Change in ownership of a granted certification.

An applicant may transfer ownership of its certification. At the time of transfer the new and former owners are required to submit information to FDA as follows: (a) The former owner must submit a letter or other document that states that all rights to the certification have been transferred to the new owner. (b) The new owner must submit a supplement under § 230.70 signed by the new owner describing any changes in the conditions in the granted certification and a letter or other document containing the date that the change in ownership is effective.