[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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