80 FR 63792 - Meeting: Clinical Laboratory Improvement Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 203 (October 21, 2015)

[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63792-63793]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26758]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Meeting: 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 p.m.., November 18, 2015.
    8:30 a.m.-12 p.m., November 19, 2015.
    Place: CDC, 2500 Century Center Boulevard, Rooms 1200/1201, 
Atlanta, Georgia 30345.
    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 and the electronic transmission of laboratory information.
    Matters for Discussion: The agenda will include agency updates from 
CDC, CMS, and FDA. Presentations and discussions will include 
laboratory information exchange (interoperability); noninvasive 
prenatal testing; CLIA waiver guidance; the Institute of Medicine (IOM) 
report ``Improving Diagnosis in Health Care;'' and FDA guidance for 
laboratory developed tests.
    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/novcliac/.
    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

[[Page 63793]]

international registrants. Register at: http://wwwn.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 
November 13, 2015 for U.S. registrants and November 8, 2015 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 public distribution. Written comments, to include the original 
signature of the submitter, should be provided to the contact person at 
the mailing or email address 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 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.

Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2015-26758 Filed 10-20-15; 8:45 am]
BILLING CODE 4163-18-P