ML19303A686
| ML19303A686 | |
| Person / Time | |
|---|---|
| Issue date: | 10/17/2019 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Jamerson K | |
| References | |
| Download: ML19303A686 (4) | |
Text
TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES October 17, 2019 MEETING
SUMMARY
PURPOSE Discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Training and Experience (T&E) Draft Subcommittee Report regarding the U.S. Nuclear Regulatory Commission (NRC) staffs evaluation of the T&E requirements for radiopharmaceuticals under Title 10 Code of Federal Regulations (10 CFR) 35.300, Use of unsealed byproduct material for which a written directive is required.
OUTCOME The ACMUI T&E Subcommittee provided a draft report on their review of the NRC staffs evaluation of the T&E requirements for radiopharmaceuticals requiring a written directive for discussion with the full ACMUI. Subcommittee members included: Mr. Gary Bloom, Dr. Ronald Ennis, Dr. Darlene Metter, Dr. A. Robert Schleipman (chair), Mr. Michael Sheetz, and Ms. Megan Shober. 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 the development of its Commission notation vote paper.
A full transcript and handout for the ACMUI teleconference meeting can be found on the NRCs public web site at: http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/.
The ACMUI Subcommittee final report is also available on the NRCs public web site at:
http://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.
AGENDA TOPICS Discuss the ACMUI T&E Subcommittees report on the staffs evaluation of training and experience requirements for radiopharmaceuticals requiring a written directive.
SUMMARY
The ACMUI T&E Subcommittee discussed its review of the staffs preliminary draft Commission paper entitled, Evaluation of Training and Experience Requirements for Administration of Radiopharmaceuticals Requiring a Written Directive. As provided in the draft subcommittee report, the subcommittee shared their comments on each of the staffs draft approaches.
RECOMMENDATIONS AND ACTIONS The ACMUI T&E Subcommittee provided the following recommendations in its draft subcommittee report:
- 1. The Subcommittee recommends maintaining the status quo under 10 CFR 35.390. While strongly affirming the structural superiority of the status quo over the other options proposed in the draft paper, we acknowledge there is room for a comprehensive review of the specific requirements in 35.390 such as the seemingly arbitrary requirement of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. The subcommittee (and likely, ACMUI) would welcome the opportunity to critically assess these details.
- 2. If the NRC proceeds to grant AU status by NRC-recognized specialty boards, the T&E should be equivalent to 35.390.
- 3. The Subcommittee recognizes the value of an alternate pathway and is willing to review and evaluate the requisite knowledge, preceptor-reviewed experience, and competency assessments.
The draft T&E Subcommittee Report (ML19143A367), and all its recommendations provided therein, was unanimously approved by the ACMUI during its public teleconference meeting on October 17, 2019. The final report (ML19296D256) will be posted on the ACMUI Subcommittee Reports webpage.
Enclosures:
- 1. Meeting Attendees
- 2. Teleconference Agenda MEETING ATTENDEES ACMUI Darlene F. Metter, M.D.
Chairman A. Robert Schleipman, Ph.D.
Vice Chairman Vasken Dilsizian, M.D.
Member Ronald Ennis, M.D.
Member Richard Green Member Michael D. OHara, M.D.
Member Zoubir Ouhib Member Michael Sheetz Member Megan Shober Member NRC Lisa Dimmick Designated Federal Officer, Medical Radiation Safety Team Leader, NMSS/MSST/MSEB Maryann Ayoade NMSS/MSST/MSEB Ian Irvin OGC/GCLR/RMR Sarah Lopas NMSS/MSST/MSEB MEMBERS OF THE PUBLIC*
Bette Blankenship American Association of Physicists in Medicine Roger Estafanos Novartis Michael Guastella Council on Radionuclides and Radiopharmaceuticals, Inc.
Caitlin Kubler Society of Nuclear Medicine and Molecular Imaging James Logan Bayer Healthcare Carol Marcus, Ph.D, M.D.
University of California at Los Angeles (UCLA)
Richard Martin AAPM Aria Razmaria, M.D.
UCLA Medical Center Gloria Romanelli American College of Radiology Bruce Thomadsen, M.D.
Unaffiliated Cindy Tomlinson American Society of Radiation Oncology
- This list is inconclusive of all teleconference participants.
Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA October 17, 2019 2:00 PM - 4:00 PM (ET)
OPEN SESSION 2:00 PM - 4:00 PM Discuss the ACMUI Training and Experience (T&E) Draft Subcommittee Report regarding the NRC staffs evaluation of the T&E requirements for radiopharmaceuticals under Title 10 Code of Federal Regulations (10 CFR) 35.300, Use of unsealed byproduct material for which a written directive is required.