ML19273A957
| ML19273A957 | |
| Person / Time | |
|---|---|
| Issue date: | 10/01/2019 |
| From: | Irene Wu Office of Nuclear Material Safety and Safeguards |
| To: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| Irene Wu, NRC/NMSS | |
| Shared Package | |
| ML19273A954 | List: |
| References | |
| Download: ML19273A957 (5) | |
Text
October 1, 2019 MEMORANDUM TO: Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs /RA by Lisa Dimmick for/
Office of Nuclear Material Safety and Safeguards FROM: Irene Wu, Project Manager 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 SEPTEMBER 12, 2019, PUBLIC TELECONFERENCE WITH EXUBRION THERAPEUTICS TO DISCUSS OPTIONS FOR CONTINUED DISCUSSIONS ON THE USE OF SN-117M IN DOGS FOR THE TREATMENT OF OSTEOARTHRITIS On September 12, 2019, a public teleconference was held at the U.S. Nuclear Regulatory Commission (NRC) Headquarters in Rockville, Maryland. The purpose of the public teleconference was to discuss options with Exubrion Therapeutics, Inc. (Exubrion) for continued discussions on the use of Sn-117m in dogs for the treatment of osteoarthritis. This teleconference was held in response to Exubrions request (in a letter dated August 7, 2019, Agencywide Documents Access and Management System (ADAMS) Accession No. ML19221B309) to have an in-person meeting to discuss the changes made to its proposed pre-screening process, proposed owner interview checklist to be used as part of the pre-screening process, and the proposed guidance for veterinary staff to customize the release instructions for a particular dog. The NRC staff began the meeting by providing an overview of the interactions to date between Exubrion and the NRC followed by a presentation of the two options being considered for continuing these discussions. These options are either (1) to follow the same process used in 2018 whereby a licensee would request authorization from the NRC for use of this treatment, which would involve a Technical Assistance Request to the medical team at NRC Headquarters for guidance on veterinary release criteria, or (2) to request approval for a hypothetical license amendment from a hypothetical licensee, which then licensees could use as a template when they prepare and submit a license amendment request to the NRC.
CONTACT: Irene Wu 301-415-1951
C. Einberg Following NRCs presentation, Exubrion and its contractors asked questions about the two options. Some specific questions asked by Exubrion and its contractors regarding the two options were how much interaction they would have with the NRC headquarters staff, what documents would be made publicly available, when in the process would the documents be reviewed by the NRCs Office of the General Counsel, and how long each process would take.
Exubrion and its contractors also raised their concern that NRC still had not asked all of its questions regarding Exubrions proposed pre-screening process, proposed owner interview checklist, and proposed guidance for veterinary staff. At the end of the teleconference, the NRC staff indicated that if Exubrion wanted to proceed with the first option, they could just inform the medical team at NRC Headquarters that a license amendment request for use of this treatment was sent to an NRC regional office. If Exubrion wanted to proceed with the second option, Exubrion would have to send in a letter indicating its notice of intent to submit a hypothetical license amendment for a hypothetical licensee.
There were 14 participants in the public teleconference meeting. Participants represented the NRC, Exubrion, and contractors to Exubrion. A list of meeting attendees and the meeting agenda are attached. The meeting handout with a description of the two options being considered is available in ADAMS Accession No. ML19253B171.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
PKG ML19273A954; Meeting Summary ML19273A957; Meeting Handout ML19253B171; Meeting Notice ML19253C426 *via email OFFICE NMSS/MSST/MSEB/PM NMSS/MSST/MSEB/TL NMSS/MSST/MSEB/BC Lisa Dimmick for:
NAME IWu LDimmick CEinberg DATE 09/26/19 10/01/19 10/01/19
Meeting Attendees Teleconference with Exubrion Therapeutics September 12, 2019 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 Ian Irvin NRC 6 Irene Wu NRC 7 Robert Gallaghar NRC 8 Penny Lanzisera NRC 9 Peter Selover Exubrion Therapeutics 10 John Donecker Exubrion Therapeutics 11 Eric Schreiber Exubrion Therapeutics 12 Martin Manco Exubrion Therapeutics 13 Matthew Arno Foxfire Scientific, Inc.
14 Chad Smith F.X. Massé Associates Enclosure 1
Meeting Agenda Teleconference with Exubrion September 12, 2019, 1:00 p.m. to 3:00 p.m. ET Time Topic Speaker 1:00 p.m. to 3:00 p.m. ET Discussion of Options NRC/Exubrion Enclosure 2