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health · HHS-FDA

Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required

Food and Drug Administration · RFA-FD-22-001

Closed

Award Range

$150K$2.5M

Expected Awards

5

Deadline

March 11, 2024

GRANTQUICK SUMMARYPlain-English Overview

Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required. Food and Drug Administration. The purpose of this funding opportunity announcement (FOA) 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... $150,000-$2,500,000 per award; ~5 awards expected.

Who Should Apply

City/township governments, Private universities/colleges, Independent school districts, Special district governments, Nonprofits (501c3) (+10 more)

Who Should NOT Apply

Organizations not matching the eligible applicant types listed above

Key Requirements (Plain English)

  • Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Educatio...
  • Deadline: 2024-03-11

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Focus your proposal on clear outcomes, alignment with agency priorities, and demonstrate organizational capacity.

Competitiveness: Very high — extremely limited awards available

What This Grant Funds

The purpose of this funding opportunity announcement (FOA) 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. 

Who Can Apply

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) 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 OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) 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) U.S. Territory or PossessionOtherIndependent School DistrictsPublic 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 Institutions)

Eligible Applicant Types

City/Township GovernmentsPrivate Colleges & UniversitiesIndependent School DistrictsSpecial District Governments501(c)(3) NonprofitsFor-Profit OrganizationsPublic Colleges & UniversitiesPublic And Indian Housing AuthoritiesOther Tribal OrganizationsOther (see NOFO for details)Small BusinessesFederally Recognized Tribal GovernmentsNonprofits without 501(c)(3)County GovernmentsState Governments

Funding Details

Minimum Award
$150K
Maximum Award
$2.5M
Expected Number of Awards
5
Cost Sharing Required?
No
Funding Instrument
grant

Key Dates

Posted: February 17, 2021
Application Deadline: March 11, 2024 (0 days remaining)

This FOA has multiple close dates. February 15, 2022, by 11:59 PM Eastern Time and March 11, 2024, by 11:59 PM Eastern Time.

Agency Contact

Shashi Malhotra Grants Management Specialist Phone 2404027592

shashi.malhotra@fda.hhs.gov

Ready to apply?

View the full NOFO and submit your application on Grants.gov