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U.S. Department of Health and Human Services

About FDA

Academic Development of a Training Program for Good Laboratory Practices in Maximum Biocontainment

Description: Develop and implement a training program to identify and share best practices ensuring data quality and integrity in animal studies in Biosafety Level (BSL) 4 to cross-educate medical countermeasure (MCM) sponsors, scientists, veterinarians, quality assurance personnel, regulators, reviewers, and policy-makers on the conduct of regulated studies in BSL 4 laboratory facilities. This training program will help facilitate the development and regulatory review of MCMs and the translation of breakthrough discoveries in science and technology into innovative, safe, and effective MCMs, increasing the ability of the US government to protect the nation from chemical, biological, radiological, and nuclear (CBRN) and emerging infectious disease threats.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Issue notice announcing grant to support development of training program

6/30/2012

Completed 6/18/2012

2. Award grant to support development of training program

8/31/2012

Completed 8/31/2012

3. Hold planning workshop

10/26/2012

Completed 10/26/2012

4. Develop course materials

1/31/2013

Completed 1/30/2013

5. Develop on-line training modules

2/28/2013

Completed 2/12/2013

6. Launch on-line training modules

3/1/2013

Completed 3/1/2013

7. Obtain course certification

3/31/2013

Completed 3/29/2013

8. Hold 5 day pilot training course

5/1 - 5/2013

Completed 4/1 - 4/5/2013

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.