ML20238B822

Third Request for Additional Information from Exubrion

ML20238B822
Person / Time
Issue date:	08/25/2020
From:	Office of Nuclear Material Safety and Safeguards
To:	Exubrion Therapeutics
Katie Tapp
Shared Package
ML20238B820	List: ML20238B821 ML20238B822
References
Download: ML20238B822 (1)

Text

Third Set of Requests for Additional Information for the Review of the Hypothetical License Amendment Application for Treatment of Dogs with Synovetin OATM Containing Sn-117m

1. As household members will need to minimize close contact interactions with dogs for several weeks following treatment so exposures will not exceed public dose limits, update the procedure to ensure licensees will contact household members to discuss post-treatment interactions. During this follow-up, the licensee should verify that the household members interactions match what was provided during the pre-screening criteria, if possible, and provide additional behavior modifications if it appears the initial instructions cannot be followed to keep the doses as low as reasonably achievable (ALARA). In addition, the licensee should remind the household members on how to keep doses ALARA. The follow-up call should occur within a few days of treatment to ensure behavior modifications can still be adjusted to ensure all public doses will be below 100 mrem and ALARA.

2. The procedure should be updated to have the licensee perform a dose assessment if the licensee finds out a household member is not following instructions. The procedure should be updated to have the licensee report to the NRC if they believe a member of the public received a dose in exceedance of the public dose limits as required by 10 CFR 20.2203.

3. Item A3.8 of the procedure states licensees can only provide treatment of Synovetin OA if the licensee is confident that the owner can comply with the Release Instructions. As all members who reside in the house must comply with the release instructions, the term owner should be changed to all household members. The procedure should be updated to exclude release if it is necessary for a young child, or someone without the capabilities to perform behavior modifications, is left alone with the dog for a significant period of time.

4. Provide survey measurements and corresponding activity rate from at least 1 dog for staff to validate Microshield calculations.

5. Staff understands Exubrion has updated its Microshield runs using a more recent version of Microshield. Please provide those updated runs and any changes to the procedure or doses provided in the technical basis.