| http://www.w3.org/ns/prov#value | - At the time of the transfer, the new and former owners are required to submit the following information to FDA:(1) The former owner or assignor of rights shall submit a letter or other document that states that all or some rights to the orphan-drug designation of the drug have been transferred to the new owner or assignee and that a complete copy of the request for orphan-drug designation, includi
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