Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a Â“rare disease or conditionÂ” and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
General information about this opportunity
Last Known Status
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Type(s) of Assistance Offered
Number of Awards Available
Who is eligible to apply/benefit from this assistance?
Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions)
What is the process for applying and being award this assistance?
Application Due Date(s): February 4, 2015; February 3, 2016; February 1, 2017; February 7, 2018. Resubmission Due Date(s): October 15, 2015; October 14, 2016; October 16, 2017; October 15, 2018). This FOA uses non-standard due dates
Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements.
Who do I contact about this opportunity?
Grants Management Specialist
Range and Average of Financial Assistance
Awards range from $250,000.00 to $500,000.00