FDA intends to procure technical support for a research program titled Molecular Mechanisms of Developmental Toxicity and Abnormalities. This effort will provide technical support directed at developing animal models for reproductive and developmental toxicity risk assessment. Specifically, the current project focuses on defining the cellular responses to physical and chemical agents and their relationship to development endpoints used in the assessment of toxicity, extending the findings that have been developed in previous project. This agreement will extend and expand on models for reproductive and development toxicity that have been developed in cooperation with the Food and Drug Administration. A sole source award is planned to the incumbent Charles River Pathology Associates International of Frederick Maryland. Charles River is uniquely qualified to continue to provide technical support including bioassays aimed at defining organ, tissue and cellular responses and their potential involvement with developmental toxicity. This will include the correlation of morphologic events related to malformations and growth retardation with alterations in cellular events that are important to normal development. Any other contractor would have to ascend a learning curve that would result in unacceptable delays in fulfilling the FDA’s requirements; also it would result in substantial duplication of costs to the Government that are not expected to be recovered through competition. See numbered note 22.

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