Notice2021-20151
Clinical Laboratory Improvement Advisory Committee (CLIAC)
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
September 17, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 webcast lines available. Check the CLIAC website on the day of the meeting for the web conference link www.cdc.gov/cliac.
Full Text
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<title>Federal Register, Volume 86 Issue 178 (Friday, September 17, 2021)</title>
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[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Page 51894]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20151]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Advisory Committee (CLIAC)
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 webcast lines available. Check the CLIAC website on the day
of the meeting for the web conference link <a href="http://www.cdc.gov/cliac">www.cdc.gov/cliac</a>.
DATES: The meeting will be held on November 3, 2021, from 11:00 a.m. to
6:00 p.m., EDT, and November 4, 2021, from 11:00 a.m. to 6:00 p.m.,
EDT.
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 <a href="http://www.cdc.gov/cliac">www.cdc.gov/cliac</a>.
FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Senior
Advisor for Clinical Laboratories, Division of Laboratory Systems,
Center for Surveillance, Epidemiology and Laboratory Services, Office
of Public Health Scientific Services, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mailstop V24-3, Atlanta, Georgia
30329-4027, Telephone: (404) 498-2741; <a href="/cdn-cgi/l/email-protection#e0aea18e848592938f8ea0838483ce878f96"><span class="__cf_email__" data-cfemail="d09e91beb4b5a2a3bfbe90b3b4b3feb7bfa6">[email protected]</span></a>.
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
and Medicaid Services (CMS). The advice and guidance pertain to general
issues related to improvement in clinical laboratory quality and
laboratory medicine practice 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 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. In addition to the general updates, agency
presentations will include an overview of the FDA's Center for
Biologics Evaluation and Research, a laboratory safety update, and a
status report on the new CLIA regulations assessment workgroup.
Presentations and CLIAC discussion will focus on next generation
sequencing in clinical and public health laboratories and laboratory
data exchange and harmonization. Agenda items are subject to change as
priorities dictate.
It is the policy of CLIAC to accept written public comments and
provide a brief period for oral public comments pertinent to agenda
items. 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 <a href="/cdn-cgi/l/email-protection#dd9e91949c9e9dbeb9bef3bab2ab"><span class="__cf_email__" data-cfemail="b5f6f9fcf4f6f5d6d1d69bd2dac3">[email protected]</span></a> or notify the contact
person at least five business days prior to the meeting date. For
individuals or groups unable to attend the meeting, 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. All written comments will be included in the meeting
Summary Report 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. 2021-20151 Filed 9-16-21; 8:45 am]
BILLING CODE 4163-18-P
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