RIS 2002-19, New Modalities To Be Regulated Under 10 CFR 35.1000
| ML022830802 | |
| Person / Time | |
|---|---|
| Issue date: | 10/21/2002 |
| Revision: | 0 |
| From: | Cool D A NRC/NMSS/IMNS |
| To: | |
| References | |
| RIS-02-019 | |
| Download: ML022830802 (6) | |
UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555October 21, 2002NRC REGULATORY ISSUE SUMMARY 2002-19NEW MODALITIES TO BE REGULATED UNDER 10 CFR 35.1000
ADDRESSEES
All medical licensees authorized to use byproduct material for therapeutic administration.
INTENT
The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS)to inform addressees of how three specific new modalities will be regulated under the revised 10 CFR Part 35, "Medical Use of Byproduct Material." No specific action nor written response is required.
BACKGROUND
There are three new modalities currently authorized by the NRC on some specific licenses.These are Y-90 microspheres (e.g., MDS Nordion Y-90 TheraSphere); liquid brachytherapy (e.g., Proxima Therapeutics' GliaSite Radiation Therapy System); and intravascular brachytherapy (e.g., Cordis CheckmateŽ System, Novoste Beta-CathŽ System, and Guidant GalileoŽ Intravascular Radiotherapy System).
SUMMARY OF ISSUE
On the effective date of the revised Part 35, October 24, 2002, Y-90 microspheres, liquidbrachytherapy, and intravascular brachytherapy will be governed by §35.1000, based on NRC's determination that they do not fit into §35.100 through §35.60 For licensees currently authorized to use these modalities, their existing license conditions applicable to these types of use will remain in effect after October 24, 2002.Specific licensees that want to be authorized to use one or more of these new modalities on orafter the effective date of the final rule should request license amendments in accordance with
§35.1000 and §35.12(d). This RIS requires no specific action nor written respons If you have any questions about thissummary, please contact the individual listed below or the appropriate regional office./RA/Donald A. Cool, DirectorDivision of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and SafeguardsContact: Ivelisse M. Cabrera, NMSS (301) 415-8152 E-mail: imc1@nrc.gov
Attachment:
List of Recently Issued NRC Regulatory Issue Summaries This RIS requires no specific action nor written respons If you have any questions about thissummary, please contact the individual listed below or the appropriate regional office.Donald A. Cool, DirectorDivision of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and SafeguardsContact: Ivelisse M. Cabrera, NMSS (301) 415-8152 E-mail: imc1@nrc.gov
Attachment:
List of Recently Issued NRC Regulatory Issue SummariesADAMS ACCESSION NUMBER: ML022830802ADAMS DOCUMENT TITLE:g:\Cabrera\new modalities under 35.1000.wpd OFFICEMSIBMSIBNMSS/EditorMSIBIMNSNAMEICabreraFBrownEKrausTEssigDCoolDATE 10/7/0210/7/0210/8/0210/8/0210/ /02OFFICIAL RECORD COPY
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