About FDA
Automated Enforcement Report Project
Description: ORA’s Office of Enforcement is enhancing the process by which the public will be able to obtain information about recalls and other regulatory and enforcement actions published in the weekly FDA Enforcement Report. Included as part of this key project is the automation of this report which will not only make the process to create the report more efficient but will ultimately make the weekly report more comprehensive by including other regulatory and enforcement actions such as seizures and injunctions in a more consumer-friendly and usable format.
A. Develop requirements for an IT solution to automate the process of publishing the weekly Enforcement Report
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Create a cross-center project team to develop processes and requirements for report automation. |
1/31/2012 |
Completed | 1/25/2012 |
|
2. Complete requirements regarding RES data fields to include in automated report. |
2/28/2012 |
Completed | 2/28/2012 |
|
3. Evaluate Phase 1 report format and display options. |
3/13/2012 |
Completed | 3/13/2012 |
|
4. Propose and pilot methodology for including Human Drug Recalls pending classification |
3/13/2012 |
Completed | 3/13/2012 |
B. Develop and test IT solution for publishing the weekly Enforcement Report
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Finalize display format for Phase 1 report. |
3/30/2012 |
Completed | 3/30/2012 |
|
2. Create weekly report in test environment. Review results and finalize review processes. |
4/20/2012 |
Completed | 4/20/2012 |
|
3. Publish Phase 1 automated report to FDA.gov |
5/4/2012 |
Completed | 5/4/2012 |
C. Usability Improvements and Expansion of Enforcement Report to include other Enforcement Actions
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Create input template for district recall coordinators for Recall Strategy field in RES |
3/13/2012 |
Completed | 3/13/2012 |
|
2. Develop Usability test questions and format to evaluate the Phase 1 product. |
5/31/2012 |
Completed | 5/13/2012 |
|
3. Develop requirements for inclusion of additional enforcement actions into weekly report |
6/30/2012 |
Completed | 6/1/2012 |
|
4. Incorporate results from usability testing into published report. |
8/31/2012 |
Completed | 8/20/2012 |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - 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.
