[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Notices]
[Page 11993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04068]
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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 space available. The meeting room accommodates
approximately 100 people. The public is also welcome to view the
meeting by webcast. Check the CLIAC website on the day of the meeting
for the webcast link www.cdc.gov/cliac.
DATES: The meeting will be held on April 16, 2020, 8:30 a.m. to 5:00
p.m., EDT and April 17, 2020, 8:30 a.m. to 11:30 a.m., EDT.
ADDRESSES: Food and Drug Administration (FDA), White Oak Campus, 10903
New Hampshire Avenue, Building 31, Great Room, Silver Spring, Maryland
20993 and via webcast at www.cdc.gov/cliac.
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
30329-4018, telephone (404) 498-2741; [email protected].
SUPPLEMENTARY INFORMATION:
Purpose: This Committee is charged with providing scientific and
technical advice and guidance to the Secretary of Health and Human
Services (HHS); the Assistant Secretary for Health; the Director,
Centers for Disease Control and Prevention; 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 Amendment (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.
All people attending the CLIAC meeting in-person are required to
register for the meeting online at least five business days in advance
for U.S. citizens and at least 10 business days in advance for
international registrants. Register at: www.cdc.gov/cliac. Register by
scrolling down and clicking the ``Register for this Meeting'' button
and completing all forms according to the instructions given. Please
complete all the required fields before submitting your registration
and submit no later than April 8, 2020, for U.S. registrants and April
1, 2020, for international registrants.
It is the policy of CLIAC to accept written public comments and
provide a brief period for oral public comments on 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 make oral comments will be limited to
a total time of five minutes (unless otherwise indicated). To assure
adequate time is scheduled for public comments, speakers should notify
the contact person below at least 5 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 5 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 provided to the contact
person at the mailing or email address below, and will be included in
the meeting's Summary Report.
The CLIAC meeting materials will be made available to the Committee
and the public in electronic format (PDF) on the internet instead of by
printed copy. Check the CLIAC website on the day of the meeting for
materials: www.cdc.gov/cliac.
Matters to be Considered: The agenda will include agency updates
from CDC, CMS, and FDA. Presentations and discussions will focus on an
update on CLIAC recommendations; an update on the Genetic Testing
Reference Materials Coordination Program (GeT-RM); an update of the
December 2019 CDC's Board of Scientific Counselors, Deputy Director for
Infectious Diseases meeting; a report from the Office of the National
Coordinator for Health Information Technology (ONC) Health Information
Technology Advisory Committee; the laboratory response to the COVID-19
coronavirus disease outbreak; and technological advances in digital
imaging. Agenda items are subject to change as priorities dictate.
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. 2020-04068 Filed 2-27-20; 8:45 am]
BILLING CODE 4163-18-P