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U.S. Department of Health and Human Services

About FDA

Office of Criminal Investigations/Center Coordination (1)

Description: Enhance the coordination, communication, and strategy in alignment of the Office of Criminal Investigations (OCI) and other FDA components by implementing the findings and recommendations of the OCI/Center coordination and Alignment Review Committee.

Accomplishment: In completion of the key project, the Office of the Counselor to the Commissioner implemented the findings and recommendations of the Office of Criminal Investigations/Center coordination and Alignment Review Committee. Outcomes of this initiative are as follows:

  • Improved procedures for the standardization and coordination of information sharing between OCI and other agency components;
  • Established mechanisms to ensure that senior leaders share information and coordinate strategic priorities to align criminal enforcement and regulatory activities;
  • Increased appropriate use of misdemeanor prosecutions through greater clarity on the criteria for approving such cases to hold corporate officials accountable; encourage preventive actions; and achieve greater deterrence;
  • Enhanced procedures to support development of debarment and disqualification actions, and clarify the circumstances under which such administrative actions may proceed concurrently with pending criminal investigations and prosecutions; and
  • Established enhanced procedures to coordinate agency response to cargo theft of FDA regulated products, such as pharmaceuticals and infant formula, to ensure that FDA’s regulatory response to cargo thefts is consistent and fully effective.
  • Issued Staff Manual Guide: Sharing Of Information Related To Criminal Violations
  • Issued Staff Manual Guide: Enhanced Communications With The Office Of Criminal Investigations (OCI) & Improved Alignment Of Criminal/Regulatory Priorities And Activities

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Meet with the Information Sharing Working Group Chairs

3/31/2010

Completed 3/2/2010

B. Draft Staff Manual Guide (SMG) to implement procedures to share information and clarify responsibilities between Centers, Office of Regulatory Affairs (ORA), and OCI

5/30/2010

Completed 5/17/2010

C. Conduct outreach to Centers and District Offices

8/31/2010

(1/31/2011)

Completed 1/31/2011

D. Incorporate a segment in ORA’s New Hire Training Curriculum on OCI’s roles and responsibilities

8/31/2010

(1/31/2011)

Completed 1/31/2011

E. Establish information system in OCI Headquarters to capture receipt and status of incoming referrals

8/31/2010

(1/31/2011)

Completed 1/31/2011

F. Reconvene working group to assess progress of implementation

9/30/2010

(1/31/2011)

Completed 1/31/2011

Footnotes

  • (1) The dates in italics under the milestone due dates are revised milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised due dates.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.