Sprague-Dawley rats (Charles River) FDA-130321

See attached Notice of Intent to Sole Source requirement for Sprague Dawley rats for protocols: E07877.01 and E07876.01 to access the toxicity of tobacco derived nicotine after repeated inhalation. Both studies will provide robust scientific data that will be used to identify and assess potential public health concerns related to nicotine inhalation exposures. This acquisition is restricted to Charles River Laboratories as these same rats were provided by Charles River for the methods development for the aforementioned approved protocols and it is imperative the lab continues using this specific strain from Charles River to ensure all behavioral testing and scientific data interpretation can be compared in ongoing research. A change in strain and supplier would result in invalidation of the studies of which any initial efforts will essentially be uninformative, unpublishable, nor can the results be used to support regulatory activities.