ML19219B315

Advisory Committee on the Medical Uses of Isotopes (ACMUI) September 10-11, 2019 Meeting Agenda

ML19219B315
Person / Time
Issue date:	09/10/2019
From:	Advisory Committee on the Medical Uses of Isotopes
To:
Jamerson, Kellee; Holiday, Sophie
References
Download: ML19219B315 (3)

Text

1 MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 10-11, 2019 Two White Flint North Building (T-2D30), 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.

Tuesday, September 10, 2019 CLOSED SESSION 7:30 - 8:30

1. Badging and Enrollment ACMUI OPEN SESSION

2. Opening Remarks Mr. Einberg will formally open the meeting and Ms. Kock will provide opening remarks.

C. Einberg, NRC A. Kock, NRC 8:30 - 10:30

3. Old Business Ms. Jamerson will review past ACMUI recommendations and provide NRC responses.

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

K. Jamerson, NRC ACMUI

5. Training and Experience Evaluation Ms. Lopas and Ms. Ayoade will provide an update on the staffs evaluation of the training and experience requirements for radiopharmaceuticals requiring a written directive.

M. Ayoade, NRC S. Lopas, NRC

6. Medical Events Subcommittee Report Dr. Ennis will provide an analysis of FY18 medical events.

R. Ennis, ACMUI 10:30 - 10:45 BREAK 10:45 - 12:15

7. Appropriateness of Medical Event Reporting Subcommittee Report Dr. Ennis will discuss the subcommittees recommendations on the appropriateness of the required medical event reporting in accordance with 10 CFR 35.3045.

R. Ennis, ACMUI

8. Evaluation of Infiltrations Subcommittee Report Ms. Martin will discuss the subcommittees recommendations on the evaluation of the NRCs 1980 infiltration decision.

M. Martin, ACMUI 12:15 - 1:30 LUNCH

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9. Special Presentation to Dr. Palestro Chairman Svinicki will make a special presentation to Dr. Palestro.

K. Svinicki, NRC 1:30 - 2:45

10. Dr. Palestros Thoughts on Leaving the ACMUI Dr. Palestro will share his thoughts on leaving the ACMUI, after serving eight years, two of which he served as ACMUI Chairman.

C. Palestro, ACMUI

11. Xcision GammaPod Licensing Guidance Subcommittee Report Dr. Wolkov will discuss the subcommittees recommendations on the NRCs draft Xcision GammaPod Licensing Guidance.

H. Wolkov, ACMUI 2:45 - 3:00 BREAK Tuesday, September 10, 2019 CLOSED SESSION 3:00 - 5:00

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INFOSEC Training

13.

Ethics Training

14.

Allegations Training R. Norman, NRC C. Safford, NRC S. Hawkins, NRC Wednesday, September 11, 2019 OPEN SESSION

15. Reducing Radioactive Materials Ms. Taalbi will provide an overview of the NNSAs initiative to reduce radioactive materials using alternative technologies.

M. Taalbi, NNSA 8:30 - 10:30

16. ACMUIs Institutional Memory Subcommittee Report Dr. Schleipman will discuss the subcommittees recommendations for improving the ACMUIs institutional memory.

A. Schleipman, ACMUI

17. Open Forum The ACMUI will discuss medical topics of interest previously identified.

ACMUI

18. ACMUI External Communications Dr. Palestro will discuss the 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting.

C. Palestro, ACMUI 10:30 - 10:45 BREAK 10:45 - 11:15

19. NRC Regulatory Process and Other Tools NRC staff will provide an overview of NRCs regulatory process, to include the lifecycle of ACMUI recommendations and open items from initiation to disposition.

20. Status of Emerging Technologies Licensed under 10 CFR 35.1000 Mr. Sheetz will provide a presentation on the status of emerging technologies licensed under 10 CFR 35.1000.

I. Irvin, NRC M. Sheetz, ACMUI

3 11:45 - 1:00

21. U.S. Pharmacopeia (USP) General Chapter <825>

Mr. Green will provide a presentation on the new USP General Chapter <825> for Radiopharmaceuticals.

22. ACMUI Membership Composition and Balance Ms. Dimmick will provide a discussion of the ACMUI membership and balance.

R. Green, ACMUI L. Dimmick, NRC

23. Administrative Closing Ms. Jamerson will provide a meeting summary and propose dates for the spring 2020 meeting.

K. Jamerson, NRC 1:00 ADJOURN