Agency Information Collection Activities: Submission for OMB Review; Comment Request, 31754-31755 [2024-08828]
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31754
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
announcements of entrants, finalists,
and winners of the contest. Information
is not collected for commercial
marketing. Winners are permitted to cite
that they won this contest.
General Conditions
CDC reserves the right to cancel,
suspend, and/or modify the Challenge,
or any part of it, for any reason, at CDC’s
sole discretion.
Participation in this Challenge
constitutes an applicants’ full and
unconditional agreement to abide by the
Challenge’s Official Rules found at
https://www.Challenge.gov.
Authority: 15 U.S.C. 3719.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2024–08899 Filed 4–24–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
lotter on DSK11XQN23PROD with NOTICES1
18:54 Apr 24, 2024
Jkt 262001
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
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 without change of a
currently approved collection; Title of
Information Collection: State Collection
and Reporting of Dental Provider and
Benefit Package Information on the
Insure Kids Now! Website and Hotline;
Use: On the Insure Kids Now (IKN)
website, the Secretary is required to post
a current and accurate list of dentists
and providers that provide dental
services to children enrolled in the state
plan (or waiver) under Medicaid or the
state child health plan (or waiver) under
SUPPLEMENTARY INFORMATION:
[Document Identifiers: CMS–10291, CMS–
10529, CMS–10722, CMS–R–148, and CMS–
10725]
VerDate Sep<11>2014
Comments on the collection(s) of
information must be received by the
OMB desk officer by May 28, 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:
Centers for Medicare & Medicaid
Services
SUMMARY:
minimize the information collection
burden.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
CHIP. States collect the information
pertaining to their Medicaid and CHIP
dental benefits. Form Number: CMS–
10291 (OMB control number: 0938–
1065); Frequency: Yearly and quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 255; Total
Annual Hours: 11,781. (For policy
questions regarding this collection
contact Andrew Snyder at 410–786–
1274.)
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Quarterly
Medicaid and CHIP Budget and
Expenditure Reporting for the Medical
Assistance Program, Administration and
CHIP; Use: The Medicaid and CHIP
Financial System is a financial reporting
system that produces budget estimate
statements for Forms CMS–37 and
CMS–21B. The Medicaid and CHIP
Budget and Expenditure System is a
financial reporting system that produces
expenditure statements for Forms CMS–
64 and CMS–21. All forms are to be
filed on a quarterly basis and need to be
certified by the states. Form Number:
CMS–10529 (OMB control number:
0938–1265); Frequency: Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 672; Total
Annual Hours: 18,144. (For policy
questions regarding this collection
contact Robert Lane at 410–786–2015.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Annual State
Report on CMS Value Based Purchasing
Arrangements (VBP) Supplemental
Rebate Agreements; Use: The reported
data is being collected to safeguard
against unnecessary utilization of such
care and services and to assure that state
payments to providers of Medicaid
services are consistent with efficiency,
economy, and quality of care. CMS will
collect this data to ensure that VBP
programs adopted by states continue to
meet these standards. Form Number:
CMS–10722 (OMB control number:
0938–1385); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 51; Total
Annual Hours: 306. (For policy
questions regarding this collection
contact Abraham Weinschneider at 410–
786–5688.)
4. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Limitations on
Provider Related Donations and Health
Care Related Taxes, Medicaid and
E:\FR\FM\25APN1.SGM
25APN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
Supporting Regulations in 42 CFR
433.68 through 433.74; Use: States may
elect to submit a waiver to CMS for the
broad based and/or uniformity
requirements for any health care related
tax program which does not conform to
the broad based and uniformity
requirements. It is also the
responsibility of each State to
demonstrate that their tax program(s) do
not violate the hold harmless provision.
For a waiver to be approved and a
determination that the hold harmless
provision is not violated, States must
submit written documentation which
satisfies the regulatory requirements.
Without this information, the amount of
FFP (Federal financial participation)
payable to a State cannot be correctly
determined. Form Number: CMS–R–148
(OMB control number: 0938–0618);
Frequency: Quarterly and occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
50; Total Annual Responses: 40; Total
Annual Hours: 3,200. (For policy
questions regarding this collection
contact Stuart Goldstein at 410–786–
0694.)
5. Title of Information Collection:
Pharmacy Benefit Manager
Transparency for Qualified Health
Plans; Type of Information Collection
Request: Revision of a currently
approved collection; Use:
Implementation of section 1150A of the
Social Security Act, as added by section
6005 of the Patient Protection and
Affordable Care Act (ACA), requires,
among other entities, Qualified Health
Plans (QHPs) and pharmacy benefit
managers (PBMs) that serve QHP issuers
to report information on prescription
drug benefits to the U.S. Department of
Health and Human Services (HHS).
PBMs are third-party administrators of
prescription programs for a variety of
types of health plans, including QHPs.
CMS finalized regulations for this
reporting at 45 CFR 156.295 and 184.50.
Under these requirements a QHP
issuer is required to report issuer and
plan level prescription drug data to
CMS only when the QHP issuer does
not contract with a PBM to administer
the prescription drug benefit for their
QHPs. Section 1150A(a)(1) of the Social
Security Act authorizes CMS to collect
the same prescription drug and rebate
information from Prescription Drug Plan
sponsors of a prescription drug plan and
Medicare Advantage organizations
offering a Medicare Advantage
Prescription Drug Plan under part D of
title XVIII. Since 2012, CMS has
collected these data from Part D
sponsors as part of the Medicare Part D
Direct and Indirect Remuneration (DIR)
reporting requirement, and detailed
VerDate Sep<11>2014
18:54 Apr 24, 2024
Jkt 262001
drug information for each National Drug
Code (NDC) from the Prescription Drug
Event (PDE) data that plans are required
to submit.
CMS is formally requesting an
extension of this ICR in connection with
submission from QHP issuers that do
not contract with a PBM and PBMs
(hereinafter referred to as ‘‘submitters’’).
The information required from
submitters and the process of
submission has changed since the
previous OMB approval. The submitters
are now required to complete a web
form that reports the allocation
methodology that is selected by the
submitters to allocate data, where
necessary. Submitters are required to
maintain internal documentation of the
allocation methodologies chosen, as
CMS may need to follow up with the
submitters to better understand the
methodology. The associated burden
estimates for this collection reflect the
time and effort for submitters to provide
prescription drug benefit information to
CMS using the Health Information
Oversight System (HIOS) module. Form
Number: CMS–10725 (OMB control
number: 0938–1394); Frequency:
Annually; Affected Public: Private
Sector, Business or other For-Profits;
Number of Respondents: 278; Number
of Responses: 278; Total Annual Hours:
1,285. (For questions regarding this
collection, contact LeAnn Brodhead at
(301) 492–4493.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–08828 Filed 4–24–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3449–N]
Announcement of the Re-Approval of
AABB (Association for the
Advancement of Blood and
Biotherapies) as an Accreditation
Organization Under the Clinical
Laboratory Improvement Amendments
of 1988
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice announces the
application of the Association for the
Advancement of Blood and Biotherapies
(AABB) for re-approval as an
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
31755
accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program. This deeming
authority is granted to AABB for the
Blood Bank and Transfusion Service
(BB/TS) program, the
Immunohematology Reference
Laboratory (IRL) program, the Molecular
Testing (MT) program, and the Cellular
Therapy (CT) program. We have
determined that AABB meets or exceeds
the applicable CLIA requirements. We
are announcing the re-approval and
grant AABB deeming authority for a
period of 6 years.
DATES: The approval is effective from
April 25, 2024 to April 25, 2030.
FOR FURTHER INFORMATION CONTACT:
Daralyn Hassan, 410–786–9360.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Pub. L. 100–578). CLIA
amended section 353 of the Public
Health Service Act. We issued a final
rule implementing the accreditation
provisions of CLIA on July 31, 1992 (57
FR 33992). Under those provisions, we
may grant deeming authority to an
accreditation organization if its
requirements for laboratories accredited
under its program are equal to or more
stringent than the applicable CLIA
program requirements in 42 CFR part
493 (Laboratory Requirements). Subpart
E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program) specifies the
requirements an accreditation
organization must meet to be approved
by CMS as an accreditation organization
under CLIA.
II. Notice of Re-Approval of AABB as
an Accreditation Organization
In this notice, we approve the
Association for the Advancement of
Blood and Biotherapies (AABB) as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements for the following specialty
and subspecialty areas under CLIA:
• Microbiology, including
Bacteriology, Mycology, Parasitology,
and Virology.
• Diagnostic Immunology, including
Syphilis Serology and General
Immunology.
• Chemistry, including Routine
Chemistry.
• Hematology.
E:\FR\FM\25APN1.SGM
25APN1
Agencies
[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Notices]
[Pages 31754-31755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08828]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10291, CMS-10529, CMS-10722, CMS-R-148, and
CMS-10725]
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 May 28, 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
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 without change
of a currently approved collection; Title of Information Collection:
State Collection and Reporting of Dental Provider and Benefit Package
Information on the Insure Kids Now! Website and Hotline; Use: On the
Insure Kids Now (IKN) website, the Secretary is required to post a
current and accurate list of dentists and providers that provide dental
services to children enrolled in the state plan (or waiver) under
Medicaid or the state child health plan (or waiver) under CHIP. States
collect the information pertaining to their Medicaid and CHIP dental
benefits. Form Number: CMS-10291 (OMB control number: 0938-1065);
Frequency: Yearly and quarterly; Affected Public: State, Local, or
Tribal Governments; Number of Respondents: 51; Total Annual Responses:
255; Total Annual Hours: 11,781. (For policy questions regarding this
collection contact Andrew Snyder at 410-786-1274.)
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Quarterly Medicaid and CHIP Budget and Expenditure Reporting for the
Medical Assistance Program, Administration and CHIP; Use: The Medicaid
and CHIP Financial System is a financial reporting system that produces
budget estimate statements for Forms CMS-37 and CMS-21B. The Medicaid
and CHIP Budget and Expenditure System is a financial reporting system
that produces expenditure statements for Forms CMS-64 and CMS-21. All
forms are to be filed on a quarterly basis and need to be certified by
the states. Form Number: CMS-10529 (OMB control number: 0938-1265);
Frequency: Quarterly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 56; Total Annual Responses: 672;
Total Annual Hours: 18,144. (For policy questions regarding this
collection contact Robert Lane at 410-786-2015.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Annual State
Report on CMS Value Based Purchasing Arrangements (VBP) Supplemental
Rebate Agreements; Use: The reported data is being collected to
safeguard against unnecessary utilization of such care and services and
to assure that state payments to providers of Medicaid services are
consistent with efficiency, economy, and quality of care. CMS will
collect this data to ensure that VBP programs adopted by states
continue to meet these standards. Form Number: CMS-10722 (OMB control
number: 0938-1385); Frequency: Yearly; Affected Public: State, Local,
or Tribal Governments; Number of Respondents: 51; Total Annual
Responses: 51; Total Annual Hours: 306. (For policy questions regarding
this collection contact Abraham Weinschneider at 410-786-5688.)
4. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Limitations on Provider Related Donations and Health Care Related
Taxes, Medicaid and
[[Page 31755]]
Supporting Regulations in 42 CFR 433.68 through 433.74; Use: States may
elect to submit a waiver to CMS for the broad based and/or uniformity
requirements for any health care related tax program which does not
conform to the broad based and uniformity requirements. It is also the
responsibility of each State to demonstrate that their tax program(s)
do not violate the hold harmless provision. For a waiver to be approved
and a determination that the hold harmless provision is not violated,
States must submit written documentation which satisfies the regulatory
requirements. Without this information, the amount of FFP (Federal
financial participation) payable to a State cannot be correctly
determined. Form Number: CMS-R-148 (OMB control number: 0938-0618);
Frequency: Quarterly and occasionally; Affected Public: State, Local,
or Tribal Governments; Number of Respondents: 50; Total Annual
Responses: 40; Total Annual Hours: 3,200. (For policy questions
regarding this collection contact Stuart Goldstein at 410-786-0694.)
5. Title of Information Collection: Pharmacy Benefit Manager
Transparency for Qualified Health Plans; Type of Information Collection
Request: Revision of a currently approved collection; Use:
Implementation of section 1150A of the Social Security Act, as added by
section 6005 of the Patient Protection and Affordable Care Act (ACA),
requires, among other entities, Qualified Health Plans (QHPs) and
pharmacy benefit managers (PBMs) that serve QHP issuers to report
information on prescription drug benefits to the U.S. Department of
Health and Human Services (HHS). PBMs are third-party administrators of
prescription programs for a variety of types of health plans, including
QHPs. CMS finalized regulations for this reporting at 45 CFR 156.295
and 184.50.
Under these requirements a QHP issuer is required to report issuer
and plan level prescription drug data to CMS only when the QHP issuer
does not contract with a PBM to administer the prescription drug
benefit for their QHPs. Section 1150A(a)(1) of the Social Security Act
authorizes CMS to collect the same prescription drug and rebate
information from Prescription Drug Plan sponsors of a prescription drug
plan and Medicare Advantage organizations offering a Medicare Advantage
Prescription Drug Plan under part D of title XVIII. Since 2012, CMS has
collected these data from Part D sponsors as part of the Medicare Part
D Direct and Indirect Remuneration (DIR) reporting requirement, and
detailed drug information for each National Drug Code (NDC) from the
Prescription Drug Event (PDE) data that plans are required to submit.
CMS is formally requesting an extension of this ICR in connection
with submission from QHP issuers that do not contract with a PBM and
PBMs (hereinafter referred to as ``submitters''). The information
required from submitters and the process of submission has changed
since the previous OMB approval. The submitters are now required to
complete a web form that reports the allocation methodology that is
selected by the submitters to allocate data, where necessary.
Submitters are required to maintain internal documentation of the
allocation methodologies chosen, as CMS may need to follow up with the
submitters to better understand the methodology. The associated burden
estimates for this collection reflect the time and effort for
submitters to provide prescription drug benefit information to CMS
using the Health Information Oversight System (HIOS) module. Form
Number: CMS-10725 (OMB control number: 0938-1394); Frequency: Annually;
Affected Public: Private Sector, Business or other For-Profits; Number
of Respondents: 278; Number of Responses: 278; Total Annual Hours:
1,285. (For questions regarding this collection, contact LeAnn Brodhead
at (301) 492-4493.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-08828 Filed 4-24-24; 8:45 am]
BILLING CODE 4120-01-P