SMG 1117.2

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF OPERATIONS

OFFICE OF INFORMATION MANAGEMENT

Effective Date: 04/07/2008

1. OFFICE OF INFORMATION MANAGEMENT (DAMAA).

A. Develops the architecture, standards, policies, governance, best practices and technology road map that support the business priorities of the Agency including managing information technology infrastructure, telecommunications, security, strategic planning, capital planning & investment control, enterprise architecture, and applications development & management.

B. Provides advice and assistance to the Commissioner and senior management officials on information technology resources and programs.

C. Establishes and oversees implementation of the Food and Drug Administration (FDA) information technology policy and governance, procedures and processes to bring the agency in conformance with the Clinger/Cohen Act and the Paperwork Reduction Act.

D. Provides leadership and direction regarding all aspects of the Agency records management program.

E. Works in full partnership with FDA business areas, develops and communicates the overall vision for the Agency’s IT program.

F. Provides expert technical evaluation and recommendations for the new and emerging technologies to ensure the Agency’s IT program can proactively adjust to changing business needs and technology drivers.

G. Represents the Agency IT program on internal and external meetings and workgroups on agency information technology programs and issues (e.g., Health and Human Services (HHS) Chief Information Officer (CIO) Council, FDA Leadership council, FDA level Review boards, etc.).

H. Established policies and procedures for system risk assessments and system business continuity and contingency planning.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this office were approved by the Deputy Commissioner for Operations, Office of Operations on April 7, 2008.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	04/07/2008	N/a	OC/OO/OM/OMP	Secretary of the Department of Health and Human Services