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Browse FDA-TRACK Program Areas or Office of the Chief Scientist Index

OWH Intramural Research Program

Description: The FDA OWH Intramural Research Program awards research grants for studies to address regulatory research questions to include: (1) health conditions and diseases that solely or disproportionately affect women; and (2) the identification and understanding of sex differences related to the safety or efficacy of FDA-regulated products.

Phase 1

Briefing Status: Completed

Prior Briefing Status: Completed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. FY 2016 Projects (new awards)
1. Issue funding announcement for intramural studies addressing women's health issues and understanding of sex differences by FDA researchers FY15 Q3
 Completed 6/10/2015
2. Complete review of Quad Charts for development of full proposal FY15 Q4
 Completed 8/30/2015
3. Complete review and scoring of full proposals, including funding recommendations, by OWH intramural reviewers FY16 Q2
 Completed 2/11/2016
4. Issue award notices and execute funding agreements with FDA researchers for selected intramural studies FY16 Q2
 Completed 3/28/2016
B. Ongoing Projects
1. FDA researchers submit mid-year progress reports for OWH review FY16 Q3
 Completed 8/15/2016
2. FDA researchers submit end of year progress reports for OWH review FY17 Q1
 Completed 3/1/2017

Phase 2

Briefing Status: Completed

Prior Briefing Status: Completed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. FY 2016 Projects (new awards)
1. Issue funding announcement for intramural studies addressing women's health issues and understanding of sex differences by FDA researchers FY16 Q3
 Completed 5/16/2016
2. Complete review of Quad Charts for development of full proposal FY16 Q4
 Completed 7/11/2016
3. Complete review and scoring of full proposals, including funding recommendations, by OWH intramural reviewers FY17 Q1
 Completed 11/30/2016
4. Issue award notices and execute funding agreements with FDA researchers for selected intramural studies FY17 Q2
 Completed 1/1/2017
B. Ongoing Projects
1. FDA researchers submit mid-year progress reports for OWH review FY16 Q3
 Completed 5/1/2016
2. FDA researchers submit end of year progress reports for OWH review FY17 Q1
 Completed 11/1/2016

Phase 3

Briefing Status: Completed

Prior Briefing Status: Completed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. FY 2018 Projects (new awards)
1. Issue funding announcement for intramural studies addressing women's health issues and understanding of sex differences by FDA researchers FY17 Q3
 Completed 4/14/2017
2. Complete review of Quad Charts for development of full proposal FY17 Q3
 Completed 6/26/2017
3. Complete review and scoring of full proposals, including funding recommendations, by OWH intramural reviewers FY18 Q1
 Completed 12/18/2017
4. Issue award notices and execute funding agreements with FDA researchers for selected intramural studies FY18 Q1
 Completed 2/2/2018
B. Ongoing Projects
1. FDA researchers submit mid-year progress reports for OWH review FY17 Q3
(TBD)
 Completed 5/1/2017
2. FDA researchers submit end of year progress reports for OWH review FY18 Q1
 Completed 11/1/2017

Phase 4

Briefing Status: Delayed

Prior Briefing Status: On Track

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. FY 2019 Projects (new awards)
1. Issue funding announcement for intramural studies addressing women's health issues and understanding of sex differences by FDA researchers FY18 Q2
 Completed 4/2/2018
2. Complete review of Quad Charts for development of full proposal FY18 Q3
 Completed 7/2/2018
3. Complete review and scoring of full proposals, including funding recommendations, by OWH intramural reviewers FY19 Q1
 Completed 12/21/2018
4. Issue award notices and execute funding agreements with FDA researchers for selected intramural studies FY19 Q2
 Completed 2/25/2019
B. Ongoing Projects
1. FDA researchers submit mid-year progress reports for OWH review FY18 Q2
 Completed 5/1/2018
2. FDA researchers submit end of year progress reports for OWH review FY19 Q1
5/1/2019
 Completed 10/1/2019

Phase 5

Briefing Status: Completed

Prior Briefing Status: Completed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. FY 2020 Projects (new awards)
1. Issue funding announcement for intramural studies addressing women's health issues and understanding of sex differences by FDA researchers FY19 Q2
 Completed 4/2/2019
2. Complete review of Quad Charts for development of full proposal FY19 Q3
 Completed 7/1/2019
3. Complete review and scoring of full proposals, including funding recommendations, by OWH intramural reviewers FY20 Q1
 Completed 12/17/2019
4. Issue award notices and execute funding agreements with FDA researchers for selected intramural studies FY20 Q2
 Completed 2/28/2019
B. Ongoing Projects
1. FDA researchers submit mid-year progress reports for OWH review FY19 Q2
 Completed 5/1/2019
2. FDA researchers submit end of year progress reports for OWH review FY21 Q1
 Completed 11/1/2020

Phase 6

Briefing Status: On Track

Prior Briefing Status: On Track

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. FY 2021 Projects (new awards)
1. Issue funding announcement for intramural studies addressing women's health issues and understanding of sex differences by FDA researchers FY20 Q2
 Completed 4/21/2020
2. Complete review of Quad Charts for development of full proposal FY20 Q3
 Completed 7/1/2020
3. Complete review and scoring of full proposals, including funding recommendations, by OWH intramural reviewers FY21 Q1
 Completed 2/15/2020
4. Issue award notices and execute funding agreements with FDA researchers for selected intramural studies FY21 Q2
 On Track
B. Ongoing Projects
1. FDA researchers submit mid-year progress reports for OWH review FY20 Q3
 Completed 5/1/2020
2. FDA researchers submit end of year progress reports for OWH review FY21 Q1
 Completed 11/1/2020

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.

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