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NRC RIN: 3150-AK80 Publication ID: Fall 2023 
Title: Requirements for Rubidium-82 Generators and Emerging Medical Technologies [NRC-2018-0297] 

This rulemaking would revise the NRC's regulations to update the requirements to allow for the inclusion of emerging medical technologies. The purpose of the rulemaking is primarily to bring established modalities currently licensed as emerging medical technologies and allow them to be licensed under other subsections of the regulations to improve licensing consistency across the country. The regulated entities affected would include all NRC, Agreement State, and Master Materials License medical licensees and permittees using microspheres and gamma stereotactic radiosurgery. This rulemaking will also add requirements to address calibration and dosage measurement for rubidium-82 generators.

Agency: Nuclear Regulatory Commission(NRC)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 10 CFR 35   
Legal Authority: 42 U.S.C. 2201    42 U.S.C. 5841   
Legal Deadline:  None
Action Date FR Cite
Regulatory Basis  07/03/2023  88 FR 42654   
Regulatory Basis Comment Period End  10/31/2023 
Regulatory Basis Extension of Comment Period   10/27/2023  88 FR 73766   
Regulatory Basis Extension of Comment Period End  12/15/2023 
NPRM  07/00/2026 
Final Rule  07/00/2027 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Andrew G. Carrera
Nuclear Regulatory Commission
Office of Nuclear Material Safety and Safeguards,
Washington, DC 20555-0001
Phone:301 415-1078