[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Proposed Rules]
[Page 13857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06819]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3355-N]
RIN 0938-AT55


Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
Proficiency Testing Regulations Related to Analytes and Acceptable 
Performance; Extension of Comment Period

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Centers 
for Disease Control and Prevention (CDC), HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: This document extends the comment period for the notice of 
proposed rulemaking with comment entitled ``Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations 
Related to Analytes and Acceptable Performance'' that appeared in the 
February 4, 2019 Federal Register. The comment period for the proposed 
rule, which would end on April 5, 2019, is extended 60 days.

DATES: The comment period for the proposed rule published February 4, 
2019, at 84 FR 1536, is extended to 5 p.m., eastern daylight time, on 
June 4, 2019.

ADDRESSES: You may submit comments as outlined in the February 4, 2019 
proposed rule (84 FR 1536). Please choose only one method listed.

FOR FURTHER INFORMATION CONTACT: Sarah Bennett, CMS, (410) 786-3531; or 
Nancy Anderson, CDC, (404) 498-2741.

SUPPLEMENTARY INFORMATION: 
    In the ``Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
Proficiency Testing Regulations Related to Analytes and Acceptable 
Performance'' proposed rule that appeared in the February 4, 2019 
Federal Register (84 FR 1536), we solicited public comments on proposed 
changes to current proficiency testing (PT) analytes, including 
acceptance limits, in addition to technical changes to the PT referral 
regulations to more closely align them with the CLIA statute.
    We received an inquiry from several PT programs regarding the 60-
day comment period for the proposed rule. The commenters stated that 
providing all stakeholders additional time to review and comment would 
allow them to conduct a more comprehensive review in order to develop 
detailed responses to the technical aspects of this proposed rule given 
that it would represent the first comprehensive change to the PT 
regulations since the implementation of CLIA in 1992.
    In order to maximize the opportunity for the public to provide 
meaningful input to CMS and CDC, we believe that it is important to 
allow additional time for the public to prepare comments on the 
proposed rule. In addition, we believe that granting an extension to 
the public comment period in this instance would further our overall 
objective to obtain public input on the potential changes related to PT 
that we are considering. Therefore, we are extending the comment period 
for the proposed rule for an additional 60 days.

    Dated: March 29, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 1, 2019.
Robert Redfield,
Director, Centers for Disease Control and Prevention and Administrator, 
Agency for Toxic Substances and Disease Registry.
[FR Doc. 2019-06819 Filed 4-4-19; 8:45 am]
 BILLING CODE 4120-01-P