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

ID: RFA-FD-21-004 • Type: Posted
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Description

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.

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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Category of Funding
Consumer Protection
Health
Science and Technology and other Research and Development
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.103 - Food and Drug Administration Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 7/9/20 Food and Drug Administration posted grant opportunity RFA-FD-21-004 for Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional) with funding of $4.1 million. The grant will be issued under grant program 93.103 Food and Drug Administration Research. It is expected that 3 total grants will be made.

Timing

Posted Date
July 9, 2020, 12:00 a.m. EDT
Closing Date
Oct. 14, 2020, 12:00 a.m. EDT Past Due
Last Updated
July 9, 2020, 11:34 a.m. EDT
Version
1
Archive Date
Nov. 13, 2020

Eligibility

Eligible Applicants
Public housing authorities/Indian housing authorities
Private institutions of higher education
Independent school districts
For profit organizations other than small businesses
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Native American tribal governments (Federally recognized)
Small businesses
Additional Info
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.

Award Sizing

Ceiling
$1,400,000
Floor
Not Listed
Estimated Program Funding
$4,100,000
Estimated Number of Grants
3

Contacts

Contact
Shashi Malhotra Grants Management Specialist
Contact Email
shashi.malhotra@fda.hhs.gov   Profile
Contact Phone
(240) 402-7592
Additional Information
Full Announcement - RFA-FD-21-004
Additional Information Site
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-004.html

Documents

Posted documents for RFA-FD-21-004

Grant Awards

Grants awarded through RFA-FD-21-004

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