forecasted
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Food and Drug Administration · FOR-FD-25-020
See source for award amount
Not specified
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits 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 Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Local Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Federal Governments U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign Organizations Non-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.
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
The purpose of this opportunity 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.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Grant. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 359987
Source ↗ · id
opportunityNumber: FOR-FD-25-020
Source ↗ · opportunityNumber
opportunityTitle: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Source ↗ · opportunityTitle
revision: 0
Source ↗ · revision
agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
Source ↗ · agencyDetails
owningAgencyCode: HHS-FDA
Source ↗ · owningAgencyCode
cfdas: [{"id":430176,"opportunityId":359987,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
Source ↗ · cfdas
forecastDesc: <p><span style="color: rgb(51, 51, 51);">The purpose of this opportunity 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.</span></p>
Source ↗ · forecastDesc
applicantTypes: [{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"}]
Source ↗ · applicantTypes
applicantEligibilityDesc: Higher Education Institutions
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits Other Than Institutions of Higher Education
Nonprofits 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 Organizations
Small Businesses
For-Profit Organizations (Other than Small Businesses)
Local Governments
State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Governments
U.S. Territory or Possession
Other
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations)
Foreign Organizations
Non-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.
Source ↗ · applicantEligibilityDesc
fundingInstruments: [{"id":"G","description":"Grant"}]
Source ↗ · fundingInstruments
fundingActivityCategories: [{"id":"AG","description":"Agriculture"},{"id":"CP","description":"Consumer Protection"},{"id":"FN","description":"Food and Nutrition"}]
Source ↗ · fundingActivityCategories
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: Jul 11, 2025 08:24:49 AM EDT
Source ↗ · lastUpdatedDate
status: forecasted
Source ↗ · oppHits[id=359987].oppStatus
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