[Food and Drug Administration (FDA)](https://www.fda.gov)

Projected July 2025

Up to $400,000 per award; typical duration not specified

Supports innovative natural history studies to accelerate medical product development for rare diseases with unmet needs.

Forecasted opportunity; all dates and details are subject to change.

--- ## Description This opportunity supports efficient and innovative natural history studies focused on rare diseases or conditions with unmet medical needs. The goal is to generate high-quality, interpretable data that address critical knowledge gaps, remove barriers to progress, and broadly impact the development of medical products for rare diseases. Projects may target a single rare disease or multiple related diseases with similar pathophysiology. The program encourages studies that will facilitate the development and evaluation of new therapies, diagnostics, or interventions in the rare disease space. --- ## Due Dates - Projected application due: July 2025 *All dates are projected based on the annual cycle; check the program page for updates.* --- ## Funding Amount - Maximum award: $400,000 per project - Typical award duration is not specified in the current forecast - No cost sharing or matching requirement --- ## Eligibility Eligible applicants include: - Higher education institutions (public/state-controlled and private) - Nonprofits (with or without 501(c)(3) status) - For-profit organizations (including small businesses) - Local, state, county, city, or township governments - Special district and regional organizations - Tribal governments and organizations (federally recognized and others) - Independent school districts - Public housing authorities/Indian housing authorities - Faith-based or community-based organizations - U.S. federal government agencies - U.S. territories or possessions - Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations --- ## Application Process - The opportunity is currently forecasted; the official Notice of Funding Opportunity (NOFO) will provide application instructions once released. - Applications will be submitted via [Grants.gov](https://www.grants.gov/search-results-detail/359985). - Prepare to demonstrate how the proposed study will fill knowledge gaps and impact rare disease medical product development. --- ## Additional Information - Clinical trials are optional for this funding opportunity. - The program is intended to address significant unmet needs within the rare disease community by generating robust natural history data. --- ## External Links - [Program Opportunity on Grants.gov](https://www.grants.gov/search-results-detail/359985) - [FDA - Office of Orphan Products Development](https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-orphan-products-development) --- ## Contact Information | Name | Email | Phone | Notes | |-----------------------|--------------------------------------|---------------|----------------------------| | Kimberly Pendleton | Kimberly.Pendleton@fda.hhs.gov | 240-402-7610 | Business e-mail address |

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

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