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OpenResearch announcementOpportunity RFA-FD-25-020

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

Food and Drug Administration · Department of Health and Human Services

At a glance

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is an open federal grant opportunity from the Food and Drug Administration (Department of Health and Human Services). Applications are due May 16, 2028. Individual awards are listed as up to $900K. Applicant types listed as eligible include others (see notice). Cost sharing is not required. It is funded under Assistance Listing 93.103 (Food and Drug Administration Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

  1. Jul 11, 2025Posted
  2. May 16, 2028Application deadlinenext date
  3. Jun 15, 2028Archived
Posted
Jul 11, 2025
Close date
May 16, 2028
Archive date
Jun 15, 2028
Award floor
Not specified
Award ceiling
$900,000
Est. total funding
Not specified
Expected awards
Not specified
Cost sharing
Not required
Funding instrument
Grant
Opportunity category
Discretionary

Who can apply

  • Others (see notice)

Additional information on eligibility (from the notice)

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Also named in the notice's eligibility text
  • Public colleges & universities
  • Federally recognized tribal governments
  • Public & Indian housing authorities
  • Native American tribal organizations
  • 501(c)(3) nonprofits
  • Private colleges & universities
  • For-profit organizations (not small businesses)
  • Small businesses
Matched from the wording above by GrantsJunction — confirm in the full announcement.

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

Full announcement & documents

The full announcement has the complete rules — page limits, required attachments, evaluation criteria and any letter-of-intent dates. Files download directly from Grants.gov.

How to apply

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Assistance Listing

What is an ALN?

Reported obligations under ALN 93.103

Historical data · not a prediction
FY18$173M
FY19$199M
FY20$212M
FY21$219M
FY22$256M est.
FY23$247M est.
Source: SAM.gov Assistance Listing 93.103. Program-wide totals, not awards from this specific opportunity.

Who was funded under ALN 93.103

Historical data · not a prediction

Since October 1, 2023, 991 grant awards had funding actions under Food and Drug Administration Research, with 430 sub-awards passed on to other organizations. These are program-wide awards, not awards from this specific notice.

  1. THE CRITICAL PATH INSTITUTE$56.2M
  2. NATIONAL ENVIRONMENTAL HEALTH ASSOCIATION$39.7M
  3. ASSOCIATION OF FOOD & DRUG OFFICIALS$29.5M
  4. DUKE UNIVERSITY$19.1M
  5. THE MEDICAL DEVICE INNOVATION CONSORTIUM$15.6M
Recipients, states, recent awards and sub-awards →Source: USAspending.gov.

Agency contact (as published)

Stephanie Bogan Grantor
Patrick.Johnson@fda.hhs.gov
3018276802

Quick answers

When is the deadline for this opportunity?

According to the official notice, applications are due May 16, 2028. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for this opportunity?

The official notice names these applicant types as eligible: Others (see notice). Additional restrictions may apply; review the full notice.

How much funding is available through this opportunity?

Per the notice, individual awards are listed as up to $900k.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity RFA-FD-25-020), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.