ML19353C760
| ML19353C760 | |
| Person / Time | |
|---|---|
| Issue date: | 12/20/2019 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Selover P Exubrion Therapeutics |
| Irene Wu, NRC/NMSS | |
| References | |
| Download: ML19353C760 (2) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 20, 2019 Mr. Peter Selover Chief Executive Officer Exubrion, Therapeutics, Inc.
5203 Bristol Industrial Way Buford, GA 30518
SUBJECT:
ACCEPTANCE REVIEW OF REQUEST FOR HYPOTHETICAL LICENSE AMENDMENT FOR TREATMENT OF DOGS WITH SYNOVETIN OATM CONTAINING SN-117M
Dear Mr. Selover:
By letter dated December 4, 2019 [Agencywide Documents Access and Management System (ADAMS) Accession No. ML19343C192], Exubrion Therapeutics, Inc. (Exubrion) submitted a request to the U.S. Nuclear Regulatory Commission to review its generic procedures for release of a dog following treatment with Synovetin OATM containing Sn-117m in a hypothetical license amendment.
The staff has conducted an acceptance review of the application and determined that it contains sufficient technical information to begin a detailed technical review. We have established a review schedule based on current workload and priorities. The schedule would allow the staff to complete and issue its requests for additional information (RAIs) in early February 2020, and a draft technical evaluation report in early May 2020, based on Exubrion satisfactorily responding to the RAIs in early March 2020.
If you have any questions, please contact me at 301-415-5422.
Sincerely,
/RA/
Chris Einberg, Branch Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
ML19353C760 *concur via email OFFICE: MSST MSST MSST NAME: IWu LDimmick CEinberg DATE: 12/19/2019 12/19/2019 12/20/2019