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SMG 1285.1

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 SCIENTIFIC COORDINATION

Effective Date: 08/01/2012

[PDF Version]

1. OFFICE OF SCIENTIFIC COORDINATION (DAECF)

A. Serves as principal authority and provides leadership for the FDA’s participation in the National Toxicology Program (NTP).

B. Directs the Center’s participation in the Interdisciplinary Toxicology (INTOX) Program.

C. Develops and provides strategies to achieve annual long term plans for research and research support in area of veterinary services.

D. Assures the animal care and use program maintains Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation and is in compliance with all laws, regulations, and guidelines applicable to use of animals in biomedical research.

E. Provides and maintains an animal breeding capability for selected species and strains. Maintains and cares for animal colonies used for breeding or research projects.

F. Organizes, plans, and directs Center for research support in the areas of pathology, diet preparation, and animal husbandry.

G. Provides and operates support services necessary to maintain the infection-free quality of the barrier operations.

H. Provides guidance, training, and technical support to the research staff in all matters of animal research.

I. Serves as the Contracting Officer Representative managing the major on-site animal care contract ensuring veterinary services for research animals and compliance of all regulations related to animal care and treatment.

J. Administers the animal care and use program including: management of all animal facilities, equipment, supplies; and development, implementation, and execution of the husbandry, technical, environmental enrichment, health monitoring, breeding, quarantine, quality control, occupational safety and health, diet preparation, and veterinary care programs.

K. 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. Also, initiates, manages, and reviews Center grants and cooperative agreements with regard to enhancing the Center research and science program activities.

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office were approved by the Center Director on August 1, 2012.

 

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