SMG 1114.70

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE CHIEF SCIENTIST

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

OFFICE OF THE CENTER DIRECTOR

OFFICE OF RESEARCH

DIVISION OF SYSTEMS TOXICOLOGY

Effective Date: 01/13/2009

1. DIVISION OF SYSTEMS TOXICOLOGY (DAECCE).

A. Advises the Deputy Director for Research in the planning and implementation of research and research support in the area of systems biology. Perform integrated OMICS research in conjunction with classic toxicology studies to provide a systems toxicology approach in support of the Food and Drug Administration’s (FDA) Critical Path.

B. Operates and maintains state of the art microarray, proteomics, and metabolic facilities. Performs and analyzes microarray studies in support of the FDA mission. Develops proteomic approaches to answer toxicological questions. Establishes metabolomics approaches and guidelines for preclinical and clinical submissions.

C. Develops and implements toxicoinformatic approaches for integrated “OMIC” analysis in support of toxicological research at the center.

D. Conducts or sponsors research aimed at developing state of the art analytical chemical methods related to the mission of FDA.

E. Develops new and improved research modals for determining the toxicological responses in liver and other target tissues of FDA regulated substances.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Deputy Commissioner, Food and Drug Administration effective January 13, 2009.