The National Center for Toxicological Research (NCTR) is an FDA research facility located near Jefferson, a rural community in south central Arkansas approximately 30 miles from Little Rock. The mission of NCTR is to conduct peer-reviewed scientific research that supports and anticipates FDA's current and future regulatory needs. This involves fundamental and applied research specifically designed to define biological mechanisms of action underlying the toxicity of products regulated by FDA. This research is aimed at understanding critical biological events in the expression of toxicity and at developing methods to improve assessment of human exposure, susceptibility and risk.

NCTR conducts integrated research with other FDA centers and leverages FDA resources through cooperative and/or collaborative agreements with other agencies, academia and industry. These interactions enhance opportunities to provide more effective risk measures for FDA-regulated products and support FDA enforcement through methods development.

NCTR research is focused within three strategic research goals:

1. The development of knowledge bases (KNLG)or the accumulation of data that have predictive values extending beyond the individual data elements and which foster the identification of data gaps and new research areas leading to the development of predictive systems in support of regulatory decisions.
2. The development of new strategies for the prediction of toxicity(PRED) based on mechanism-based assays that contribute to a profile of information that supports a regulatory decision.
3. The conduct of method- (METH), agent-(AGNT), or concept-driven (CNPT) research or the modification and development of better analytical and toxicological test methods, and the provision of data on specific agents of interest to FDA to facilitate current and anticipated regulatory needs.

NCTR research is conducted within the auspices of eight research divisions whose goals, ongoing research accomplishments and FY97 plans are summarized herein. All NCTR research is directed toward the resolution of scientific and regulatory issues that provide the basis for regulatory decisions.

An NCTR extramural Science Advisory Board, its subcommittees and liaison members from each of the other FDA centers/ORA actively provide guidance on the relevance and quality of these research efforts.

B.A. Schwetz, D.V.M., Ph.D.
Director, NCTR