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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E8-18014 Medical Use of Byproduct Material-Amendments/Medical Event Definitions Proposed Rule The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations that govern medical use of byproduct material related to reporting and notifications of medical events (MEs) to clarify requirements for permanent implant brachytherapy. The proposed amendments would change the criteria for defining an ME for permanent implant brachytherapy from dose-based to activity-based; add a requirement to report, as an ME, any administration requiring a written directive (WD) if a WD was not prepared; clarify requirements for WDs for permanent implant brachytherapy; and make certain administrative and clarification changes. These amendments regarding permanent implant brachytherapy are being proposed in response to several incidents involving therapeutic use of byproduct material. The proposed changes are based in part on recommendations from NRC's Advisory Committee on the Medical Use of Isotopes (ACMUI) and the NRC's Medical Radiation Safety Team. This proposed rule would affect all medical licensees that perform procedures using byproduct material that require completion of a WD. 2008-08-06 2008 8 https://www.federalregister.gov/documents/2008/08/06/E8-18014/medical-use-of-byproduct-material-amendmentsmedical-event-definitions https://www.govinfo.gov/content/pkg/FR-2008-08-06/pdf/E8-18014.pdf Nuclear Regulatory Commission 383 The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations that govern medical use of byproduct material related to reporting and notifications of medical events (MEs) to clarify requirements for permanent implant brachytherapy. The...  

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