81 FR 36543 - 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 81, Issue 109 (June 7, 2016)

Page Range		36543-36544
FR Document		2016-13438

Federal Register, Volume 81 Issue 109 (Tuesday, June 7, 2016)

[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Notices]
[Pages 36543-36544]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13438]


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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, the electronic 
transmission of laboratory information, and mechanisms to improve the 
integration of public health and clinical laboratory practices.
    CLIAC consists of 20 members including the Chair, 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 
Officer (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 year, 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 to be considered for 
nomination. The deadline for receipt of materials for the 2017 term is 
August 1, 2016:
     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

[[Page 36544]]

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.
    Submission of Candidate Information or Suggestions for Meeting 
Topics: 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. 2016-13438 Filed 6-6-16; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices 36543

placement of approximately 50,258 and soliciting suggestions for topics to mycobacteriology, mycology,
cubic yards of suitable oyster reef be considered for future Committee parasitology, and virology), immunology
substrate through the use of barges and deliberation. CLIAC provides scientific (including histocompatibility),
high-pressure water. Areas to be and technical advice and guidance to chemistry, hematology, pathology
restored would be marked with buoys or the Secretary, Department of Health and (including histopathology and cytology),
clearly marked stakes. Following the Human Services (HHS); the Assistant or genetic testing (including
completion of the planting, oyster Secretary for Health, HHS; the Director, cytogenetics); representatives from the
density sampling would be conducted Centers for Disease Control and fields of medical technology, public
and analyzed at a minimum of six Prevention (CDC); the Commissioner, health, and clinical practice; and
months, one year and two years after Food and Drug Administration (FDA); consumer representatives. Members
clutching at each restoration site. and the Administrator, Centers for may be invited to serve for terms of up
Ecological benefits associated with Medicare & Medicaid Services (CMS). to four years.
the Project would be realized through an The advice and guidance pertain to The U.S. Department of Health and
array of ecological services in the form general issues related to improvement in Human Services policy stipulates that
of increased fishery and wildlife habitat; clinical laboratory quality and Committee membership be balanced in
increased biodiversity and trophic laboratory medicine. In addition, the terms of professional training and
dynamics; increased filtering capacity to Committee provides advice and background, points of view represented,
improve water quality and recycle guidance on specific questions related and the committee’s function.
nutrients; increased structural stability to possible revision of the CLIA Consideration is given on the basis of
to reduce coastal erosion and to protect standards. Examples include providing geographic, ethnic and gender
near shore resources; protection of water guidance on studies designed to representation. Nominees must be U.S.
quality; and the protection of healthy, improve safety, effectiveness, efficiency, citizens, and cannot be full-time
diverse and sustainable living coastal timeliness, equity, and patient- employees of the U.S. Government.
marine resources. Beyond the fact that centeredness of laboratory services; Current participation on federal
oysters and oyster reef communities revisions to the standards under which workgroups or prior experience serving
represent important food sources for clinical laboratories are regulated; the on a federal advisory committee does
many species of commercially impact of proposed revisions to the not disqualify a candidate; however,
important fish and invertebrates, standards on medical and laboratory HHS policy is to avoid excessive
functioning oyster reefs are also practice; and the modification of the individual service on advisory
recognized as critical structural and standards and provision of non- committees and multiple committee
community components which stabilize regulatory guidelines to accommodate memberships. Committee members are
and sustain a broad array of ecological technological advances, such as new Special Government Employees,
relationships. Additional outcomes test methods, the electronic requiring the filing of financial
include economic benefits through transmission of laboratory information, disclosure reports at the beginning and
harvesting, processing, and marketing and mechanisms to improve the annually during their terms. CDC
fishery products locally and regionally integration of public health and clinical reviews potential candidates for CLIAC
by all who enjoy high-quality seafood. laboratory practices. membership each year, and provides a
Additional information on this CLIAC consists of 20 members slate of nominees for consideration to
Project, including metrics of success, including the Chair, and represents a the Secretary of HHS for final selection.
response to science reviews and more is diverse membership across laboratory HHS notifies selected candidates of
available in an activity-specific specialties, professional roles their appointment near the start of the
appendix to the FPL, which can be (laboratory management, technical term in July, or as soon as the HHS
found here: https:// specialists, physicians, nurses) and selection process is completed. Note
www.restorethegulf.gov. (Please see the practice settings (academic, clinical, that the need for different expertise and
table on page 24 of the FPL and click on public health), and includes a consumer individuals to maintain the appropriate
Apalachicola Bay Oyster Restoration, representative. In addition, the demographic balance varies from year to
Implementation.) Committee includes three ex officio year and a candidate who is not selected
Justin R. Ehrenwerth,
members (or designees), including the in one year may be reconsidered in a
Director, CDC; the Administrator, CMS; subsequent year.
Executive Director, Gulf Coast Ecosystem
Restoration Council.
and the Commissioner, FDA. A Candidates should submit the
nonvoting representative from the following items to be considered for
[FR Doc. 2016–13356 Filed 6–6–16; 8:45 am]
Advanced Medical Technology nomination. The deadline for receipt of
BILLING CODE 6560–58–P
Association (AdvaMed) serves as the materials for the 2017 term is August 1,
industry liaison. The Designated Federal 2016:
Officer (DFO) or their designee and the • Current curriculum vitae, including
DEPARTMENT OF HEALTH AND Executive Secretary are present at all complete contact information (name,
HUMAN SERVICES meetings to ensure meetings are within affiliation, mailing address, telephone
applicable statutory, regulatory and number, email address).
Centers for Disease Control and HHS General Administration manual • Letter(s) of recommendation from
Prevention directives. person(s) not employed by the U.S.
Request for Candidates: Nominations Department of Health and Human
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Request for Nominations of
Candidates To Serve on the Clinical are being sought for individuals who Services.
have expertise and qualifications Request for Suggested Meeting Topics:
Laboratory Improvement Advisory
necessary to contribute to Consideration of topics for meeting
Committee (CLIAC) and Request for
accomplishing CLIAC’s objectives. agendas begins approximately four
Suggested Meeting Topics for CLIAC
Nominees will be selected by the HHS months prior to each meeting. The
The Centers for Disease Control and Secretary or designee from authorities agendas are developed by CDC in
Prevention (CDC) is soliciting knowledgeable across the fields of collaboration with CMS, FDA, and the
nominations for membership on CLIAC microbiology (including bacteriology, CLIAC Chair. Topics within the scope of

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Document Created: 2018-02-08 07:31:26
Document Modified: 2018-02-08 07:31:26

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		81 FR 36543

81 FR 36543 - 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 81, Issue 109 (June 7, 2016)

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