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
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 10/03/2002 All U.S. Nuclear Regulatory Additional Physical Protection Commission specific power Measures for the Transportation of reactor licensees, research and Spent Nuclear Fuel Greater than test reactor licensees,
100 Grams 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, Proposed Changes to the Safety 09/30/2002 All holders of operating licenses Sup. 1 System Unavailability Performance for nuclear power reactors, except Indicators 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 09/19/2002 All holders of operating licenses Service Verification 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 08/28/2002 All authorized recipients and Encryption Systems for the holders of sensitive unclassified Electronic Transmission of safeguards information (SGI).
Safeguards Information
2002-14 Proposed Changes to the Safety 08/28/2002 All holders of operating licenses System Unavailability Performance for nuclear power reactors, except Indicators those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.
Note: NRC generic communications may be received in electronic format shortly after they are issued by subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the message portion:
subscribe gc-nrr firstname lastname
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OL = Operating License CP = Construction Permit