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Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for UG3/UH3 cooperative agreements to support the development of a publicly available core set(s) of COAs and their related endpoints for specific disease indications or for disease impacts that span multiple rare diseases
of similar phenotypes.The UG3/UH3 Phase Innovation Award Cooperative Agreement involves 2 phases.
The UG3 phase will provide funding for 1 to 2 years to conduct planning activities.
The UH3 phase will provide funding for 3 to 4 years to projects that successfully complete the planning activities and reach the projected milestones set in the UG3 phase.
UH3 phase awards will be awarded after administrative review of eligible UG3 phase awards that have met the scientific milestone and feasibility requirements necessary for UH3 phase implementation.
The number of awards is dependent on the availability of funds.
The UG3/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA.
The total award project period will not exceed 5 years.
of similar phenotypes.The UG3/UH3 Phase Innovation Award Cooperative Agreement involves 2 phases.
The UG3 phase will provide funding for 1 to 2 years to conduct planning activities.
The UH3 phase will provide funding for 3 to 4 years to projects that successfully complete the planning activities and reach the projected milestones set in the UG3 phase.
UH3 phase awards will be awarded after administrative review of eligible UG3 phase awards that have met the scientific milestone and feasibility requirements necessary for UH3 phase implementation.
The number of awards is dependent on the availability of funds.
The UG3/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA.
The total award project period will not exceed 5 years.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $4,100,000
Office: Food and Drug Administration
Estimated Funding: $4,100,000
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement - RFA-FD-21-004
Additional Information of Eligibility:
Additional Information on Eligibility : Foreign Institutions Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U. S. Organizations are eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-004.html
Contact:
Agency Email Description:
shashi.malhotra@fda.hhs.gov
Agency Email:
Date Posted:
2020-07-09
Application Due Date:
Archive Date:
2020-11-13
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