Clinical Laboratory Improvement Advisory Committee, 55812 [2022-19569]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Notices]
[Page 55812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clinical Laboratory Improvement Advisory Committee

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of meeting.

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SUMMARY: In accordance with the Federal Advisory Committee Act, the CDC 
announces the following meeting for the Clinical Laboratory Improvement 
Advisory Committee (CLIAC). This meeting is open to the public, limited 
only by the number of webcast lines available. Time will be available 
for public comment.

DATES: The meeting will be held on November 9, 2022, from 11:00 a.m. to 
6:00 p.m., EST, and November 10, 2022, from 11:00 a.m. to 6:00 p.m., 
EST.

ADDRESSES: This is a virtual meeting. Meeting times are tentative and 
subject to change. The confirmed meeting times, agenda items, and 
meeting materials, including instructions for accessing the live 
meeting broadcast, will be available on the CLIAC website at https://www.cdc.gov/cliac. Check the website on the day of the meeting for the 
web conference link.

FOR FURTHER INFORMATION CONTACT: Heather Stang, MS, Deputy Chief, 
Quality and Safety Systems Branch, Division of Laboratory Systems, 
Center for Surveillance, Epidemiology, and Laboratory Services, Deputy 
Director for Public Health Science and Surveillance, Centers for 
Disease Control and Prevention, 1600 Clifton Road NE, Mailstop V24-3, 
Atlanta, Georgia 30329-4027; Telephone: (404) 498-2769; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Purpose: This Committee is charged with providing scientific and 
technical advice and guidance to the Secretary, HHS; the Assistant 
Secretary for Health; the Director, CDC; the Commissioner, Food and 
Drug Administration (FDA); and the Administrator, Centers for Medicare 
& Medicaid Services (CMS). The advice and guidance pertain to general 
issues related to improvement in clinical laboratory quality and 
laboratory medicine and specific questions related to possible revision 
of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
standards. Examples include providing guidance on studies designed to 
improve quality, safety, effectiveness, efficiency, timeliness, equity, 
and patient-centeredness of laboratory services; revisions to the 
standards under which clinical laboratories are regulated; the impact 
of proposed revisions to the standards on medical and laboratory 
practice; and the modification of the standards and provision of non-
regulatory guidelines to accommodate technological advances, such as 
new test methods, the electronic transmission of laboratory 
information, and mechanisms to improve the integration of public health 
and clinical laboratory practices.
    Matters To Be Considered: The agenda will include agency updates 
from CDC, CMS, and FDA. Presentations and CLIAC discussions will focus 
on the clinical and public health response to the monkeypox outbreak, 
efforts to address public health and clinical laboratory workforce 
challenges, and reports from two CLIAC workgroups: the CLIA Regulations 
Assessment Workgroup and the CLIA Certificate of Waiver and Provider-
performed Microscopy Procedures Workgroup. Agenda items are subject to 
change as priorities dictate.

Public Participation

    It is the policy of CLIAC to accept written public comments and 
provide a brief period for oral public comments pertinent to agenda 
items.
    Oral Public Comment: Public comment periods for each agenda item 
are scheduled immediately prior to the Committee discussion period for 
that item. In general, each individual or group requesting to present 
an oral comment will be limited to a total time of five minutes (unless 
otherwise indicated). Speakers should email [email protected] or notify the 
contact person above (see FOR FURTHER INFORMATION CONTACT) at least 
five business days prior to the meeting date.
    Written Public Comment: CLIAC accepts written comments until the 
date of the meeting (unless otherwise stated). However, it is requested 
that comments be submitted at least five business days prior to the 
meeting date so that the comments may be made available to the 
Committee for their consideration and public distribution. Written 
comments should be submitted by email to [email protected] or to the 
contact person above. All written comments will be included in the 
meeting minutes posted on the CLIAC website.
    The Director, Strategic Business Initiatives Unit, Office of the 
Chief Operating Officer, Centers for Disease Control and Prevention, 
has been delegated the authority to sign Federal Register notices 
pertaining to announcements of meetings and other committee management 
activities, for both the Centers for Disease Control and Prevention and 
the Agency for Toxic Substances and Disease Registry.

Kalwant Smagh,
Director, Strategic Business Initiatives Unit, Office of the Chief 
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2022-19569 Filed 9-9-22; 8:45 am]
BILLING CODE 4163-18-P