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 8:30 - 10:15

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

C. Einberg, NRC K. Williams, NRC

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

T. Gupta Sarma, NRC

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

ACMUI, NRC

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

M. OHara, ACMUI 10:15 - 10:30 BREAK 10:30 - 12:00

5. Training and Experience for All Modalities 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.

H. Jadvar, ACMUI

6. Review of the Lutetium (Lu)-177-PSMA Radiopharmaceutical Dr. Brenneman will provide an overview of the NRCs staff review of a new Lu-177-PSMA radiopharmaceutical 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.

K. Brenneman, NRC

7. Radioactive Source Security and Accountable 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.

A. Carrera, NRC 12:00 - 1:15 LUNCH 1:15 - 3:00

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

ML072670110 generators and emerging medical technologies.

9. Decommissioning Financial Assurance for Sealed and 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.

G. Trussell, NRC 3:00 - 3:15 BREAK 3:15 - 4:15

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

ACMUI, NRC

11. Special Recognition for Dr. Ennis Mr. Williams will make a special presentation to Dr. Ennis.

K. Williams, NRC

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

R. Ennis, ACMUI

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

T. Gupta Sarma, NRC 4:15 - 4:30 BREAK Tuesday, December 6, 2022 OPEN SESSION 10:00 - 12:15

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

ACMUI

15. Group Photo The ACMUI will take a group photo with and without the Commission.

ACMUI 12:15 - 1:30 LUNCH Tuesday, December 6, 2022 CLOSED SESSION 1:30 - 3:30

16. INFOSEC Training B. Stapleton, NRC

17. Ethics Training J. Scro & A.

Cermeno, NRC

18. Allegations Training S. Hawkins, NRC ADJOURN