An orphan drug designation can be submitted on a single compact disk (CD) with a signed cover letter attached. It is preferred to be sent by regular or express mail. An orphan drug designation request cannot be submitted by email or by any other physical media, such as a thumb drive. Additional information and the address for sending the orphan drug designation request to the Office of Orphan Products Development (OOPD) can be found at Corresponding with OOPD Drug Designation Programs.
