Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Meeting of the Advisory Committee on the Medical Uses of Isotopes Docket Number: (n/a) Location: Teleconference Date: Monday, March 30, 2020 Work Order No.: NRC-0868 Pages 1-262 NEAL R. GROSS AND CO., INC. Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION + + + + + ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES + + + + + TELECONFERENCE + + + + + MONDAY, MARCH 30, 2020 + + + + + The meeting was convened by teleconference, at 9:30 a.m., Dr. Darlene F. Metter, ACMUI Chairman, presiding. MEMBERS PRESENT: 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 L. GREEN, Member HOSSEIN JADVAR, Member MELISSA C. MARTIN, Member MICHAEL D. O'HARA, Ph.D., Member ZOUBIR OUHIB, Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 2 MICHAEL SHEETZ, Member MEGAN L. SHOBER, Member HARVEY B. WOLKOV, M.D., Member DESIGNATED FEDERAL OFFICERS: CHRISTIAN EINBERG, Chief, Medical Safety and Events Assessment Branch (MSEB) LISA DIMMICK, Medical Radiation Safety Team Leader, NMSS/MSST/MSEB KELLEE JAMERSON, ACMUI Coordinator NRC STAFF PRESENT: KEVIN WILLIAMS, Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST) MARYANN AYOADE, NMSS/MSST/MSEB SAID DAIBES, Ph.D., NMSS/MSST/MSEB DANIEL DIMARCO, NMSS/MSST/MSEB JASON DRAPER, NMSS/MSST/MSEB ROBIN ELLIOTT, NMSS/MSST/MSEB JENNIFER FISHER, NMSS/MSST/MSEB SARA FORSTER, NMSS/MSST/MSEB ROBERT GALLAGHAR, R-I/DNMS/MLAB ANITA GRAY, Ph.D., NMSS/MSST/SMPB VINCENT HOLAHAN, NMSS/MSST NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 3 ESTHER HOUSEMAN, OGC/GCLR/RMR DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB IAN IRVIN, OGC/GCLR/RMR JANELLE JESSIE, COMM/OCMJB PENNY LANZISERA, R-I/DNMS/MLAB SARAH LOPAS, NMSS/MSST/MSEB KATHY MODES, NMSS/MSST/SLPB JANICE NGUYEN, R-I/DNMS/MLAB DENNIS O’DOWD, R-III/DNMS/MIB SHAWN SEELEY, R-I/DNMS/MLAB VERED SHAFFER, RES/DSA/RPB ZAHID SULAIMAN, R-III/DNMS/MIB ROBERT SUN, NMSS/MSST/MSEB KATIE TAPP, Ph.D., NMSS/MSST/MSEB IRENE WU, NMSS/MSST/MSEB MEMBERS OF THE PUBLIC: JENNA ABBOTT, Illinois Emergency Management Agency SUKHJEET AHUJA, Society of Nuclear Medicine and Molecular Imaging REX AYERS, Northwest Medical Physics Center JAMIE BARNES, Cook Children’s Medical Center AMY BOLAR, Illinois Emergency Management Agency KEITH BROWN, University of Pennsylvania NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 4 MARY BURKHART, Illinois Emergency Management Agency ASHLEY COCKERHAM, Mercurie Consulting LELAND COGLIANI, Unaffiliated SUSAN COREY, Cook Children’s Medical Center ELAINE CRESCENZI, Pennsylvania Department of Environmental Protection DAVID CROWLEY, North Carolina Department of Health and Human Services, Radiation Protection Section MATT DENNIS, CRD Associates, LLC TERRI DODSON, Illinois Emergency Management Agency ARIEL DOUCET, Virtua Health ADAM EKSTEDT, Illinois Emergency Management Agency BRIAN ERASMUS, Boston Scientific KELSEY EVERETT, University of Pennsylvania LYNN FAIROBENT, Unaffiliated LISA FORNEY, Pennsylvania Department of Environmental Protection JORDAN FRENGUT, Unaffiliated MIKE FULLER, Virginia Department of Health SANDY GABRIEL, Unaffiliated DEBBIE GILLEY, International Atomic Energy NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 5 Agency MIGUEL de la GUARDIA, Cooks Children’s Medical Center GARY HALL, Fort Bragg Department of Public Health MATTHEW HALL, Sirtex STANLEY HAMPTON, Eli Lilly MEG HARKINS, University of Pennsylvania JAMES HARVEY, NorthStar Medical Radioisotopes DANIEL HILL, Cardinal Health JAMES HIRN, Illinois Emergency Management Agency MARY ELLEN JAFARI, Gundersen Health JANELLE JESIKIEWICZ, University of Pennsylvania JOSH KNOWLAND, Lucerno Dynamics TODD LAFRENZE, Illinois Emergency Management Agency RON LATTANZE, Lucerno Dynamics GEORGIA LAWRENCE, American Society of Nuclear Cardiology RALPH LIETO, St. Joseph Mercy Health System WILLIAM LORENZEN, Boston Children’s Hospital CAROL MARCUS, Ph.D., M.D., University of California at Los Angeles RICHARD MARTIN, American Association of Physicists in Medicine NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 6 JEFFREY MASON, Department of Veterans Affairs CANDI MCDOWELL, University of Pennsylvania THOMAS MOHAUPT, NorthStar Medical Radioisotopes VANESSA MONGEON, Boston Scientific TOM NAMSA, BWX Technologies JON NEUHOFF, U.S. Department of Energy, Isotope Program RICHARD PEROS, New Jersey Department of Environmental Protection MICHAEL PETERS, American College of Radiology DERON ROBBINS, Illinois Emergency Management Agency GRACE SCHOENIGER, Pennsylvania Department of Environmental Protection KATIE SCOTT, Pennsylvania Department of Environmental Protection DIANA THOMPSON, Sirtex CINDY TOMLINSON, American Society for Radiation Oncology GIBB VINSON, Illinois Emergency Management Agency KARAMDEEP VIRK, Illinois Emergency Management Agency JOSEPH WISSING, St. Joseph Mercy Health System MELONIE WISSING, Department of Veterans Affairs NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 7 C-O-N-T-E-N-T-S Opening Remarks....................................8 Old Business by Ms. Kellee Jamerson, NRC..........18 Open Forum........................................26 Trends in Radiopharmaceuticals....................33 Patient Intervention Subcommittee Report..........68 NMED Overview....................................119 Medical Related Events ..........................151 Interventional Radiologist Subcommittee Report ..212 Open Forum.......................................226 Administrative Closing...........................252 Adjourn..........................................262 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 8 P R O C E E D I N G S 9:30 a.m. OPERATOR: Welcome and thank you for standing by. For today's call, I'd like to inform all parties that your line has been placed in listen-only mode until the question-answer session of today's conference. It is now my pleasure to turn the call over to Dr. Metter. Thank you, and you may begin. CHAIR METTER: Thank you very much. Good morning, and welcome to the Spring 2020 ACMUI meeting. At this time, I would like to thank the NRC and ACMUI for their flexibility during these very challenging times and for your commitment to continue the Committee's work for our patients and for the public. At this time, I would also like to acknowledge all the dedicated workers in our country and our health care professionals in taking care of patients, even at the risk of their own health. So please join me in taking a moment of silence for those lost and those currently dealing with the COVID-19 disease. Thank you. Since we are on a conference call, please remember to state your name before speaking. And at this time, I would like to turn the meeting over to Mr. Chris Einberg who will now open the meeting, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 9 followed by Mr. Kevin Williams with some other opening remarks. Mr. Einberg. MR. EINBERG: Thank you, Dr. Metter. As the Designated Federal Officer for this meeting, I'm pleased to welcome you to this public meeting of the Advisory Committee on the Medical Uses of Isotopes. My name is Chris Einberg. I'm the Branch Chief of the Medical Safety and Events Assessment Branch and I have been designated as the federal officer for this Advisory Committee in accordance with 10 CFR Part 7.11. Present today we have Lisa Dimmick, our Medical Radiation Safety Team Leader, and Kellee Jamerson, our ACMUI Coordinator, as Designated Federal Officers for the ACMUI. This is an announced meeting of the Committee. It is being held in accordance with the rules and regulations of the Federal Advisory Committee Act and the Nuclear Regulatory Commission. This meeting is being transcribed by the NRC and may also be transcribed or recorded by others. The meeting was initially announced in the February 19th, 2020 edition of the Federal Register, Volume 85, page 9484. The function of the Committee is to advise NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 10 the staff on issues and questions that arise under medical use of byproduct material. The Committee provides counsel to many staff but does not determine nor direct the actual decisions of the staff or the Commission. The NRC solicits the views of the Committee and values their opinions. I request that whenever possible, we try to reach a consensus on the various issues that will be discussed today but I also recognize there may be minority or dissenting views. If you have such opinions, please allow them to be read into the record. At this point, I would like to perform a roll call of the ACMUI members participating today. Dr. Darlene Metter,