SMG 1117.25

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF OPERATIONS

OFFICE OF INFORMATION MANAGEMENT

DIVISION OF TECHNOLOGY

Effective Date: 04/07/2008

1. DIVISION OF TECHNOLOGY (DAMAF).

A. Reviews and evaluates the appropriateness of new and emerging information technologies, including those with potential science &laboratory benefits and enterprise architecture, for incorporation into existing systems & applications and for use in future Agency supported initiatives.

B. Oversees the establishment and implementation through an enterprise approach of common IT frameworks, connectivity and consistent practices, standards & policies to enable and support interoperability and consistency throughout the Agency.

C. Establishes and manages through an enterprise approach the development of standards, including governance for reusable templates, services and common functions for application development.

D. Interacts with HHS, and other interagency groups to guide and align FDA to Government-wide initiatives regarding information technology.

E. Regularly attends industry and other technology meetings to stay abreast of emerging trends and technologies.

F. Directs and implements the FDA information security program to ensure that security controls for hardware, software and telecommunications solutions are effective, that it facilitates the continuity of operations for FDA information systems, it protects privacy, confidentiality and availability of FDA Data and that it manages system security policies and standards for FDA information systems enterprise-wide in accordance with the Agency, HHS, GSA, OMB and other Federal government security requirements.

G. Directs and responds to security audits and collaborates with assessment teams and other agency groups to develop and implement corrective action plans.

H. Establishes and communicates policies and procedures for system risk assessments and system business continuity & contingency planning.

I. Oversees disaster recovery planning for data center operations and coordinates with other divisions within OIM to plan, monitor, and test recovery plans for all applications throughout FDA.

J. Develops and monitors scientific workstation standards, as well as design and implement new IT methods and applications for scientific computing for Bioinformatics

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.