ML18092B615
| ML18092B615 | |
| Person / Time | |
|---|---|
| Issue date: | 03/01/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18092B615 (5) | |
Text
TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES March 1, 2018 MEETING
SUMMARY
PURPOSE To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Training and Experience Requirements for All Modalities Subcommittees interim report on the recommendations for the total number of training and experience (T&E) hours for authorized users (AU) under Title 10 of the Code of Federal Regulations (10 CFR) 35.300 that is necessary for safety.
OUTCOME The ACMUI Training and Experience Requirements for All Modalities Subcommittee provided an interim report for discussion with the full Committee. Subcommittee members included: Dr.
Darlene Metter, Dr. Christopher Palestro (Chair), Dr. John Suh, and Ms. Laura Weil. The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the Committees comments 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.
A full transcript and handout for the ACMUI teleconference meeting can be found on NRCs public Web site at: http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/.
The ACMUI Subcommittee Interim Report is available on NRCs public Web site under ACMUI Subcommittee Reports: http://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.
AGENDA TOPIC Discuss the Interim Report of the ACMUI Training and Experience Requirements for All Modalities Subcommittee
SUMMARY
The ACMUI Training and Experience Requirements for All Modalities Subcommittee discussed two developments that indicated a need to reconsider the creation of an additional alternative pathway for AUs under 10 CFR 35.390. These developments include the U.S. Food and Drug Administrations approval of lutetium-177 dotatate for treatment of certain neuroendocrine tumors and the decrease in the number of first-time candidates sitting for the Certification Examination of the American Board of Nuclear Medicine. Due to future broad indications for use, this agentlutetium-177 is expected to have a considerable demand. Coupled with the waning number of first-time candidates of nuclear medicine physician as AUs eligible under the board certification pathway, the subcommittee believes there is reasonable concern for a near-future decline in patient access. Therefore, the subcommittee will review and evaluate T&E criteria for an additional alternate pathway.
The ACMUI Subcommittee on Training and Experience Requirements for All Modalities Interim Report (ML18051A725) is posted on the ACMUI Subcommittee Reports Webpage.
Attachments:
- 1. Meeting Attendees
- 2. Teleconference Agenda
MEETING ATTENDEES ACMUI Philip O. Alderson, M.D. Chairman Pat B. Zanzonico, Ph.D. Vice Chairman Vasken Dilsizian, M.D. Member Darlene F. Metter, M.D. Member Michael D. OHara, Ph.D. Member Christopher J. Palestro, M.D. Member Michael Sheetz Member John H. Suh, M.D. Member Laura M. Weil Member Richard Green Non-Voting Member Zoubir Ouhib Non-Voting Member Megan Shober Non-Voting Member NRC Christian Einberg Acting, Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Douglas Bollock Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Sophie Holiday Alternate Designated Federal Officer/ACMUI Coordinator Maryann Ayoade NMSS/MSST Jennifer Bishop RIII Said Daibes, Ph.D. NMSS/MSST Robin Elliott RI Sara Forster RIII Latischa Hanson RIV Vincent Holahan, Ph.D. NMSS/MSST Esther Houseman OGC Donna-Beth Howe, Ph.D. NMSS/MSST Jan Nguyen RI Patricia Pelke RIII Gretchen Rivera-Capella NMSS/MSST Raeann Shane NMSS Zahid Sulaiman RIII Katherine Tapp, Ph.D. NMSS/MSST Lester Tripp RI Tara Weidner RI Jenny Weil OCA Irene Wu NMSS/MSST MEMBERS OF THE PUBLIC Bette Blankenship American Association of Physicists in Medicine (AAPM)
Mary Burkhart Illinois Emergency Management Agency (IEMA)
David Burpee Bayer Health Care Whitney Cox IEMA
Robert Dansereau New York State Department of Health Brian Erasmus British Technology Group (BTG)
Sherrie Flaherty Minnesota Department of Health Karen Flanigan New Jersey Radioactive Materials Program Sandra Gabriel unaffiliated Munir Ghesani New York University Langone Health Bennett Greenspan Society of Nuclear Medicine and Molecular Imaging (SNMMI)
Michael Guastella Council on Radionuclides and Radiopharmaceuticals Caitlin Kubler SNMMI Ralph Lieto Saint Joseph Mercy Health System Carol Marcus University of California, Los Angeles Richard Martin AAPM Michael Peters American College of Radiology Josephine Piccone unaffiliated Wayne Powell SNMMI A. Robert Schleipman Partners Healthcare Eugenio Silverstrini Northwell Health Bobby Smith Mississippi Department of Health Glenn Sullivan Cardinal Health Cindy Tomlinson American Society of Radiation Oncology Tony Wang New York Presbyterian/Columbia University Medical Center James Yu Yale School of Medicine
Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Thursday, March 1, 2018 2:00 PM - 4:00 PM (ET)
OPEN SESSION 2:00 - 4:00 pm Discuss the Draft Interim Report of the ACMUI Training and Experience Requirements for All Modalities Subcommittee