[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Notices]
[Page 9521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04475]



[[Page 9521]]

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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 https://wwwn.cdc.gov/cliac/. Please see 
information regarding attending the meeting in the summary section 
below.

DATES: The meeting will be held on April 10, 2018, 8:30 a.m. to 5:30 
p.m., EDT and April 11, 2018, 8:30 a.m. to 1:00 p.m., EDT.

ADDRESSES: Food and Drug Administration (FDA) White Oak Campus, 10903 
New Hampshire Avenue, Building 31, Great Room, Silver Spring, MD 20993.

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 F-11, Atlanta, Georgia 
30329-4027 telephone (404) 498-2741; [email protected].

SUPPLEMENTARY INFORMATION: All people attending the CLIAC meeting in-
person are required to register for the meeting online at least 5 
business days in advance for U.S. citizens and at least 10 business 
days in advance for international registrants. Register at: https://wwwn.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 2, 
2018 for U.S. registrants and March 26, 2018 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, one hard copy with original 
signature, 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: https://wwwn.cdc.gov/cliac/.
    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.
    Matters to be Considered: The agenda will include agency updates 
from CDC, CMS, and FDA. Presentations and discussions will focus on the 
clinical laboratory workforce; implementation of next generation 
sequencing in clinical laboratories; laboratory interoperability; and 
using clinical laboratory data to improve quality and laboratory 
medicine practices. Agenda items are subject to change as priorities 
dictate.
    The Director, Management Analysis and Services Office, 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.

Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2018-04475 Filed 3-5-18; 8:45 am]
 BILLING CODE 4163-19-P