The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal year (FY) 2024 to support natural history studies for rare diseases and conditions. This funding opportunity is intended to support prospective or retrospective, efficient, and innovative natural history studies with a focus on collaborative and standardized approaches to ensure data quality and interpretability. 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.
Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01)
Deadline for submission: February 13, 2024
FOA Number: RFA-FD-22-001
• Purpose: To support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs
• Focus: Efficiency, Innovation, Impact, Data quality and interpretability, Leveraging Patient Input, Infrastructure and Financial Resources, Future use of data
• Contact: Katherine Needleman, Director, Orphan Products Grants Program
• Additional Information: OOPD Website