RIS 2002-19, New Modalities to Be Regulated Under 10 CFR 35.1000
| ML022830802 | |
| Person / Time | |
|---|---|
| Issue date: | 10/21/2002 |
| From: | Cool D NRC/NMSS/IMNS |
| To: | |
| References | |
| RIS-02-019 | |
| Preceding documents: |
|
| Download: ML022830802 (6) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555 October 21, 2002 NRC REGULATORY ISSUE SUMMARY 2002-19 NEW 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 Checkmate' System, Novoste Beta-Cath' System, and Guidant Galileo' Intravascular Radiotherapy System).
SUMMARY OF ISSUE
On the effective date of the revised Part 35, October 24, 2002, Y-90 microspheres, liquid brachytherapy, and intravascular brachytherapy will be governed by §35.1000, based on NRCs determination that they do not fit into §35.100 through §35.600. 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 or after 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 response. If you have any questions about this summary, please contact the individual listed below or the appropriate regional office.
/RA/
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Contact: Ivelisse M. Cabrera, NMSS
(301) 415-8152 E-mail: imc1@nrc.gov Attachment: List of Recently Issued NRC Regulatory Issue Summaries
ML022830802 ADAMS DOCUMENT TITLE:g:\\Cabrera\\new modalities under 35.1000.wpd OFFICE
MSIB
MSIB
NMSS/Editor MSIB
IMNS
NAME
ICabrera FBrown EKraus TEssig DCool DATE
10/7/02
10/7/02
10/8/02
10/8/02
10/ /02
______________________________________________________________________________________
OL = Operating License CP = Construction Permit Attachment LIST OF RECENTLY ISSUED
NRC REGULATORY ISSUE SUMMARIES
_____________________________________________________________________________________
Regulatory Issue Date of Summary No.
Subject Issuance Issued to
_____________________________________________________________________________________
2002-18 Issuance of Orders Imposing Additional Physical Protection Measures for the Transportation of Spent Nuclear Fuel Greater than
100 Grams
10/03/2002 All U.S. Nuclear Regulatory Commission specific power reactor licensees, research and test reactor licensees, independent spent fuel storage installation licensees, and special nuclear material licensees, who possess spent nuclear fuel; and general licensees under
10 CFR 70.20a who transport spent nuclear fuel greater than
100 grams.
2002-14, Sup. 1 Proposed Changes to the Safety System Unavailability Performance Indicators
09/30/2002 All holders of operating licenses for nuclear power reactors, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.
2002-17 Guidance on Performing Military Service Verification
09/19/2002 All holders of operating licenses for nuclear power reactors.
2002-16 Current Incident Response Issues
09/13/2002 All holders of operating licenses for nuclear power plants.
2002-15 NRC Approval of Commercial Data Encryption Systems for the Electronic Transmission of Safeguards Information
08/28/2002 All authorized recipients and holders of sensitive unclassified safeguards information (SGI).
2002-14 Proposed Changes to the Safety System Unavailability Performance Indicators
08/28/2002 All holders of operating licenses for nuclear power reactors, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.
Note:
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