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FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

FDA OFFICIAL COUNCILS AND COMMITTEES

SMG 2010.7 - FDA BIOINFORMATICS BOARD

Effective Date: October 16, 2007

1. PURPOSE.

This charter describes the duties and responsibilities of the Food and Drug Administration (FDA) Bioinformatics Board, its membership, and its subcommittees. Its operating procedures also are explained.

2. BACKGROUND.

FDA recognizes the need to establish the Bioinformatics Board in order to achieve the Agency’s goal for a modern, well-integrated, reliable, efficient and affordable information infrastructure to support FDA administrative and regulatory business operations. The Agency’s approach is based on the premise that oversight of the design, building and maintenance of such an infrastructure must be both business-driven and business-owned. The Agency’s regulatory business leaders must ultimately be responsible for the quality, performance and cost of the information systems that are built. Because the FDA business of public health protection involves regulatory decision making using biological, medical, behavioral and health data, FDA is using the term “bioinformatics”1 to describe the thrust and direction of this business oversight function.

On February 21, 2006, the FDA’s Senior Management approved the formation of a Bioinformatics Board to oversee the planning and control of FDA's bioinformatics activities and to ensure that the activities related to its charge are communicated to all levels of the Agency. The formation of the Bioinformatics Board addresses a growing number of business automation challenges facing FDA, and is intended to ensure that Agency planning for future business automation meets the needs of FDA programs while satisfying external demands on the Agency.

3. SCOPE.

The Bioinformatics Board will work under a strategic framework for automation established by the Commissioner and implemented by the Management Council. The Bioinformatics Board will coordinate and oversee all activities related to business automation planning, acquisition, and implementation decisions throughout FDA. The Bioinformatics Board will also ensure coordination of activities among FDA representatives to the Federal Health Architecture program and other federal health informatics initiatives, the FDA Regulation Policy Council, the FDA Data Standards Council, and the Enterprise Architecture Review Board, particularly with regard to business process planning and regulatory policies. The Bioinformatics Board will report directly to the FDA Management Council.

4. RESPONSIBILITIES.

The following are the responsibilities of the Bioinformatics Board:

• Act as the Management Council’s delegated Information Technology Investment Review Board (ITIRB) for FDA’s business process automation and bioinformatics activities, clearing major decisions with Management Council.
• Approve all IT budget execution decisions beginning in FY 2007.
• Oversee business decisions on priority, planning and execution of Agency cross-cutting automation projects, and direct the related business process analyses.
• Adopt standard practices and methodologies as recommended by Office of Planning for standardized approach to business process analysis.
• Adopt data standards and a standards development plan to be proposed by the Data Standards Council.
• Ratify plans for necessary adjustments to regulations and guidance.
• Ratify information technology standards as developed by the Chief Information Officer.
• Facilitate resolution of related resource issues, including staffing for cross center initiatives.
• Oversee planning activities to ensure coordination between data and terminology standards development, regulatory analysis and modifications, business process analysis, application software requirements, and IT hardware/ systems requirements as they relate to business automation activities of the board.
• Direct the work of the Business Review Boards (BRBs) and vote on proposals put forth by the Business Review Boards.

In performing these responsibilities the Bioinformatics Board will:

• Provide quarterly updates to Management Council.
• Establish regular meeting schedules for designated BRBs with routine reporting of progress against established work plans and budgets.
• Establish and oversee standing subcommittees and establish needed ad hoc working groups.
• Review findings and recommendations of the BRBs and working groups with the goal of making decisions for implementation.
• Maintain records of Bioinformatics Board recommendations, decisions, and actions.
• Communicate recommendations and decisions up and down all levels of FDA's organization.
• Provide input to and work with other Agency/Federal components as necessary to achieve FDA goals (e.g., the Data Standards Council, Federal Health Architecture group).
• Facilitate the exchange of best practices across Centers/Offices to ensure successful mission development and implementation.

5. ORGANIZATION.

The Bioinformatics Board will be organized as follows:

The Bioinformatics Board reports to the Management Council, which is the most senior-level sponsoring body for the FDA bioinformatics. The Deputy Commissioner, Chief Operating Officer, and Deputy Commissioner, Chief Medical Officer will be Co-Chairs of the Bioinformatics Board. The Chairs are responsible for:

• Directing the activities of the Bioinformatics Board;
• Overseeing the activities of subcommittees and working groups; and
• Coordinating the collection, management and dissemination of recommendations, decisions, actions, and other information related to the responsibilities of the Bioinformatics Board.

Membership will be as follows:

Deputy Commissioner, Chief Operating Officer (Co-Chair)
Deputy Commissioner, Chief Medical Officer (Co-Chair)
Assistant Commissioner for Planning
Associate Commissioner for Policy and Planning or Assistant Commissioner for Policy
Associate Commissioner for Regulatory Affairs
Senior representative, Office of Management
Two senior program representatives each from CBER, CDRH, CDER, CFSAN, CVM, NCTR, and one additional senior program representative from ORA
Chief Information Officer
Chair, Data Standards Council

The Center/Office senior program representatives will be Office/Division Director level or above, and will be delegated the appropriate authority by their Center Director / Office Commissioner to act and make decisions on the behalf of their organization.

Members of the Bioinformatics Board will serve as long as they are in the above mentioned positions. The Bioinformatics Board is for Principals only. A list of alternates who can attend and act on behalf of the Principals 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 Chair.

Staffing

The Bioinformatics Board will be staffed by an Executive Director and Executive Secretary provided by the Office of the Commissioner. Additional analytical support may be provided by a senior operations research analyst, a senior financial analyst, and other analysts as necessary.

Executive Director. The Executive Director is appointed by the Chairs and is responsible for the following:

• Provides Bioinformatics Board with timely executive-level information on Business Review Board(s) activities to enable the Board to make strategic and tactical corrections to information management direction;
• Sets agenda for the Bioinformatics Board in consultation with the Chairs;
• Monitors all Business Review Board content and progress on activities, elevating issues that require Bioinformatics Board attention;
• Ensures Bioinformatics Board directions are appropriately executed by Business Review Boards;
• Ensures that proper agency-level analysis and recommendations regarding future agency cross-cutting work, including Federal initiatives, are fully vetted; and
• Evaluates Business Review Board Program Managers.

Executive Secretary. The Executive Secretary is appointed by the Chairs and is responsible for the following:

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

Other Organizational Relationships

Other organizations/individuals who will report into the Bioinformatics Board include the following:

FDA Federal Health Informatics Program Liaison
Regulation Policy Council
Data Standards Council
Enterprise Architecture Review Board
PDUFA Review Board

The Chair / Lead of each of these will ensure that the Bioinformatics Board is informed of activities occurring within their purview, and coordinate releases and activities through the Bioinformatics Board.

6. PROCEDURES.

Bioinformatics Board Meetings:

• Will be held bi-weekly and ad hoc as needed.
• Will be chaired by the Executive Director or Chief Information Officer if neither Co-Chair is available 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 Bioinformatics Board members or their official alternates, and Bioinformatics Board Staff will attend. The Board may invite subject matter experts or others to attend specific meetings.

Meeting agenda:

• Proposed agenda items may be submitted by a Bioinformatics Board member to the Executive Secretary or developed by the Chairs and Executive Director
• The Chairs will determine the applicability of a proposed item and decide if it will be included on the agenda.
• The decision will be communicated to the individual who submitted the proposal by the Executive Secretary.
• Agenda items generally will be submitted at least one week in advance. It will be indicated on the agenda if this is a decision meeting. Action documents will be provided to the Bioinformatics Board members and assistants at least 4 working days before a meeting.

Voting:

• Agreements generally are reached through consensus.
• In cases where consensus has not been reached, a vote achieving two-thirds majority of the voting members present is necessary for passage.
• When voting is conducted, a roll call vote will be taken and recorded by the Executive Secretary.
• In situations where a two-thirds majority or consensus cannot be reached, the decision will be referred to the Management Council. Management Council decisions may be appealed to the FDA Commissioner by principals of the Management Council.
• Individual principal components (ORA and the Centers) can also request Management Council review of decisions in cases of disagreement.
• Twelve members will constitute a quorum. The Board will not vote in the absence of a quorum.

Records:

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

Amendments:

Amendments to the Bioinformatics Board Charter can be proposed by Bioinformatics Board members at any time. Adoption of amendments to the Bioinformatics Board Charter will be by consensus. When consensus cannot be reached, a two-thirds majority vote will be required for passage.

7. SUBCOMMITTEES.

Business Review Boards. Business Review Boards (BRBs) that correspond to the core business areas identified in the Agency’s common business process model will be established as standing subcommittees of the Bioinformatics Board. In addition, a BRB to support the scientific computing and computational science work of the FDA will be established. The BRBs include:

• Pre-Market Review
• Product Quality and Compliance
• Post-Market Safety
• Administrative Services
• Scientific Computing/Computational Science

Membership and procedures for each of the standing BRBs will be established by the Bioinformatics Board. Each BRB will support the Bioinformatics Board in its respective areas of expertise, including:

• Act as the agency-wide “business sponsor” of new systems development.
• Provide oversight and direction of the work being performed on IT systems and projects within their defined area.
• Review at a high level recommended new data standards, revisions to current regulations, changes in business process, and functional and technical requirements.
• Review staffing of projects to ensure that the most appropriate experts from their programs are involved in that work.
• Identify candidate projects for cross-agency initiatives.
• Prepare and present proposals to the Bioinformatics Board for review and approval.
• Advise and assist the Bioinformatics Board in responding to questions on specific issues.
• Develop policies and procedures for the Bioinformatics Board (when developing policies and procedures, the subcommittee should actively gather input from others in the agency).
• Document meetings with brief minutes.

Business Review Board organization:

• Each BRB will have a Chair who will direct the group's activities.
• The Chair and members will be selected by the Bioinformatics Board 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 BRB.
• Membership within each BRB will generally be kept small (six to eight members).
• Each BRB will have a Program Manager who will support the BRB Chair and coordinate the BRB’s activities with the Bioinformatics Board, other BRBs, and the Project Teams.
• Each BRB will be supported by analysts who provide expertise in the following areas:
• Policy
• Business process planning
• Data standards
• Information technology
• Finance

The Chief Information Officer (CIO) will identify the appropriate IT Program Manager to support the BRBs.

Project Teams. The BRBs will establish project teams to support major cross-agency initiatives within or across the core business areas to investigate and make recommendations on the following topics:

• Identify staff to serve as Business Managers for identified projects
• Provide necessary input to BRB for assigned projects regarding new data standards, revisions to current regulations, changes in business processes, and functional and technical requirements.
• Assure that user requirements are analyzed and met throughout the system lifecycle.

The Chief Information Officer (CIO) or his/her delegate will identify the appropriate IT project managers for these initiatives.

Project teams are responsible for:

• Defining their specific member responsibilities and timelines
• Presenting conclusions and recommendations to the appropriate Business Review Board.
• Providing work products to the Business Review Board in a timely manner
• Representing their views to the working group
• Attending meetings on a regular basis

Project teams will have a limited lifetime and will adjourn when:

• They have successfully completed their goal
• They are disbanded by the Bioinformatics Board

Ad Hoc Subcommittees. The Bioinformatics Board can establish other subcommittees in the following situations:

• When issues arise that cut across multiple core business areas.
• When the Board identifies a specific need that could be best addressed by a few members with particular familiarity or interest in the subject.
• To achieve specific objectives.

8. EFFECTIVE DATE.

The effective date of this Charter is October 16, 2007. This Charter will be valid until 5 years after the effective date, at which time the Charter will be certified as current or revised as needed.

Footnote: ¹ This usage is consistent with a definition of bioinformatics provided by Lacroix and Critchlow: “Bioinformatics is the design and development of computer-based technology that supports life science.” (Zoe Lacroix and Terence Critchlow, Bioinformatics: Managing Scientific Data. San Francisco: Morgan Kaufman Publishers, 2003.)

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