ML19274B862

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

ML19274B862
Person / Time
Issue date:	09/11/2019
From:	Office of Nuclear Material Safety and Safeguards
To:
Jamerson K, NMSS
References
Download: ML19274B862 (7)

Text

MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 10-11, 2019 MEETING

SUMMARY

PURPOSE To discuss issues related to the implementation of the medical regulations in Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material.

OUTCOME The Advisory Committee on the Medical Uses of Isotopes (ACMUI) made recommendations, and the U.S. Nuclear Regulatory Commission (NRC) staff gained a better understanding of the views and opinions of the ACMUI, as well as other stakeholders views and opinions. The NRC staff will consider these views in its continuing effort to make 10 CFR Part 35 more useful, practical, and not overly burdensome on licensees, while maintaining public health and safety.

Full transcripts and handouts from the ACMUI meeting can be found on the ACMUI Meetings Web page, located on NRCs public Web site:

http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/

RECOMMENDATIONS AND ACTIONS The following recommendations and actions resulted from the discussions that took place on the topics listed on the ACMUI meeting agenda (Enclosure 2):

Effective September 23, 2019, Dr. Darlene Metter and Dr. A. Robert Schleipman will serve as ACMUI Chair and Vice Chair, respectively.

Dr. Palestro amended the membership of the Training and Experience Requirements for All Modalities Subcommittee to remove Dr. Metter as Chair. Subcommittee membership now includes Dr. Ennis, Dr. Schleipman (chair), Mr. Sheetz, and Ms. Shober. It is at the discretion of the subcommittee to allow Dr. Metter to continue to serve on the subcommittee. Ms. Maryann Ayoade remains the NRC staff resource.

The ACMUI endorsed the Medical Events Subcommittee report as presented.

The ACMUI endorsed the Appropriateness of Medical Event Reporting Subcommittee report and the recommendations therein.

The ACMUI endorsed the Evaluation of Extravasations Subcommittee report, as amended, to note that under future revisions to Part 35 rulemakings, extravasations be captured as a type of passive patient intervention within the definition of patient intervention.

The ACMUI endorsed the Xcision GammaPod' Licensing Guidance Subcommittee report, as amended, to include the rationale that (1) the written directive should include both dose and frequency and (2) replacing the chemical/physical form line to describe the sealed source rather than the device.

The ACMUI endorsed the Institutional Memory Subcommittee report, as amended, to include the recommendation that a complete list of ACMUI members be updated and added to the ACMUI webpage. The subcommittee membership was amended to add Dr. Wolkov. The updated subcommittee membership includes Dr. Ennis, Dr. OHara, Dr. Schleipman (chair), Ms.

Shober, and Dr. Wolkov. The NRC staff resource is Ms. Kellee Jamerson.

Dr. Palestro formed a subcommittee to evaluate the definition of patient intervention and other actions and circumstances that are exclusive of medical events. Subcommittee membership includes Mr. Bloom, Dr. Dilsizian, Dr. Ennis, and Mr. Sheetz (chair). The NRC staff resource is Ms. Maryann Ayoade.

Dr. Palestro charged the existing Bylaws Subcommittee with determining the following: (1)

Should there be term limits for the ACMUI Chair and Vice Chair? If so, how long should those terms be? and (2) Should the ACMUI Vice Chair automatically become the ACMUI Chair? The subcommittee membership was amended to remove Dr. Schleipman and add Dr. Wolkov as Chair. The updated subcommittee membership includes Mr. Sheetz, Ms. Shober, and Dr.

Wolkov (chair). Ms. Kellee Jamerson will replace Ms. Sophie Holiday as the NRC staff resource.

Dr. Palestro formed a subcommittee to investigate the need for an Interventional Radiologist on the ACMUI and determine whether this position should serve as a non-voting consultant or a full Committee member. Subcommittee membership includes Dr. Dilsizian, Dr. Ennis, Dr. Jadvar (pending security clearance), and Ms. Shober (chair). It is at the discretion of the subcommittee to allow Dr. Metter to serve on the subcommittee. The NRC staff resource is Dr. Katie Tapp.

The Committee tentatively scheduled the spring 2020 meeting for March 23-24, 2020. The alternate meeting date is March 30-31, 2020, subject to Commission availability.

Enclosures:

1. Meeting Attendees

2. Meeting Agenda MEETING ATTENDEES ACMUI Christopher J. Palestro, M.D.

Chairman Darlene F. Metter, M.D.

Vice Chairman Vasken Dilsizian, M.D.

Member Ronald D. Ennis, M.D.

Member Richard Green Member Michael D. OHara, Ph.D.

Member Zoubir Ouhib Member A. Robert Schleipman, Ph.D.

Member Michael A. Sheetz Member Megan Shober Member Harvey B. Wolkov, M.D.

Member Gary Bloom Non-Voting Member Hossein Jadvar, M.D.

Non-Voting Member NRC Kristine Svinicki Chairman, U.S. Nuclear Regulatory Commission John Lubinski Director, Office of Nuclear Material Safety and Safeguards (NMSS)

Rob Lewis Deputy Director, NMSS Andrea Kock Director, Division of Materials Safety, State, and Tribal Programs (MSST)

Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Lisa Dimmick Team Lead, Medical Radiation Safety Team, MSEB Kellee Jamerson Designated Federal Officer and ACMUI Coordinator Maryann Ayoade NMSS Jenny Fisher NMSS Tomas Herrera NMSS Sophie Holiday NMSS Vincent Holahan, Ph.D.

NMSS Donna-Beth Howe, Ph.D.

NMSS Ian Irvin OGC Sarah Lopas NMSS Tim Mossman NMSS Katie Tapp, Ph.D.

NMSS Irene Wu NMSS MEMBERS OF THE PUBLIC PRESENT Ashley Cockerham Mercurie Consulting Leland Cogliani Unaffiliated Miguel de la Guardia Unaffiliated Matt Dennis CRD Associates, LLC/Lucerno Dynamics Michael Guastella Council on Radionuclides and Radiopharmaceuticals, Inc.

Caitlin Kubler Society of Nuclear Medicine and Molecular Imaging Ronald Lattanze Lucerno Dynamics Carol Marcus Unaffiliated Richard Martin American Association of Physicists in Medicine Michael Peters American College of Radiology Joe Rubin United Pharmacy Partners, Inc.

Nan Silverman-Wise National Nuclear Security Administration (NNSA)

Malika Taalbi NNSA 5

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 6

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

12.

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 7

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