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U.S. Department of Health and Human Services

About FDA

Quantitative Cancer Risk Assessments

Description: Develop and improve strategies for assessing cancer mode actions for quantitative cancer risk assessments.

Definition: It is important for FDA to be able to assess the level of risk for humans exposed to chemicals including food contaminants that are carcinogens. This is done using mathematical models where these models are selected based on the mode by which the chemical causes cancer.

Understanding the potential hazards of dietary supplements and food contaminants as they relate to cancer will provide FDA better information for decision-making in cancer prevention.

Public Health Outcome: This research will improve the cancer risk assessments of dietary supplements and food contaminants.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Present and discuss risk assessments and biological dose-response models (to date) with the scientific community at the Society for Toxiciology Meeting

3/31/2010

Completed 3/31/2010

2. Approve concept paper for new research program to use in vivo mutation data to inform cancer mode of action

5/31/2010

Completed 5/1/2010

3. Approve the CRADA with FDA and TERA for collaborative research on new strategy for assessing cancer mode of action

6/30/2010

(12/31/2010)

Completed 2/1/2011

4. Complete discussions with external collaborators on the technical aspects and logistics for cancer mode of action research for the model chemical ethlene oxide

8/31/2010

Completed 8/31/2010

5. Initiate the inhalation exposure for the ethylene oxide study (by external collaborators)

9/30/2010

(3/1/2011)

Completed 3/1/2011

6. Receive samples from external collaborator

3/1/2011

(5/1/2011)

Completed 5/1/2011

7. Complete the assessment of research findings

1/1/2012

Completed 5/30/2012

8. Develop draft technical report/manuscript/publication

6/1/2012

On Track

9. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publication

12/21/2012

On Track

10. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

2/28/2012

On Track

11. Submit final technical report, manuscript and/or publication to a scientific journal

3/31/2012

On Track

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

concept paper

a description of a planned research activity that is submitted to the NCTR Director in advance of the submission of a protocol

in vivo

within a living organism

CRADA

Cooperative Research and Development Agreement

TERA

Toxicology Excellence for Risk Assessment

chemical ethlene oxide

used for medical sterilization

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.