About FDA
Enhance FDA’s Science Decisions through the NTP
Description: The missions of FDA and NTP overlap where toxicology data-gaps exist on chemicals/compounds/materials that are regulated by the FDA (1). This interagency agreement is in its 18th year supporting toxicology studies at FDA/NCTR, providing data for FDA and other regulatory agencies to protect the United States public.
Public Health Outcome: Provide toxicology data for FDA risk assessment and risk management decisions by the FDA.
Accomplishment: Meetings were held in May and November 2010 to discuss ongoing studies and newly proposed study designs that are part of the interagency agreement between the FDA and NTP/NIEHS that support the FDA risk-assessment process. The meetings are comprised of regulatory scientists and subject experts from the FDA Centers and ORA, NIEHS, and invited subject-matter experts from other government agencies, industry and academia. Ongoing studies that were discussed include dietary supplements, food contaminants, and medical device components. Newly proposed studies include Oxybenzone and Goldenseal.
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Communicate NTP studies, programs, and summaries to FDA Centers |
3/31/2010 |
Completed | 3/31/2010 |
|
2. Establish Working Group on dietary supplements, herbals, and botanicals |
4/1/2010 |
Completed | 5/17/2010 |
|
3. Establish Working Group on sunscreen monograph (CDER initiative to define toxicity data gaps and coordinate studies with NTP and NCTR) ingredients |
4/1/2010 |
Completed | 1/6/2010 |
Footnotes
- (1) NTP is an intra-Agency program between the National Institutes of Health (NIH) and NCTR whereby NIH directs the toxicological research and NCTR performs the research.
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
NTP
National Toxicology Program
NIEHS
National Institute of Environmental Health Sciences
Oxybenzone
sunscreen
Goldenseal
dietary supplement
CDER
Center for Drug Evaluation and Research
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.
