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U.S. Department of Health and Human Services

About FDA

Nanotechnology Toxicity Studies Support

Description: Nanotechnology is a rapidly expanding manufacturing method that is being used to develop a wide range of products that are, or will, be evaluated for efficacy and toxicity by the FDA. The FDA has created a core facility on the NCTR and Office of Regulatory Affairs/Arkansas Regional Laboratory (ORA/ARL) campus that provides NCTR and ORA scientists with the tools and expertise to characterize and determine the toxicity of nanotechnology-based, potentially FDA-regulated nanomaterials. This Core Facility is jointly funded by the FDA and NIEHS/NTP.

Public Health Outcome: Providing FDA regulatory scientists and study scientists with the tools to properly conduct toxicity studies on nanotechnology-based materials and products.

Accomplishment: The NCTR/ORA Nanotechnology Core Facility is providing support to FDA by providing materials characterization, the use of external techniques to probe into the internal structure and properties of a material, analytical support and electron microscopy support for a broad range of nanomaterial studies. Nanotechnology research will aid in the development of guidelines for the safe and effective use of these materials in drug products, devices, foods, cosmetics, and dietary components. By continuing nanomaterials research, FDA will have a better understanding of the consequences of human exposure to nanoscale materials. The Nanotechnology Core Facility was able to hire key scientific personnel and purchase and install equipment during the 2011 fiscal year. These new additions will ensure a strong scientific core for nanotechnology research in FDA.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Recruit Electron Microscopist

12/1/2010

Completed 2/4/2011

2. Recruit Electron Microscope Laboratory Technician

2/15/2010

Completed 5/1/2010

3. Recruit Nanotoxicologist

4/1/2010

Completed 7/6/2010

4. Complete installation of TEM, which shall improve current imaging capabilities

5/6/2010

(7/30/2010)

Completed 7/30/2010

5. Recruit Electron Microscopist Laboratory Technician

6/1/2010

(5/1/2011)

Completed 4/15/2011

6. Purchase Particle Size Analyzer (including developing acquisition plan, requesting bids, evaluating bids, and selecting bid)

6/1/2010

Completed 6/30/2010

7. Establish SOPs and process for submission of samples for Electron Microscope Analysis

6/1/2010

Completed 8/15/2010

8. Purchase Scanning Electron Microscope (including developing acquisition plan, requesting bids, evaluating bids, and selecting bid)

8/1/2010

Completed 9/8/2010

9. Establish SOPs for all equipment in NCTR/ORA Nanotechnology Core Facility

10/1/2010

Completed 10/1/2010

10. Recruit analytical Chemists for NanoCore Projects

11/1/2010

(5/1/2011)

Completed 7/5/2011

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

NIEHS

National Institute of Environmental Health Services

NTP

National Toxicology Program

TEM

Transmission Electron Microscope

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.