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

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Information about this document as published in the Federal Register.

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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.

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Elaine L. Baker,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.

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[FR Doc. 2015-13313 Filed 6-1-15; 8:45 am]

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