ML19319A465
| ML19319A465 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/2019 |
| From: | Irene Wu Office of Nuclear Material Safety and Safeguards |
| To: | Christian Einberg Office of Nuclear Material Safety and Safeguards |
| Irene Wu, NRC/NMSS | |
| Shared Package | |
| ML19319A423 | List: |
| References | |
| Download: ML19319A465 (5) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 November 15, 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 NOVEMBER 6, 2019, PRE-SUBMITTAL PUBLIC MEETING WITH EXUBRION THERAPEUTICS On November 6, 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 to discuss Exubrion Therapeutics, Inc. (Exubrion) intent to submit a hypothetical license amendment containing generic release procedures and instructions following the treatment of osteoarthritis in dogs with Synovetin OATM, a radioactive colloid containing Sn-117m. This meeting was held in response to Exubrions request (in a letter dated September 20, 2019, Agencywide Documents Access and Management System (ADAMS) Accession No. ML19267A301) for a pre-submittal meeting to discuss the structure and sequence of the process going forward and the necessary content of the hypothetical license amendment. NRC staff provided an overview of the process, tentative schedule, regulatory requirements associated with the release of animals containing radioactive material, and information which staff would need to complete this review. NRC staff and Exubrion staff and its contractors engaged in discussion throughout NRCs slide presentation. Specific issues that were discussed in greater detail included the need for more justification for how the 2 mrem in any one hour public dose limit will be met following dog release; more measurement data or models, peer-reviewed journal articles, or other basis to provide justification for any non-conservative assumptions used to demonstrate public dose limits are met; and figures to show distances and geometries for measurements.
Following this discussion, the public was provided an opportunity to comment. Dr. Dennis Law, a veterinarian, encouraged NRC to move forward with this effort because there are many dogs who could benefit from this treatment.
C. Einberg There were 22 participants in the public meeting. Participants represented the NRC, Exubrion, contractors to Exubrion, and the public. A list of meeting attendees and the meeting agenda are attached. NRCs slide presentation is available in ADAMS under Accession No. ML19308C187.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
PKG ML19319A423; Meeting Summary ML19319A465; NRC Slide Presentation ML19308C187; Meeting Notice ML19309D594
- via email OFFICE NMSS/MSST/MSEB/PM NMSS/MSST/MSEB/TL NMSS/MSST/MSEB/BC NAME IWu LDimmick CEinberg DATE 11/13/19 11/13/19 11/13/19 Meeting Attendees Pre-Submittal Meeting with Exubrion Therapeutics, Inc.
November 6, 2019 NRC One White Flint North, O-11B4 9:00 AM - 1:00 PM Name Organization 1 Irene Wu NRC 2 Katie Tapp NRC 3 Betsy Ullrich NRC 4 Vincent Holahan NRC 5 Chris Einberg NRC 6 Kevin Williams NRC 7 Ian Irvin NRC 8 Lisa Dimmick NRC 9 Donna-Beth Howe NRC 10 Sarah Lopas NRC 11 Vered Shaffer NRC 12 Colleen Casey NRC 13 Peter Selover Exubrion Therapeutics 14 John Donecker Exubrion Therapeutics 15 Steve Fox Exubrion Therapeutics 16 Nigel Stevenson Exubrion Therapeutics 17 Eric Schreiber Exubrion Therapeutics 18 Martin Manco Exubrion Therapeutics 19 Matthew Arno Foxfire Scientific, Inc.
20 Chad Smith F.X. Massé Associates 21 Dennis Law Public 22 Roland Benke Renaissance Code Development Enclosure 1
Meeting Agenda Pre-Submittal Meeting with Exubrion Therapeutics, Inc.
November 6, 2019, 9:00 AM to 1:00 PM NRC One White Flint North, O-11B4 11555 Rockville Pike Rockville, MD Time Topic Speaker 9:00 AM Introductions and Opening Remarks NRC NRC Presentation NRC NRC and Exubrion Discussion NRC and Exubrion Public Comments Public Adjourn NRC Enclosure 2