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    Subject Term: "Systems modernization"

    1 publication with a total of 2 open recommendations
    Director: Melvin, Valerie C
    Phone: (202) 512-6304

    2 open recommendations
    Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to, in completing the assessment of Mission Accomplishments and Regulatory Compliance Services (MARCS), develop an integrated master schedule (IMS) that (1) identifies which legacy systems will be replaced and when; (2) identifies all current and future tasks to be performed by contractors and FDA; and (3) defines and incorporates information reflecting resources and critical dependencies.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: In commenting on our report, the Department of Health and Human Services neither agreed nor disagreed with our recommendations. However, in response to this recommendation, FDA officials developed an integrated master schedule (IMS) for the Mission Accomplishment and Regulatory Compliance System, along with corresponding sub-project schedules. The officials also provided explanations of their approach for updating the schedules and estimating resources that are reflected in the schedules, and evidence that the agency is updating the schedule regularly. However, the IMS did not identify all legacy systems to be replaced, did not trace all tasks and contractor subproject schedules, and did not include information reflecting the use of government resources. In 2016, we requested that FDA provide an update on their efforts to address these limitations. As of September 2017, the agency restructured MARCS into two projects and notified us that it was working to establish an IMS for each. FDA officials expect to complete the schedules by the end of calendar year 2017. Until FDA takes steps to address the noted deficiencies, it will lack key information needed for determining what work remains and for identifying and addressing potential problems, thus increasing risks to the success of the agency's modernization efforts. We will continue to work with the Department to address this recommendation.
    Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to monitor progress of MARCS against the integrated master schedule IMS.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: In commenting on the report, the Department of Health and Human Services neither agreed nor disagreed with our recommendations. However, in response to this recommendation, FDA officials provided a baseline schedule, integrated master schedule (IMS), and sub-project schedules intended to be used to monitor progress of the agency's efforts to implement changes to the Mission Accomplishment and Regulatory Compliance System (MARCS). Nonetheless, while the IMS is updated regularly, it contains data anomalies, and FDA has not documented reasons for changes to the schedule. Consequently, the schedule does not include complete and reliable information needed for monitoring progress of the system investment. As of September 2017, the agency restructured MARCS into two projects and notified us that it was working to establish an IMS for each. FDA officials expect to complete the schedules by the end of calendar year 2017, and to use the schedules to continually monitor the status of the projects. Until FDA takes steps to address deficiencies noted in the IMS for MARCS, it will continue to lack key data needed to monitor progress of the implementation of the system, and increase the risks of this key component of the agency's modernization efforts. We will continue to work with the Department to address this recommendation.