Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional)

The summary for the Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

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.

Federal Grant Title:	Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional)
Federal Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Consumer Protection Health Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-21-004
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	October 14th, 2020
Original Application Deadline:	October 14th, 2020
Posted Date:	July 9th, 2020
Creation Date:	July 9th, 2020
Archive Date:	November 13th, 2020
Total Program Funding:	$4,100,000
Maximum Federal Grant Award:	$1,400,000
Minimum Federal Grant Award:
Expected Number of Awards:	3
Cost Sharing or Matching:	No
Last Updated:	July 9th, 2020

Applicants Eligible for this Grant: State governments - County governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on 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.
Link to Full Grant Announcement: Full Announcement - RFA-FD-21-004
Grant Announcement Contact: Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected]
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