Title 21

SECTION 516.27

516.27 Change in sponsorship.

§ 516.27 Change in sponsorship.

(a) A sponsor may transfer sponsorship of a MUMS-designated drug to another person. A change of sponsorship will also transfer the designation status of the drug which will remain in effect for the new sponsor subject to the same conditions applicable to the former sponsor provided that at the time of a potential transfer, the new and former sponsors submit the following information in writing and obtain permission from FDA:

(1) The former sponsor shall submit a letter to FDA that documents the transfer of sponsorship of the MUMS-designated drug. This letter shall specify the date of the transfer. The former sponsor shall also certify in writing to FDA that a complete copy of the request for MUMS-drug designation, including any amendments to the request, and correspondence relevant to the MUMS-drug designation, has been provided to the new sponsor.

(2) The new sponsor shall submit a letter or other document containing the following information:

(i) A statement accepting the MUMS-drug designated file or application;

(ii) The date that the change in sponsorship is intended to be effective;

(iii) A statement that the new sponsor has a complete copy of the request for MUMS-drug designation, including any amendments to the request and any correspondence relevant to the MUMS-drug designation;

(iv) A statement that the new sponsor understands and accepts the responsibilities of a sponsor of a MUMS-designated drug established elsewhere in this subpart;

(v) The name and address of a new primary contact person or permanent resident U.S. agent; and

(vi) Evidence that the new sponsor is capable of actively pursuing approval with due diligence.

(b) No sponsor may relieve itself of responsibilities under the act or under this subpart by assigning rights to another person without:

(1) Assuring that the new sponsor will carry out such responsibilities; and

(2) Obtaining prior permission from FDA.

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