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SMG 1265.10

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF INFORMATION AND TECHNOLOGY

Effective Date: 02/10/2005

[PDF Version]

1. OFFICE OF INFORMATION AND TECHNOLOGY (DBNE).

A. Plans and directs Center information technology operations and services. 

B. Serves as the point of contact for the Center’s information technology programs to both internal and external organizations.

C. Establishes and manages Center policies for information technology operations.

2. APPLIED TECHNOLOGIES STAFF (DBNE-1).

A. Provides quality assurance of corporate information systems during information technology development life-cycle and production.

B. Provides configuration management and operational support of corporate databases.

C. Coordinates the development, review, and maintenance of nomenclature standards for corporate databases.

3. ENTERPRISE ARCHITECTURE STAFF (DBNE-2).

A. Provides general technology support services to the Office.

B. Provides a central point in the Office for general information technology data and service requests by users.

C. Defines and coordinates implementation of the Center’s information technology security policy.

4. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office and Staffs were approved by the Deputy Commissioner for Operations effective June 26, 1997. Title changes to the staffs were approved by the Acting Director, Center for Drug Evaluation and Research on February 10, 2005. 

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial02/10/2005N/aOC/OA/OM/OMPActing Director, Center for Drug Evaluation and Research