[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