The subject acquisition is a sole source modification to the Mission Accomplishments and Regulatory Compliance Systems (MARCS) task order awarded under the FDA Enterprise System Life Cycle Management Support (ELMS) contract (HHSF2232009500071/HHSF22301001T). The contract is for the Operations and Maintenance (O&M) and Development, Modernization, and Enhancement (DME) of over 25 Information Technology (IT) systems for Office of Regulatory Affairs (ORA). The acquisition is to extend the period of performance by 12 months to include Operations and Maintenance and Program Management and to increase the ceiling for DME work from $108 million by $42 million to $150 million. These systems provide mission-critical IT functions to the Office of Regulatory Affairs (ORA), including processing of products submitted for import into the United States, inspection of FDA-regulated facilities, initiating and tracking recalls, and the tasks necessary to carry out compliance actions necessary to maintain public health and safety.
