Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Forecasted Federal grant Posted
- Opportunity number
- FOR-FD-25-017
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications expected due
- Not on record
- Award size
- Up to $400,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- Other
- Points of contact
-
- Kimberly Pendleton kimberly.pendleton@fda.hhs.gov (240) 402-7610
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration is soliciting applications for efficient and innovative natural history studies addressing unmet needs in rare diseases under CFDA 93.103 (Food and Drug Administration Research), with clinical trials optional. This is a forecast notice; a specific application deadline has not yet been announced. Eligible applicants include higher education institutions (public and private), nonprofits with and without 501(c)(3) status, for-profit organizations, small businesses, local and state governments, Indian/Native American tribal governments (federally and non-federally recognized), U.S. territories, faith-based and community-based organizations, regional organizations, and foreign organizations. Non-domestic components of U.S. organizations and foreign components as defined in the NIH Grants Policy Statement are eligible.
The program supports natural history studies that advance medical product development by addressing critical knowledge gaps and removing major barriers to progress in rare disease fields. FDA expects funded studies to generate high-quality, interpretable data elements that exert significant and broad impact on specific rare diseases or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
Cost share and award structure details are not specified in this forecast announcement. The source does not indicate award ceiling, award floor, expected number of awards, period of performance, or place of performance. Evaluation criteria and weighting are not described in the forecast material. Applications under CFDA 93.103 have been awarded at 90 to 167 per year over the past five years, with recent project grants and cooperative agreements ranging from approximately $50 thousand to several million dollars depending on scope.
Forecast synopsis
The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
Eligibility
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. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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