Sprague-Dawley rats (Charles River) FDA-130321
Summary
AI-generated · Aug 24, 2025Sourcing of Sprague-Dawley rats must be from Charles River Laboratories under a sole-source arrangement to support the toxicity studies of tobacco-derived nicotine after repeated inhalation (protocols E07877.01 and E07876.01). These studies require the same rat strain provided by Charles River for methods development to ensure consistent behavioral testing and data interpretation.
Maintaining this exact strain from the same supplier is essential for comparability across ongoing research; a change in strain or supplier would invalidate the studies, make initial efforts uninformative or unpublishable, and prevent results from supporting regulatory activities.
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.
From Special Notice posted on Jul 14, 2025Notice history
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