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U.S. Department of Health and Human Services

About FDA

Optimize Legal, Regulatory and Policy Framework

Description: Modernize and optimize the legal, regulatory, and policy framework for efficient preparedness and response by assessing current laws and regulations and proposing changes that will facilite an efficient response to public health emergencies.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Establish a legal and policy team (EPIC--Emergency Use Authorization (EUA) Policy Implementation Committee) to review and analyze current laws and regulations and recommend changes

12/31/2010

Completed 1/6/2011

2. Draft chapter on the medical countermeasures "FDA Emergency Preparedness and Response Roles and Authorities" for inclusion in a publication being issued by the Food and Drug Law Institute (FDLI), Food and Drug Law and Regulation Book

6/1/2011

Completed 6/13/2011

3. Propose to the Department changes to FDA's authorities to facilitate MCM availability as part of the Department's legislative package for reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). Revisions would allow FDA to issue EUAs in advance of a CBRN event, facilitate mass dispensing of approved products and authorize shelf-life extension.

6/30/2011

Completed 6/1/2011

4. Develop and issue doxycycline mass dispensing EUA

5/30/2012

Completed 7/21/2011

5. Develop and issue doxycycline USPS EUA for Cities Readiness Program

7/30/2012

Completed 10/14/2011

Footnotes

  • Additional milestones are currently under development.

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.