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CLIAC Charter

Charter Effective Date: Monday, February 06, 2012

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Authority


The Clinical Laboratory Improvement Advisory Committee was established under Section 222 of the Public Health Service Act [42 U.S.C. ยง 217a], as amended. The committee is governed by the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App., which sets forth standards for the formation and use of advisory committees.

Objective and Scope of Activities


The Secretary is authorized under the Clinical Laboratory Improvement Amendments (CLIA) at Section 353 (42 U.S.C. Section 263a) of the Public Health Service Act, as amended, to establish standards for quality assurance and quality control; personnel; proficiency testing; maintenance of records, equipment, and facilities that must be met by all clinical laboratories in the United States. These standards should ensure consistent, accurate, and reliable test results. Further, under Section 301 (42 U.S.C. Section 241) ofthe Public Health Service Act, as amended, the Secretary is authorized to encourage, cooperate with, and render assistance to other public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of diseases.

Description of Duties


The Clinical Laboratory Improvement Advisory Committee shall provide scientific and technical advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Assistant Secretary for Health; the Director, Centers for Disease Control and Prevention (CDC); 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. In addition, the committee shall provide 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 submission of laboratory information.

Agency or Official to Whom the Committee Reports


The committee reports to the Secretary, HHS; the Assistant Secretary for Health; the Director, CDC; the Commissioner, FDA; and the Administrator, CMS.

Support


Management and support services shall be provided by the Office of Surveillance, Epidemiology, and Laboratory Services, CDC.

Estimated Annual Operating Costs and Staff Years


Estimated annual cost for operating the committee, including compensation and travel expenses for members, but excluding staff support, is $177,499. Estimate of annual person-years of staff support required is 2.3 at an estimated annual cost of $274,956.

Designated Federal Officer


CDC will select a fulltime or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each board meeting and ensure that all procedures are within applicable statutory, regulatory, and HHS General Administration manual directives. The DFO will approve and prepare all meeting policies and agendas, call all of the board and subcommittee meetings, adjourn any meeting when the DFO deems adjournment to be in the public interest, and chair meetings when directed to do so by the official to whom the board reports. The DFO or his/her designee shall be present at all meetings of the full board and subcommittees.

Estimated Number and Frequency of Meetings


Meetings shall be held approximately two times per year at the call of the DFO, in consultation with the Chair.

Meetings shall be open to the public except as determined otherwise by the Secretary, HHS, or other official, to whom the authority has been delegated, in accordance with the Government in the Sunshine Act [5 U.S.C. Section 552b(c)] and Section IO(d) of the Federal Advisory Committee Act. Notice of all meetings shall be given to the public.

Duration


Continuing.

Termination


Unless renewed by appropriate action prior to expiration, the Clinical Laboratory Improvement Advisory Committee will terminate two years from the date this charter is filed.

Membership and Designation


The committee shall consist of 20 members, including the Chair, and may include a Federal employee. Members shall be selected by the Secretary from authorities knowledgeable in the fields of microbiology (including bacteriology, mycobacteriology, mycology, parasitology, and virology); immunology (including histocompatibility); chemistry; hematology; pathology (including histopathology and cytology); genetic testing (including cytogenetics); representatives from the fields of medical technology, public health, and clinical practice; and consumer representatives. Members shall be deemed Special Government Employees.

The committee shall also consist of three voting ex officio members, or designees: the Director, CDC; the Commissioner, FDA; and the Administrator, CMS; and such additional officers of the United States government that the Secretary deems are necessary for the committee to effectively carry out its functions. The committee shall also include a nonvoting liaison representative who is a member of the Advanced Medical Technology Association and such other nonvoting liaison representatives as the Secretary deems necessary to effectively carry out the functions of the committee. Liaisons shall be deemed representatives.

Members shall be invited to serve for overlapping terms of up to four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of that term. Terms of more than two years are contingent upon the renewal of the committee by appropriate action prior to its termination. A member may serve 180 days after the expiration of that member's term if a successor has not taken office.

Subcommittees


Subcommittees composed of members and nonmembers of the parent committee may be established with the approval of the Secretary, HHS, or his/her designee. The subcommittees must report back to the parent committee and do not provide advice or work products directly to the agency. The Department Committee Management Officer will be notified upon establishment of each subcommittee and will be provided information on its name, membership, function, and estimated frequency of meetings.

Recordkeeping


The records of the board, established subcommittees, or other subgroups of the board, shall be managed in accordance with General Records Schedule 26, Item 2, or other approved agency records disposition schedule. These records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. Section 552.

Filing Date


February 19, 2012
Contact Us:
  • Centers for Disease Control and Prevention,
    Division of Laboratory Programs, Standards, and Services
    1600 Clifton Road
    Mailstop F-11
    Atlanta, GA 30333, USA
  • CLIAC Direct Line:
    404-498-2290
  • CLIAC@cdc.gov
 
USA.gov: The U.S. Government's Official Web PortalDepartment of Health and Human Services
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