Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington; Exemption Period Extension, 67301 [2023-21460]
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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
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:
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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–1561/1561A Health Insurance
Benefit Agreement
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.
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Information Collection
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Notice; exemption period
extension.
ACTION:
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Health
Insurance Benefit Agreement; Use: The
CMS–1561 form applies to specific
types of health care providers and
opioid treatment programs and the
CMS–1561A form applies to rural health
clinics (RHCs). The CMS–1561 and
CMS–1561A forms are health insurance
benefits agreements that are essential for
the Centers for Medicare and Medicaid
Services (CMS) to ensure that applicants
to the Medicare program have made a
binding commitment to comply with all
applicable Federal requirements. The
CMS–1561/1561A forms are essential in
that they allow CMS to ensure that
applicants are in compliance with the
requirements. Applicants will be
required to sign the completed form and
provide operational information to CMS
to assure that they continue to meet the
requirements after approval. The
collection is made only once, when the
provider or RHC submits their
application for participation in
Medicare by signing the completed
CMS–1561 or CMS–1561A form (as
applicable). Form Number: CMS–1561/
1561A (OMB control number: 0938–
0832); Frequency: Once only; Affected
Public: Private sector—(Business or
other for-profits and Not-for-profit
institutions); Number of Respondents:
2,050; Total Annual Responses: 2,050;
Total Annual Hours: 2,050. (For policy
questions regarding this collection
contact Caroline Gallaher at 410–786–
8705).
Dated: September 25, 2023
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
The Centers for Medicare &
Medicaid Services (CMS) announce the
extension of the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) exemption period for the State of
Washington. The exemption period is
extended for 6 months, that is until
April 2, 2024.
DATES: The exemption granted by this
notice is effective from October 2, 2023
to April 2, 2024.
FOR FURTHER INFORMATION CONTACT:
Mary Hasan, (410) 786–6480.
SUPPLEMENTARY INFORMATION: In the
‘‘Medicare, Medicaid, and CLIA
Programs; Clinical Laboratory
Improvement Amendments of 1988
Exemption of Laboratories Licensed by
the State of Washington’’ notice that
appeared in the September 30, 2019
Federal Register (84 FR 51591), we
announced that laboratories located in
and licensed by the State of Washington
that possess a valid license under the
Medical Test Site law, Chapter 70.42 of
the Revised Code of Washington, are
exempt from the requirements of the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) for a
period of 4 years. This period expires on
October 2, 2023. Pending re-approval of
Washington State’s CLIA exemption
period, we are extending Washington
State’s current CLIA exemption period
for 6 months, that is until April 2, 2024.
The Administrator of CMS, Chiquita
Brooks-LaSure, having reviewed and
approved this document, authorizes
Chyana Woodard, who is the Federal
Register Liaison, to electronically sign
this document for purposes of
publication in the Federal Register.
SUMMARY:
[FR Doc. 2023–21334 Filed 9–28–23; 8:45 am]
Chyana Woodard,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
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[FR Doc. 2023–21460 Filed 9–28–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Clinical Laboratory Improvement
Amendments of 1988 Exemption of
Laboratories Licensed by the State of
Washington; Exemption Period
Extension
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
AGENCY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Developing Drugs, Biological
Products, and Certain Devices for
Prevention or Treatment; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Page 67301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21460]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3383-N2]
Clinical Laboratory Improvement Amendments of 1988 Exemption of
Laboratories Licensed by the State of Washington; Exemption Period
Extension
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice; exemption period extension.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) announce
the extension of the Clinical Laboratory Improvement Amendments of 1988
(CLIA) exemption period for the State of Washington. The exemption
period is extended for 6 months, that is until April 2, 2024.
DATES: The exemption granted by this notice is effective from October
2, 2023 to April 2, 2024.
FOR FURTHER INFORMATION CONTACT: Mary Hasan, (410) 786-6480.
SUPPLEMENTARY INFORMATION: In the ``Medicare, Medicaid, and CLIA
Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption
of Laboratories Licensed by the State of Washington'' notice that
appeared in the September 30, 2019 Federal Register (84 FR 51591), we
announced that laboratories located in and licensed by the State of
Washington that possess a valid license under the Medical Test Site
law, Chapter 70.42 of the Revised Code of Washington, are exempt from
the requirements of the Clinical Laboratory Improvement Amendments of
1988 (CLIA) for a period of 4 years. This period expires on October 2,
2023. Pending re-approval of Washington State's CLIA exemption period,
we are extending Washington State's current CLIA exemption period for 6
months, that is until April 2, 2024.
The Administrator of CMS, Chiquita Brooks-LaSure, having reviewed
and approved this document, authorizes Chyana Woodard, who is the
Federal Register Liaison, to electronically sign this document for
purposes of publication in the Federal Register.
Chyana Woodard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-21460 Filed 9-28-23; 8:45 am]
BILLING CODE 4120-01-P
