80 FR 31378 - Request for Nominations of Candidates To Serve on the Clinical Laboratory Improvement Advisory Committee (CLIAC) and Request for Suggested Meeting Topics for CLIAC

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

Federal Register Volume 80, Issue 105 (June 2, 2015)

[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Page 31378]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Request for Nominations of Candidates To Serve on the Clinical 
Laboratory Improvement Advisory Committee (CLIAC) and Request for 
Suggested Meeting Topics for CLIAC

    The Centers for Disease Control and Prevention (CDC) is soliciting 
nominations for membership on CLIAC and soliciting suggestions for 
topics to be considered for future Committee deliberation. CLIAC 
provides scientific and technical advice and guidance to the Secretary, 
Department of Health and Human Services (HHS); the Assistant Secretary 
for Health, HHS; the Director, Centers for Disease Control and 
Prevention (CDC); the Commissioner, Food and Drug Administration (FDA); 
and the Administrator, Centers for Medicare & Medicaid Services (CMS). 
The advice and guidance pertain to general issues related to 
improvement in clinical laboratory quality and laboratory medicine. In 
addition, the Committee provides advice and guidance on specific 
questions related to possible revision of the 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.
    CLIAC consists of 20 members and represents a diverse membership 
across laboratory specialties, professional roles (laboratory 
management, technical specialists, physicians, nurses) and practice 
settings (academic, clinical, public health), and includes a consumer 
representative. In addition, the Committee includes three ex officio 
members (or designees), including the Director, CDC; the Administrator, 
CMS; and the Commissioner, FDA. A nonvoting representative from the 
Advanced Medical Technology Association (AdvaMed) serves as the 
industry liaison. The Designated Federal Official (DFO) or their 
designee and the Executive Secretary are present at all meetings to 
ensure meetings are within applicable statutory, regulatory and HHS 
General Administration manual directives.
    Request for Candidates: Nominations are being sought for 
individuals who have expertise and qualifications necessary to 
contribute to accomplishing CLIAC's objectives. Nominees will be 
selected by the HHS Secretary or designee from authorities 
knowledgeable across the fields of microbiology (including 
bacteriology, mycobacteriology, mycology, parasitology, and virology), 
immunology (including histocompatibility), chemistry, hematology, 
pathology (including histopathology and cytology), or genetic testing 
(including cytogenetics); representatives from the fields of medical 
technology, public health, and clinical practice; and consumer 
representatives. Members may be invited to serve for terms of up to 
four years.
    The U.S. Department of Health and Human Services policy stipulates 
that Committee membership be balanced in terms of professional training 
and background, points of view represented, and the committee's 
function. Consideration is given on the basis of geographic, ethnic and 
gender representation. Nominees must be U.S. citizens, and cannot be 
full-time employees of the U.S. Government. Current participation on 
federal workgroups or prior experience serving on a federal advisory 
committee does not disqualify a candidate; however, HHS policy is to 
avoid excessive individual service on advisory committees and multiple 
committee memberships. Committee members are Special Government 
Employees, requiring the filing of financial disclosure reports at the 
beginning and annually during their terms. CDC reviews potential 
candidates for CLIAC membership each fall, and provides a slate of 
nominees for consideration to the Secretary of HHS for final selection. 
HHS notifies selected candidates of their appointment near the start of 
the term in July, or as soon as the HHS selection process is completed. 
Note that the need for different expertise and individuals to maintain 
the appropriate demographic balance varies from year to year and a 
candidate who is not selected in one year may be reconsidered in a 
subsequent year.
    Candidates should submit the following items for nomination 
consideration. The deadline for receipt of materials is September 15, 
2015:
     Current curriculum vitae, including complete contact 
information (name, affiliation, mailing address, telephone number, 
email address).
     Letter(s) of recommendation from person(s) not employed by 
the U.S. Department of Health and Human Services.
    Request for Suggested Meeting Topics: Consideration of topics for 
meeting agendas begins approximately four months prior to each meeting. 
The agendas are developed by CDC in collaboration with CMS, FDA, and 
the CLIAC Chair. Topics within the scope of the Committee's charge are 
selected and questions for CLIAC deliberation are developed to align 
with the agenda. The agenda is published in the Federal Register not 
less than 15 days before the meeting date and is posted on the CLIAC 
Web site (http://wwwn.cdc.gov/cliac/default.aspx). Suggested meeting 
topics are invited at any time for consideration at future meetings.
    Candidate suggestions and potential meeting topics may be submitted 
by:
     Email in care of the CLIAC Secretariat at [email protected].
     U.S. Postal Service: Attention: CLIAC Secretariat, 1600 
Clifton Road, NE., Mailstop F-11, Atlanta, GA 30329.
    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 
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. 2015-13313 Filed 6-1-15; 8:45 am]
 BILLING CODE 4163-18-P