ML20269A275
| ML20269A275 | |
| Person / Time | |
|---|---|
| Issue date: | 10/30/2020 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Heather Gepford, Donna Janda, Robert Orlikowski Division of Nuclear Materials Safety I, Division of Nuclear Materials Safety III, Division of Nuclear Materials Safety IV |
| TAPP KATIE/NMSS/MSST | |
| Shared Package | |
| ML20269A274 | List: |
| References | |
| Download: ML20269A275 (3) | |
Text
October 30, 2020 MEMORANDUM TO: Donna M. Janda, Chief Medical and Licensing Assistance Branch Division of Nuclear Materials Safety Region I Robert J. Orlikowski, Chief Materials Licensing Branch Division of Nuclear Materials Safety Region III Heather J.Gepford, Chief Licensing and Decommissioning Branch Division of Nuclear Materials Safety Region IV FROM: Christian E. Einberg, Chief Medical Safety and Events Assessment Branch Christia Digitally signed by Christian Division of Materials Safety, Security, State n Einberg Date:
and Tribal Programs Office of Nuclear Materials Safety Einberg 2020.10.30 09:42:38 -04'00' and Safeguards
SUBJECT:
NOTIFICATION OF 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 By letter dated December 4, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19343C192 (package)), Exubrion Therapeutics (Exubrion) submitted a proposed license application template to support the submission of license amendments by veterinary licensees. These license amendments would allow veterinary licensees to release dogs following treatment of Synovetin OA, a radioactive tin (Sn-117m) colloid, to treat osteoarthritis (OA) in a dogs elbows. Exubrion is the manufacturer of Synovetin OA. Exubrions application template was revised several times, with the most recent version provided to the NRC on September 13, 2020 (ADAMS Accession No. ML20282A513). This application template included the procedure for using Synovetin OA, which includes a prescreening questionnaire and release instruction template; its technical basis for release of animals following treatment; and a generic release procedure for dogs following treatment.
CONTACT: Katherine Tapp 301-415-0236
D. Janda, et al. 2 provides the Nuclear Regulatory Commission (NRC) staffs technical evaluation report (TER) which documents staffs review of Exubrions proposed procedure to release dogs following Synovetin OA treatment. The staffs evaluation was specific to Exubrions request of a maximum administered dose of up to 222 MBq (6 mCi) of Sn-117m to the dogs elbows.
NMSS recommends license reviewers accept Exubrions release procedure contained in their application dated June 1, 2020 (ADAMs Accession Number ML20282A513) as part of an individual license amendment to treat dogs with up to 222 MBq (6 mCi) of Sn-117m as part of Synovetin OA treatment. License reviewers should closely evaluate any specific licensee deviations from Exubrions proposed release procedure analyzed in the TER before approval of the deviation. In addition to the release procedure, the license reviewer should evaluate all other pertinent information as described in the most recent revision of NUREG 1556, Volume 7.
Particular attention should be given to the guidance in NUREG 1556, Volume 7, Appendix D, Guidance for Laboratory Animal and Veterinary Medicine Uses (ADAMS Accession No. ML18065A006).
As documented in the TER, the NRC staff found Exubrions release procedure provides adequate assurance that public dose limits will not be exceeded when licensees perform adequate prescreening and post-treatment release instructions are followed. However, as there is potential to exceed public dose limits if prescreening and release instructions are not followed, staff recommends license reviewers obtain the commitments contained in enclosure 2 from individual licensees prior to approving use of this procedure.
Enclosures
- 1. U.S. Nuclear Regulatory Commission Technical Evaluation Report for the Exubrion Therapeutics Proposed License Application Template for the Release of Dogs Following Treatment with a Tin-117m Colloid
- 2. Notes to License Reviewers Evaluating License Applications to Treat Dogs with Synovetin OA
ML20269A274 (Package) *via email OFFICE NMSS/MSST OGC NLO NMSS/MSST NAME KTapp IIrvin* Bullrich*
DATE 9/22/2020 10/9/2020 10/13/2020 OFFICE NMSS/MSST NMSS/MSST NAME VHolahan CEinberg*
DATE 10/14/2020* 10/30/2020