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U.S. Department of Health and Human Services

About FDA

Non-Public Information Sharing Program

Description: Utilize the Agency-wide IT system (AIMS) for tracking and reporting exchanges of non-public information between the FDA and foreign counterparts. Utilizing this system will allow accurate, detailed and timely information exchanges, the ability to monitor and track public health trends as a result of analyzing the type of information that is being requested and shared, and the capability to run detailed reports. For example, by sharing public and non-public information with international regulatory counterparts about recalls in the U.S. of products that have been distributed abroad, FDA advances and expands its consumer protection mission, regardless of where those consumers are located, especially in a globalized economy where supply chains have no borders.

OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Redesign database

4/30/2010

Completed 5/4/2010

B. Create centralized data input system

6/30/2010

Completed 11/8/2010

C. System requirements review (make modifications based on Centers' input)

8/30/2010

Completed 8/20/2010

D. Usability testing and production readiness review)

9/30/2010

Completed 11/8/2010

E. Agency-wide system deployment of the non-public information sharing system and implementation

12/30/2010

Completed 11/8/2010

F. Create user accounts for all OIP staff members and provide each user with account information

12/30/2010

Completed 11/9/2010

G. Create a SOP and user guide for use of the AIMS system in OIP

4/30/2011

Completed 4/30/2011

H. Roll out the new system to all OIP staff members, including training

5/1/2011

Completed 5/18/2011

I. Select a detailee to input, monitor and track all requests in the AIMS database

9/15/2011

Completed 9/15/2011

J. Hire an FTE to input, monitor and track all requests in the AIMS database (1)

N/A

N/A N/A

K. Reassess system and provide first annual report (1)

N/A

N/A N/A

L. Consider and implement enhancements based upon a reassessment of the system and user input during the first year (1)

N/A

N/A N/A

Footnotes

  • (1) Milestones were not completed while this project was tracked in FDA-TRACK.

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.