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

The Food and Drug Administration (FDA) is seeking applications for efficient and innovative natural history studies that address unmet needs in rare diseases. The goal of this funding opportunity is to support studies that advance medical product development in rare diseases/conditions with unmet needs. The 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. • The award ceiling for this grant is $400,000. • The funding instrument for this opportunity is a grant. • The applicant eligibility includes higher education institutions, nonprofits, for-profit organizations, local governments, state governments, and federal governments. • The FDA expects to support natural history studies with high-quality and interpretable data elements. • The funding activity categories for this opportunity include agriculture, consumer protection, and food and nutrition.