Notice2026-07850
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 22, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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 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 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.
Full Text
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<title>Federal Register, Volume 91 Issue 77 (Wednesday, April 22, 2026)</title>
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[Federal Register Volume 91, Number 77 (Wednesday, April 22, 2026)]
[Notices]
[Pages 21502-21504]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07850]
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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).
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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 (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
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 June 22, 2026.
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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>
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).
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: This is an
extension package. The Clinical Laboratory Improvement Amendments of
1988 (CLIA) section 353 of the Public Health Service Act requires the
Department of Health and Human Services (HHS) to establish
certification requirements for any entity, with certain exceptions
contained in the regulation, that performs testing on human beings to
meet performance requirements based on test complexity and risk factors
related to erroneous test results in order to be certified by HHS.
This information collection reflects a series of records required
to be maintained by laboratories participating in the CLIA program and
are based upon the publication of a final quality assessment rule on
January 24, 2003, and the publication of the final fee,
histocompatibility, personnel, and alternative sanction rule on
December 28, 2023 (88 FR 89976). Included in the revisions were
amendments to the histocompatibility and personnel regulations under
CLIA to address obsolete regulations and update the regulations to
incorporate technological changes, and that are reflected in this
extension package.
The previous iteration was a revision of the information
collection. Based on notice of final rulemaking, CMS-3326-F (88 FR
89976) published on December 28, 2023, we revised the ICR by adding
additional sections.
The final rule addressed recommendations provided by the Centers
for Disease Control and Prevention (CDC)'s Clinical Laboratory
Improvement Advisory Committee (CLIAC). CMS and CDC incorporated
changes in the rulemaking to remove specific regulations already
covered in the general requirements and laboratory director
responsibilities. The additional requirements included sections
493.1278, 493.1359, 493.1405-1411; 493.1423, 493.1443-1445, 493.1461-
1463; 493.1483; 493.1489-1491. These sections included
histocompatibility (493.1278) and personnel (493.1359, 493.1405-1411;
493.1423, 493.1443-1445, 493.1461-1463; 493.1483; 493.1489-1491) which
required 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 Penny Keller at 410-786-2035).
2. Type of Information Collection Request: Extension 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:
This is an extension package. The Clinical Laboratory Improvement
Amendments of 1988 (CLIA) established a new section 353 of the Public
Health Service Act (PHSA) which requires the Department of Health and
Human Services (HHS) to establish certification requirements, with
certain exceptions, for any laboratory that performs testing on human
specimens. Laboratories must meet performance requirements based on
test complexity in order to be certified by HHS. CLIA also provides for
the recognition of private accreditation organizations and State
licensure programs whose standards are determined to be equal to or
more stringent than the HHS requirements.
Final regulations were published on February 28, 1992, at 42 CFR
part 493 which implemented the certificate,
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laboratory standards and inspection requirement sections of CLIA. There
have been several subsequent rules that have modified these
regulations.
On July 31, 1992, final regulations implementing the provisions of
353 PHSA concerning the recognition of private accreditation
organizations and State licensure programs for CLIA purposes were
published as Subpart E of part 493. These regulations establish that we
may approve a private, nonprofit organization as an accreditation
organization for clinical laboratories under the CLIA program if the
organization's requirements for its accredited laboratories are equal
to or more stringent than the applicable CLIA program requirements of
part 493. These regulations also provide for the CLIA exemption of
laboratories in a State that applies licensure requirements that are
equal to or more stringent than those of CLIA.
On May 14, 1998, revisions to Subpart E were published as part of
other CLIA final rulemaking. The revisions to Subpart E eliminated
duplicative information by restructuring and consolidating requirements
for accreditation organizations and State licensure programs seeking
approval under CLIA. The revised Subpart better reflects the
information required and process involved in obtaining approval. This
restructuring did not change the requirements, but only redesignated
them into a more customer-oriented document, making them easier for
users to understand. In this process we used new section numbers, but
retained all the requirements for Subpart E.
The last iteration required accreditation organizations and State
licensure programs to revise and update policies and procedures
applicable to new or amended requirements in the final rule, CMS-3326-
F, to remain complaint with the regulations at 493.553-557. The
accreditation organizations or State licensure programs are required to
meet or exceed the CLIA regulations. The final rule, CMS-3326-F, was
published on December 28, 2023 (88 FR 89976). 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 Penny Keller at 410-786-2035.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2026-07850 Filed 4-21-26; 8:45 am]
BILLING CODE 4120-01-P
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