ML20311A516
| ML20311A516 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/2020 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Jamerson, Kellee NMSS/MSST | |
| References | |
| Download: ML20311A516 (7) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 21-22, 2020 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 NRCs ACMUI Meetings webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/.
RECOMMENDATIONS AND ACTIONS The ACMUI endorsed the following subcommittee reports. The reports and their recommendations can be viewed, in their entirety, on the NRCs ACMUI Subcommittee Reports webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.
- The ACMUI endorsed the Medical Events Subcommittee report and its recommendations, as presented.
The recommendation passed unanimously with thirteen favorable votes.
Other topics discussed and/or presented during the meeting include:
- Dr. David Hamby, Renaissance Code Development, LLC, provided a presentation on the dosimetry methodology update for the Phase 2 revision of Regulatory Guide 8.39, Release of Patients Administered Radioactive Material. The ACMUI Regulatory Guide 8.39 Subcommittee will have the opportunity to review the preliminary draft Phase 2 update when it becomes available. This presentation was informational and requires no action of the ACMUI.
- Mr. Frank Lutterodt, U.S. Food & Drug Administration (FDA), provided a presentation on the FDAs process for new drug development and labeling. This presentation was informational and requires no action from the ACMUI.
The following actions resulted from discussions that took place during the meeting:
- At the conclusion of the report of Non-Medical Events, the ACMUI recommended that the National Materials Program evaluate the issue of detection of short-lived medical isotopes in municipal waste (waste from nuclear medicine patients that could possibly be triggering the landfill alarms) and provide some level of guidance, best practices, or additional instructions.
The recommendation passed unanimously with thirteen favorable votes.
- The ACMUI tentatively scheduled its spring 2021 meeting for March 15-16, 2021.
The alternate meeting date is March 22-23, 2021. A virtual or in-person meeting for spring 2021 is to be determined.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING ATTENDEES ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Darlene F. Metter, M.D. Chairman A. Robert Schleipman, Ph.D. Vice Chairman Gary Bloom Member Vasken Dilsizian, M.D. Member Ronald D. Ennis, M.D. Member Richard Green Member Hossein Jadvar, M.D. Member Melissa Martin Member Michael D. OHara, Ph.D. Member Zoubir Ouhib Member Michael A. Sheetz Member Megan Shober Member Harvey B. Wolkov, M.D. Member NRC STAFF Kevin Williams Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Jacob Zimmerman Acting Deputy Director, MSST Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Kellee Jamerson Designated Federal Officer and ACMUI Coordinator, MSEB Maryann Ayoade NMSS/MSST/MSEB Stephanie Bush-Goddard RES/DSA Theresa Clark NMSS/REFS Said Daibes, Ph.D. NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB Lisa Dimmick Medical Radiation Safety Team Leader, MSS/MSST/MSEB Jason Draper R-III/DNMS/MIB Robin Elliott R-I/DNMS/MLAB Sarah Forster R-III/DNMS/MLB Robert Gallaghar R-I/DNMS/MLAB Anita Gray, Ph.D. NMSS/MSST/SMPB Valerie Gray NMSS/MSST/MSEB Michelle Hammond R-IV/DNMS/MLDB Vincent Holahan, Ph.D. NMSS/MSST Esther Houseman OGC/GCLR/RMR Donna-Beth Howe, Ph.D. NMSS/MSST/MSEB Ian Irvin OGC/GCLR/RMR Penny Lanzisera R-I/DNMS/MLAB Sarah Lopas NMSS/MSST/MSEB Kathy Modes NMSS/MSST/SLPB Jan Nguyen R-I/DNMS/MLAB Robert Orlikowski R-III/DNMS/MLB Vered Shaffer RES/DSA/RPB Zahid Sulaiman R-III/DNMS/MIB Robert Sun NMSS/MSST/MSEB Enclosure 1
Katherine Tapp, Ph.D. NMSS/MSST/MSEB Elizabeth Tindle-Engelman R-I/DNMS/MLAB John Tomon RES/DSA/RPB Duncan White NMSS/MSST/SLPB PUBLIC PARTICIPANTS Alex Bakken Niowave, Inc.
Jaime Barnes Cook Childrens Medical Center Rebecca Branum CRD Associates Haley Brown Emory University Keith Brown University of Pennsylvania Janet Bukovcan Boston Scientific Mary Burkhart Illinois Emergency Management Agency Paul Burns Mount Sinai Ashley Cockerham Mercurie Consulting Thomas Conley University of Kansas Health System Whitney Cox Illinois Emergency Management Agency Elaine Crescenzi Pennsylvania Department of Environmental Protection Corey Creveling State of Nevada, Radiation Control Program David Crowley North Carolina Department of Health and Human Services, Radiation Protection Section Bruce Curran VCU Health System Matt Dennis CRD Associates, LLC Newbegin Devaraj National Institutes of Health Nick Dorrell University of Virginia Ariel Doucet Virtua Health Dawn Edgerton American Society of Nuclear Cardiology Brian Erasmus Boston Scientific Teresa Fisher National Institutes of Health John Follette State of Nevada, Radiation Control Program Lisa Forney Pennsylvania Department of Environmental Protection Sandy Gabriel Unaffiliated Debbie Gilley International Atomic Energy Agency Richard Granberg NorthStar Carl Granlund Johns Hopkins University Johnny Graves Tennessee Department of Environment and Conservation, Division of Radiological Health Miguel de la Guardia Cook Childrens Medical Center Michael Guastella CORAR Michael Hall Emory University David Hamby, PhD. RCD Radiation Protection Association Stanley Hampton Eli Lilly Kathleen Hintenlang American College of Radiology Rachel Houseman SHINE Medical Technologies Josh Knowland Lucerno Dynamics Joseph Koshy Pennsylvania Department of Environmental Protection Sasikala Krishnasarma Tennessee Department of Environment and Conservation, Division of Radiological Health Kevin Kunder Florida Department of Health, Bureau of Radiation Control Ronald Lattanze Lucerno Dynamics Enclosure 1
Ralph Lieto St. Joseph Mercy Health System Frank Lutterodt U.S. Food and Drug Administration Carol Marcus, MD, PhD. University of California at Los Angeles Richard Martin American Association of Physicists in Medicine Candi McDowell University of Pennsylvania Tara Medich Massachusetts General Hospital Christopher Mitchell Kettering Health Network Thomas Mohaupt NorthStar Medical Radioisotopes Vanessa Mongeon Boston Scientific Jennifer Noll Pennsylvania Department of Environmental Protection Ron Parsons Tennessee Department of Environment and Conservation, Division of Radiological Health Michael Peters American College of Radiology Andrea Ravard Radiation Protection & Training Erin Reynolds Pennsylvania Department of Environmental Protection Tracy Scherer Pennsylvania Department of Environmental Protection Grace Schoeniger Pennsylvania Department of Environmental Protection Katie Scott Pennsylvania Department of Environmental Protection Michael Semon Monongahela Valley Hospital Meredith Semon-Pomposelli Monongahela Valley Hospital Michael Stabin NV5 Carol Wen Christiana Care Neil Whiteside Yale New Haven Hospital Colin Whitney ASTRO Melonie Wissing Department of Veterans Affairs John Witkowski UPPI Enclosure 1
MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 21-22, 2020 WEBEX 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.
Monday, September 21, 2020 OPEN SESSION
- 1. Opening Remarks C. Einberg, NRC Mr. Einberg will formally open the meeting and provide opening remarks.
- 2. Old Business K. Jamerson, NRC Ms. Jamerson will review past ACMUI actions and recommendations 10:00 - 11:30 and provide NRC responses.
- 4. Medical Events Subcommittee Report R. Ennis, ACMUI Dr. Ennis will provide an analysis of FY19 medical events.
11:30 - 12:15 BREAK/LUNCH
- 5. Non-Medical Events M. Sheetz, ACMUI Mr. Sheetz will provide an analysis of FY19 non-medical events reported by medical use facilities and commercial pharmacies.
- 6. New Drug Development and Labeling F. Lutterodt, FDA 12:15 - 2:00 Mr. Lutterodt will discuss the U.S. Food and Drug Administrations regulatory process for new drug development and labeling.
- 7. Dosimetry Methodology Update for Regulatory Guide 8.39, D. Hamby, Phase 2 Revision RCD Radiation Dr. Hamby will discuss the dosimetry methodology update for the Protection Assoc.
Regulatory Guide 8.39, Phase 2 revision.
2:00 ADJOURN FOR THE DAY Tuesday, September 22, 2020 CLOSED SESSION
- 8. INFOSEC Training R. Norman, NRC 10:00 - 12:00 9. Ethics Training C. Safford, NRC
- 10. Allegations Training S. Hawkins, NRC 12:00 - 12:15 BREAK Enclosure 2
Tuesday, September 22, 2020 OPEN SESSION
- 11. Medical Team Updates L. Dimmick, NRC Ms. Dimmick will provide an update on Medical Radiation Safety Team activities.
12:15 - 1:45 12. Open Forum ACMUI The ACMUI will discuss medical topics of interest previously identified.
- 13. Administrative Closing K. Jamerson, NRC Ms. Jamerson will provide a meeting summary and propose dates for the spring 2021 meeting.
1:45 ADJOURN Enclosure 2