SUPPLEMENTARY INFORMATION:

Purpose: The Clinical Laboratory Improvement Advisory Committee (CLIAC) is charged with providing scientific and technical advice and guidance to the Secretary, Department of Health and Human Services; 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 & Medicaid Services (CMS). The advice and guidance pertain to general issues related to improvement in clinical laboratory quality and laboratory medicine and specific questions related to possible revision of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) standards. Examples include providing guidance on studies designed to improve quality, 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; the modification of the standards and provision of non-regulatory guidelines to accommodate technological advances, such as new test methods, electronic transmission of laboratory information, and mechanisms to improve the integration of public health and clinical laboratory practices.

Matters to be Considered: The agenda will include CDC, CMS, and FDA agency updates. Presentations and CLIAC discussions will focus on reports from two CLIAC workgroups, the Biosafety Workgroup and the Next Generation Sequencing Workgroup; cybersecurity requirements in the clinical laboratory; the determination of clinically relevant range of values for proficiency testing samples; and the utilization of remote technology for competency assessments. Agenda items are subject to change as priorities dictate.

Public Participation

It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments pertinent to agenda items.

Oral Public Comment: Public comment periods for each agenda item are scheduled immediately prior to the Committee discussion period for that item. In general, each individual or group requesting to present an oral comment will be limited to a total time of five minutes (unless otherwise indicated). Speakers should email CLIAC@cdc.gov or notify the contact person above (see FOR FURTHER INFORMATION CONTACT ) at least five business days prior to the meeting date.

Written Public Comment: CLIAC accepts written comments until the date of the meeting (unless otherwise stated). However, it is requested that comments be submitted at least five business days prior to the meeting date so that the comments may be made available to the Committee for their consideration and public distribution. Written comments should be submitted by email to CLIAC@cdc.gov or to the contact person above. All written comments will be included in the meeting minutes posted on the CLIAC website.

The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, 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.