ML24178A444

June 17 2024 Summary of Meeting Advisory Committee on the Medical Uses of Isotopes (ACMUI)

ML24178A444
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Issue date:	06/17/2024
From:	Advisory Committee on the Medical Uses of Isotopes
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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 2:00 PM -

4:00PM

1. Opening Remarks Mr. Christian Einberg will formally open the meeting.

C. Einberg, NRC

2. Report on Nuclear Medicine Injection Extravasations as Medical Events Ms. Martin will discuss the ACMUIs draft subcommittee report on the NRC staffs draft proposed rule and associated draft implementation guidance for reporting nuclear medicine injection extravasations as medical events.

M. Martin, ACMUI

3. Closing and Adjournment Dr. Jadvar will close the meeting.

H. Jadvar, ACMUI