[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10862-10863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clinical Laboratory Improvement Advisory Committee

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC) announces the following committee meeting.
    Times And Dates: 8:30 a.m.-5:00 p.m., April 13, 2016; 8:30 a.m.-
12:00 p.m., April 14, 2016.
    Place: CDC, 1600 Clifton Road NE., Tom Harkin Global Communications 
Center, Building 19, Auditorium B, Atlanta, Georgia 30333.
    Status: Open to the public, limited only by the space available. 
The meeting room accommodates approximately 100 people. This meeting 
will also be webcast, please see information below.
    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 For Discussion: The agenda will include agency updates from 
CDC, CMS, and FDA. Presentations and discussions will include methods 
for improving the effectiveness/efficiency of CLIAC meetings; an 
overview of the CMS Advisory Panel on Clinical Diagnostic Laboratory 
Tests; laboratory interoperability including the Office of the National 
Coordinator for Health Information Technology (ONC) policies and 
engagement with clinical laboratories; update on the cytology workload 
project; update on laboratory biosafety in clinical laboratories; and 
future CLIAC topics.
    Agenda items are subject to change as priorities dictate.
    Webcast: The meeting will also be webcast. Persons interested in 
viewing the webcast can access information at: http://cdclabtraining.adobeconnect.com/aprilcliac/.
    In-Person Attendance Online Registration Required: 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: http://www.cdc.gov/cliac/Meetings/MeetingDetails.aspx#.
    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 7, 2016 for U.S. 
registrants and March 31, 2016 for international registrants.
    Providing Oral or Written Comments: It is the policy of CLIAC to 
accept written public comments and provide a brief period for oral 
public comments on agenda items whenever possible.
    Oral Comments: In general, each individual or group requesting to 
make oral comments will be limited to a total time of five minutes 
(unless otherwise indicated). Speakers must also submit their comments 
in writing for inclusion in the meeting's Summary Report. To assure 
adequate time is scheduled for public comments, speakers should notify 
the contact person below at least one week prior to the meeting date.
    Written Comments: 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 one week prior to the meeting date so that the 
comments may be made available to the Committee for their consideration 
and for public distribution. Written comments, one hard copy with 
original signature, should be provided to the contact person listed 
below, and will be included in the meeting's Summary Report.
    Availability of Meeting Materials: To support the green initiatives 
of the federal government, 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 Web site on 
the day of the meeting for materials: http://wwwn.cdc.gov/cliac/cliac_meeting_all_documents.aspx.

    Note: If using a mobile device to access the materials, please 
verify that the device's browser is able to download the files from 
the CDC's Web site before the meeting. Alternatively, the files can 
be downloaded to

[[Page 10863]]

a computer and then emailed to the portable device. An internet 
connection, power source, and limited hard copies may be available 
at the meeting location, but cannot be guaranteed.

    Contact Person for Additional Information: Nancy Anderson, Chief, 
Laboratory Practice Standards Branch, 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 
30329-4018; telephone (404) 498-2741; or via email at 
[email protected].
    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 CDC 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. 2016-04590 Filed 3-1-16; 8:45 am]
 BILLING CODE 4163-18-P