RIS 2002-23, Availability of Licensing Guide for Diagnostic Nuclear Medicine

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Availability of Licensing Guide for Diagnostic Nuclear Medicine
ML023180136
Person / Time
Issue date: 11/27/2002
From: Frant S
NRC/NMSS/IMNS
To:
References
10 CFR Part 35 RIS-02-023
Download: ML023180136 (5)


UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 November 27, 2002 NRC REGULATORY ISSUE SUMMARY 2002-23 AVAILABILITY OF GUIDE FOR

DIAGNOSTIC NUCLEAR MEDICINE

ADDRESSEES

All medical licensees.

INTENT

The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS)

to inform addressees of the availability, from the NRC, of a Guide for Diagnostic Nuclear Medicine, prepared by the American College of Nuclear Physicians and the Society of Nuclear Medicine (ACNP / SNM) and published under the auspices of the SNM. No written response or action is required.

BACKGROUND

The NRC published its revised regulations for the Medical Use of Byproduct Material, 10 CFR Part 35, on April 24, 2002, with an effective date of October 24, 2002 (67 FR 20249). In parallel with the development of the rule, NRC staff developed NUREG-1556, Volume 9, Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Medical Use Licenses.

Stakeholders have also identified the need for guidance applicable only to diagnostic uses of byproduct material under 10 CFR 35.100 and 35.200.

SUMMARY OF ISSUE

The NRC recognizes the need of the medical community for information specific to diagnostic applications of byproduct material under revised Part 35 and appreciates the efforts undertaken by the ACNP / SNM to meet that need. NUREG-1556, Volume 9 provides guidance for licensing of all medical uses of byproduct material. Furthermore, applicants and licensees are advised that they may look to NUREG-1556, Volume 9 for guidance that represents a way of implementing 10 CFR Part 35 which is acceptable to NRC staff. The SNM's Guide for Diagnostic Nuclear Medicine provides information that may be useful to nuclear medicine professionals in understanding the applicability of NRC requirements to the medical use of byproduct material in diagnostic settings, and provides measures that practitioners may use to facilitate implementation of the revised rule. The information provided in the document is not a substitute for NRC regulations; licensees are required to comply with all applicable Parts of Title 10 of the Code of Federal Regulations.

The ACNP / SNM Guide is available on the NRC's web site. Single copies, on paper or CD-rom (also including a copy of NUREG-1556, Volume 9), may be requested by writing to the U.S.

Nuclear Regulatory Commission, ATTN: Mrs. Carrie Brown, Mail Stop T 9-C24, Washington, DC 20555-0001; e-mail: CXB@nrc.gov; telephone: 301-415-8092.

No specific action or written response is required for this RIS. If you have any questions about this summary, please contact Roger W. Broseus or the appropriate regional office.

/RA/

Susan Frant, Deputy Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Technical Contact:

Roger W. Broseus, NMSS

(301) 415-7608 E-mail: RWB@nrc.gov Attachment: List of Recently Issued NRC Regulatory Issue Summaries

ML023180136 ADAMS DOCUMENT TITLE: *See previous concurrence OFFICE: RGB:IMNS RGB:IMNS NMSS Editor RGB:IMNS

NAME: RBroseus SWastler* EKraus* PHolahan DATE: 11/04/2002 11/4/2002 10/31/2002 11/ 4 /2002 OFFICE: OGC nlo IMNS

NAME: STreby* SFrant DATE: 11/5/2002 11/ 14 /2002

Attachment LIST OF RECENTLY ISSUED

NRC REGULATORY ISSUE SUMMARIES

_____________________________________________________________________________________

Regulatory Issue Date of Summary No. Subject Issuance Issued to

_____________________________________________________________________________________

2002-22 Use of EPRI/NEI Joint Task Force Pending All holders of operating licenses Report, Guideline on Licensing for nuclear power reactors, except Digital Upgrades: EPRI those who have permanently TR-102348, Revision 1, NEI 01-01: ceased operations and have a Revision of EPRI TR-102348 to certified that fuel has been Reflect Changes to the 10 Cfr permanently removed from the

50.59 Rule reactor vessel.

2002-21 National Guard and Other 11/08/2002 All holders of operating licenses Emergency Responders Located for nuclear power reactors, in the Licensees Controlled Area including those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.

2002-20 Clarification of Requirements 11/07/2002 All medical licensees.

Under 10 CFR 35.432, Calibration Measurements of Brachytherapy Sources

2002-19 New Modalities to be Regulated 10/21/2002 All medical licensees authorized to Under 10 CFR 35.1000 use byproduct material for therapeutic administration.

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.

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