SMG 1280.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE CHIEF SCIENTIST

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

Effective Date: 07/08/2011

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1. NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (DAEC)

A. Conducts peer-reviewed scientific research that supports and anticipates the Food and Drug Administration's (FDA) current and future regulatory needs involving fundamental and applied research specifically designed to define the biological mechanisms of action underlying the toxicity of products regulated by the FDA

B. Conducts additional research programs that utilize facilities and expertise of the Center and contribute to its overall scientific capability

C. Develops Center programs as a national resource in close cooperation with other agencies in the Department of Health and Human Services, Environmental Protection Agency (EPA), Consumer Product Safety Commissioner (CSPC), and other Federal agencies. Participates in the National Toxicology Program (NTP) as the FDA's representative

D. Operates with the advice of a Science Advisory Board consist­ing of members appointed by the FDA's Deputy Commissioner. The NCTR Science Advisory Board recommends research program priorities, reviews program and research results, reviews budget requirements and allotments, and recommends policy

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office 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	07/29/2008	N/a	OC/OO/ OM/OMP	Associate Director, Office of Executive Programs and Services, NCTR
Revision	1/13/2009	N/a	OC/OO/ OM/OMP	Commissioner of the Food and Drug Administration
Revision	07/08/2011	N/a	OO/OM	Secretary of the Department of Health and Human Services