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 Annette L. Digitally signed by Annette L. Vietti-Cook FROM: Annette L. Vietti-Cook, Secretary Vietti-Cook Date: 2022.01.13 09:52:55 -05'00'
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 Use 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