1. 1 JOINT NRC/OAS PERMANENT IMPLANT BRACHYTHERAPY WORKING GROUP Michael Fuller, US NRC Cheryl Rogers, OAS

2. 2 Background SRM-SECY-10-0062 SECY-11-0035 Prostate Permanent Implant Brachytherapy and Associated Medical Event Questions and Answers

3. Joint NRC/OAS Working Group Working Group has one singular objective, to create supplement to: –Inspection Manual Chapter (IMC) 2800, “Materials Inspection Program” –Inspection Procedure (IP) 87132, “Brachytherapy Programs” 3

4. Joint NRC/OAS Working Group Will provide specific guidance for inspection of licensee performance under 10 CFR 35.40, “Written Directives,” and 10 CFR 35.3045, “Report and Notification of a Medical Event,” for permanent implant brachytherapy medical use 4

5. Joint NRC/OAS Working Group Included in the guidance will be recommendations for dispositioning situations, both historic and future, in which the results of implant procedures are considered to be clinically acceptable, within established medical practice, but are also not in conformity with one or more of the current medical event reporting requirements. 5

6. Joint NRC/OAS Working Group Will be co-chaired by NRC and OAS –Ronald Zelac, Ph.D., FSME/DMSSA, NRC –Chris Timmerman, WI, OAS Other members: OAS, NRC Regions, NRC/OE, NRC/OGC, NRC/FSME/DILR, NRC/FSME/DMSSA, Medical Consultant 6

7. Anticipated Schedule Kick-Off Meeting: Aug. 2011 Draft Supplemental Guidance: Oct. 2011 Draft final document enter NRC concurrence and review for acceptance by the OAS: Nov. 2011 Approval of Draft Final Supplemental Guidance: Dec. 2011 7

8. Joint NRC/OAS Steering Committee Will provide guidance and direction to the working group (WG) Will review issues when draft WG products are proposed Will provide technical, regulatory, or policy expertise as needed Will review the WG progress and provide feedback 8

9. Joint NRC/OAS Steering Committee Will be co-chaired by NRC and OAS –Terrence Reis, Acting Division Director, FSME/DMSSA, NRC –Cheryl Rogers, WI, OAS Other members: NRC Regions, NRC/OGC, NRC/FSME/DILR, and NRC/FSME/DMSSA 9

10. Joint NRC/OAS Working Group QUESTIONS? 10

11. Acronyms CFR: Code of Federal Regulations DILR: Division of Intergovernmental Liaison and Rulemaking DMSSA: Division of Materials Safety and State Agreements FSME: Federal and State Materials and Environmental Management IMC: Inspection Manual Chapter 11

12. Acronyms IP: Inspection Procedure NRC: Nuclear Regulatory Commission OAS: Organization of Agreement States OE: Office of Enforcement OGC: Office of the General Counsel SECY: Office of the Secretary SRM: Staff Requirements Memorandum 12