoxicity Testing (Revision 2).’’ This
draft guidance has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This draft guidance
recommends a Standard Battery of Tests
that can be used for the evaluation of
the genotoxicity of veterinary drug
residues in food.
DATES: Submit either electronic or
written comments on the draft guidance
by November 29, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2000–D–0598 for ‘‘Studies to Evaluate
the Safety of Residues of Veterinary
Drugs in Human Food: Genotoxicity
Testing (Revision 2).’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
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]]>Agencies
[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79613-79614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22345]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10516]
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 October 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 79614]]
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. Title of Information Collection: Program Integrity II; Type of
Information Collection Request: Extension without change of a currently
approved collection; 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. On June 19, 2013, the Department of
Health and Human Services (HHS) published proposed rule CMS-9957-P:
Program Integrity: Exchanges, SHOP, Premium Stabilization Programs, and
Market Standards (78 FR 37302) (Program Integrity Proposed Rule) which,
among other things, contained third party disclosure requirements and
data collections that supported the oversight of premium stabilization
programs, State Exchanges, and qualified health plan (QHP) issuers in
Federally-facilitated Exchanges (FFEs). Parts of the proposed rule were
finalized as Patient Protection and Affordable Care Act; Program
Integrity: Exchange, Premium Stabilization Programs, and Market
Standards; Amendments to the HHS Notice of Benefit and Payment
Parameters for 2014; Final Rule (Program Integrity Final Rule II), 78
FR 25326 (October 24, 2013). This information collection request
relates to a portion of the information collection requirements set
forth in the final rule. Form Number: CMS-10516 (OMB control number:
0938-1277); Frequency: Annually; Affected Public: Private Sector,
State, Local, or Tribal Governments; Business or other for-profits, and
Not-for Profits; Number of Respondents: 457; Number of Responses: 457;
Total Annual Hours: 42,771. (For questions regarding this collection,
contact Andrea Honig at (301) 492-4147.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-22345 Filed 9-27-24; 8:45 am]
BILLING CODE 4120-01-P
