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Charter for the Science Advisory Board to NCTR
The Science Advisory Board to the National Center for Toxicological Research was established
under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350,
U.S.C. 217a, 241,242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); Pub. L. 92-463 (5 U.S.C.
App.), the Federal Advisory Committee Act, which sets forth standards for the formation and use
of advisory committees.
Objectives and Scope of Activities
The Science Advisory Board to the National Center for Toxicological Research advises the
Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe
and effective drugs for human use and, as required, any other product for which the Food and
Drug Administration has regulatory responsibility.
Description of Duties
The Board advises the Director, NCTR, in establishing, implementing and evaluation the
research programs that assist the Commissioner of Food and Drugs in fulfilling his regulatory
responsibilities. The Board provides an extra-agency review in ensuring that the research
programs at NCTR are scientifically sound and pertinent.
Agency or Official to Whom the Committee Reports
The Committee provides advice to the Commissioner of Food and Drugs
Management and support services shall be provided by the National Center for Toxicological
Estimated Annual Operating Costs and Staff Years
The estimated annual cost for operating the Committee, including compensation and travel
expenses for members but excluding staff support, is $57,963. The estimated person years of
staff support required is . 70, at an estimated annual cost of $170,820.
Designated Federal Officer
FDA will select a fulltime or permanent part-time Federal employee to serve as the Designated
Federal Officer (DFO) to attend each Committee 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 agendas, call all of the Committee and subcommittee
meetings, adjourn any meeting when the DFO determines adjournment to be in the public
interest and chair meetings when directed to do so by the official to whom the Committee
reports. The DFO shall be present at all meetings of the full committee and subcommittees.
Estimated Number and Frequency of Meetings
Meetings shall be held approximately once a year. Meetings shall be open to the public except
as determined otherwise by the Commissioner or designee in accordance with the Government in
the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act. Notice of all
meetings shall be given to the public.
Unless renewed by appropriate action the Science Advisory Board to the National Center for
Toxicological Research will terminate two years from the date the charter is filed.
Membership and Designation
The Committee shall consist of a core of nine voting members including the Chair. Members
and the Chair are selected by the Commissioner or designee from among authorities
knowledgeable in the fields of toxicological research. Members will be invited to serve for
overlapping terms of up to four years. Almost all non-Federal members of this committee serve
as Special Government Employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-oriented organizations or other
The Commissioner or designee shall have the authority to select members of other scientific and
technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily
as voting members and to designate consultants to serve temporarily as voting members when:
(1) expertise is required that is not available among current voting standing members ofthe
Committee (when additional voting members are added to the Committee to provide needed
expertise, a quorum will be based on the combined total of regular and added members), or (2) to
comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking.
Because of the size of the Committee and the variety in the types of issues that it will consider,
FDA may, in connection with a particular committee meeting, specify a quorum that is less than
a majority ofthe current voting members. The Agency's regulations (21 CFR §14.22(d))
authorize a committee charter to specify quorum requirements.
If functioning as a medical device panel, a non-voting representative of consumer interests and a
non-voting representative of industry interests will be included in addition to the voting
Temporary subcommittees consisting of two or more Committee members may be established by
the Commissioner or designee as needed to address specific issues within their respective areas
Subcommittees make preliminary recommendations regarding specific issues for subsequent
action by the full Committee. The Department Committee Management Officer shall be notified
upon establishment of each subcommittee, and shall be provided information on its name,
membership, function, and estimated frequency of meetings.
The records of the Committee, established subcommittees, or other subgroups of the committee,
shall be handled in accordance with General Records Schedule 26, Item 2 or other approved
agency records disposition schedule.
June 2, 2014
Jill Hartzler Warner, J.D.
Associate Commissioner for Special Medical Programs