Opportunity ID: 328044

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-21-004
Funding Opportunity Title: Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Consumer Protection
Health
Science and Technology and other Research and Development
Category Explanation:
Expected Number of Awards: 3
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Jul 09, 2020
Last Updated Date: Jul 09, 2020
Original Closing Date for Applications: Oct 14, 2020
Current Closing Date for Applications: Oct 14, 2020
Archive Date: Nov 13, 2020
Estimated Total Program Funding: $4,100,000
Award Ceiling: $1,400,000
Award Floor:

Eligibility

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

Additional Information

Agency Name: Food and Drug Administration
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.

Link to Additional Information: Full Announcement – RFA-FD-21-004
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Shashi Malhotra

Grants Management Specialist

Phone 2404027592
Email:shashi.malhotra@fda.hhs.gov

Version History

Version Modification Description Updated Date

Related Documents

Packages

Agency Contact Information: Shashi Malhotra
Grants Management Specialist
Phone 2404027592
Email: shashi.malhotra@fda.hhs.gov
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
93.103 RFA-FD-21-004 FORMS F PKG00262496 Jul 14, 2020 Oct 14, 2020 View

Package 1

Mandatory forms

328044 RR_SF424_2_0-2.0.pdf

328044 PHS398_CoverPageSupplement_5_0-5.0.pdf

328044 RR_OtherProjectInfo_1_4-1.4.pdf

328044 PerformanceSite_2_0-2.0.pdf

328044 RR_KeyPersonExpanded_2_0-2.0.pdf

328044 RR_Budget_1_4-1.4.pdf

328044 PHS398_ResearchPlan_4_0-4.0.pdf

328044 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf

Optional forms

328044 RR_SubawardBudget30_1_4-1.4.pdf

328044 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-10T11:53:04-05:00

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