VR-SECY-21-0013, SRM-SECY-21-0013: Rulemaking Plan to Establish Requirements for Rubidium-82 Generators and Emerging Medical Technologies
| ML22013A266 | |
| Person / Time | |
|---|---|
| Issue date: | 01/13/2022 |
| From: | Annette Vietti-Cook NRC/SECY |
| To: | Dan Dorman NRC/EDO |
| References | |
| SECY-21-0013, VR-SECY-21-0013 SRM-SECY-21-0013 | |
| Download: ML22013A266 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
January 13, 2022
MEMORANDUM TO: Daniel H. Dorman Executive Director for Operations
FROM: Annette L. Vietti-Cook, Secretary
SUBJECT:
STAFF REQUIREMENTS - SECY-21-0013 - RULEMAKING PLAN TO ESTABLISH REQUIREMENTS FOR RUBIDIUM-82 GENERATORS AND EMERGING MEDICAL TECHNOLOGIES
The Commission has approved the staffs recommended Option 3, to initiate a rulemaking that would address rubidium-82 generators along with all current, well-established emerging medical technologies (EMTs), plus create added flexibility throughout Title 10 of the Code of Federal Regulations Part 35, Medical U se of Byproduct Material, to accommodate future EMTs.
If the staff finds that the complexity of this approach would result in a timeframe substantially longer than the current estimate, the staff should notify the Commission and provide a recommendation about whether to proceed with a more targeted rulemaking to address only Rb-82 generators, gamma stereotactic radiosurgery units, and yttrium -90 microspheres, as envisioned in Option 2
cc: Chairman Hanson Commissioner Baran Commissioner Wright OGC CFO OCA OPA