FDA sole source for human neural network NAM to evaluate developmental neurotoxicity.
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The FDA intends to award a sole source contract to Hesperos, Inc. for the development of a human neural network formation new approach method (NAM) to evaluate potential developmental neurotoxicity. The work involves creating a microphysiological system using human iPSC-derived neurons and glial cells to model neural network formation and assess chemical effects. The contractor must have demonstrated expertise in human neural network formation assays and microelectrode array technology. The contract is anticipated to be a single award with a period of performance of 12 months. This notice is not a request for competitive proposals.