FDA -- Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01)

Funding Agency:
National Institutes of Health

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.


  • 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

Agency Website

Amount Description

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

Funding Type





Engineering and Physical Sciences
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

February 13, 2024