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U.S. Department of Health and Human Services

About FDA

Federal Regulatory Compliance

Description: Provide standardized records keeping program (in accordance with HHS, FDA, and NARA standards).

Accomplishment: During FY 2011, the Records Staff organized the general records within the NCTR records repository by NCTR division and owner. Records were inventoried and categorized according to the record label and placed on a quarterly review cycle. Records meeting their designated cut-off retention timeframes were removed and destroyed according to regulation. Non-sensitive records were recycled directly into the recycle bin while sensitive records were shredded. As a result of this project, NCTR has maintained its compliance with HHS, FDA, and NARA standards.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Establish records management system

12/31/2009

Completed 7/1/2009

2. Develop and present Records Management Training for all NCTR Staff

7/1/2010

Completed 7/1/2010

a. Complete training for all Administrative Staff

3/1/2010

Completed 3/1/2010

b. Complete training for all Scientific Staff

7/1/2010

Completed 7/1/2010

3. Catalog/index all records within NCTR Archives

10/1/2010

Completed 12/1/2010

a. Complete catalog/indexing of GLP study records

3/1/2010

Completed 3/1/2010

b. Complete catalog/indexing of all subjects study records

7/1/2010

Completed 7/1/2010

c. Complete catalog/indexing of all general records

10/1/2010

Completed 12/1/2010

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

HHS

Department of Health and Human Services

NARA

National Archives and Records Administration

GLP

Good Laboratory Practices

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.