ML18225A266
| ML18225A266 | |
| Person / Time | |
|---|---|
| Issue date: | 08/13/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18225A266 (3) | |
Text
MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 20-21, 2018 One White Flint North Building (Commission Hearing Room), Rockville, Maryland NOTE: Sessions of the meeting may be closed pursuant to 5 U.S.C. 552(b) to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACMUI; information the release of which would constitute a clearly unwarranted invasion of personal privacy; information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action; and disclosure of information which would risk circumvention of an agency regulation or statute.
Thursday, September 20, 2018 CLOSED SESSION 7:30 - 8:30 1. Badging and Enrollment PERSEC, NRC 8:30 - 9:00 2. INFOSEC Training R. Norman, NRC 9:00 - 9:30 3. Allegations Training D. Willis, NRC 10:00 - 10:30 4. ETHICS Training J. Suttenberg & J. Ezell, NRC 10:30 - 11:00 BREAK OPEN SESSION 11:00 - 11:15 5. Opening Remarks D. Bollock & S. Atack, NRC Mr. Bollock will formally open the meeting and Ms. Atack will provide opening comments.
11:15 - 11:30 6. Old Business L. Dimmick, NRC Ms. Dimmick will review past ACMUI recommendations and provide NRC responses.
11:30 - 11:45 7. Open Forum ACMUI The ACMUI will identify medical topics of interest for further discussion.
11:45 - 12:45 LUNCH 12:45 - 1:30 8. Medical Events Subcommittee Report R. Ennis, ACMUI Dr. Ennis will present the subcommittees analysis of medical events for fiscal year 2017.
1:30 - 2:00 9. Non-Medical Events M. Sheetz, ACMUI Mr. Sheetz will discuss non-medical events reported by medical use facilities and commercial pharmacies for fiscal year 2017.
2:00 - 2:30 10. ABS Medical Event Case Study Program Z. Ouhib, ACMUI Mr. Ouhib will discuss the American Brachytherapy Societys effort to reach out to the brachytherapy community for creative corrective actions regarding events that have taken place.
2:30 - 2:45 BREAK
2:45 - 3:05 11. T&E for All Modalities Subcommittee Update D. Metter, ACMUI Dr. Metter will provide an update on the actions of the training and experience for all modalities subcommittee and the planned path forward.
3:05 - 3:35 12. T&E Stakeholder Outreach Plan M. Ayoade, NRC Ms. Ayoade will present the staffs outreach plan for the continued evaluation of training and experience.
3:35 - 3:55 13. ACMUI-SNMMI Session at the 2018 SNMMI Annual C. Palestro, ACMUI Meeting Dr. Palestro will provide an overview of the topics discussed by ACMUI at the 2018 Society of Nuclear Medicine and Molecular Imaging meeting in Philadelphia, PA.
3:55 - 4:15
- 14. Nursing Mother Guidelines Subcommittee Report D. Metter, ACMUI Dr. Metter will discuss the subcommittees final report on the nursing mother guidelines for exposure from diagnostic and therapeutic radiopharmaceuticals.
4:15 - 5:00
- 15. ACMUI Comments on the Draft Revision of the Leksell J. Suh, ACMUI Gamma Knife Perfexion and Leksell Gamma Knife Icon Licensing Guidance Dr. Suh will discuss the subcommittees comments on the draft revision of the Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon licensing guidance.
Friday, September 21, 2018 OPEN SESSION 8:30 - 8:45 16. Special Presentation to Dr. Suh M. Dapas, NRC Mr. Dapas will make a special presentation to Dr. Suh.
8:45 - 9:00 17. Dr. Suhs Thoughts on Leaving ACMUI J. Suh, ACMUI Dr. Suh will share his thoughts on leaving the ACMUI.
9:00 - 9:15 18. Special Presentation to Dr. Alderson M. Dapas, NRC Mr. Dapas will make a presentation to Dr. Alderson.
9:15 - 9:30 19. Dr. Aldersons Thoughts on Leaving ACMUI P. Alderson, ACMUI Dr. Alderson will share his thoughts on leaving the ACMUI.
9:30 - 9:50 20. ACMUI Comments on the Draft Ge-68/Ga-68 Generator R. Green, ACMUI Licensing Guidance Mr. Green will discuss the subcommittees comments on the draft Germanium-68/Gallium-68 Generator Licensing Guidance.
9:50 - 10:15 21. Medical Team Highlights L. Dimmick, NRC Ms. Dimmick will recap the work of the Medical Radiation Safety Team for fiscal year 2018.
10:15 - 10:45 BREAK
10:45 - 11:30 22. Y-90 Microspheres Brachytherapy Licensing Guidance K. Tapp, NRC Dr. Tapp will discuss the current status of the yttrium-90 working groups revised guidance and planned actions.
11:30 - 12:00 23. Compounding of Sterile and Non-Sterile R. Green, ACMUI Radiopharmaceuticals Mr. Green will discuss the establishment of an Expert Panel by USP to develop USP Standards of sterile and non-sterile radiopharmaceutical preparation.
12:00 - 1:00 LUNCH 1:00 - 2:00 24. ACMUI, Subcommittees, NRC staff, NRC management: R. Chazell & D. Bollock, NRC How the Team Works Under FACA Mr. Chazell and Mr. Bollock will discuss the roles and responsibilities of each under the Federal Advisory Committee Act (FACA).
2:00 - 2:45 25. ACMUI Subcommittees, Subcommittee Membership, and C. Palestro, ACMUI the ACMUI Chair Dr. Palestro will discuss the possible need for ACMUI bylaw changes and the need to update subcommittee membership, form new subcommittees and sunset other subcommittees.
2:45 - 3:00 26. Licensing Th-227 Chloride L. Dimmick, NRC Ms. Dimmick will discuss the current status of licensing thorium-227 chloride for medical use.
3:00 - 3:15 27. Open Forum ACMUI The ACMUI will discuss medical topics of interest previous identified.
3:15 - 3:30 L. Dimmick, NRC
- 28. Administrative Closing Ms. Dimmick will provide a meeting summary and propose dates for the spring 2019 meeting.
3:30 ADJOURN