SMG 1114.69

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE CHIEF SCIENITIST

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

OFFICE OF THE CENTER DIRECTOR

OFFICE OF RESEARCH

DIVISION OF MICROBIOLOGY

Effective Date: 01/13/2009

1. DIVISION OF MICROBIOLOGY (DAECCD).

A. Advises the Deputy Director for Research in the planning and implementation of strategies for achieving annual and long-range plans for research and research support in the area of microbiology.

B. Conducts independent or collaborative applied research and development in the various fields of microbiology as they relate to programs involving biochemical toxicology, genetic and reproductive toxicology, developmental toxicology, neurotoxicology, molecular epidemiology and toxicity evaluations.

C. Develops, modifies, and validates microbial testing procedures which contribute to the assessment to toxic industrial chemical, drugs, food additives, or naturally occurring and potentially toxic materials in the environment.

D. Directs and implements a microbiological surveillance program, providing quality assurance for all laboratory animal operations and toxicology experiments involving animal systems.

E. Investigates and implements quality assurance tests to ensure that toxicological experimentation is not interrupted or confounded by microbiological entities. Develops techniques to detect food-borne pathogens.

F. Defines the role of microorganisms in degradation and detoxification of potentially hazardous compounds.

G. Determines the kinetics of biodegradation using environmental models.

H. Defines the role of intestinal microflora in activation or detoxification of xenobiotics.

I. Uses microorganisms as models to predict metabolic pathways of drugs in mammals.

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.