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)

Page Range		31378-31378
FR Document		2015-13313

Federal Register, Volume 80 Issue 105 (Tuesday, 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]


-----------------------------------------------------------------------

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 CLIAC@cdc.gov.
     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 
NAnderson@cdc.gov.
    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

31378 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices

Leroy A. Richardson, and the Commissioner, FDA. A Candidates should submit the
Chief, Information Collection Review Office, nonvoting representative from the following items for nomination
Office of Scientific Integrity, Office of the Advanced Medical Technology consideration. The deadline for receipt
Associate Director for Science, Office of the Association (AdvaMed) serves as the of materials is September 15, 2015:
Director, Centers for Disease Control and industry liaison. The Designated Federal
Prevention. • Current curriculum vitae, including
Official (DFO) or their designee and the
[FR Doc. 2015–13384 Filed 6–1–15; 8:45 am] complete contact information (name,
Executive Secretary are present at all
BILLING CODE 4163–18–P meetings to ensure meetings are within affiliation, mailing address, telephone
applicable statutory, regulatory and number, email address).
HHS General Administration manual • Letter(s) of recommendation from
DEPARTMENT OF HEALTH AND directives. person(s) not employed by the U.S.
HUMAN SERVICES Request for Candidates: Nominations Department of Health and Human
are being sought for individuals who Services.
Centers for Disease Control and
have expertise and qualifications
Prevention Request for Suggested Meeting Topics:
necessary to contribute to
accomplishing CLIAC’s objectives. Consideration of topics for meeting
Request for Nominations of agendas begins approximately four
Candidates To Serve on the Clinical Nominees will be selected by the HHS
Secretary or designee from authorities months prior to each meeting. The
Laboratory Improvement Advisory agendas are developed by CDC in
Committee (CLIAC) and Request for knowledgeable across the fields of
microbiology (including bacteriology, collaboration with CMS, FDA, and the
Suggested Meeting Topics for CLIAC
mycobacteriology, mycology, CLIAC Chair. Topics within the scope of
The Centers for Disease Control and parasitology, and virology), immunology the Committee’s charge are selected and
Prevention (CDC) is soliciting (including histocompatibility), questions for CLIAC deliberation are
nominations for membership on CLIAC chemistry, hematology, pathology developed to align with the agenda. The
and soliciting suggestions for topics to (including histopathology and cytology), agenda is published in the Federal
be considered for future Committee or genetic testing (including Register not less than 15 days before the
deliberation. CLIAC provides scientific cytogenetics); representatives from the meeting date and is posted on the
and technical advice and guidance to fields of medical technology, public CLIAC Web site (http://wwwn.cdc.gov/
the Secretary, Department of Health and health, and clinical practice; and cliac/default.aspx). Suggested meeting
Human Services (HHS); the Assistant consumer representatives. Members topics are invited at any time for
Secretary for Health, HHS; the Director, may be invited to serve for terms of up consideration at future meetings.
Centers for Disease Control and to four years.
Prevention (CDC); the Commissioner, The U.S. Department of Health and Candidate suggestions and potential
Food and Drug Administration (FDA); Human Services policy stipulates that meeting topics may be submitted by:
and the Administrator, Centers for Committee membership be balanced in • Email in care of the CLIAC
Medicare & Medicaid Services (CMS). terms of professional training and Secretariat at CLIAC@cdc.gov.
The advice and guidance pertain to background, points of view represented,
general issues related to improvement in • U.S. Postal Service: Attention:
and the committee’s function.
clinical laboratory quality and Consideration is given on the basis of CLIAC Secretariat, 1600 Clifton Road,
laboratory medicine. In addition, the geographic, ethnic and gender NE., Mailstop F–11, Atlanta, GA 30329.
Committee provides advice and representation. Nominees must be U.S. Contact Person for Additional
guidance on specific questions related citizens, and cannot be full-time Information: Nancy Anderson, Chief,
to possible revision of the CLIA employees of the U.S. Government. Laboratory Practice Standards Branch,
standards. Examples include providing Current participation on federal Division of Laboratory Systems, Center
guidance on studies designed to workgroups or prior experience serving for Surveillance, Epidemiology and
improve safety, effectiveness, efficiency, on a federal advisory committee does Laboratory Services, Office of Public
timeliness, equity, and patient- not disqualify a candidate; however, Health Scientific Services, Centers for
centeredness of laboratory services; HHS policy is to avoid excessive Disease Control and Prevention, 1600
revisions to the standards under which individual service on advisory Clifton Road, NE., Mailstop F–11,
clinical laboratories are regulated; the committees and multiple committee Atlanta, Georgia 30329–4018; telephone
impact of proposed revisions to the memberships. Committee members are (404) 498–2741; or via email at
standards on medical and laboratory Special Government Employees, NAnderson@cdc.gov.
practice; and the modification of the requiring the filing of financial
standards and provision of non- disclosure reports at the beginning and The Director, Management Analysis
regulatory guidelines to accommodate annually during their terms. CDC and Services Office, has been delegated
technological advances, such as new reviews potential candidates for CLIAC the authority to sign Federal Register
test methods and the electronic membership each fall, and provides a notices pertaining to announcements of
transmission of laboratory information. slate of nominees for consideration to meetings and other committee
CLIAC consists of 20 members and the Secretary of HHS for final selection. management activities for both the
represents a diverse membership across HHS notifies selected candidates of Centers for Disease Control and
laboratory specialties, professional roles their appointment near the start of the Prevention, and the Agency for Toxic
asabaliauskas on DSK5VPTVN1PROD with NOTICES

(laboratory management, technical term in July, or as soon as the HHS Substances and Disease Registry.
specialists, physicians, nurses) and selection process is completed. Note
practice settings (academic, clinical, that the need for different expertise and Elaine L. Baker,
public health), and includes a consumer individuals to maintain the appropriate Director, Management Analysis and Services
representative. In addition, the demographic balance varies from year to Office, Centers for Disease Control and
Committee includes three ex officio year and a candidate who is not selected Prevention.
members (or designees), including the in one year may be reconsidered in a [FR Doc. 2015–13313 Filed 6–1–15; 8:45 am]
Director, CDC; the Administrator, CMS; subsequent year. BILLING CODE 4163–18–P

VerDate Sep<11>2014 17:26 Jun 01, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\02JNN1.SGM 02JNN1

Document Created: 2015-12-15 15:12:23
Document Modified: 2015-12-15 15:12:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		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.
FR Citation		80 FR 31378

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 SERVICESCenters for Disease Control and Prevention

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

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