ML20303A319
| ML20303A319 | |
| Person / Time | |
|---|---|
| Issue date: | 10/30/2020 |
| From: | Kevin Williams NRC/NMSS/DMSST |
| To: | Crowley D State of NC, Dept of Health & Human Services |
| TAPP, K - NMSS/MSST | |
| Shared Package | |
| ML20303A318 | List: |
| References | |
| Download: ML20303A319 (3) | |
Text
October 30, 2020 Mr. David Crowley, Chair Organization of Agreement States Radioactive Materials Branch Manager Division of Health Service Regulation, Radiation Protection Section North Carolina Department of Health and Human Services 5505 Creedmoor Rd., First Floor Raleigh, NC 27612
SUBJECT:
RESPONSE TO COMMENTS BY THE ORGANIZATION OF AGREEMENT STATES ON THE REVISED TECHNICAL EVALUATION REPORT FOR THE EXUBRION THERAPEUTICS PROPOSED LICENSE APPLICATION TEMPLATE FOR THE RELEASE OF DOGS FOLLOWING TREATMENT WITH A TIN-117M COLLOID
Dear Mr. Crowley:
Thank you for the Organization of Agreement States (OAS) October 26, 2020, letter (Agencywide Documents Access and Management System (ADAMS) Accession No. ML20301A416) with additional comments to the NRC for consideration on Exubrion Therapeutics (Exubrions) proposed license application. OASs thorough review of the application helped us produce a better technical evaluation report (TER) and license reviewer notes. Although the TER and reviewer notes are designated as Compatibility Category D and Agreement States have the flexibility to choose whether or not to approve requests from veterinary licensees to treat dogs with Synovetin OA, our collaborative work on the Exubrion proposed license amendment will help the National Materials Program (NMP) to thoroughly evaluate applications and make informed decisions on protecting public health and safety.
Going forward, we have identified a number of priorities to work in the coming years, including reviewing extravasations, developing a communication platform, risk-informing inspection procedures, and the recruiting and retaining of NMP staff. I look forward to working with you, the OAS Board, the NMP Champions, and all the Agreement States in tackling these challenges. Our continued commitment to partnership and communication in addressing all of our priorities will benefit the entire NMP.
As stated in your letter, I understand the OAS Board still has concerns on the Exubrion application due to the use of prescreening discussion and post-treatment instructions to ensure compliance with public dose limits. We understand that the OAS Board is concerned with the potential for the public dose limits to be exceeded if an owner provides incomplete or inadequate information during prescreening and the household members do not follow instructions. However, the U.S. Nuclear Regulatory Commission (NRC) staff finds measures described in treatment and release procedure provide for reasonable assurance that the public dose limits will not be exceeded when owners provide complete and accurate information and follow the release instructions. These are additional measures not previously described in NUREG-1556, Volume 7 Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope,
D. Crowley 2
Including Electron Capture Devices and X-Ray Fluorescence Analyzers (ADAMS Accession No. ML18065A006), and NRC staff believes they provide adequate protection of public health and safety. A more detailed response of individual comments in your letter can be found in the enclosure.
As we have previously discussed, the NRC plans to start development of comprehensive guidance for animal release following veterinary procedures using byproduct material. We look forward to closely collaborating with the Agreement States on this guidance and other NMP priorities. Feel free to contact me or we can work through our respective NMP Champions.
Sincerely, Kevin Williams, Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Exubrion Technical Evaluation OAS Comment Resolution Table cc: L. Cox Kevin Williams Digitally signed by Kevin Williams Date: 2020.10.30 09:02:41
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ML20303A318 (Package)
- via email OFFICE NMSS/MSST NMSS/MSST NMSS/MSST NAME KTapp*
DWhite*
CEinberg*
DATE 10/29/2020 10/29/2020 10/29/2020 OFFICE NMSS/MSST NAME KWilliams DATE 10/30/2020