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Clinical Trials Advisory Committee
Charter Summary

AUTHORITY

42 U.S.C. 285a-2(b)(7), section 413(b)(7) of the PHS Act, as amended. The Committee is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

STRUCTURE

The Committee shall consist of 25 members, who may include the Director, NCI as Chair or a designee appointed by the NCI Director will chair the Committee. Five members will hold concurrent membership on either the National Cancer Advisory Board, Board of Scientific Advisors, Board of Scientific Counselors (Basic Sciences and Clinical Epidemiology), or Director’s Consumer Liaison Group. Members shall be authorities knowledgeable in the fields of community oncology, surgical oncology, medical oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory agencies, pharmaceutical industry, public health, clinical trials design, management and evaluation, drug development and developmental therapeutics, cancer education, cancer information services, community outreach, vaccine development, cellular oncology, molecular oncology, pediatric oncology, clinical, basic and translational research, cancer center administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, community outreach, oncology health care providers, pharmacology, pathology, biostatistics, quality of life, pain management, cancer treatment and restorative care, and education of health professionals. None of these members serve as Representatives.

Ex officio members include NCI Deputy Directors, the Director, Division of Extramural Activities, NCI, the Director, Division of Cancer Treatment and Diagnosis, an NCI intramural scientist engaged in clinical research, and representatives from the Food and Drug Administration, Centers for Medicare and Medicaid Services, the Department of Defense and Department of Veterans Affairs.

Members of the National Cancer Advisory Board, Board of Scientific Advisors, Board of Scientific Counselors (Basic Sciences and Clinical Epidemiology), and Director’s Consumer Liaison Group shall serve for the duration of their terms as members of their respective Boards/Committees.

Members shall be invited to serve for overlapping four-year terms; terms of more than two years are contingent upon the renewal of the Committee’s Charter by appropriate action prior to its expiration. A member may serve after the expiration of that member’s term until a successor has taken office.

As necessary, subcommittees may be established by the Executive Secretary or other designated Government official within the Committee's jurisdiction. The advice/recommendations of a subcommittee must be deliberated by the parent advisory committee. A subcommittee may not report directly to a Federal official unless there is statutory authority to do so.

Subcommittee membership may be drawn in whole or in part from the parent advisory committee. All subcommittee members may vote on subcommittee actions and all subcommittee members count towards the quorum for a subcommittee meeting. Ad hoc consultants do not count towards the quorum and may not vote. Subcommittee members who are not members of the parent committee may attend closed sessions of the parent committee meeting but they may not count towards the quorum of the parent committee and they cannot vote on committee actions. The Department Committee Management Officer shall be notified upon establishment of each standing subcommittee and shall be provided information on its name, membership, function, and estimated frequency of meetings.

A quorum for the conduct of business by the full Committee shall consist of a majority of currently appointed members. A quorum for the conduct of business by each standing subcommittee shall consist of the majority of currently appointed members.

The Director, NCI will assign a full-time or permanent part-time NCI employee to serve as the Executive Secretary, (also known as a Designated Federal Official or Government official) of the Committee. Management and support services shall be provided by the Coordinating Center for Clinical Trials, NCI.

FUNCTION

As necessary, and with the approval of the Executive Secretary, the Committee and subcommittees may call upon special consultants, assemble ad hoc working groups, and convene conferences and workshops.

MEETINGS

Meetings of the full Committee shall be held approximately three times a year, at the call of the Executive Secretary or other designated Government official. A Government official shall give advance approval of the agenda and be present at all the meetings of the Committee and its subcommittees.

Meetings shall be open to the public except as determined otherwise by the Secretary of Health and Human Services in accordance with subsection (c) of section 552b of Title 5, U.S.C. Notice of all meetings shall be given to the public.

Meetings shall be conducted and records of the proceedings kept, as required by applicable laws and Departmental policies.


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