Charter of the Science Board to the Food and Drug Administration

Purpose:
The Secretary and, by delegation, the Assistant Secretary for the Office of Public Health and Science and the Commissioner of Food and Drugs are charged with the administration of the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and various provisions of the Public Health Service Act. The Science Board to the Food and Drug Administration (Board) advises the Commissioner in discharging responsibilities as they relate to addressing specific and technically complex scientific issues of regulatory importance to FDA. The Board consists of a group of senior scientists with exceptionally accomplished backgrounds in evolving areas of new scientific research which will provide advice and further interaction between FDA, industry, academia, and other government agencies on technically complicated issues of regulatory importance.

Authority:
15 U.S.C. 1451 et seq.; 21 USC 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b), 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14, 330.10(a); the Board is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App.2), which sets forth standards for the formation and use of advisory committees.

Function:
The Board shall provide advice primarily to the Commissioner and other appropriate officials on specific complex and technical issues as well as, emerging issues within the scientific community. Additionally, the Board will provide advice to the Agency on keeping pace with technical and scientific evolutions in the fields of regulatory science; on formulating an appropriate research agenda; and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of Agency sponsored intramural and extramural scientific research programs.

Structure:
The Board shall consist of a core of 21 members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, or other scientific disciplines such as systems biology, wireless healthcare devices, nanotechnology, medical imaging, robotics, cell and tissue based products, regenerative medicine, and combination products. Members shall be chosen from academia and industry. The Board 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 interested persons. The Board may also include technically qualified federal members.

The Commissioner or designee shall have the authority to select members of other scientific and technical FDA Advisory Committees (normally not to exceed 30 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 of the Board (when additional voting members are added to the Board 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.

Members shall be invited to serve for overlapping four-year terms. Terms of more than two years are contingent upon the renewal of the Board by appropriate action prior to its expiration.

Temporary subcommittees consisting of two or more Board members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise. Subcommittees make preliminary recommendations regarding specific issues for subsequent action by the full Board. 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.

Management and support services shall be provided by the Executive Secretary of the Board located in the Office of Science and Health Coordination in the Office of the Commissioner, Food and Drug Administration.

Meetings:
Meetings shall be held approximately quarterly at the call of the Designated Federal officer, who shall also approve the agenda. A Designated Federal officer shall be present at all meetings.

Because of the size of the Board 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 of the current voting members. The Agency’s regulations (21 CFR 14.22(d)) authorize a committee charter to specify quorum requirements.

Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government and 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.

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

Compensation:
Members who are not full-time Federal employees shall be paid at the rate of the General Schedule 15, step 10, per day for time spent at meetings plus per diem and travel expenses in accordance with Standard Government Travel Regulations.

Annual Cost Estimate:
The estimated annual cost for operating the Board, including compensation and travel expenses for members but excluding staff support, is $253,797.00. The estimated person years of staff support are 2.2 FTE, at an estimated annual cost of $237,188.00.

Reports:
In the event that a portion of a meeting is closed to the public, in accordance with the Government and the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act, a report shall be prepared not later than November 1 of each year which contains as the minimum the function of the Board, a list of members and their business addresses, the dates and places of meetings, and a summary of the Board’s activities and recommendations during the preceding year. A copy of the report shall be provided to the Department Committee Management Officer.

Termination Date:
Unless renewed by appropriate action prior to its expiration, the Science Board to the Food and Drug Administration will terminate on June 26, 2010.

Approved:

Date: May 05, 2008

/s/
Randall W. Lutter, Ph.D.
Deputy Commissioner for Policy, FDA