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Category:Meeting Agenda
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Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES June 17, 2024 MEETING
SUMMARY
PURPOSE To review and provide feedback and recommendations on the U.S. Nuclear Regulatory Commission (NRC) staffs draft proposed rule, associated draft implementation guidance, and draft model procedures for reporting nuclear medicine injection extravasations as medical events.
OUTCOME 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 staff will consider the ACMUIs comments and recommendations prior to finalizing the meeting document.
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 following addendums were made to the subcommittee report as resulted from discussion that took place during the meeting.
The ACMUI recommended that the subcommittee report be clarified that their recommendation was that the NRC should not be making requirements about informed consent and not a general recommendation about informed consents.
The ACMUI also added the recommendation to replace the term potential with either likely or expected in the proposed rule.
The ACMUI unanimously endorsed, with one abstention, the subcommittee report with the addendums. 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.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING ATTENDEES
June 17, 2024
ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
Hossein Jadvar, MD, PhD Chair
Richard Green Vice Chair
Richard Harvey, DrPh Member
Josh Mailman Member
Melissa Martin Member
Michael D. OHara, PhD Member
Zoubir Ouhib Member
Megan Shober Member
Harvey B. Wolkov, MD Member
Andrew Einstein, MD Member
Michael R. Folkert, MD, PhD Member
Joanna R. Fair, MD, PhD Member
Rebecca Allen Member
John F. Angle, MD Consultant to the Committee
NRC STAFF Kevin Williams Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Christian Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer
Celimar Valentin-Rodriguez NMSS/MSST/MSEB and Designated Federal Officer
Lillian Armstead NMSS/MSST/MSEB and Designated Federal Officer
Aaron Thomlinson NMSS/MSST/MSEB
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 Shaw NMSS/MSST/MSEB
Sarah Spence NMSS/MSST/MSEB
Katherine Tapp NMSS/MSST/MSEB
Janice Nguyen R-I/DRSS/MLAB
Travis Jones OGC/LHE/MFW
Brian Allen RES/DSA/RPB
Latischa Hanson R-IV/DRSS/MLB
Jason VonEhr R-I/DRSS/MLAB
Sarah Lopas NMSS/REFS
PUBLIC PARTICIPANTS
John Rumson
Josh Knowland
Lingyun Chen
Mateo Kajic
Christopher M. Helstern
Claire Drozd
Lynes Matos
Christopher M. Helstern
Carol Marcus
Jenni Johnston
James Norweck
Deirdre H. Elder
Chris Mitchell
Deborah M. Barrickman
Todd Senglaub
Ralph Lieto
Noelle Geier
Manuel Diaz
Emily C Rostel
Ike Hall
Julia Bellinger
Jenny Parra
Kendall E. Berry
Rex G. Ayers
Billie Harvey
Carley M. Hansen
Jeffrey S. Mason
Alan Jackson Sun-Woo Lee
Kevin Kunder
Vanessa E. Holfeltz
Sandy Gabriel
Harriet Karagiannis
Logan A. Cowart
Paul Wallner
Eric Anderson
Hannah Jones
Teresa Fisher
Sean Chapel
Anthony Pacella
Sue Bunning
Wendy W. Terrenoire
Michael Roberson
Lisa Marie Guarino
Carmine M. Plott
Karen Burgard
Doug Burrichter
Jennifer A. Schroeder
Jennifer Papich
Douglas L. Miller
Jason C. Mace
Leelavathi Sreenivas
Rebecca Maxey
Marie S. Hubbard
Mike Drelich
Michael Sheetz
Joshua Johnson Holli Allen
Cathy Cutler
Kim C. Wiebeck
Adam C. Quinton
Stephen Holmes
Christopher Pagan
Jonathan D. Moore
Shawn Seeley
Tony Gonzalez
David Bierman
Isabella Aristeguieta Pirela
Erik Lyons
Erin Grady
Samantha Everett
Alexus Willis
Michael Peters
Phillip Peterson
Jessica Rodgers
Jonathan J. Otten
William Hinchcliffe
Tim David Kleyn
Ann Marie Derby
Ron Lattanze
Harral Logaras
Chu Wang
Peter Duyshart
Korressa Lee
Chris Comfort
Jean-Luc Omitsa Lopez
Danielle Hjelm
Gabriel J. Munoz
David Pellicciarini
Willie M. Crawford
Christopher L. Ogan
Jussi Sillanpaa
Jason D. Hout
Tim Turkington
Amol Patil
Kelly N. Lewis
Daniel Chiappetta
Matt Wait
Andrew Hoy
Miguel de la Guardia
Olga Stafford
Helen Nadel
Ashley Cockerham
Deb Lemay
Stephanie Aranki
Laura M. Knox
Erin Desemple
Kyle K. Underwood
Brad K.
Emma Anderson
Kayla Vom Dorp
Edward Case
Jaime A. Barnes
Neil Petry Will R. Gibbons
Sebastien Gros
Neil Whiteside
Hillary K. Haskins
Virginia Pappas
Emma Duncan
David Crowley
Matt Reiter
Joshua Young
Justin L. Brown
Cathey Rivers
Heather A. Jacene
Cami Still
Luke Schwartz
Casey Schmitz
Richard Scott Blackwell
Susan Suchan
Aaron Smith
Scott Fuller
Jill Shepherd
Olusegun A. Larinde
Blaine T. Mischen
David L. Bushnell
Kevin Tello
Michael A. Welling
Matty Mozzor
Castellon Krupskaya
Ariel Doucet
Bill Erwin Paula Lang
Trisha Laake
Marjorie Gonzalez
Xingyu Nie
Brad K.
Candi Mcdowell
Tina Shoemaker
Robert C. Harris
Whitney Cox
William White
Ramon Li
Matt Dennis
Sharn M. Jeffries
Joseph M. Beckman
Robert Naylor
Curtis Liddle
Claudia C. Stenstrom
David M. Schuster
Becki Harisis
Jimmy Uhlemeyer
Sandra M. Ramirez
Kathleen Hintenlang
Robin Elliott
Jackie Cook
Stanley D Hampton
Elizabeth Franklin
Brian M. Kelley
William C. Chen
Tim Turkington Yuanqing Guo
Barbara Hamrick
John P. Metyko
Matthew Williamson
Sandy Gabriel
Christopher D. Nation
Ed Leidholdt
Rachel Nichols
Jennifer R. House
Rich Anderson
Robin Elliott
Sussie DeMello
Vineetha Ram
Susan Corey
Mandie S. Hubbard
Ed Nicho
Court Reporter
Emma Bower
Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Monday, June 17, 2024 2:00 PM - 4:00 PM ET
OPEN SESSION
- 1. Opening Remarks C. Einberg, NRC Mr. Christian Einberg will formally open the meeting.
- 2. Reporton Nuclear Medicine Injection Extravasations as M. Martin, ACMUI Medical Events 2:00 PM - Ms. Martin will discuss the ACMUIs draft subcommittee report on the 4:00PM NRC staffs draft proposed rule and associated draft implementation guidance for reporting nuclear medicine injection extravasations as medical events.
- 3. Closing and Adjournment H. Jadvar, ACMUI Dr. Jadvar will close the meeting.