{"data":{"id":"us/21-cfr-316.27","jurisdiction":"us","citation":"21 CFR 316.27","heading":"Change in ownership of orphan-drug designation.","body":"(a) A sponsor may transfer ownership of or any beneficial interest in the orphan-drug designation of a drug to a new sponsor. At the time of the transfer, the new and former owners are required to submit the following information to FDA:\n(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, including any amendments to the request, supplements to the granted request, and correspondence relevant to the orphan-drug designation, has been provided to the new owner or assignee.\n(2) The new owner or assignee of rights shall submit a statement accepting orphan-drug designation and a letter or other document containing the following:\n(i) The date that the change in ownership or assignment of rights is effective;\n(ii) A statement that the new owner has a complete copy of the request for orphan-drug designation including any amendments to the request, supplements to the granted request, and correspondence relevant to the orphan-drug designation; and\n(iii) A specific description of the rights that have been assigned and those that have been reserved. This may be satisfied by the submission of either a list of rights assigned and reserved or copies of all relevant agreements between assignors and assignees; and\n(iv) The name and address of a new primary contact person or resident agent.\n(b) No sponsor may relieve itself of responsibilities under the Orphan Drug Act or under this part by assigning rights to another person without:\n(1) Assuring that the sponsor or the assignee will carry out such responsibilities; or\n(2) Obtaining prior permission from FDA.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 316—ORPHAN DRUGS","Subpart C—Designation of an Orphan Drug"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"9f5bc54a028715e04ca0200fa4372b8e33017f6b7fae142739436e69aef83437","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-316.26","next":"us/21-cfr-316.28"},"notice":"GroundRules: Original legal text. Not legal advice."}