Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
ID: 360007Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $600K

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/360007

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-017.html
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)." This initiative aims to support innovative natural history studies that generate high-quality data to advance medical product development for rare diseases with significant unmet needs. The funding is crucial for addressing knowledge gaps and facilitating the development of treatments in this area. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, and government entities, with grant amounts reaching up to $600,000. The application deadline is February 8, 2028, and interested parties can contact Kimberly Pendleton at Kimberly.Pendleton@fda.hhs.gov for further information.

    Files
    Title
    Posted
    RFA-FD-25-017.html
    The Department of Health and Human Services, through the FDA's Office of Orphan Products Development, is offering funding opportunities for innovative natural history studies focused on rare diseases. This funding aims to address significant unmet needs in the field by generating high-quality data essential for medical product development. Eligible organizations, including higher education institutions, nonprofits, and government entities, can apply for grants under the R01 Research Project Grant mechanism. Funding for prospective studies can reach $400,000 per year for up to four years, while retrospective studies can receive up to $150,000 per year for two years. Key application dates include submission deadlines in early 2026 and 2028, with specific guidelines on data quality, collaboration, and patient input emphasized. The FDA encourages applicants to use innovative methods and frameworks, including effective patient engagement and standardized approaches to data collection. Successful applications will undergo a rigorous review process based on their scientific and technical merit, which is pivotal for advancing understanding in rare diseases and ensuring efficient drug development.
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