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

306 words·~1 min read·/us/cfr/t21/s§ 316.27·

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

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§ 316.27

Change in ownership of orphan-drug designation.

Fed. Reg.×2

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