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  1. Designating an Orphan Product: Drugs and Biological Products

Orphan Drug Designation Request Form

The content and format of a request for orphan drug designation is described in 21 CFR 316.20. This form (FDA 4035) is designed to assist sponsors in providing the required content completely and succinctly. Do not write in any fields that say “For FDA Use Only”.  

Form FDA 4035 is a dynamic form. It may not open directly from the FDA website in Chrome or Firefox. If you receive a “Please wait …” message, go to the upper right download arrow and download the form.  Also, the form may not work properly using the free version of Adobe Acrobat.  Adobe Acrobat XI Pro, or equivalent, is recommended.

Download one copy of the completed PDF form (with attachments) onto a CD. References should be placed in another PDF file on the same CD.  

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Mail the CD along with a signed cover letter as described at Corresponding with the OOPD Drug Designation Programs.

Recommended Tips for Creating an Orphan Drug Designation Application