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FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

FDA OFFICIAL COUNCILS AND COMMITTEES

SMG 2010.6 - FDA MANAGEMENT AND OPERATIONS COUNCIL

Effective Date: March 3, 2005

1. PURPOSE.

This charter describes the duties and responsibilities of the Management and Operations Council (MOC), Food and Drug Administration (FDA). The Charter includes the organization of its membership and operating procedures, as well as explains the MOC’s structure and reporting relationship to the FDA Management Council (MC) and other councils and committees.

2. SCOPE.

In partnership with and accountability to the MC, the MOC provides the expert leadership necessary for development, implementation and oversight of the Agency’s administrative management and operations. The MOC advances the consistent and effective operation of management services, including budget/finance, information technology activities, human resources and similar functions. The MOC ensures that management issues and policies are addressed and resolved in a manner that enhances the best interests of the Agency.

The MOC is the Agency’s ultimate, knowledgeable resource regarding FDA-wide administrative management and operations issues. As such, each member provides vital counsel to the senior leadership of his/her organization regarding these issues. The MOC provides a forum for members to discuss, plan and support new and ongoing management initiatives, including HHS goals and the current administration’s initiatives. The MOC directs action and provides oversight on budget planning and execution; addresses and resolves problems or points of contention on issues within respective organizations; and shares the very best practices in the areas of administrative management and operations.

The MOC also serves as the Competitive Sourcing Council and the Chief Financial Officer (CFO) Council.

3. RESPONSIBILITIES

The MOC’s major Agency responsibilities include identifying, clarifying, prioritizing and making decisions or recommendations regarding management and operations initiatives.

In performing these responsibilities, the MOC will:

• Implement HHS, OMB and Presidential initiatives;
• Develop and implement FDA management initiatives;
• Serve in a senior expert advisory capacity to the MC on management issues by providing recommendations following debates and discussions;
• Communicate recommendations, decisions, and actions to MC and other interested parties;
• Review proposed new management initiatives for their development and implementation, taking only those with the greatest Agency controversy or funding implications to the MC;
• Collaborate on budget and performance planning issues and CFO Council topics;
• Serve as a forum for discussion of issues and challenges on issues from within their respective centers/offices and forward those determined to be most pertinent to the MC;
• Seek out best management practices and share them with the MC. This would be done as proven best practices surface or as they produce outstanding outcomes;
• Brief their OC/ORA/Center Directors on pertinent subjects from the MOC prior to the MC final decision meetings on the issues/problems. The briefing should include pros/cons on the issue and their recommendation, advice and counsel;
• Maintain records of MOC recommendations, decision, and actions;
• Serve as a communication channel through which all FDA employees will be able to express ideas as they relate to management and operations issues;
• Provide an annual report of its activities and recommendations to the FDA Management Council.

4. RELATIONSHIP TO OTHER COUNCILS.

The MOC works in parallel to several Agency councils and committees and does not have overlapping jurisdiction. These groups include but are not limited to the following:

• Customer Council – responsible for service agreements, strategic direction, and overall accountability for the Office of Shared Services;
• ITR Board – responsible for review and recommendations related to Agency information technology investment projects.
• FDA Management Council – responsible for coordinating business processes and management initiatives across the Agency.

5. STRUCTURE.

The MOC is comprised of each Office Director who reports directly to the FDA Associate Commissioner for Management and each Center/ORA/OC Executive Officer.

The Associate Commissioner for Management or, if required, the Assistant Commissioner for Management serves as Chairperson. The Chairperson is responsible for:

• Directing the activities of the MOC and planning its work agendas;
• Scheduling the discussion of activities;
• Coordinating the collection, management and dissemination of information and providing to the FDA Management Council recommendations, decisions, actions, and other information related to the responsibilities of the MOC.

Voting Members
Associate Commissioner for Management (or Assistant) - Chair
Center, OC, and ORA Executive Officers
Director, Office of Financial Management
Chief Information Officer
Chief, Office of Shared Services
Director, Office of Management Programs
(or their designees, who are authorized to make decisions on behalf of their principal)

Non-Voting Members
Assistant Commissioner for Management (except when serving as Chairperson)
Special Assistant to the Associate Commissioner for Management
Project Manager
OCC Executive Officer

The Project Manager is appointed by the Chairperson and is responsible for:

• Maintaining an accurate attendance list and distribution list;
• Arranging and organizing meetings including agendas;
• Distributing documents to the MOC members and assistants;
• Maintaining records of the activities, tasks and decisions assigned during meetings;
• Tracking and monitoring activities/tasks and regularly communicating milestones and status;
• Ensuring accuracy of the MOC documents;
• Preparing, tracking and monitoring action items for the MOC;
• Recording meeting minutes and other pertinent information related to the MOC;
• Compiling an annual report of the MOC’s activities and recommendations;
• Maintaining a list of designated alternate members.

Other participants, observers, and consultants from within the Agency and from other Federal government organizations or the private sector may participate at the discretion of the Chairperson or Assistant Commissioner for Management.

6. PROCEDURES.

Meetings:

• The meetings are held the first and third Thursday afternoon, if the agenda warrants, but no less than once each month;
• If the Associate Commissioner or Assistant Commissioner for Management is unavailable to chair the meeting, an elected Executive Officer (nominated by the Executive Officers who will serve a term of one-year) will run the meeting. However, major policy decisions will be deferred until either the Associate Commissioner or Assistant Commissioner for Management is in attendance;
• The Project Manager will be responsible for all activities as listed in the “Structure” section above.
• Only MOC members or their official designee will attend unless the chairperson approves the proposed attendee. Alternate members will be identified by principals and recorded by Project Manager for the purpose of maintaining accurate records as outlined in “Structure” above.

Meeting agenda:

• Proposed agenda items may be submitted by a MOC member to the Project Manager and the Chairperson;
• 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 MOC members and assistants the Monday before 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.
• When a vote is required, the Project Manager will call the roll and record the vote.
• When a 2/3 majority or consensus cannot be reached, the Associate Commissioner for Management (or Assistant) will make the final decision or escalate to the FDA Management Council, as appropriate.

Records:

• The Chairperson will ensure that the MOC activities, including recommendations, decisions, issues, action items, meeting summaries and other pertinent materials attributable to the MOC are documented and communicated to senior management and relevant staff, as appropriate, and in a timely manner.
• Records will generally be made available to Agency staff on the Office of Management Web site.

Amendments to the Management and Operations Council Charter can be proposed by MOC members at any time. Adoption of amendments to the charter 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.

7. EFFECTIVE DATE.

The effective date of this charter is March 3, 2005.

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