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  1. Orphan Products Clinical Trials Grants Program

Grant Application Overview


The purpose of the Clinical Trials grants is to support efficient and innovative clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis.  



The Clinical Trials 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. Only applications proposing clinical trials will be accepted.


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. However, the length of support will depend on the nature of the study.



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 May 28, 2019, 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