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Effective Date: October 16, 2007


1. Purpose
2. Background
3. Scope
4. Responsibilities
5. Organization
6. Procedures
7. Subcommittees
8. Effective Date
9. Document History


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.


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.


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.


The following are the responsibilities of the Bioinformatics Board:

In performing these responsibilities the Bioinformatics Board will:


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:

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.


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:

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

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.


Bioinformatics Board Meetings:

Meeting agenda:




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.


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:

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:

Business Review Board organization:

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:

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

Project teams are responsible for:

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

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


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.

9. Document History -- SMG 2010.7, FDA Bioinformatics Board
1.0 Initial 04/17/2006 n/a Executive Secretary, FDA Management Council Janet Woodcock, Chair, FDA Management Council
2.0 Revision 10/16/2007 n/a Executive Director, Bioinformatics Board John R. Dyer, Deputy Commissioner for Operations. Janet Woodcock, Deputy Commissioner for Scientific and Medical Programs

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.)

FDA Official Councils and Committees: Index Page

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