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U.S. Department of Health and Human Services

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.

Accomplishment: OEIO completed their Automated Enforcement Report Key Project ahead of schedule. Pursuant to Title 21, Code of Federal Regulations (21 CFR) Part 7.50, OEIO publishes a weekly Enforcement Report that includes all recalls that are newly classified according to level of health hazard associated with the recalled products. Through the Automated Enforcement Report Key Project, OEIO has streamlined this process so reports are generated by electronic means, making the process more efficient and reports more comprehensive and consumer-friendly. Review the most recent Enforecement Reports on FDA’s website.

A. Develop requirements for an IT solution to automate the process of publishing the weekly Enforcement Report

Milestone DescriptionMilestone DateMilestone StatusMilestone 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 DescriptionMilestone DateMilestone StatusMilestone 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 DescriptionMilestone DateMilestone StatusMilestone 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 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.