View source for RIS 2002-19, New Modalities to Be Regulated Under 10 CFR 35.1000

{{Adams
| number = ML022830802
| issue date = 10/21/2002
| title = New Modalities to Be Regulated Under 10 CFR 35.1000
| author name = Cool D
| author affiliation = NRC/NMSS/IMNS
| addressee name = 
| addressee affiliation = 
| docket = 
| license number = 
| contact person = 
| document report number = RIS-02-019
| document type = NRC Regulatory Issue Summary
| page count = 6
}}
{{#Wiki_filter: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 &sect;35.1000, based on NRCs determination that they do not fit into &sect;35.100 through &sect;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
&sect;35.1000 and &sect;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
______________________________________________________________________________________
OL = Operating License CP = Construction Permit
}}

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