[Federal Register Volume 88, Number 131 (Tuesday, July 11, 2023)]
[Notices]
[Pages 44131-44132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14582]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-26 and CMS-R-185]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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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 (the 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
[[Page 44132]]
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 September 11, 2023.
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
http://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-26 Clinical Laboratory Improvement Amendments (CLIA) Regulations
CMS-R-185 Granting and Withdrawal of Deeming Authority to Private
Nonprofit Accreditation Organizations and CLIA Exemption Under State
Laboratory Programs
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: Revision of a currently
approved collection; Title of Information Collection: Clinical
Laboratory Improvement Amendments (CLIA) Regulations; Use: The
information is necessary to determine an entity's compliance with the
Congressionally-mandated program with respect to the regulation of
laboratory testing (CLIA). In addition, laboratories participating in
the Medicare program must comply with CLIA requirements as required by
section 6141 of OBRA 89. Medicaid, under the authority of section
1902(a)(9)(C) of the Social Security Act, pays for services furnished
only by laboratories that meet Medicare (CLIA) requirements.
This is a revision of the information collection. Based on the
notice of proposed rulemaking, published in the Federal Register on
July 26, 2022 (87 FR 44896), we are revising the information collection
request by adding sections. The additional requirements include
sections 493.1278, 493.1359, 493.1405-1411; 493.1423, 493.1443-1445,
493.1461-1463; 493.1483; 493.1489-1491. These sections include
histocompatibility (493.1278) and personnel (493.1359, 493.1405-1411;
493.1423, 493.1443-1445, 493.1461-1463; 493.1483; 493.1489-1491)
require laboratories to revise and update policies and procedures
applicable to new or amended requirements. Form Number: CMS-R-26 (OMB
Control Number: 0938-0612); Frequency: Monthly, occasionally; Affected
Public: Business or other for-profits and Not-for-profit institutions,
State, Local or Tribal Governments, and the Federal government; Number
of Respondents: 49,626; Total Annual Responses: 88,259,802; Total
Annual Hours: 14,514,802. (For policy questions regarding this
collection contact Jelani Sanaa at 410-786-6782).
2. Type of Information Collection Request: Revision of currently
approved collection; Title of Information Collection: Granting and
Withdrawal of Deeming Authority to Private Nonprofit Accreditation
Organizations and CLIA Exemption Under State Laboratory Programs; Use:
The information required is necessary to determine whether a private
accreditation organization/State licensure program standards and
accreditation/licensure process is at least equal to or more stringent
than those of the Clinical Laboratory Improvement Amendments of 1988
(CLIA). If an accreditation organization is approved, the laboratories
that it accredits are ``deemed'' to meet the CLIA requirements based on
this accreditation. Similarly, if a State licensure program is
determined to have requirements that are equal to or more stringent
than those of CLIA, its laboratories are considered to be exempt from
CLIA certification and requirements. The information collected will be
used by HHS to: determine comparability/equivalency of the
accreditation organization standards and policies or State licensure
program standards and policies to those of the CLIA program; to ensure
the continued comparability/equivalency of the standards; and to
fulfill certain statutory reporting requirements.
We are revising the information collection request by adding and
amending collection requirements for 493.553-557. The proposed rule
published in the Federal Register on July 26, 2022 (87 FR 44896). These
require laboratories to revise and update policies and procedures
applicable to new or amended requirements. Form Number: CMS-R-185 (OMB
control number: 0938-0686); Frequency: Occasionally; Affected Public:
Private Sector--Business or other for-profits and Not-for-profit
institutions; Number of Respondents: 9; Total Annual Responses: 9;
Total Annual Hours: 5,359. (For policy questions regarding this
collection contact Arlene Lopez at 410-786-6782.)
Dated: July 6, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-14582 Filed 7-10-23; 8:45 am]
BILLING CODE 4120-01-P