Inactive Total Small Business Set-Aside (FAR 19.5)

The Food and Drug Administration (FDA), the Office of Acquisitions and Grants Services (OAGS) intends to inform the public that the FDA anticipates issuing an award to procure the development of an un... The Food and Drug Administration (FDA), the Office of Acquisitions and Grants Services (OAGS) intends to inform the public that the FDA anticipates issuing an award to procure the development of an unambiguous, comprehensive database/repository model that can allow for mapping and classifying evidence of the relationship between molecular (genotype) mechanism of resistance and phenotypic resistance for clinically relevant human bacterial pathogens. The services needed shall capture existing knowledge about phenotypic resistance and molecular detection, to make the results of an in vitro diagnostic device “actionable” when reporting results in the same manner as current phenotypic antimicrobial susceptibility test methods ; this can only be accomplished by a ‘living’ database, one that FDA, sponsors, and clinicians can use for regulatory and clinical practice. The Period of Performance includes a one-year Base Period.