The purpose of this funding opportunity announcement (FOA) 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.
Deadlines:
- Letter of Intent Due Date(s): January 14, 2022; January 12, 2024
- Application Due Date(s): February 15, 2022; February 13, 2024
RFA-FD-22-001 Expiration Date February 14, 2024
Prospective Natural History Studies
Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in maximum total costs (direct and indirect) and maximum years of support:
YR 01: $400,000
YR 02: $400,000
YR 03: $400,000
YR 04: $400,000
Retrospective Natural History Studies or Survey Studies
YR 01: $150,000
YR 02: $150,000