3150-AK91 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 3150 Nuclear Regulatory Commission NRC Reporting Nuclear Medicine Injection Extravasations as Medical Events [NRC-2022-0218]

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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 10 CFR 35 44 USC 2201 44 USC 5841 No 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 The NRC published preliminary proposed rule language for a rulemaking on the reporting of nuclear medicine injection extravasations as medical events (88 FR 24130; April 19, 2023). The NRC extended the comment period to September 1, 2023 (88 FR 45824; July 18, 2023). The NRC posed questions to obtain input from stakeholders to inform the development of a proposed rulemaking planned for publication in late 2024. The NRC held a public meeting on May 24, 2023, to facilitate feedback. No No None No No No Sarah Lopas 3150 Nuclear Regulatory Commission NRC 301 415-6360 sarah.lopas@nrc.gov Office of Nuclear Material Safety and Safeguards, Washington DC 20555-0001