Rule2024-01942
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction
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
February 1, 2024
Effective
January 27, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories" (referred to hereafter as the "December 2023 final rule").
Full Text
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<title>Federal Register, Volume 89 Issue 22 (Thursday, February 1, 2024)</title>
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[Federal Register Volume 89, Number 22 (Thursday, February 1, 2024)]
[Rules and Regulations]
[Pages 6431-6432]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01942]
[[Page 6431]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 493
[CMS-3326-CN]
RIN 0938-AT47
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees;
Histocompatibility, Personnel, and Alternative Sanctions for
Certificate of Waiver Laboratories; Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS) and Centers for
Disease Control and Prevention (CDC), Department of Health and Human
Services (HHS).
ACTION: Final rule; correction.
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SUMMARY: This document corrects technical and typographical errors in
the final rule that appeared in the December 28, 2023, Federal Register
entitled, ``Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Fees; Histocompatibility, Personnel, and Alternative Sanctions for
Certificate of Waiver Laboratories'' (referred to hereafter as the
``December 2023 final rule'').
DATES: This correction is effective January 27, 2024.
FOR FURTHER INFORMATION CONTACT: Penny Keller, CMS, (410) 786-2035; or
Heather Stang, CDC, (404) 498-2769.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2023-28170 of December 28, 2023, the December 2023 final
rule (88 FR 89976), there were technical and typographical errors that
are identified and corrected in this correcting document. These
corrections are effective as if they had been included in the December
2023 final rule.
II. Summary of Errors in the Regulation Text
On page 90040, in the revision for Sec. 493.1423(b)(7)(i), we
inadvertently omitted two redesignated paragraph references for
individuals who meet the regulatory qualifications to perform blood gas
analysis. We are correcting the revision for Sec. 493.1423(b)(7)(i) to
include references to Sec. 493.1423(b)(5) and (6).
On page 90043, in amendatory instruction 30, we inadvertently
omitted the specific paragraph references for the changes to paragraph
(e), which were set out in the amendment text. We are correcting the
instruction to specify paragraphs (e)(1) through (4).
On page 90044, in the revisions for Sec. 493.1483(b)(3), we
inadvertently omitted the December 28, 2024 effective date.
On page 90044, in amendatory instruction 37, we inadvertently
included an incorrect effective date. The December 2023 final rule
contained two separate effective dates, January 27, 2024, and December
28, 2024 and we erroneously included the December 28, 2024, effective
date rather than the January 27, 2024, effective date.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA),
the agency is required to publish a notice of the proposed rulemaking
in the Federal Register before the provisions of a rule take effect.
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.
Section 553(b)(B) of the APA authorizes an agency to dispense with
normal rulemaking requirements for good cause if the agency makes a
finding that the notice and comment process is impracticable,
unnecessary, or contrary to the public interest. In addition, section
553(d)(3) of the APA allows the agency to avoid the 30-day delay in
effective date where such delay is contrary to the public interest and
an agency includes a statement of support.
We believe this correcting document does not constitute a rule that
would be subject to the notice and comment or delayed effective date
requirements. This document merely corrects technical and typographical
errors in the December 2023 final rule but does not make substantive
changes to the policies that were adopted in the December 2023 final
rule. Instead, this correcting document is intended to ensure that the
information in the December 2023 final rule accurately reflects the
policies adopted in that document.
In addition, even if this were a rule to which the notice and
comment procedures and delayed effective date requirements applied, we
find that there is good cause to waive such requirements. Undertaking
further notice and comment procedures to incorporate the corrections in
this document into the December 2023 final rule or delaying the
effective date would be contrary to the public interest because it is
in the public's interest to ensure that the December 2023 final rule
accurately reflects the policies finalized in that final rule.
Furthermore, such procedures would be unnecessary, as we are not
altering our policies, but rather, we are simply correctly implementing
the policies we finalized. This final rule correction is intended to
ensure that the December 2023 final rule accurately reflects those
policies. Therefore, we believe we have good cause to waive the notice
and comment and delayed effective date requirements.
IV. Correction of Errors in the Regulation Text
In FR Doc. 2023-28170 of Thursday, December 28, 2023 (88 FR 89976),
we are making the following corrections:
Sec. 493.1423 [Corrected]
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1. On page 90040, in the third column, in Sec. 493.1423(b)(7)(i),
``(i) Be qualified under paragraph (b)(1), (2), (3), or (4) of this
section; or'' is corrected to read ``(i) Be qualified under paragraph
(b)(1), (2), (3), (4), (5), or (6) of this section; or''.
Sec. 493.1461 [Corrected]
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2. On page 90043, in the third column, amendment 30, the instruction
``Effective December 28, 2024, amend Sec. 493.1461 by revising
paragraphs (c), (d)(3)(i), and (e) to read as follows:'' is corrected
to read ``Effective December 28, 2024, amend Sec. 493.1461 by revising
paragraphs (c), (d)(3)(i), and (e)(1) through (4) to read as
follows:''.
Sec. 493.1483 [Corrected]
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3. On page 90044, in the second column, in Sec. 493.1483(b)(3), ``(3)
Notwithstanding any other provision of this section, an individual is
considered qualified as a cytotechnologist under this section if they
were qualified and serving as a cytotechnologist in a CLIA-certified
laboratory as of [effective date of the final rule], and have done so
continuously since December 28, 2024'' is corrected to read ``(3)
Notwithstanding any other provision of this section, an individual is
considered qualified as a cytotechnologist under this section if they
were qualified and serving as a cytotechnologist in a CLIA-certified
laboratory as of December 28, 2024, and have done so continuously since
December 28, 2024''.
Sec. 493.1804 [Corrected]
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4. On page 90044, in the third column, amendment 37, the instruction
``Effective December 28, 2024, amend Sec. 493.1804 by revising
paragraph (c)(1) to read as follows:'' is corrected to read ``Effective
January 27, 2024, amend
[[Page 6432]]
Sec. 493.1804 by revising paragraph (c)(1) to read as follows:''.
Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2024-01942 Filed 1-26-24; 5:15 pm]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on February 1, 2024.
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