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FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

FDA OFFICIAL COUNCILS AND COMMITTEES

SMG 2010 - FDA MANAGEMENT COUNCIL

Effective Date: July 1, 2004

1. PURPOSE.

This charter describes the duties and responsibilities of the Food and Drug Administration (FDA) Management Council, the organization of its membership, and its operating procedures. This charter also explains the method for establishing expert working groups that report to the Management Council and their responsibilities, organization, and operating procedures.

2. BACKGROUND.

Within the current regulatory structure, the Management Council was formed to coordinate the business processes and management initiatives across the agency.

3. SCOPE.

The Management Council ensures that strategic initiatives are supported by FDA management activities. It is the decision-making body for FDA-wide management issues. The Management Council reports directly to the Commissioner, Food and Drugs who serves as the Chair of the Council.

4. RESPONSIBILITIES.

The following are the responsibilities of the Management Council:

• Identifies, clarifies, and prioritizes decision-making on FDA management initiatives
• Discusses and ratifies strategic management decisions
• Ensures that strategic management initiatives are supported by administrative management activities
• Approves the FDA Business Plan
• Serves as reporting body for designated subcommittees of the Management Council
• Serves as the OPDIV-level Information Technology Investment Review Board and is responsible for the prioritization and evaluation of investments that comprise the FDA Information Technology portfolio

In performing these responsibilities the Management Council will:

• Establish and oversee subcommittees for the purpose of fulfilling the Council's responsibilities
• Review work products of the subcommittees appointed by the Management Council to develop recommendations/options for management initiative implementation
• Communicate recommendations, decisions, and actions to senior management staff and other interested parties
• Maintain records of Management Council recommendations, decision, and actions
• Provide input to and work with other agency components as necessary to achieve FDA goals
• Provide an opportunity to exchange best practices across Centers/Offices for mission implementation

5. ORGANIZATION.

The Management Council will be organized as follows:

The Commissioner or Deputy Commissioner for Operations will be the Chairperson. The Chairperson is responsible for:

• Directing the activities of the team
• Overseeing the activities of subcommittees
• Coordinating the collection, management and dissemination of Management Council recommendations, decisions, actions, and other information related to the responsibilities of the Management Council

Membership will be as follows:

Voting Members
Deputy Commissioners
Associate Commissioner for Management
Center Directors
Associate Commissioner for Regulatory Affairs
Assistant Commissioner for Planning
Chief Information Officer
Chief, Office of Shared Services
or their designees with decision-making authority only

Non-Voting Members
Commissioner
Senior Advisor for Policy and Operations
Assistant Commissioner for Management
Director, Medical Policy Development
Director, Office of Financial Management
Director, Office of Management Programs
Director, Scientific Policy Development
Executive Officers from each Center
Executive Secretary

The Executive Secretary is appointed by the Chairperson and will be responsible for the following

• Maintaining an accurate membership list
• Arranging and organizing meetings
• Distributing documents to Management Council members and assistants
• Maintaining records of Management Council activities
• Ensuring accuracy of Management Council documents
• Preparing action items for the Management Council

Members of the Management Council will serve as long as they are in the above mentioned positions. The Management Council is for Principals only. A list of alternates will be provided to the Executive Secretary.

Other participants, observers, and consultants from within the agency and from other Federal government organizations may participate at the discretion of the Chairperson.

6. PROCEDURES.

Management Council meetings:

• Will be held on the first and third Thursdays of each month
• Will not be held if the Commissioner or Deputy Commissioner of Operations is unavailable to chair the meeting
• Will have actions items summarized in writing promptly after they are held. At a minimum, summaries should record attendees, issues presented, decisions made, and any outstanding action items. The minutes will be maintained by the Executive Secretary.
• Only Management Council members or their official designee will attend.

Meeting agenda:

• Proposed agenda items may be submitted by a Management Council member to the Executive Secretary, who will see that the Chairperson receives the item.
• The Chairperson will determine the applicability of a proposed item and decide if will included on the agenda.
• The decision will be communicated to the individual who submitted the proposal by the Executive Secretary.
• The agenda items should be submitted at least one week in advance. It will be indicated on the agenda if this is a decision meeting. "Act on documents" will be provided to the Management Council members and assistants the Friday (or as soon as available) prior to the meeting.

Voting

• Agreements generally are reached through consensus.
• When consensus has not been reached, a vote achieving 2/3 majority of the voting members is necessary for passage.
• A roll call vote will be taken and recorded by the Executive Secretary.
• When a 2/3 majority or consensus cannot be reached, the Commissioner will make the final decision.

Records

• The chairperson will ensure that Management Council activities including recommendations, decisions, issues, action items, meeting summaries and other pertinent materials attributable to the management Council are documented and communicated to senior management and relevant staff, as appropriate, in a timely manner.
• Records will generally be made available to agency staff on the FDA intranet.

7. SUBCOMMITTEES.

Subcommittees may be established under the following circumstances:

• The Management Council identifies a specific need, which could be best addressed by a few members with particular familiarity or interest in the subject.
• The FDA Management Council establishes a new subcommittee to achieve specific objectives.

Subcommittees will have a limited lifetime and will adjourn when:

• They have successfully completed their goal. or
• Additional work is not required from the subcommittee as determined by the Management Council.

Subcommittees are responsible for:

• Confirming objectives with the Management Council
• Defining member responsibilities
• Providing work products to the Management Council in a timely manner

Subcommittee members are responsible for:

• Representing their views to the Subcommittee
• Communicating the discussions of the Subcommittee to their Center/Office management and obtaining input from their Centers/Offices for communication to the subcommittee.
• Attending the Subcommittee meetings

Subcommittee organization:

• Each subcommittee will have a Chairperson who will direct the group's activities.
• The subcommittee chairperson and members will be selected by the Management Council from among a list of volunteers or by recommendation. Member selection will be based on Center/Office affiliation, qualifications, expertise, and ability to contribute to the expert-working group.
• Some subcommittees may contain representatives from other groups within the agency to provide needed expertise.
• Subcommittee membership will generally be kept small (six to eight members).

Each Subcommittee will support the Management Council in its area of expertise. This includes:

• Advising and assisting the Management Council in responding to agency staff
• Developing policies and procedures for the Management Council (when developing policies and procedures, the subcommittee should actively gather input from others in the agency).
• Responding to questions from the subcommittee on specific issues
• Documenting meetings with brief minutes

Amendments to the Management Council Charter can be proposed by Management Council members at any time. Adoption of amendments to the Management Charter Council will be by consensus. When consensus cannot be reached, a 2/3 majority vote will be required for passage.

This Charter will be valid until 5 years after the effective date, at which time the Charter will need to be certified as current or revised as needed.

8. EFFECTIVE DATE.

The effective date of this guide is July 1, 2004.

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