[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Page 56803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clinical Laboratory Improvement Advisory Committee (CLIAC)

    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 meeting of the aforementioned 
committee:

Times and Dates: 8:30 a.m.-5:00 p.m., November 5, 2014; 8:30 a.m.-
12:00 p.m., November 6, 2014.

    Place: CDC, Century Center, 2500 Century Parkway NE., Room 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 
the FDA Draft Guidance on Laboratory Developed Tests; CLIA-waived 
testing, including the process and criteria for waiver approval; a 
report from the workgroup charged with providing input to CLIAC 
regarding the acceptability and application of virtual cross-
matching in lieu of serologic cross-matching for transplantation; 
and issues related to laboratory biosafety in the United States.
    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://wwwn.cdc.gov/cliac/default.aspx
    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://wwwn.cdc.gov/cliac/default.aspx by scrolling down and 
clicking the link under ``Meeting Registration'' 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, 2014 for U.S. registrants and October 22, 
2014 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 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, one hard 
copy with original signature, should be provided to the contact 
person 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. 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. http://wwwn.cdc.gov/cliac/cliac_meeting_all_documents.aspx. 
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 
Science and Standards, Laboratory Science, Policy and Practice 
Program Office, Office of Surveillance, Epidemiology and Laboratory 
Services, CDC, 1600 Clifton Road NE., Mailstop F-11, Atlanta, 
Georgia 30329-4018; telephone (404) 498-2741; fax (404) 498-2210; 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 the Centers for Disease Control and Prevention and 
the Agency for Toxic Substances and Disease Registry.

Claudette Grant,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2014-22532 Filed 9-22-14; 8:45 am]
BILLING CODE 4163-18-P