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NRC RIN: 3150-AK91 Publication ID: Fall 2024 
Title: Reporting Nuclear Medicine Injection Extravasations as Medical Events [NRC-2022-0218] 
Abstract:

This rulemaking would amend the NRC’s regulations to require reporting of certain nuclear medicine injection extravasations as medical events and to require medical licensees to develop, implement, and maintain written procedures for evaluating and reporting extravasations. This proposed rule would affect medical licensees that administer intravenous radiopharmaceuticals for diagnostic and therapeutic purposes. The NRC engaged the public during the pre-rulemaking stage through meetings with stakeholders; the publication of preliminary proposed rule language; and public meetings.

 
Agency: Nuclear Regulatory Commission(NRC)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 10 CFR 35   
Legal Authority: 44 USC 2201    44 USC 5841   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Preliminary Proposed Rule Language  04/19/2023  88 FR 24130   
Comment Period End  07/18/2023 
Comment Period Extended  07/18/2023  88 FR 45824   
Comment Period Extension End  09/01/2023 
NPRM  12/00/2024 
Final Rule  09/00/2026 
Additional Information: The proposed rule package (SECY-24-0067, ADAMS Accession No. ML24016A294) was submitted to the Commission on August 13, 2024.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Sarah Lopas
Nuclear Regulatory Commission
Office of Nuclear Material Safety and Safeguards,
Washington, DC 20555-0001
Phone:301 415-6360
Email: sarah.lopas@nrc.gov