Clinical Laboratory Improvement Amendments (CLIA) Proficiency Testing Related to Analytes and Acceptable Performance; Correction, 68912 [2022-24990]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Rules and Regulations]
[Page 68912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24990]



[[Page 68912]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3355-F2]
RIN 0938-AT55


Clinical Laboratory Improvement Amendments (CLIA) Proficiency 
Testing Related to Analytes and Acceptable Performance; Correction

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Final rule; correction.

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

SUMMARY: In the July 11, 2022 issue of the Federal Register, we 
published a final rule that updated proficiency testing (PT) 
regulations under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) to address current analytes (that is, substances or 
constituents for which the laboratory conducts testing) and newer 
technologies. The effective date was August 10, 2022, except for the 
amendments in amendatory instructions 2 and 5 through 21, which are 
effective July 11, 2024. This document corrects one technical error 
identified in the July 11, 2022 final rule.

DATES: This document is effective July 11, 2024, and is applicable 
beginning August 10, 2022.

FOR FURTHER INFORMATION CONTACT: Sarah Bennett, CMS, (410) 786-3531; or 
Heather Stang, CDC, (404) 498-2769.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2022-41513 (87 FR 41240), the final rule entitled 
``Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency 
Testing Regulations Related to Analytes and Acceptable Performance'' 
(hereinafter referred to as the July 11, 2022 final rule), there was a 
technical error that is identified and corrected in the regulation text 
of this correction. The provision of this correction revises a 
regulation that become effective on July 11, 2024.

II. Summary of Errors

    On page 41240 of the July 11, 2022 final rule, we made a technical 
error in ``Table 2 to Paragraph (c)(2)'' of Sec.  493.933. In this 
table, we inadvertently noted the units for ``Carcinoembryonic antigen 
(CEA)'' as ``ng/dL'' when the correct units are ``ng/mL.'' Accordingly, 
we are revising ``Table 2 to Paragraph (c)(2)'' of Sec.  493.933.

III. Waiver of Proposed Rulemaking and Delay in Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register to provide a period for public comment before the 
provisions of a rule take effect in accordance with section 553(b) of 
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we 
can waive this notice and comment procedure if the Secretary finds, for 
good cause, that the notice and comment process is impracticable, 
unnecessary, or contrary to the public interest, and incorporates a 
statement of the finding and the reasons therefore in the rulemaking.
    Section 553(d) of the APA ordinarily requires a 30-day delay in 
effective date of final rules after the date of their publication in 
the Federal Register. This 30-day delay in effective date can be 
waived, however, if an agency finds for good cause that the delay is 
impracticable, unnecessary, or contrary to the public interest, and the 
agency incorporates a statement of the findings and its reasons in the 
rule issued.
    This correction merely corrects an error in one analyte unit of 
measurement in the regulation text of the July 11, 2022 final rule. We 
are correcting this technical error to ensure that the table accurately 
reflects the policy adopted in the final rule. Therefore, we find that 
undertaking further notice and comment procedures to incorporate this 
minor technical correction into the final rule is unnecessary and 
contrary to the public interest.
    For the same reasons, we are also waiving the 30-day delay in 
effective date for this correction. We believe that it is in the public 
interest to ensure that the July 11, 2022 final rule accurately states 
the correct units. Thus delaying the effective date of this correction 
would be contrary to the public interest. Therefore, we also find good 
cause to waive the 30-day delay in effective date.

Correction

0
Effective July 11, 2024, in FR Doc. 2022-41513, appearing at 87 FR 
41194 in the Federal Register of July 22, 2022, on page 41240, in 
amendatory instruction 18 for Sec.  493.933, in table 2 to paragraph 
(c)(2), the entry for ``Carcinoembryonic antigen (CEA)'' is corrected 
to read as follows:


Sec.  493.933   [Corrected]

* * * * *
    (c) * * *
    (2) * * *

                        Table 2 to Paragraph (c)(2)--Criteria for Acceptable Performance
----------------------------------------------------------------------------------------------------------------
The criteria for acceptable performance are--Analyte or
                          test                                     Criteria for acceptable performance
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Carcinoembryonic antigen (CEA).........................  Target value 15% or 1 ng/mL
                                                          (greater).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2022-24990 Filed 11-15-22; 4:15 pm]
BILLING CODE 4120-01-P