ML23340A235

October 23, 2023 Meeting Summary ACMUI

ML23340A235
Person / Time
Issue date:	10/23/2023
From:	Advisory Committee on the Medical Uses of Isotopes
To:
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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 mak e 10 CFR Part 35 more useful, practical, and not overly burdensome on licensees, while mainta ining public health and safety.

Full transcripts and handouts from the ACMUI meeting can be fou nd 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 p lace on the topics on the ACMUI meeting agenda (Enclosure 2).

The ACMUI endorsed the following subcommittee report. This repo rt and its recommendations can be viewed, in their entirety, on the NRCs ACMUI Subcommitt ee Reports webpage, located at the following link: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/in dex.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 microsp here administrations from the manufacturers.

The ACMUI accepted April 8 - 9, 2024 as dates for its Spring 20 24 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