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Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
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Service Source Final Application Due Date Funding Available Match Required
Health Care Federal
HHS
See FOA N/A No Match
Required
  • Service
  • Source
  • Final Application Due Date
  • Funding Available
  • Match Required
Status
  • Past
  • Current
  • Forecasted
  • N/A
  • $400,000
  • Award Floor
  • Award Ceiling
    • Opportunity Type Discretionary
    • CFDA

      93.103 -- Food and Drug Administration Research

    Description

    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
    • IHE
    • Local Government
    • Non-Profit
    • Other
    • State Government
    • Tribal Government
    Additional Eligibility Information

    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.

    Key Date(s)
    • July 11, 2025: Last Updated Date
    • July 11, 2025: Forecasted Date
    Contact Information
    Kimberly Pendleton 240-402-7610 Kimberly.Pendleton@fda.hhs.gov

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