---
kind: "section"
citation: "21 C.F.R. § 316.27"
title: "21"
number: "316.27"
heading: "Change in ownership of orphan-drug designation."
url: "https://uscodex.org/cfr/21/316.27"
---

# §316.27. Change in ownership of orphan-drug designation.

- (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:
  - (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.
  - (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:
    - (i) The date that the change in ownership or assignment of rights is effective;
    - (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
    - (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
    - (iv) **The name and address of a new primary contact person or resident agent.**
- (b) No sponsor may relieve itself of responsibilities under the Orphan Drug Act or under this part by assigning rights to another person without:
  - (1) Assuring that the sponsor or the assignee will carry out such responsibilities; or
  - (2) **Obtaining prior permission from FDA.**

## Notes

### Amendments

[57 FR 62085, Dec. 29, 1992; 58 FR 6167, Jan. 26, 1993]

### Authority

Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.

### Source

Source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

### Amendments

[57 FR 62085, Dec. 29, 1992; 58 FR 6167, Jan. 26, 1993]