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The U.S. Nuclear Regulatory Commission's Consideration of Potential Changes to Medical Event Reporting Requirements for Permanent Implant Brachytherapy and Other Medical Issues Being Considered for Rulemaking

The U.S. Nuclear Regulatory Commission (NRC) plans to hold a series of public workshops, and is requesting stakeholder comments on issues associated with the Medical Event (ME) definition, including sections involving reporting and notifications of MEs for permanent implant brachytherapy and other medical issues that are currently being considered for rulemaking.

In a Staff Requirements Memoranda (SRM-SECY-10-0062), the Commission specifically directed staff to work closely with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and the broader medical and stakeholder community to develop event definitions that will protect the interests of patients, allow physicians the flexibility to take actions that they deem medically necessary, while continuing to enable the agency to detect failures in process, procedure, and training as well as any misapplication of byproduct materials by authorized users. In addition to the ME definition, NRC staff believes that it would be beneficial to the development of proposed rulemaking language to discuss a number of other medical issues that are currently being considered for rulemaking.

The facilitated workshops will specifically cover the following issues:

  • Medical Event Definition Associated with Permanent Implant Brachytherapy,
  • Relaxation of Preceptor Attestation Requirements and Extending Grandfathering to Certain Certified Individuals(Ritenour Petition),
  • Naming Associate/Assistant Radiation Safety Officers (RSOs) on NRC Medical Licenses,
  • Additional Molybdenum Breakthrough Testing and Reporting Requirements,
  • Additional Items under Consideration for Rulemaking as identified in the Federal Register Notice (FRN).

The first workshop will be held on June 20-21, 2011, in New York, NY. The NRC also plans to hold a second meeting August 11-12, 2011 in Houston, TX. Each of the meetings will include a panel of participants, selected in a convening process to represent the diversity of stakeholders for these issues. In addition to the panel, the NRC is encouraging observation and participation by all interested individuals. The meeting agenda will specifically include opportunities for viewpoints to be expressed from individuals in attendance who are not members of the panel. The NRC plans to transcribe the meetings.

The FRN announcing the meeting can be found at http://www.gpo.gov/fdsys/pkg/FR-2011-05-20/pdf/2011-12048.pdf. This notice includes details on the background leading to this request for comments, the issues that have been identified, and questions that have been posed by the NRC staff for consideration. If you need further information, please contact Mrs. Gretchen Rivera-Capella of the NRC staff at Gretchen.Rivera-Capella@nrc.gov or 301-415-5944.

Information about the specific meeting venues, hotel accommodations, and access to public transportation is available on the Location/Lodging page. We encourage you to keep checking this Web site for the most current agenda and links to subsequent documents as they become available. Documents relevant to the workshop will also be continually posted on this site.


To access documents relevant to the medical event definition associated with Permanent Implant Brachytherapy and other medical issues that are currently being considered for rulemaking, and the public meetings' notice see the following:

Date

Description

05/18/2010

Reproposed Rule: Medical Use of Byproduct Material – Amendments/Medical Event Definitions (RIN 3150 - AI26)
Link: http://www.nrc.gov/reading-rm/doc-collections/commission/secys/2010/secy2010-0062/2010-0062scy.pdf

08/10/2010

Staff Requirements-SECY-10-0062- Reproposed Rule: Medical Use of Byproduct Material – Amendments/Medical Event Definitions (RIN 3150 - AI26)
Link: http://pbadupws.nrc.gov/docs/ML1022/ML102220233.pdf

06/06/2008

Proposed Rule: Medical Use of Byproduct Material – Amendments/Medical Event Definitions (RIN 3150 - AI26)
Link: http://www.nrc.gov/reading-rm/doc-collections/commission/secys/2008/secy2008-0080/2008-0080scy.pdf

05/14/2008

Petition for Rulemaking (PRM 35-20, Ritenour Petition) Link: http://www.regulations.gov/#!docketDetail;dct=FR+PR+N+O+SR;rpp=10;po=0;D=NRC-2008-0175

Note: Some of the following links on this page are to documents in the NRC Agencywide Documents Access and Management System (ADAMS), and others are to documents in Adobe Portable Document Format (PDF) on the NRC public Web site. ADAMS documents are provided in either PDF or Tagged Image File Format (TIFF). To obtain free viewers for displaying these formats, see the links on the NRC public Web site Plugins, Viewers, and Other Tools page. If you have questions about search techniques or problems with viewing or printing documents from ADAMS, you may contact the NRC Public Document Room staff.