ML19270E566
| ML19270E566 | |
| Person / Time | |
|---|---|
| Issue date: | 09/30/2019 |
| From: | Irene Wu NRC/NMSS/DMSST |
| To: | Christian Einberg NRC/NMSS/DMSST |
| IRENE WU MSST | |
| Shared Package | |
| ML19270E565 | List: |
| References | |
| Download: ML19270E566 (5) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 September 30, 2019 MEMORANDUM TO: 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 FROM: Irene Wu, Project Manager /RA/
Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF JULY 29, 2019, PUBLIC MEETING WITH EXUBRION THERAPEUTICS TO DISCUSS ITS VETERINARY USES OF SN-117M On July 29, 2019, a public meeting was held at the U.S. Nuclear Regulatory Commission (NRC)
Headquarters in Rockville, Maryland. The purpose of the public meeting was for Exubrion Therapeutics, Inc. (Exubrion) to discuss its veterinary uses of Sn-117m. This meeting was held in response to Exubrions request (in a letter dated June 17, 2019, Agencywide Documents Access and Management System (ADAMS) Accession No. ML19217A165) to have an in-person meeting to discuss NRCs concerns and questions regarding the veterinary use of Sn-117m. Exubrion gave a presentation to support the release of canines administered Sn-117m Synovetin OATM that included an overview of osteoarthritic dogs, how Sn-117m treatment works, assumptions for common dog behaviors that could factor into the public dose assessment, dose rates for the public dose evaluation, veterinary screening process, and proposed written instructions. Following Exubrions slide presentation, the NRC engaged in some discussion with Exubrion and its contractors and provided feedback on the assumptions used in Exubrions public dose assessment and how compliance with the public dose limit may be achieved. Specific concerns raised by NRC staff included the need for the release criteria to address the full range of possible dog behaviors and human-dog interactions, not just averages, and the need for the pre-screening process to include open-ended questions to fully understand the owners interactions with its dog.
CONTACT: Irene Wu, NMSS/MSST 301-415-1951
C. Einberg 2 There were 11 participants in the public meeting. Participants represented the NRC, Exubrion, and contractors to Exubrion. A list of meeting attendees and the meeting agenda are attached.
Exubrions slide presentation is available in ADAMS under Accession No. ML19206A448.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
ML19270E565 *via email OFFICE MSST MSST MSST NAME IWu LDimmick CEinberg DATE 09/26/19 9/27/19 9/30/19 Meeting Attendees Public Meeting with Exubrion Therapeutics July 29, 2019 NRC One White Flint North, 12B4 1:00 p.m. to 3:00 p.m. ET Name Organization 1 Donna-Beth Howe NRC 2 Christian Einberg NRC 3 Lisa Dimmick NRC 4 Vincent Holahan NRC 5 Katie Tapp NRC 6 Peter Selover Exubrion Therapeutics 7 John Donecker Exubrion Therapeutics 8 Steve Fox Exubrion Therapeutics 9 Nigel Stevenson Exubrion Therapeutics 10 Matthew Arno Foxfire Scientific, Inc.
11 Chad Smith F.X. Massé Associates
Meeting Agenda Public Meeting with Exubrion Therapeutics July 29, 2019, 1:00 p.m. to 3:00 p.m.
NRC One White Flint North, 12B4 11555 Rockville Pike Rockville, MD Time Topic Speaker 1:00 Exubrion Therapeutics presentation