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As of October 25, 2020, there are 4812 open recommendations, of which 473 are priority recommendations. Recommendations remain open until they are designated as Closed-implemented or Closed-not implemented.
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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 2018, we confirmed that FDA, in response to our recommendation, began efforts to identify which legacy systems will be replaced. FDA also developed an IMS for fiscal year (FY) 2017 and 2018 that identifies current and future tasks to be performed by contractors and FDA. However, FDA's IMS for FY 2017 and 2018 does not fully and clearly define resources. For example, although the FY 2017 IMS includes 265 names, roles, and teams, only 16 percent of activities have resource assignments. Further, FDA's fiscal year 2018 IMS does not fully define critical dependencies. For example, there are 14 activities and milestones with finish dates that are not properly tied to logic. Specifically, the finish dates of the 14 activities are not clearly tied to succeeding activities in the schedule. We contacted FDA in September and December 2019 and January 2020 for an update on the actions taken to implement the recommendation, but have not received a response. We will update the recommendation when additional information is obtained.
