Sprague-Dawley rats (Charles River)

The FDA's Office of Acquisition and Grant Services has issued a Notice of Intent to Sole Source for the procurement of Sprague-Dawley rats from Charles River Laboratories. This special notice pertains to the acquisition of 128 rats (64 male and 64 female) for protocol E07877.01 and 114 rats (57 male and 57 female) for protocol E07876.01. The rats will be used by the FDA's National Center for Toxicological Research to study the toxicity of tobacco-derived nicotine after repeated inhalation exposure. The procurement is classified under NAICS code 112930 (Fur-Bearing Animal and Rabbit Production) with a small business size standard of $3.75 million. The agency intends to award a brand name, firm fixed price purchase order specifically to Charles River Laboratories due to their previous involvement in developing the research protocols.

The primary objective of this acquisition is to support ongoing toxicological research that will generate scientific data to identify and assess potential public health concerns related to nicotine inhalation exposures. The procurement is restricted to Charles River Laboratories because they previously supplied the same strain of rats for methods development, and maintaining consistency in the animal strain and supplier is critical for ensuring valid behavioral testing and scientific data interpretation. Interested parties may submit capability statements to Suzanne Martella at suzanne.martella@fda.hhs.gov before the deadline of July 18, 2025 at 2:00 PM Central Time. If no responsive capability statements are received by this deadline, the award will proceed to Charles River Laboratories under FAR 13.106-1(b)(1) authority. The agency emphasizes that changing strains or suppliers would invalidate the studies and render initial research efforts uninformative and unpublishable.