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U.S. Department of Health and Human Services

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SMG 1283.2

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 GENETIC AND MOLECULAR TOXICOLOGY

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF GENETIC AND MOLECULAR TOXICOLOGY (DAECCB)

A. 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 molecular toxicology

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

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

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

E. Conducts research on improved methodology for screening chemical toxicants

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

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

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

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

J. Develops in vivo and in vitro systems to for use in the evaluation of molecular toxicology

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

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

M. Assesses human risk as the result of exposure to genetic toxicants

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of Health and Human Services, effective July 8, 2011.

STATUS (I, R, C) DATE APPROVED LOCATION
OF CHANGE HISTORY		 CONTACT APPROVING OFFICIAL
Initial 07/08/2011 N/a OO/OM Secretary of the Department of Health and Human Services
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