U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. Developing Products for Rare Diseases & Conditions
  4. Orphan Products Natural History Grants
  5. Grant Application Overview
  1. Developing Products for Rare Diseases & Conditions

Grant Application Overview

Grant Application Overview

Purpose:

The purpose of the Natural History Study grants is to support efficient and innovative studies which characterize the natural history of rare diseases/conditions with unmet needs and are expected to exert a significant and broad impact.

 

Eligibility:

The Natural History Study grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including state and local units of government). Federal agencies may not apply.

 

Budget and Project Period:

Application budgets are not limited, but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 4 years for prospective studies and 2 years for retrospective studies. However, the length of support will depend on the nature of the study.

 

Note:

An applicant planning to submit a grant application with $500,000 or more in direct costs in any year is required to provide this notification in writing to the FDA Orphan Products Grants Program Director at least 4 weeks prior to the application deadline (i.e., by December 13, 2018 by 11:59 PM Eastern Time). The applicant must receive a letter in response from OOPD confirming approval to include in an appendix of the submitted grant application. Please see the following for more information: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/supplemental -instructions-forms-d.pdf