The Department of Health and Human Services Food and Drug Administration awarded a $1,916,514.00 definitive contract to The Trustees of Columbia University in the City of New York, doing business as Health Sciences Division, to conduct research on neurodevelopmental outcomes in infants receiving opioid-replacement pharmacotherapy for neonatal opioid withdrawal syndrome (NOWS). The contract has a completion date of June 30, 2024 and does not utilize a set-aside designation. As part of this research, Columbia University has subcontracted with the University of California, Berkeley and Kaiser Foundation Hospitals Kaiser Foundation Research Institute Division (doing business as Kaiser Permanente) to leverage their expertise in statistics, clinical research, and data analytics. This contract supports the Department of Health and Human Services' mission to protect public health and the FDA's work on issues related to opioids and maternal-child health.