Scout | RFA-FD-25-020: Notice of Funding Opportunity (NOFO) for Clinical Trials of Orphan Products

grant RFA-FD-25-020

Notice of Funding Opportunity (NOFO) for Clinical Trials of Orphan Products

Summary

This grant opportunity is designed to fund clinical trials for orphan products aimed at treating rare diseases with unmet medical needs. It supports trials in any phase (1, 2, or 3) of product development, focusing on assessing the safety and/or effectiveness of medical products for new uses or updated labeling.

The goal of this Notice of Funding Opportunity (NOFO) is intended to support clinical trials of orphan products in all phases of product development (phase 1, 2 and/or 3) for rare diseases with unmet medical needs. These clinical trials should evaluate safety and/or efficacy of medical products …

Funding Source

Agency: National Institutes of Health

Awards & funding

Award Ceiling: $900,000

Eligibility

School Districts: Independent School Districts

Housing Authorities: Public Housing Authorities/Indian Housing Authorities

Faith-based or Community-based Organizations

Regional Organizations

Foreign/Non-domestic Entities (Foreign Organizations)

Other (Unspecified)

Government: Local Governments (general)

Tribal Organizations (other than Federally recognized tribal governments)

Higher Education Institutions: Private Institutions of Higher Education

Nonprofits (Other than Institutions of Higher Education): without 501(c)(3) IRS Status

For-Profit Organizations: Other than Small Businesses

Foreign/Non-domestic (non-U.S.) entities are eligible to apply. Non-domestic (non-U.S.) components of U.S. organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Required registrations (must be completed prior to submis…

Dates

Letter of Intent Due Date: September 22, 2025

Application Due Date: October 21, 2025

Resubmission ONLY Application Due Date: May 19, 2026

Letter of Intent Due Date: September 21, 2026

Application Due Date: October 20, 2026

Resubmission ONLY Application Due Date: May 18, 2027

Letter of Intent Due Date: September 20, 2027

Application Due Date: October 19, 2027

Resubmission ONLY Application Due Date: May 16, 2028

Supporting links

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