[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