Notice of Funding Opportunity (NOFO) for Clinical Trials of Orphan Products
Department of Health and Human Services
Description
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 …
Source
Grant ID
RFA-FD-25-020
Agency
Department of Health and Human Services
Subcategory/Subagency
National Institutes of Health
Key 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
Eligibility
The following categories of applicants are invited to apply:
- Higher Education Institutions: Public/State Controlled Institutions of Higher Education
- Higher Education Institutions: Private Institutions of Higher Education
- Nonprofits (Other than Institutions of Higher Education): with 501(c)(3) IRS Status
- Nonprofits (Other than Institutions of Higher Education): without 501(c)(3) IRS Status
- For-Profit Organizations: Small Businesses
- For-Profit Organizations: Other than Small Businesses
- Government: Federal Governments
- Government: State Governments
- Government: County Governments
- Government: City or Township Governments
- Government: Special District Governments
- Government: U.S. Territory or Possession
- Government: Local Governments (general)
- School Districts: Independent School Districts
- Housing Authorities: Public Housing Authorities/Indian Housing Authorities
- Tribal Governments (Federally Recognized)
- Tribal Governments (Other than Federally Recognized)
- Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Foreign/Non-domestic Entities (Foreign Organizations)
- Other (Unspecified)
Awards & Funding
Award Ceiling
$900,000
Funding Amount
Discretionary
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