ML20091M255: Difference between revisions
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==Dear Mr. Selover:== | ==Dear Mr. Selover:== | ||
By letter dated December 4, 2019 (Agencywide Documents Access and Management System | By {{letter dated|date=December 4, 2019|text=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 (NRC) to review its generic procedures for the release of a dog following treatment with Synovetin OATM containing Sn-177m in a hypothetical license amendment. The NRC has reviewed the information contained in the request and has identified areas where additional information is needed to complete its review. | [ADAMS] Accession No. ML19343C192), Exubrion Therapeutics, Inc. (Exubrion) submitted a request to the U.S. Nuclear Regulatory Commission (NRC) to review its generic procedures for the release of a dog following treatment with Synovetin OATM containing Sn-177m in a hypothetical license amendment. The NRC has reviewed the information contained in the request and has identified areas where additional information is needed to complete its review. | ||
The enclosure lists the requests for additional information (RAIs). As part of the RAIs, staff included some licensing-specific questions unrelated to animal release procedures since that information was included as part of Exubrions application. These questions are included in the enclosure to provide Exubrion with a general idea of the types of information that an NRC license reviewer would need to review as part of a specific license amendment request. If Exubrions intent is that specific licensees provide additional information for these questions, the application should be updated to direct specific licensees to ensure they address it for their specific application. | The enclosure lists the requests for additional information (RAIs). As part of the RAIs, staff included some licensing-specific questions unrelated to animal release procedures since that information was included as part of Exubrions application. These questions are included in the enclosure to provide Exubrion with a general idea of the types of information that an NRC license reviewer would need to review as part of a specific license amendment request. If Exubrions intent is that specific licensees provide additional information for these questions, the application should be updated to direct specific licensees to ensure they address it for their specific application. | ||
Latest revision as of 05:00, 25 September 2022
| ML20091M255 | |
| Person / Time | |
|---|---|
| Issue date: | 04/27/2020 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Selover P Exubrion Therapeutics |
| Irene Wu, NMSS/MSEB | |
| Shared Package | |
| ML20091M172 | List: |
| References | |
| Download: ML20091M255 (3) | |
Text
April 27, 2020 Mr. Peter Selover Chief Executive Officer Exubrion Therapeutics, Inc.
5203 Bristol Industrial Way Buford, GA 30518
SUBJECT:
REQUESTS FOR ADDITIONAL INFORMATION FOR THE REVIEW OF THE HYPOTHETICAL LICENSE AMENDMENT APPLICATION 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 (NRC) to review its generic procedures for the release of a dog following treatment with Synovetin OATM containing Sn-177m in a hypothetical license amendment. The NRC has reviewed the information contained in the request and has identified areas where additional information is needed to complete its review.
The enclosure lists the requests for additional information (RAIs). As part of the RAIs, staff included some licensing-specific questions unrelated to animal release procedures since that information was included as part of Exubrions application. These questions are included in the enclosure to provide Exubrion with a general idea of the types of information that an NRC license reviewer would need to review as part of a specific license amendment request. If Exubrions intent is that specific licensees provide additional information for these questions, the application should be updated to direct specific licensees to ensure they address it for their specific application.
As discussed during the pre-submittal meeting, your response to the RAIs should be provided to the NRC within 30 days from the date of this letter to stay on the schedule discussed. However, please contact me if more time is needed to ensure appropriate responses.
P. Selover 2 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: 2020.04.27 14:16:04 -04'00' Christian 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
Enclosure:
Requests for Additional Information Cc w/encl: Distribution List
ML20091M172 - Package *via e-mail OFFICE MSST MSST MSST MSST NAME IWu* KTapp* LDimmick CEinberg DATE 04/23/20 04/23/20 04/27/20 04/27/20