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{{#Wiki_filter:MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES | {{#Wiki_filter:MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES October 23, 2023 MEETING | ||
October 23, 2023 | |||
MEETING | |||
==SUMMARY== | ==SUMMARY== | ||
PURPOSE | 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. | |||
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. | 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/. | ||
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 | |||
Full transcripts and handouts from the ACMUI meeting can be | |||
The meeting attendees are listed in Enclosure 1. | The meeting attendees are listed in Enclosure 1. | ||
RECOMMENDATIONS AND ACTIONS | RECOMMENDATIONS AND ACTIONS The following provides a summary of the discussions that took place on the topics on the ACMUI meeting agenda (Enclosure 2). | ||
The ACMUI endorsed the following subcommittee report. This report and its recommendations can be viewed, in their entirety, on the NRCs ACMUI Subcommittee Reports webpage, located at the following link: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/index.html. | |||
The following provides a summary of the discussions that took | |||
The ACMUI endorsed the following subcommittee report. This | |||
The ACMUI endorsed the report from the Subcommittee on Medical Events Report, as presented. | The ACMUI endorsed the report from the Subcommittee on Medical Events Report, as presented. | ||
The following actions resulted from discussion that took place during the meeting. | The following actions resulted from discussion that took place during the meeting. | ||
NRC staff will seek to obtain the number of annual Y-90 microsphere administrations from the manufacturers. | |||
NRC staff will seek to obtain the number of annual Y-90 | The ACMUI accepted April 8 - 9, 2024 as dates for its Spring 2024 meeting. | ||
The ACMUI accepted April 8 - 9, 2024 as dates for its Spring | |||
==Enclosures:== | ==Enclosures:== | ||
: 1. Meeting Attendees | : 1. Meeting Attendees | ||
: 2. Meeting Agenda | : 2. Meeting Agenda | ||
MEETING ATTENDEES October 23, 2023 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 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 Andrew Einstein, M.D. | |||
Member Michael R. Folkert, M.D., Ph.D. | |||
Member John F. Angle, M.D. | |||
Consultant to the Committee NRC STAFF Kevin Williams 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 Lillian Armstead NMSS/MSST/MSEB and Designated Federal Officer Maryann Ayoade NMSS/MSST/MSEB Kenneth Brenneman NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB Cindy Flannery NMSS/MSST/MSEB Vincent Holahan NMSS/MSST | |||
Daniel | Christine Pineda NMSS/MSST/MSEB Daniel Shaw NMSS/MSST/MSEB Jill Shepherd NMSS/REFS/MRPB Sarah Spence NMSS/MSST/MSEB Katherine Tapp NMSS/MSST/MSEB Brian Allen RES/DSA/RPB Candace Spore NMSS/MSST Charles Kreuzberger OGC/LHE/MFW Ed Miller NRR/DORL/LPL2-1 Edward Harvey RES/DSA/RPB Irene Wu NMSS/REFS/MRPB Janice Nguyen R-I/DRSS/MLAB John Tomon RES/DSA/RPB Keith Lassman R-III/DRSS/MLB Latischa Hanson R-IV/DRSS/MLB Rigel Flora RES/DSA/RPB Ryan Stolt R-III/DRSS/MIB Samantha Everett R-IV/DRSS/MLB Suzanne Dennis COM/Wright Ian Irvin OGC/LHE/MFW Timothy Wilson OIG/AIGA/NMW Travis Jones OGC/LHE/MFW Cassandra Frazier R-III/DRSS/MLB Irene Wu NMSS/REFS/MRPB Miranda Ross OCHCO/ADHRTD/NRANB Trisha Gupta Sarma OCHCO/ADHRTD/NRANB PUBLIC PARTICIPANTS Virginia Pappas | ||
Sandy Gabriel Sam Wojack Mary Burkhart Jeffrey Mason Josh Knowland Stanley D. Hampton Nick Dorrell Matthew Gabriel Matthew Greenwood Ralph P. Lieto Kaci Studer Claire Drozd Daniel Samson Michael Peters Brandi Woods Joyce L. Petersen Sean Wilson Sean Chapel Billie Harvey Erin Niven Debbie Wenke Richard Peros Bill Edwin William Hinchcliffe Ashley Cockerham Lei Ding Christopher Lease Ariel Doucet Kathi Haldeman Mary Ann Spilker | |||
Sean Odell Wilson | Josie Piccone Gabriel J. Munoz Tony R Davila Neil Whiteside Jaime Barnes William Lorenzen Jennifer Gersman Andrew Halloran Michael A Sheetz Sean Odell Wilson Kim C. Wiebeck Thomas E Huston Melonie Paige Mike Welling Bryce Armstrong Julia Bellinger Carrie R. Carson Manar Sakalla Greg Taglialatela Jeffrey T. Cessna Venkata Neti Barb Hodge William Gibbons Dan Samson Colin Whitney Cindi Luckett Gilbert Jimmy Uhlemeyer Nicole Nardecchia Bella Elizabeth Johnson Emilio Vega | ||
Timothy Houston}} | Lara Renz Paciello Vanessa Gates Sivakumar Munisamy Jeffrey S. Mason Whitney Cox Daniel J. Samson Jonathan J. Otten Carol Wen Sean Odell Wilson Timothy Houston}} | ||
Latest revision as of 07:35, 25 November 2024
| ML23340A235 | |
| Person / Time | |
|---|---|
| Issue date: | 10/23/2023 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| Download: ML23340A235 (6) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES October 23, 2023 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).
The ACMUI endorsed the following subcommittee report. This report and its recommendations can be viewed, in their entirety, on the NRCs ACMUI Subcommittee Reports webpage, located at the following link: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/index.html.
The ACMUI endorsed the report from the Subcommittee on Medical Events Report, as presented.
The following actions resulted from discussion that took place during the meeting.
NRC staff will seek to obtain the number of annual Y-90 microsphere administrations from the manufacturers.
The ACMUI accepted April 8 - 9, 2024 as dates for its Spring 2024 meeting.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING ATTENDEES October 23, 2023 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 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 Andrew Einstein, M.D.
Member Michael R. Folkert, M.D., Ph.D.
Member John F. Angle, M.D.
Consultant to the Committee NRC STAFF Kevin Williams 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 Lillian Armstead NMSS/MSST/MSEB and Designated Federal Officer Maryann Ayoade NMSS/MSST/MSEB Kenneth Brenneman NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB Cindy Flannery NMSS/MSST/MSEB Vincent Holahan NMSS/MSST
Christine Pineda NMSS/MSST/MSEB Daniel Shaw NMSS/MSST/MSEB Jill Shepherd NMSS/REFS/MRPB Sarah Spence NMSS/MSST/MSEB Katherine Tapp NMSS/MSST/MSEB Brian Allen RES/DSA/RPB Candace Spore NMSS/MSST Charles Kreuzberger OGC/LHE/MFW Ed Miller NRR/DORL/LPL2-1 Edward Harvey RES/DSA/RPB Irene Wu NMSS/REFS/MRPB Janice Nguyen R-I/DRSS/MLAB John Tomon RES/DSA/RPB Keith Lassman R-III/DRSS/MLB Latischa Hanson R-IV/DRSS/MLB Rigel Flora RES/DSA/RPB Ryan Stolt R-III/DRSS/MIB Samantha Everett R-IV/DRSS/MLB Suzanne Dennis COM/Wright Ian Irvin OGC/LHE/MFW Timothy Wilson OIG/AIGA/NMW Travis Jones OGC/LHE/MFW Cassandra Frazier R-III/DRSS/MLB Irene Wu NMSS/REFS/MRPB Miranda Ross OCHCO/ADHRTD/NRANB Trisha Gupta Sarma OCHCO/ADHRTD/NRANB PUBLIC PARTICIPANTS Virginia Pappas
Sandy Gabriel Sam Wojack Mary Burkhart Jeffrey Mason Josh Knowland Stanley D. Hampton Nick Dorrell Matthew Gabriel Matthew Greenwood Ralph P. Lieto Kaci Studer Claire Drozd Daniel Samson Michael Peters Brandi Woods Joyce L. Petersen Sean Wilson Sean Chapel Billie Harvey Erin Niven Debbie Wenke Richard Peros Bill Edwin William Hinchcliffe Ashley Cockerham Lei Ding Christopher Lease Ariel Doucet Kathi Haldeman Mary Ann Spilker
Josie Piccone Gabriel J. Munoz Tony R Davila Neil Whiteside Jaime Barnes William Lorenzen Jennifer Gersman Andrew Halloran Michael A Sheetz Sean Odell Wilson Kim C. Wiebeck Thomas E Huston Melonie Paige Mike Welling Bryce Armstrong Julia Bellinger Carrie R. Carson Manar Sakalla Greg Taglialatela Jeffrey T. Cessna Venkata Neti Barb Hodge William Gibbons Dan Samson Colin Whitney Cindi Luckett Gilbert Jimmy Uhlemeyer Nicole Nardecchia Bella Elizabeth Johnson Emilio Vega
Lara Renz Paciello Vanessa Gates Sivakumar Munisamy Jeffrey S. Mason Whitney Cox Daniel J. Samson Jonathan J. Otten Carol Wen Sean Odell Wilson Timothy Houston