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ClosedResearch announcementOpportunity RFA-FD-22-001

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

Food and Drug Administration · Department of Health and Human Services

At a glance

Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required is a closed federal grant opportunity from the Food and Drug Administration (Department of Health and Human Services). The application deadline was March 11, 2024. Individual awards are listed as $150K – $2.5M, with about 5 awards expected. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 10 more. 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. Feb 17, 2021Posted
  2. Mar 11, 2024Application deadline
Posted
Feb 17, 2021
Close date
Mar 11, 2024
Award floor
$150,000
Award ceiling
$2,500,000
Est. total funding
Not specified
Expected awards
5
Cost sharing
Not required
Funding instrument
Grant
Opportunity category
Discretionary

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public colleges & universities
  • Federally recognized tribal governments
  • Public & Indian housing authorities
  • Native American tribal organizations
  • 501(c)(3) nonprofits
  • Nonprofits without 501(c)(3) status
  • Private colleges & universities
  • For-profit organizations (not small businesses)
  • Small businesses
  • Others (see notice)

Additional information on eligibility (from the notice)

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)

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 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. 

Additional information from the agency ↗

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)

Shashi Malhotra Grants Management Specialist
shashi.malhotra@fda.hhs.gov
2404027592

Quick answers

Who is eligible to apply for this opportunity?

The official notice names these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 3 more. Additional restrictions may apply; review the full notice.

How much funding is available through this opportunity?

Per the notice, individual awards are listed as $150k – $2.5m and the agency expects to make about 5 awards.

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-22-001), 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.