SMG 1114.68

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 PERSONALIZED NUTRITION AND MEDICINE

Effective Date: 01/13/2009

	1. Division of Personalized Nutrition and Medicine
	2. Biometry Branch
	3. Pharmacogenomics Branch
	4. Authority and Effective Date

1. DIVISION OF PERSONALIZED NUTRITION AND MEDICINE (DAECCC). 

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. BIOMETRY BRANCH (DAECCC1). 

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.

3. PHARMACOGENOMICS BRANCH (DAECCC2). 

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 molecular epidemiology.

B. Administers and leads the Center’s scientific research initiatives in the area of molecular epidemiology.

C. Conducts studies aimed at the development, validation and clinical application of molecular biomarkers of exposure and susceptibility.

D. Extrapolates results of animal bioassays and mechanistic studies to humans.

E. Develops and validates alternatives to the standard rodent bioassay for carcinogenicity.

F. Quantities measures of human exposure to a chemical carcinogen, along with an estimate of dose to the carcinogen target issue.

G. Assesses individual differences in human susceptibility to carcinogenesis by a chemical or class of chemicals.

4. 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