ML23005A166
| ML23005A166 | |
| Person / Time | |
|---|---|
| Issue date: | 12/05/2022 |
| From: | NRC/NMSS/DMSST/MSEB |
| To: | |
| Valentin-Rodriguez C | |
| References | |
| Download: ML23005A166 (8) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES December 5th, 2022 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/.
The meeting attendees are listed in Enclosure 1.
RECOMMENDATIONS AND ACTIONS The following provides a summary of the discussions that took place on the topics on the ACMUI meeting agenda (Enclosure 2).
Dr. OHara provided an overview of the Y-90 Medical Events Subcommittee report. This evaluated the issue of Y-90 microsphere medical events and propose how to decrease the number of medical events through consultation with the vendors.
Dr. Jadvar discussed the Training and Experience for All Modalities subcommittees ongoing evaluation of the potential impact of the American Board of Radiologys request to terminate NRC recognition of their board certification process.
Dr. Brenneman from the NRC provided an overview of the NRCs staff review of a new lutetium (Lu)-177-PSMA radiopharmaceutical approved by the FDA. This radiopharmaceutical is specifically for the treatment of patients with prostate-specific membrane antigen positive metastatic castration resistant prostate cancer.
Mr. Carrera from the NRC provided an overview of the NRC's rulemaking to amend its regulations to require safety and security equipment and facilities to be in place for certain applicants before granting a license for possession and use of radioactive materials regulations.
Ms. Shober provided an overview the Emerging Medical Technologies/Rubidium (Rb)-82 Generator Subcommittees report, including comments and recommendations, regarding the NRC staffs draft regulatory basis for the rulemaking to establish requirements for Rb-82 generators and emerging medical technologies.
Mr. Trussell from the NRC provided a status update on the NRCs rulemaking that would amend its regulation for decommissioning financial assurance for sealed and unsealed radioactive materials.
The full committee unanimously accepted the Y-90 Medical Events Subcommittee report, which included recommendations that the NRC issue an information notice to licensees regarding Y-90 microsphere medical events and that the NRC review vendor-prepared, spreadsheets, and other tools. The full committee also unanimously approved the Emerging Medical Technologies/Rb-82 Generator Rulemaking Subcommittee report.
Two new subcommittees were established, including a subcommittee to create generic process checklists to be used during medical administrations and a subcommittee to review the proposed rule for decommissioning financial assurance for sealed and unsealed radioactive materials. The Subcommittee for Nursing Mother Guidelines was reestablished to update the guidelines last updated in 2019. Finally, the membership of the Medical Events Subcommittee was updated.
The ACMUI tentatively decided to meet for the Spring 2023 meeting for May 1st or May 15th.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING ATTENDEES December 5th, 2022 ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Darlene F. Metter, M.D.
Chair Hossein Jadvar, M.D., Ph.D.
Vice Chair Rebecca Allen Member Ronald D. Ennis, M.D.
Member Richard Green Member Richard Harvey, Ph.D.
Member Josh Mailman Member Melissa Martin Member Michael D. OHara, Ph.D.
Member Zoubir Ouhib Member Megan Shober Member Harvey B. Wolkov, M.D.
Member John F. Angle, M.D.
Consultant to the Committee Andrew Einstein, M.D.
Future Member NRC STAFF Theresa Clark Deputy Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Celimar Valentin-Rodriguez Medical Team Leader, NMSS/MSST/MSEB Trisha Gupta Sarma ACMUI Coordinator, NMSS/MSST/MSEB Maryann Ayoade NMSS/MSST/MSEB Kenneth Brenneman NMSS/MSST/MSEB Andrew Carrera NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB
Cindy Flannery NMSS/MSST/MSEB Anita Gray NMSS/MSST/SMPB Vincent Holahan NMSS/MSST Sarah Lopas NMSS/REFS Christine Pineda NMSS/MSST/MSEB Jill Shepherd NMSS/REFS/MRPB Adam Schwartzan NMSS/DUWP Katherine Tapp NMSS/MSST/MSEB Gregory Trussell NMSS/REFS/MRPB Kelly Sullivan OCHCO/HRTD/NRAN Suzanne Dennis COM/Wright Lisa Dimmick COM/Hanson Kathy Modes NMSS/MSST/SLPB Shirley Xu NMSS/MSST/MSTB Luis Cruz Rosado OCHCO/HRTB/NRAN Marilyn Diaz Maldonado COM/Caputo Nathan Denny OCHCO/HRTD/NRAN Stephanie Garza OCHO/HRTD/NRAN Daniel Fiedorek OCHCO/HRTD/NRAN Jade Adams OCHCO/HRTD/NRAN Torre Taylor REFS/MRPB Anthony Valiaveedu OCHCO/HRTD/NRAN Miranda Ross OCHCO/HRTD/NRAN Kayla Gamin OGC/LHE/SE Blake Vaisey OGC/LRAA/RASFB Candance Spore NMSS/MSST Andrew Pessin OGC/LRAA/RASFB Ryan Whited NMSS/DUWP George Tartal REFS/MRPB
Ian Irvin OGC PUBLIC PARTICIPANTS Alan David Jacobson Alex Carter Alyssa Afram Andreai Mouzorou Andy Miller Ashley Cockerham Bill Erwin Bill Hinchcliffe Bradley Kelly Brent Colby Brent Wagner Brian Kelley Brian Serencsits Bryan Lemieux Candi Mcdowell Carl Granlund Cindy Tomlinson Charles Kreuzberger Chris Alston Chris Mitchell Christopher Helstern Christopher Lease Clay Nuquist Dan C Daniel McDonald Daniel Miodownik Daniel Yokell Danielle Goetz Danielle Hjelm David Bierman David Crowley David Vassy Debbie Gilley Dena Abdelhameed Diana Diaz Toro Donna-Beth Howe Eric Andersen Eric Rohren Erik Lyons
Evan Boote Gabriel Munoz Grace Wong Greg Gibbs Heather Merchantz Hope Alvarez Ira Schneider Jack Younan Jacob Kamen Jade Parisey Jaime Barnes James Nunn James Underwood Janelle Jesikiewicz Janet Franco Jason Mace Jeffrey Brunette Jeffrey Mason Jennifer Gersman Jeremy Iman Jerry Thomas Jessica Clements Jessica Rodgers John Curtis Kwasniewski Jose Antony Joseph Giardina Judi Buckalew Karen Langley Katherine Boyd Kavya Prasad Kay Moyer Kelsey Everett Kendall Berry Kendell Wiliams Kim Wiebeck Krista Dillingham Krista Dillingham Larinde Olusegun Akano Lynne Fairobent Marc Gregoire Maris Hanson Mark Seddon Mark Sitek Mary Ann Spilker
Mary Burkhart Mateo Kajic Matt Barrett Matt Dennis Matt Hall Matthew Williamson Matty Mozzor Meghan Cromie Melonie Wissing Michael Bellamy Michael Benson Michael Sheetz Michael Stanfield Miguel de la Guardia Mike Blair Mike Peters Miyuki Yoshida-Hay Nathan Denny Nicholas Paul Borges Paul Wallner Paula Jeter Phillip Peterson Ralph Lieto Richard Martin Robert Golduber Robert Wilson Ron Lattanze Ron Parsons Ryan Toolin Sandy Gabriel Scott Fuller Sean Chapel Sean Odell Wilson Sheila Shaffer Silverstrini Hernandez Sophia Ibal Sripriya Rayadurgam Stan Hampton Stan Hapton Suphatra Gillbert Susan Stanford Tara Medich Tianliang Gu Timothy Houston
Trisha Laake Tyler Fisher Vanessa Louise Gates Vineetha Ram Wendy Terrenoire Whitney Cox William Gibbons William Ruck II William White