ML22304A049

Advisory Committee on the Medical Uses of Isotopes (ACMUI) Agenda December 5-6, 2022

ML22304A049
Person / Time
Issue date:	10/31/2022
From:	Celimar Valentin-Rodriguez Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards
To:
Valentin-Rodriguez C
References
Download: ML22304A049 (2)

Text

MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES December 5-6, 2022 One White Flint North Building (Commissioners Hearing Room), Rockville, Maryland Two White Flint North Building (TWFN-3D06), Rockville, Maryland NOTE: Sessions of the meeting may be closed pursuant to 5 U.S.C. 552b 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.

Monday, December 5, 2022 OPEN SESSION

1. Opening Remarks C. Einberg, NRC Mr. Einberg will formally open the meeting and Mr. Williams K. Williams, NRC will provide opening comments.

2. Old Business T. Gupta Sarma, Ms. Gupta Sarma will review past ACMUI recommendations NRC and provide NRC responses.

8:30 - 10:15

3. Open Forum ACMUI, NRC The ACMUI will identify medical topics of interest for further discussion.

4. Y-90 Medical Events Subcommittee Report M. OHara, ACMUI Dr. OHara will discuss the subcommittees recommendations on its evaluation of Y-90 medical events.

10:15 - 10:30 BREAK

5. Training and Experience for All Modalities H. Jadvar, ACMUI Subcommittee Report Dr. Jadvar will discuss the subcommittees recommendations on the impact of the American Board of Radiologys request to terminate NRC recognition of their board certification process and of the NRCs current specialty board recognition criteria.

6. Review of the Lutetium (Lu)-177-PSMA K. Brenneman, NRC Radiopharmaceutical Dr. Brenneman will provide an overview of the NRCs staff review of a new Lu-177-PSMA radiopharmaceutical 10:30 - 12:00 approved by the FDA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.

7. Radioactive Source Security and Accountable A. Carrera, NRC Rulemaking Mr. Carrera will provide an overview of the NRC's rulemaking to amend its regulations to require safety and security equipment and facilities to be in place for certain applicants before granting a license for possession and use of radioactive materials regulations.

12:00 - 1:15 LUNCH

8. EMT/Rb-82 Generator Rulemaking Subcommittee M. Shober, ACMUI Report 1:15 - 3:00 Ms. Shober will discuss the subcommittees recommendations regarding the NRC staffs draft regulatory basis for the rulemaking to establish requirements for Rb-82

generators and emerging medical technologies.

9. Decommissioning Financial Assurance for Sealed and G. Trussell, NRC Unsealed Radioactive Materials Mr. Trussell will provide a status update on the NRCs rulemaking that would amend its regulations for decommissioning financial assurance for sealed and unsealed radioactive materials.

3:00 - 3:15 BREAK

10. Open Forum ACMUI, NRC The ACMUI will identify medical topics of interest for further discussion.

11. Special Recognition for Dr. Ennis K. Williams, NRC 3:15 - 4:15 Mr. Williams will make a special presentation to Dr. Ennis.

12. Thoughts on Leaving the ACMUI R. Ennis, ACMUI Dr. Ennis will share his thoughts on leaving the ACMUI.

13. Administrative Closing T. Gupta Sarma, Ms. Gupta Sarma will provide a meeting summary and NRC propose dates for the spring 2023 meeting.

4:15 - 4:30 BREAK Tuesday, December 6, 2022 OPEN SESSION

14. Commission Meeting with the ACMUI ACMUI The ACMUI will brief the Commission on various topics in a public meeting.

15. Group Photo ACMUI 10:00 - 12:15 The ACMUI will take a group photo with and without the Commission.

12:15 - 1:30 LUNCH Tuesday, December 6, 2022 CLOSED SESSION

16. INFOSEC Training B. Stapleton, NRC 1:30 - 3:30 17. Ethics Training J. Scro & A.

Cermeno, NRC

18. Allegations Training S. Hawkins, NRC ADJOURN ML072670110