SMG 1114.65

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF SCIENTIFIC AND MEDICAL PROGRAMS

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

OFFICE OF THE CENTER DIRECTOR

OFFICE OF RESEARCH

Effective Date: 01/13/2009

1. OFFICE OF RESEARCH ( DAECC)

A. Organizes, plans, and directs Center research programs in accordance with Center-wide strategic direction. Implements Center-wide strategies for achieving annual and long-range plans for research.

B. Provides leadership and direction for communications among scientific and administrative staffs.

C. Organizes, plans, and directs Center for research support in the areas of pathology, diet preparation, and animal husbandry.

D. Directs studies on the kinetics and metabolism of chemicals prerequisite to the implementation of carcinogenic, teratogenic, mutagenic experiments; directs the development of protocols for safety evaluation of toxic chemicals.

E. Directs the development methods used to extrapolate test results from animals to humans.

F. Directs the development of in-vitro models to serve as links in the assessment of toxic manifestations expected in mammals in general and in humans in particular.

G. Directs research to expand comparative physiology and biochemistry for primates and other potentially applicable experimental species.

H. Coordinates research in Center program areas with leading scientists in other segments of FDA and the scientific community at large and promotes and coordinates the transfer of the Center’s technology transfer under the provisions of the Federal Technology Transfer Act.

I. Coordinates with other Center and Agency components and top level officials of other agencies to provide input for long-term research planning in responsible program areas. Insures that programs implemented are responsive to the Center’s portion of the Agency’s integrated research plan.

J. Provides scientific oversight of Center research contracts and agreements.

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.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	07/29/2008	N/a	OC/OO/OM/OMP	Associate Director, Office of Executive Programs and Services, NCTR
Revision	01/13/2009	N/a	OC/OO/OM/OMP	Commissioner of the Food and Drug Administration