Skip to content
Simpler Grants

No. RFA-FD-25-020 · Food and Drug Administration

Open

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

grants.gov listing Full announcement (NOFO)
Dealbreakers No cost share required Audit: not stated Reimbursement-only: not stated
Award range
$0 – $900,000
Expected awards
Not specified
Application deadline
May 16, 2028
Posted
Jul 11, 2025
Last verified
4 days ago

At a glance

AI summary

This program funds clinical trials of orphan products for rare diseases that address unmet needs. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, governments, tribal entities, foreign organizations, and certain community-based and faith-based organizations. The award budget may be up to $650,000 in total costs per year for years 1 through 4, with up to an additional $250,000 per year for innovative and efficient trial approaches, for a maximum of $900,000 per year. The project period can be up to 4 years, with continued support after year 1 depending on annual appropriations, funding availability, performance, and regulatory compliance.

AI-generated summary — verify against the announcement

What it funds

  • Agriculture
  • Consumer Protection
  • Food and Nutrition
  • Research & Discovery
  • Patients & People with Health Conditions
  • Biomedical & Disease Research
Official description from grants.gov

The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Who can apply

  • Others
Geographic restriction None found in the announcement — likely nationwide

Program history

USASpending.gov

Assistance listing 93.103 · Food and Drug Administration Research

Real awards this federal program has made — the whole assistance listing (93.103), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 2 $674,557 $362,279 – $986,836
FY 2025 128 $449,605 $217,500 – $750,000
FY 2024 95 $350,000 $101,736 – $1,005,321
FY 2023 176 $570,625 $154,967 – $997,677
FY 2022 136 $292,635 $128,510 – $1,080,535
FY 2021 131 $1,247,596 $218,607 – $2,622,614

For comparison, this notice advertises $0 – $900,000.

Who wins it Higher education (212), State government (196), Nonprofit (141) of 668 awards — categories can overlap.
Top states PA (45) · CA (43) · NY (28) · MD (25) · MA (20)
Largest recent awards
  1. NATIONAL ENVIRONMENTAL HEALTH ASSOCIATION $36,000,000 · FY 2021
  2. FOOD & AGRICULTURE, CALIFORNIA DEPARTMENT OF $24,423,552 · FY 2021
  3. ASSOCIATION OF FOOD & DRUG OFFICIALS $13,305,546 · FY 2022
  4. UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL $12,840,004 · FY 2023
  5. REGENTS OF THE UNIVERSITY OF MINNESOTA $7,424,773 · FY 2022

Source: USASpending.gov · refreshed Aug 16, 2026