SMG 1114.67

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

DIVISION OF GENETIC AND REPRODUCTIVE TOXICOLOGY

Effective Date: 01/13/2009

1. DIVISION OF GENETIC AND REPRODUCTIVE TOXICOLOGY (DAECCB).

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 areas of genetic and reproductive toxicology.

B. Organizes, plans, develops and directs scientific research in the areas of genetic toxicology and reproduction.

C. Advises the Director, Office of Research, in the planning and implementation of strategies for achieving annual and long-range plans for research in the areas of genetic toxicology and reproductive toxicology.

D. Provides leadership and direction to staff regarding all division functions.

2. GENETIC TOXICOLOGY LABORATORY (DAECCB1).

A. Performs research aimed at developing testing procedures for evaluating mutagenic effects of chemical toxicants and, in particular, in developing improved methods for detecting genetic alteration.

B. Conducts research on improved methodology for screening chemical toxicants.

C. Conducts research on developing techniques for mutagenic screening in mammals.

D. Provides expertise regarding the mechanisms of mutation as a function of dose, as a consequence of DNA damage, and relative to occurrence of tumor.

E. Develops short-term assays to detect single gene mutations, to detect chromosomal mutations, to detect DNA damage, and for dosimeters of exposure.

F. Develops in vivo and in vitro approaches for utilizing transgenic systems to assess and predict mutagenic and carcinogenic processes.

3. REPRODUCTIVE TOXICOLOGY LABORATORY (DAECCB2).

A. Develops short-term assays to detect single gene mutations, to detect chromosomal mutations, to detect DNA damage, and for dosimeters of exposure.

B. Develops in vivo and in vitro systems to evaluate reproductive toxins.

C. Conducts studies to determine the effect of toxicants on the progeny of exposed animals using morphological, pharmacokinetic, DNA and RNS-based methodology.

D. Expands positive findings into species reflecting morphology.

E. Conducts studies comparing the pharmacodynamics of compounds in common laboratory animals including rats, mice, rabbits, dogs, and primates.

F. Conducts studies which will support the development of knowledge bases.

G. Assesses human risk as the result of exposure to reproductive and developmental toxicants.

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.