SMG 1114.71

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 NEUROTOXICOLOGY

Effective Date: 01/13/2009

1. DIVISION OF NEUROTOXICOLOGY (DAECCF).

A. Develops and validates quantitative biomarkers of neurotoxicity and utilizes these biomarkers to clarify mechanisms of neurotoxicity.

B. Develops a multidisciplinary approach that integrates neurohistological, neurochemical, neurophysiological, and behavioral assessments to determine effects and mechanisms in neurotoxicology.

C. Determines target tissue concentrations and cellular interactions of neurotoxicants.

D. Reduces the uncertainty of extrapolation of neurotoxicity across species by using rodent and nonhuman primate animal models and comparing the results to humans when possible.

E. Administers and has lead scientific responsibilities for NCTR’s Neurotoxicology Program.

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.