• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

SMG 3210.1





Transmittal Number 99-14 -- Date: 12/15/1998

Effective Date: 01/01/1999

[PDF Version]

 1. Purpose
 2. Background
 3. Definitions
 4. Policy
 5. Responsibilities
 6. Supersession
 7. Effective Date


This Staff Manual Guide (SMG) establishes Agency policy and outlines the roles and responsibilities in support of the information technology (IT) needs of the Agency to ensure compliance with legislative and executive level guidance.


Government and private industry must improve services and reduce costs to survive in the current political and economic environment. Congress recognizes that better management practices, enabled by IT, are critical for success. The Clinger-Cohen Act (CCA) of 1996 was passed to compel Federal organizations to be more accountable for economic and efficient management of IT, and directed agencies to establish a Chief Information Officer (CIO) position specifically for that purpose. The Agency must implement the requirements of the CCA in a manner consistent with the requirements of other legislation, such as the Paperwork Reduction Act (PRA) of 1995.

a. Clinger-Cohen Act of 1996. The CCA requires the head of each executive agency to design and implement a process for maximizing the value and assessing and managing the risks of IT acquisitions and requires agencies to designate a CIO for whom information resources management is the primary responsibility.

b. Establishment of FDA CIO. Pursuant to the requirements of the CCA, in a memorandum to Operating Division (OPDIV) Heads dated August 2, 1996, the Department of Health and Human Services (HHS) CIO requested OPDIV Heads to designate a CIO. On August 27, 1996, the Deputy Commissioner for Management and Systems established and designated the CIO for FDA.

c. Paperwork Reduction Act of 1995. PRA requires that agencies develop and maintain an ongoing process to ensure that IRM operations and decisions are integrated with organization planning, budget, financial management and program decisions. Further, agency program officials are required to develop and maintain a strategic IRM plan that describes how IRM activities help to accomplish agency missions and improve agency performance.


  • Information technology as defined in the CCA, means any equipment or subsystem of equipment that is used in the automatic acquisition, storage, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the Agency. The term "information technology" includes computers, ancillary equipment, software, firmware and related resources.
  • Information systems architecture (known as information technology architecture in the CCA) is an integrated framework for evolving or maintaining existing information technology and acquiring new information technology to achieve strategic goals and information resources management goals.
  • IT business planning is long-term planning that integrates organizational IT requirements and activities with an emphasis on development of supporting business cases.


It is the policy of FDA to implement and maintain a sound, integrated and cost-effective IT program and to comply with all applicable legislative requirements.


A. FDA Chief Information Officer

As outlined in the CCA, each agency must designate a CIO whose responsibilities include the following:

  • Provides advice and other assistance to the head of the agency and other senior management personnel to ensure that IT is acquired and information resources are managed in a manner that implements the policies and procedures of the CCA.
  • Develops, maintains, and facilitates the implementation of a sound and integrated IT architecture.
  • Promotes the effective and efficient design and operation of major information resources management processes.

In addition to the CIO, FDA resources instrumental in meeting CCA requirements include the Information Resources Management (IRM) Council, Technical Review Board (TRB), Technical Working Group (TWG), and Information Technology Investment Review Board (ITIRB).

B. Information Resources Management Council

The IRM Council, chaired by the CIO, is a central mechanism for coordinating, sharing, and disseminating technical information across the Agency. It serves as a forum to gain consensus on cross-cutting issues, and to implement policies, procedures and activities that are necessary to carry out FDA's IT management responsibilities. Responsibilities include the following:

  • Develop and/or review proposed or existing Agency-wide IRM strategies, policies, standards, and initiatives that cut across Center/Office organizational lines and recommend viable alternatives or action plans when necessary.
  • Review proposals made by the TWG (see d) and sub-working groups created to address technical issues and standards and recommend appropriate action.

C. Technical Review Board

The TRB, co-chaired by a senior official from the Office of the Chief Information Officer and a member of the TRB, is composed of senior IRM Officials from each Center/Office. It was created in support of the Agency's IT business planning process. The TRB is responsible for assessing the technical risk and soundness of IT investments, and for providing technical input to the ITIRB (see e).

D. Technical Working Group

The TWG is a cross-Center, cross-functional technical work group, which provides a cooperative forum for addressing technical issues, resolving implementation problems, and sharing experience about emerging information technologies. It is a single standing committee consisting of two representatives and one alternate from each Center/Office appointed by its designated senior IRM official. It is Chaired by a senior official from the Office of the Chief Information Officer, and Vice-Chaired by a member of the TWG. Responsibilities include the following:

  • Operate as an adjunct technical arm of the IRM Council. Reports to IRM Council on assigned issues and advises and recommends to the IRM Council methods, mechanisms, and solutions to improve implementation of IT within the Agency.
  • Form sub-working groups as needed, with the approval of the IRM Council, to address issues of interest in greater depth.

E. Information Technology Investment Review Board

The ITIRB, composed of Executive Officers, FDA CIO, and the Director of the Office of Financial Management, was created in support of the Agency's IT business planning process. While the TRB assesses the technical risk and soundness of the investment (see c above), the ITIRB, utilizing the TRB results, assesses the business value of the investment. Recommendations are submitted to senior management for final decision-making.


This SMG supersedes the following:

a. SMG FDA 1405.4, Authority for Information Resources, dated 5/24/95.

b. SMG FDA 2710.1, Information Management Council, dated 3/22/91.


January 1, 1999.