ML20303A332
| ML20303A332 | |
| Person / Time | |
|---|---|
| Issue date: | 10/30/2020 |
| From: | Christian Einberg NRC/NMSS/DMSST |
| To: | Selover P Exubrion Therapeutics |
| TAPP, K/NMSS/MSST | |
| Shared Package | |
| ML20303A331 | List: |
| References | |
| Download: ML20303A332 (2) | |
Text
October 30, 2020 Mr. Peter Selover Chief Executive Officer Exubrion Therapeutics, Inc.
5203 Bristol Industrial Way Buford, GA 30518
SUBJECT:
ISSUANCE OF TECHNICAL EVALUATION REPORT FOR THE EXUBRION THERAPEUTICS PROPOSED LICENSE APPLICATION TEMPLATE FOR THE RELEASE OF DOGS FOLLOWING TREATMENT WITH A TIN-117M COLLOID
Dear Mr. Selover:
By letter dated December 4, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19343C192), Exubrion Therapeutics (Exubrion) submitted a proposed license application template to support the submission of license amendments by veterinary licensees. Since that time, Exubrion has submitted several revisions to its proposed license application template based on discussions with the U.S. Nuclear Regulatory Commission (NRC) staff, with the most recent version provided to the NRC on September 13, 2020 (ADAMS Accession No. ML20282A513). The NRC has evaluated the information contained in the request and has determined that Exubrions proposed release procedure following treatment provides adequate measures to ensure public dose limits will not be exceeded when owners provide complete and accurate information as described in the enclosed technical evaluation report (TER). Therefore, my staff is recommending that NRC regional license reviewers accept the release procedure contained in the September 13, 2020 submittal as part of individual license amendments. Since my staffs evaluation was specific to the request submitted by Exubrion, my staff is also recommending that license reviewers closely evaluate any specific licensee deviations from the proposed release procedure analyzed in the TER before approval of the deviation. If you have any questions regarding this request, please contact me at 301-415-5422, or via e-mail at Christian.Einberg@nrc.gov.
Sincerely, Christian Digitally signed by Christian Einberg Einberg Date: 2020.10.30 09:44:43 -04'00' Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Technical Evaluation Report
ML20303A331 - Package *via e-mail OFFICE NMSS/MSST NMSS/MSST NAME KTapp* CEinberg DATE 10/29/20 10/30/20