Nonhuman primates have become essential in a number of health-related 
activities, including basic biological and behavioral research as well 
as for biological production and for testing products. In this document, 
the aggregate of these uses has been referred to as health needs. Fourt 
general groups of activities are identified in the biomedical use of 
primates. 
* Legal and Regulatory . Procedures prescribed by law or regulation, 
e.g., those pertaining to production, potency testing, and safety 
testing of viral vaccine seed suspensions and vaccine lots of 
licensed products.^ 
* Biological Production . Preparation of biological material such 
as experimental vaccines, tissue cultures, serum products, and 
biological diagnostic reagents. This includes activities using 
primates for production phases of thse materials which are not 
specifically required by law or regulation. 
* Testing . Evaluation of efficacy or safety of products for 
prophylactic, therapeutic, and nutritional purposes. This in¬ 
cludes activities concerned with efficacy and safety testing of 
vaccines prior to licensure, and of other compounds, materials, 
apparatuses, or other devices prior to approval for marketing; 
it also includes activities using primates tissues for reference 
diagnostic purposes. 
* Research . The use of primates as models for the study of various 
disease processes or the development of information useful in 
understanding human behavior. Research on the biology of various 
primate species is also included here since this is fundamental 
to the better use of these animals in all of the aforementioned 
activities. 
The following tables represent a compilation of data on all nonhuman 
primates required for each categorical activity. The numbers contained 
within these tables are based upon analysis of usage trends over the 
past several years, current researc and development priorities re¬ 
lating to use of primates, and the opinions of experts in this field. 
They represent the best available data and can be expected to reasonably 
reflect national requirements for the next few years. 
^Title 21 CFR 600-680 (Food & Drugs; 
Biologies) 
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