Notice2025-21690
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
December 1, 2025
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 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.
Full Text
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<title>Federal Register, Volume 90 Issue 228 (Monday, December 1, 2025)</title>
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[Federal Register Volume 90, Number 228 (Monday, December 1, 2025)]
[Notices]
[Pages 55129-55130]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21690]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10690]
Agency Information Collection Activities: Submission for OMB
Review; 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 (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 December 31, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <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 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 of a currently
approved collection; Title of Information Collection: CLIA Proficiency
Testing (PT); Use: This is an extension package. The purpose of this
package is to request Office of Management and Budget (OMB) approval
for the information collection request (ICR) for proficiency testing
(PT) and reapproval of PT programs. The ICR includes laboratories
filling in PT submission forms for microbiology PT and document
collection for a PT program if it needs to reapply for approval using
the initial approval process.
On October 31, 1988, Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (Pub. L. 100-578) (CLIA'88), codified at
42 U.S.C. 263a, to ensure the accuracy and reliability of testing in
all laboratories, including, but not limited to, those that participate
in Medicare and Medicaid, that test human specimens for purpose of
providing information for the diagnosis, prevention, or treatment of
any disease or impairment, or the assessment of health, of human
beings. The Secretary established the initial regulations implementing
CLIA on February 28, 1992 at 42 CFR part 493 (57 FR 7002). Among other
things, those regulations required laboratories conducting moderate or
high complexity testing to enroll in an approved PT program for each
specialty, subspecialty, and analyte or test for which the laboratory
is certified under CLIA. PT evaluates a laboratory's performance by
testing of unknown samples just as it would test patient samples.
A Health and Human Services (HHS)-approved PT program sends unknown
samples to a laboratory for analysis. After testing, the laboratory
reports its results to the PT program. The program grades the results
using the CLIA grading criteria and provides the laboratory with its
scores. PT is crucial to maintaining the quality of laboratory testing
because it independently verifies the accuracy and reliability of
laboratory testing, including the competency of testing personnel. PT
referral was further addressed by enactment of the Taking Essential
Steps for Testing Act of 2012 (Pub. L. 112-202, December 4, 2012) (TEST
Act) and our implementing regulations (79 FR 25435 and 79 FR 27105). As
of July 2025, there were 307,193 CLIA-certified laboratories, of which
33,990 Certificate of Compliance (CoC) and Certificate of Accreditation
(CoA) laboratories were required to enroll in an HHS-approved PT
program and comply with the PT regulations.
Testing has evolved significantly since 1992, and technology is now
more accurate and precise than the methods in use at the time the PT
regulations became effective for all laboratories in 1994. In addition,
many tests for analytes for which PT was not initially required are now
in routine clinical use. For example, tests for cardiac markers, such
as troponins, and hemoglobin A1c test commonly used to monitor glycemic
control in persons with diabetes, were not routinely performed prior to
1992. Recognizing these changes, we finalized revisions to our existing
PT regulations in the Clinical Laboratory Improvement Amendments of
1988 (CLIA) Proficiency Testing Regulations Related to Analytes and
Acceptable Performance (CMS 3355-F) which published July 11, 2022 (87
FR 41194). Each PT program supplies laboratories with its forms
required for enrolling in microbiology PT; and reapplication for
approval has no standardized forms required.
The original CLIA regulation PRA Supporting Statement for CLIA (OMB
control number: 0938-0612) did not include the collection requirements
for microbiology PT provisions or PT programs included in this final
rule. We determined during the proposed rule phase that this ICR would
be needed to cover the additional information collections. We plan to
include these two information collections when the
[[Page 55130]]
PRA package under OMB control number: 0938-0612 is due for renewal.
Laboratories are currently required to report PT results for
microbiology organism identification to the highest level that they
report results on patient specimens. We are clarifying that this is
required when reporting microbiology PT results to PT programs. The
information that the laboratory submits to the PT program will be used
by the PT program to determine successful participation in PT. Form
Number: CMS-10690 (OMB control number: 0938-1357); Frequency: Yearly;
Affected Public: Private sector--Not-for-profit organizations; Number
of Respondents: 1,335; Total Annual Responses: 1,335 Total Annual
Hours: 1,407. (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. 2025-21690 Filed 11-28-25; 8:45 am]
BILLING CODE 4120-01-P
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