FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
CENTER FOR BIOLOGICS, EVALUATION AND RESEARCH
OFFICE OF MANAGEMENT
DIVISION OF VETERINARY SERVICES
Effective Date: 07/08/2011
1. DIVISION OF VETERINARY SERVICES (DKKBBG).
A. Plans and conducts safety, neurovirulence, and potency tests on licensed biological product lots when such tests require the use of nonhuman primates. Plans and conducts research to improve existing neurovirulence and safety tests for live viral vaccines.
B. Provides pathology in support of Center research projects and product testing using animals. Conducts histopathological preparation and microscopic examinations of tissues of experimental animals.
C. Evaluates the acceptability of toxicological and other safety test data submitted as part of Investigational New Drugs (INDs), license applications and amendments, and in manufacturers protocols for licensed biological product lots.
D. Provides technical direction for extramural contracts concerned with rhesus monkey and chimpanzee breeding colonies and assists in collaborative research and management of contract-supported activities.
E. Conducts applied research on biological products in primate models, in collaboration with other federal investigators.
F. Oversees the use of and provides veterinary services for all animals used for testing and research in the Center by maintaining accreditation with the American Association for the Accreditation of Laboratory Animal Care.
G. Provides technical direction for extramural contracts concerned with animal care and training on updated methods of laboratory animal care to all Center animal facilities.
H. Provides veterinary expertise to the CBER Animal Care and Use Committee and approves all animal use proposals submitted by Center investigators.
2. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Division were approved by the Secretary of Health and Human Services on July 8, 2011.
|STATUS (I, R, C)||DATE APPROVED||LOCATION |
OF CHANGE HISTORY
|Initial||07/08/2011||N/a||OO/OBS||Secretary of Health and Human Services|