ML18222A409
| ML18222A409 | |
| Person / Time | |
|---|---|
| Issue date: | 07/16/2018 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Wu I | |
| References | |
| Download: ML18222A409 (5) | |
Text
1 TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES July 16, 2018 MEETING
SUMMARY
PURPOSE To discuss the draft report of the Advisory Committee on the Medical Uses of Isotopes (ACMUI)
Subcommittee on Training and Experience Requirements for All Modalities, which includes the subcommittees comments and recommendations on the NRC staffs evaluation of the training and experience requirements for different categories of radiopharmaceuticals in Title 10 of the Code of Federal Regulations (10 CFR), Part 35, Medical Use of Byproduct Material, Subpart E, Unsealed Byproduct Material - Written Directive Required.
OUTCOME The ACMUI Training and Experience Requirements for All Modalities Subcommittee provided a draft report for discussion with the full ACMUI. Subcommittee members included: Dr. Philip Alderson, Dr. Darlene Metter (Chair), Ms. Megan Shober, 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 and recommendations 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 Draft 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 Draft Report of the ACMUI Subcommittee on Training and Experience Requirements for All Modalities
SUMMARY
The ACMUI Training and Experience Requirements for All Modalities Subcommittee provided a summary of the NRC staffs draft SECY paper and provided their comments and recommendations on the paper. The subcommittee recommended: (1) reconsideration of the existing pathways to an authorized user (AU) status; (2) that for the limited AU status, the educational program must be all inclusive to cover the knowledge topics required for all AUs involved in 10 CFR 35.300; (3) having an objective method to assess AU competency that documents both initial and maintenance of competency for the limited AU status; (4) the need for greater and broader stakeholder input on this topic; and (5) having NRC staff conduct ongoing monitoring for potential AU shortage for 10 CFR 35.300, including data on the geographic distribution and practice patterns of AUs. Additional comments were provided by external stakeholders including, the American Society of Radiation Oncology (ASTRO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), American College of Nuclear Medicine (ACNM), American College of Radiology (ACR), Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR), and Bayer Health Care.
The Draft Training and Experience Requirements for All Modalities Subcommittee Report (ML18186A517), including all of its recommendations in its entirety, was unanimously approved by the full ACMUI. The Final Training and Experience Requirements for All Modalities Subcommittee Report (ML18201A417) is posted on the ACMUI Subcommittee Reports Webpage.
Enclosures:
- 1. Meeting Attendees
- 2. Teleconference Agenda MEETING ATTENDEES ACMUI Christopher J. Palestro, M.D.
Chairman Darlene F. Metter, M.D.
Vice Chairman Philip O. Alderson, M.D.
Member Vasken Dilsizian, M.D.
Member Ronald D. Ennis, M.D.
Member Richard L. Green Member Michael D. OHara, Ph.D.
Member Zoubir Ouhib Member Michael Sheetz Member Megan L. Shober Member John H. Suh, M.D.
Member Laura M. Weil Member Melissa Martin Non-Voting Member Robert Schleipman, M.D.
Non-Voting Member NRC Sabrina Atack Acting, Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Douglas Bollock Chief, Medical Safety and Events Assessment Branch, and Designated Federal Officer Lisa Dimmick Alternate Designated Federal Officer/Medical Radiation Safety Team Leader Maryann Ayoade Office of Nuclear Material Safety and Safeguards (NMSS)/MSST Jacqueline Cook Region IV Samantha Crane Office of Commissioner David A. Wright Jennifer Dalzell Region III Chris Einberg NMSS/MSST Robin Elliott Region I Said Daibes, Ph.D.
NMSS/MSST Farrah Gaskins Region I Richard Jervey NMSS/Fuel Cycle Safety, Safeguards, and Environmental Review Vincent Holahan, Ph.D.
NMSS/MSST Sophie Holiday NMSS/MSST Esther Houseman Office of the General Counsel Penny Lanzisera Region I Tim Mossman Office of the Executive Director for Operations Patty Pelke Region III Shawn Seeley Region I Daniel Strohmeyer Region III Katherine Tapp, Ph.D.
NMSS/MSST Lester Tripp Region I Irene Wu NMSS/MSST
2 MEMBERS OF THE PUBLIC Felicity Beckfield University of Missouri David Burpee Bayer Health Care Dalton Clark SNMMI Whitney Cox Illinois Emergency Management Agency Brian Erasmus British Technology Group Lynne Fairobent unaffiliated Sandy Gabriel unaffiliated Wendy Galbraith The University of Oklahoma College of Pharmacy Munir Ghesani New York University Langone Health Shaemus Gleason Bayer Health Care Bennett Greenspan SNMMI Michael Guastella CORAR Matthew Hadden U.S. Department of Veterans Affairs Stanley Hampton Eli Lilly and Company Scott Hudek Advanced Accelerator Applications Brandon Juran Minnesota Department of Health Caitlin Kubler SNMMI Sue Langhorst unaffiliated Cindi Luckett-Gilbert Shertech Pharmacy Carol Marcus University of California, Los Angeles Michael Peters ACR Gloria Romanelli ACR Rachel Semon Advanced Accelerator Applications Cindy Tomlinson ASTRO Paul Wallner ACR Kara Weatherman Purdue College of Pharmacy John Witkowski United Pharmacy Partners, LLC Miguel de la Guardia Cooks Childrens Hospital Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Monday, July 16, 2018 2:00 PM - 4:00 PM (ET)
OPEN SESSION 2:00 - 4:00 pm Discuss the Draft Report of the ACMUI Subcommittee on Training and Experience Requirements for All Modalities, which will include the subcommittees comments on the NRC staffs evaluation of the training and experience requirements for different categories of radiopharmaceuticals in Title 10 of the Code of Federal Regulations (10 CFR), Part 35, Medical Use of Byproduct Material, Subpart E, Unsealed Byproduct Material - Written Directive Required.