ForecastedOpportunity FOR-FD-25-017

Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

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 Optional) is a forecasted federal grant opportunity from the Food and Drug Administration (Department of Health and Human Services). The agency has forecast this opportunity but has not yet set an application deadline. Individual awards are listed as up to $400K. Applicant types listed as eligible include others (see notice). 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

Posted: Jul 11, 2025
Est. close date: Not listed
Award floor: Not specified
Award ceiling: $400,000
Est. total funding: Not specified
Expected awards: Not specified
Cost sharing: Not required
Funding instrument: Grant
Opportunity category: Discretionary
Fiscal year: FY2025

Who can apply

Others (see notice)

Additional information on eligibility (from the notice)

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.

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 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.

Assistance Listing

What is an ALN?

93.103Food and Drug Administration ResearchProgram →

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.

Agency contact (as published)

Kimberly Pendleton
Kimberly.Pendleton@fda.hhs.gov
240-402-7610

Quick answers

Is this opportunity open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. Forecast details and dates can change.

Who is eligible to apply for this opportunity?

The official notice lists these applicant types as eligible: Others (see notice). Additional restrictions may apply; review the full notice.

How much funding is available through this opportunity?

Per the notice, individual awards are listed as up to $400k.

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 FOR-FD-25-017), 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.

OpenALN 93.103