[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45765-45766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18745]
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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 250 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 November 6, 2019, 8:30 a.m. to 5:30
p.m., EST and November 7, 2019, 8:30 a.m. to 12:00 p.m., EST.
ADDRESSES: CDC, 1600 Clifton Road NE, Tom Harkin Global Communications
Center, Building 19, Auditorium B, Atlanta, Georgia 30329-4027 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
30329-4027, 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 15 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 October 29, 2019 for U.S. registrants and
October 15, 2019 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. At this meeting, CLIAC
is specifically soliciting public comments to address the questions
below. Information provided via public comments will not be considered
advice directly addressed to HHS. Rather, it will be used by CLIAC to
inform their deliberations and recommendations to HHS and to help focus
a CLIAC workgroup that will be convened in response to an April 2019
CLIAC recommendation that such a workgroup be charged with providing
input to CLIAC in advising how CLIA might be updated.
1. Are bioinformaticists needed in clinical and public health
laboratories? If so, what are the current roles, responsibilities, and
competencies of bioinformaticists in these settings?
2. What areas exist in CLIA where specific requirements or guidance
might be needed to ensure the accuracy and reliability of new and
emerging
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laboratory technologies and nontraditional testing workflow models,
including next generation sequencing, biomarker testing, metagenomics,
and others?
3. What data are available that could assist in answering how CLIA
may need to be revised or where guidance may be needed to ensure the
accuracy and reliability of emerging technologies?
In general, each individual or group requesting to make oral
comments will be limited to a total time of ten minutes (unless
otherwise indicated). To assure adequate time is scheduled for public
comments, speakers should notify the contact person below at least five
business days prior to the meeting date. For individuals or groups
unable to attend the meeting or that wish to provide data in response
to the questions above, 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
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 from the Association of Public Health Opioids Task Force; an
update on the clinical laboratory workforce; return of research results
to research participants; and improving integration of laboratory
information systems with electronic health records. There will be an
extended public comment session focusing on emerging technologies and
the clinical laboratory. 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. 2019-18745 Filed 8-29-19; 8:45 am]
BILLING CODE 4163-18-P