SMG 1283.7

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE CHIEF SCIENTIST

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

OFFICE OF RESEARCH

DIVISION OF SYSTEMS BIOLOGY

Effective Date: 07/08/2011

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1. DIVISION OF SYSTEMS BIOLOGY (DAECCE)

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

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

C. Develops and implements bioinformatic 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 innovative technology and analytical chemical methods related to the mission of FDA

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

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of Health and Human Services, effective July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	07/08/2011	N/a	OO/OM	Secretary of the Department of Health and Human Services