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 BIOINFORMATICS AND BIOSTATISTICS
Effective Date: 08/01/2012
1. DIVISION OF BIOINFORMATICS AND BIOSTATISTICS (DAECCC)
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 biometry and risk assessment.
B. Develops statistical testing methods and predictive systems for identifying potential health hazards associated with toxic substances.
C. Develops biometrical methods for estimating risks associated with toxic substances to enable setting exposure levels that correctly reflect underlying uncertainties.
D. Develops mathematical models for better representation of internal exposure levels of biological mechanisms in order to reduce uncertainty in estimates of risk.
E. Provides expertise to NCTR scientists on design, conduct and analysis of research studies to evaluate the toxicity of regulated products.
F. Assists other FDA centers in conducting risk assessments for the regulation of specific products and in investigating generic risk assessment issues.
G. Participates in interagency risk assessment activities to maintain knowledge of the state of the art, and to promote the improvement and unification of risk assessment practices across agencies.
H. Conducts research in bioinformatics and chemoinformatics, and develops and coordinates informatics capabilities within NCTR, across FDA Centers, and in the larger toxicology community.
I. Develop methods for the analysis and integration of omics (genomic, transcriptomic, proteomic, and metabolomic) databases with the objective of knowledge discovery and the elucidation of mechanisms of toxicity.
J. Conduct of scientific computing which involves application of algorithms to extract knowledge, construct models, and make inferences from scientific data to support FDA regulatory need.
2. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Division were approved by the Center Director on August 1, 2012.