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Medical Uses Licensee: Recent Activities

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Posted Notice
08/13/07 Federal Register Notice (72 FR 45181), August 13, 2007, Medical Use of Byproduct Material - Minor Corrections and Clarifications, Proposed Rule is available for comment.  It may be found on the GPO Access web site at: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-15762.pdf exit icon
08/13/07

Federal Register Notice (72 FR 45147), August 13, 2007, Medical Use of Byproduct Material - Minor Corrections and Clarifications, Direct Final Rule can be found on the GPO Access web site at: http://www.gpoaccess.gov/fr/browse.html exit icon

08/08/07 New Licensing Guidance for the Leksell Gamma Knife® Perfexion™ is available and posted on the Medical Uses Licensee Toolkit web site at http://www.nrc.gov/materials/miau/mediuse-toolkit/perdexion-guidance.pdf.
08/08/07 The Licensing Guidance for using the NRC Form 313A Series of Forms has been revised and is posted on the Medical Uses Licensee Toolkit web site at http://www.nrc.gov/materials/miau/med-use-toolkit/licensing-guidance-form313a.pdf.
08/02/07

NUREG-1556, Volume 9, Revision 2, Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses, Draft Report is available for comment. It may be viewed at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/. It was noticed in the Federal Register on August 2, 2007, for a 30-day public comment period at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-15049.pdf. exit icon

07/31/07

"Advisory Committee on the Medical Uses of Isotopes: Meeting Notice" was noticed in the Federal Register on July 31, 2007 to announce a teleconference meeting that will be held on August 16 to continue the open discussion on 10 CFR Part 35 Training and Experience (T&E) Implementation Issues. It may be viewed at: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-14715.pdf. exit icon

07/19/07 NRC Information Notice 2007-25, "Suggestions from the Advisory Committee on the Medical Uses of Isotopes for Consideration to Improve Compliance with Sodium Iodide I-131 Written Directive Requirements in 10 CFR 35.40 and Supervision Requirements in 10 CFR 35.27," dated July 19, 2007, is available. It may be viewed at: http:www.nrc.gov/reading-rm/doc-collections/gen-comm/info-notices/2007/
07/16/07 Advisory Committee on the Medical Uses of Isotopes: Call for Nominations for the position of Agreement State Representative was noticed in the Federal Register (72 FR 38844) on July 16, 2007. It may be viewed at: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-13723.pdf exit icon

07/03/07

NUREG-1556, Volume 13, Revision 1, "Consolidated Guidance About Materials Licenses, Program-Specific Guidance About Commercial Radiopharmacy Licenses" Draft Report is available for comment. It may be viewed at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v13/r1/sr1556v13r1.pdf. It was noticed in the Federal Register on July 3, 2007, for a 30-day public comment period at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-12856.pdf exit icon

06/27/07

Regulatory Issue Summary 2006-27, Supplement 1, "Availability of NRC 313A Series of Forms and Guidance for Their Completion," dated June 27, 2007, is available. It may be viewed at: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/2006/ri200627sup1.pdf

06/25/07

A generic malfunction concerning stereotactic radiotherapy equipment has come to the attention of the NRC.  The use of Brainscan or iPlan RT Dose 3.0., 3.0.1, 3.0.2 software used in combination with the stereotactic Leksell frame may lead to a deviation of 1.25 mm of the beam.  Centers offering radiosurgery treatments without this specific configuration do not experience the shift in target area alignment.

The treatment is a linear accelerator based treatment and therefore is not regulated under NRC's jurisdiction.  However, NRC is sending this announcement for the purpose of raising awareness of the issue.  NRC became aware of this issue by means of a report from the International Atomic Energy Agency (IAEA).

For more information on the specific mechanical component/software incompatibility, please reference the press release from BrainLAB at: http://salesandmarketingnetwork.com/news_release.php?ID=2018958&key=BrainLAB exit icon



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Wednesday, August 29, 2007