The content and format of a request for orphan drug designation is described in 21 CFR 316.20(b). The FDA Orphan Designation Request Form (FDA 4035) is designed to assist sponsors in providing the required content of the orphan drug designation request completely and succinctly. A resource for sponsors in compiling the orphan drug request is the Recommended Tips for Creating an Orphan Drug Designation Application webinar and PowerPoint slides which can be found at Education and Media Resources for Orphan Designation Program .
