ML19120A532

04/03-04/2019 Summary of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting

ML19120A532
Person / Time
Issue date:	04/04/2019
From:	Office of Nuclear Material Safety and Safeguards
To:
Jamerson K
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Download: ML19120A532 (7)

Text

MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 3-4, 2019 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 ACMUI Meetings Web page, located on NRCs public Web site:

http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/

RECOMMENDATIONS AND ACTIONS The following recommendations and actions resulted from the discussions that took place on the topics listed on the ACMUI meeting agenda (Enclosure 2):

The Committee recommended that the NRC add an additional column to the Recommendations and Action Items Chart to include the anticipated date of completion for NRC staff actions.

The Committee recommended that the NRC staff request a presentation from the National Nuclear Security Administration to provide a review of their plans for isotope utilization in the United States. The presentation will be given at the fall 2019 ACMUI Meeting.

Dr. Palestro formed a subcommittee to review the NRCs 1980 determination related to infiltrations and medical event reporting [45 FR 31703]. The subcommittee is expected to report to the Committee at the fall 2019 meeting with any recommendations. Subcommittee membership includes Dr. Dilsizian, Mr. Green, Ms. Martin (chair), Mr. Sheetz, Ms. Shober, and Ms. Weil. The NRC staff resource is Ms. Maryann Ayoade.

Dr. Palestro formed a subcommittee to improve the ACMUIs institutional memory and provide possible recommendations for methods of tracking and/or retrieving ACMUI documents.

Subcommittee membership includes Dr. Ennis, Dr. OHara, Dr. Schleipman (chair), Ms. Shober, and Ms. Weil. The NRC staff resource is Ms. Kellee Jamerson.

The Committee endorsed the Yttrium-90 Microspheres Brachytherapy Licensing Guidance, Rev.

10 Subcommittee report, and the recommendations therein, with the caveat to replace the term drug with the term device.

The Committee endorsed the Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance, Rev. 1 Subcommittee report and the recommendations therein.

The Committee endorsed the ACMUI Bylaws Subcommittee report, with the following amendments: 1) amend the subcommittees recommendation regarding the ACMUI Chairmans role on subcommittees in Section 1.3.6 to remove the phrase in these instances; 2) add language in Section 1.3.6 regarding the ACMUI Chairman serving on a subcommittee at the subcommittees discretion; and 3) amend the subcommittees recommendation regarding the explicit language defining Conflict of Interest in Section 4.1 to instead reference the appropriate Office of Government Ethics citation.

The NRC staff will amend its Opening Remarks such that a statement regarding conflict of interest will be included at every ACMUI meeting.

The Committee tentatively scheduled the fall 2019 meeting for September 11-12, 2019. The alternate meeting date is September 10-11, 2019.

Enclosures:

1. Meeting Attendees

2. Meeting Agenda MEETING ATTENDEES ACMUI Christopher J. Palestro, M.D. Chairman Darlene F. Metter, M.D. Vice Chairman Vasken Dilsizian, M.D. Member Ronald D. Ennis, M.D. Member Richard Green Member Melissa Martin Member Michael D. OHara, Ph.D. Member Zoubir Ouhib Member A. Robert Schleipman, Ph.D. Member Michael A. Sheetz Member Megan Shober Member Laura M. Weil Member Harvey B. Wolkov, M.D. Non-Voting Member NRC Scott Moore Deputy Director, Office of Nuclear Material Safety and Safeguards (NMSS)

Kevin Williams Deputy Director, Division of Materials Safety, State, and Tribal Programs (MSST)

Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Lisa Dimmick Team Lead, Medical Radiation Safety Team, MSEB Kellee Jamerson Designated Federal Officer and ACMUI Coordinator Maryann Ayoade NMSS Laura Cender RIII Jennifer Dalzell RIII Said Daibes, Ph.D. NMSS Sara Forster RIII Cassandra Frazier RIII Robert Gallaghar RI Sophie Holiday NMSS Vincent Holahan, Ph.D. NMSS Esther Houseman OGC Donna-Beth Howe, Ph.D. NMSS Ian Irvin OGC Donna Janda RI Janelle Jessie COMM/OCMJB Erin Kennedy RIII Penny Lanzisera RI Sarah Lopas NMSS Henry Lynn OCHCO Robert MacDougall NMSS Janice Nguyen RI Dennis ODowd RIII Patricia Pelke RIII David Pelton RIII Shawn Seeley RI Vered Shaffer RES Alexa Sieracki NMSS Katie Tapp, Ph.D. NMSS Irene Wu NMSS MEMBERS OF THE PUBLIC Jenna Abbot Illinois Emergency Management Agency Danny Allen NuTech, Inc.

Eric Andersen Dana-Farber Cancer Institute Michael Baxter American Pharmacists Association Bette Blankenship American Association of Physicists in Medicine (AAPM)

Kendall Berry Fox Chase Cancer Center Jeff Brunette Mayo Clinic Janet Bukovcan British Technology Group Mary Burkhart Illinois Emergency Management Agency Steven Chilinski Radiopharmacy Ashley Cockerham SirTex Medical Jason Collier Lehigh Valley Health Network Whitney Cox Illinois Emergency Management Agency Willie Crawford Virginia Office of Radiological Health Cory Daignault Virginia Office of Radiological Health Nick Dorrell University of Virginia Ariel Doucet Virtua Health Mark Driscoll University of Michigan Brian Erasmus British Technology Group Lynne Fairobent Unaffiliated Sherrie Flaherty Minnesota Radioactive Materials Unit Mark Flickinger Virginia Office of Radiological Health Michael Fuller Virginia Office of Radiological Health Sandy Gabriel Unaffiliated Reid Gadziala PharmaLogic Wendy Galbraith University of Oklahoma Health Sciences Center Noel Geier Froedtert & the Medical College of Wisconsin Vinson Gibb Illinois Emergency Management Agency Rebecca Grabarkewitz Virginia Office of Radiological Health Matthew Hadden Virginia Office of Radiological Health Gary Hall Virginia Office of Radiological Health Matthew Hall NorthShore University Health System Stanley Hampton Eli Lilly Curtis Hicks Brigham and Womens Hospital, Harvard Medical School William Hinchcliffe Yale New Haven Hospital William House Virginia Office of Radiological Health Sarah Hughes University of Louisville Paul Kanabrocki Virginia Office of Radiological Health Heather Karmansky SirTex Medical Caitlin Kubler Society of Nuclear Medicine and Molecular Imaging Ralph Lieto St. Joseph Mercy Health System William Lorenzen Boston Childrens Hospital, Harvard Medical School Richard Martin American Association of Physicists in Medicine (AAPM)

Jeff Mason Virginia Office of Radiological Health Steve Mattmuller Kettering Health Andy McKinley American Society of Nuclear Cardiology (ASNC)

Andrew McKusick Unknown Ashley Mishoe University of California San Francisco Christopher Mitchell Kettering Health Joshua Myers Pennsylvania Department of Environmental Protection Christopher Nation Virginia Office of Radiological Health Scott Nemmers U.S. Air Force Joseph Oberender Virginia Office of Radiological Health Michael Peters American College of Radiology (ACR)

Brad Price GE Healthcare Priya Rayadurgam Cleveland Clinic Joe Rubin United Pharmacy Partners, Inc. (UPPI)

Manar Sakalla Georgetown University Eugenio Silvestrini Northwell Health Ed Sims Cleveland Clinic Andres Sinisterra UConn Health Lakshmi Sivasubramanian University of Massachusetts Medical School Diana Thompson University of Illinois at Chicago Cindy Tomlinson American Society of Radiation Oncology (ASTRO)

David Townsend Unaffiliated Michael Ujhelyi British Technology Group Matthew White SSM Health Neil Whiteside Yale New Haven Hospital Matthew Williams Georgetown University Matthew Williamson Memorial Sloan Kettering Cancer Center Robert Wilson University of Tennessee Health Science Center Melonie Wissing Virginia Office of Radiological Health Miyuki Yoshida-Hay Northwell Health

Enclosure 2 MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 3-4, 2019 Three White Flint North Building, 11601 Landsdown Street, Room 1-C03/1-C05, North Bethesda, Maryland 20852 NOTE: Sessions of the meeting may be closed pursuant to 5 U.S.C. 552(b) to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACMUI; information the release of which would constitute a clearly unwarranted invasion of personal privacy; information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action; and disclosure of information which would risk circumvention of an agency regulation or statute.

Wednesday, April 3, 2019 OPEN SESSION

1. Opening Remarks C. Einberg, NRC Mr. Einberg will formally open the meeting and Ms. Kock will provide opening A. Kock, NRC remarks.

2. Old Business S. Holiday, NRC Ms. Holiday will review past ACMUI recommendations and provide NRC responses.

8:30 - 10:30 3. Open Forum ACMUI The ACMUI will identify medical topics of interest for further discussion.

4. Yttrium-90 Microspheres Brachytherapy Licensing Guidance M. OHara, ACMUI Subcommittee Report Dr. OHara will discuss the subcommittees recommendations on the NRCs draft Revision 10 to the Yttrium-90 Microspheres Brachytherapy Licensing Guidance.

5. Lucerno Dynamics LARA Infiltration Detection R. Lattanze, Mr. Lattanze will provide an overview about a product that can assist with Lucerno Dynamics detecting nuclear medicine injection infiltrations.

10:30 - 10:45 BREAK

6. Summary of Changes to 10 CFR Part 35 L. Dimmick, NRC Ms. Dimmick will discuss the changes to the final rule 10 CFR Part 35 that went into effect January 2019.

10:45 - 12:00

7. Germanium-68/Gallium-68 Subcommittee Report M. Shober, ACMUI Ms. Shober will discuss the subcommittees recommendations on the NRCs draft revision to the Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance.

12:00 - 1:00 LUNCH

8. Medical Related Events DB. Howe, NRC Dr. Howe will provide an update on recent medical events.

1:00 - 2:45 9. Appropriateness of Medical Event Reporting Subcommittee Report R. Ennis, ACMUI Dr. Ennis will discuss the subcommittees recommendations on the appropriateness of the required medical event reporting in accordance with 10 CFR 35.3045.

Enclosure 2 2:45 - 3:15 BREAK (public portion ends)

WEDNESDAY, APRIL 3, 2019 CLOSED SESSION 3:15 - 5:00 10. ACMUI Working Session: Biennial Evaluations and Commission ACMUI Meeting Presentation Development THURSDAY, APRIL 4, 2019 OPEN SESSION

11. ACMUI Reporting Structure K. Jamerson, NRC Members will discuss the reporting structure of the Committee and provide feedback to the NRC staff.

8:30 - 9:30 12. Special Presentation to Ms. Weil S. Moore, NRC Mr. Moore will make a special presentation to Ms. Laura Weil

13. Thoughts on Leaving the ACMUI L. Weil, ACMUI Ms. Weil will share her thoughts on leaving the ACMUI, after serving two full terms (8 years).

9:30 - 10:00 BREAK

14. Commission Meeting with the ACMUI ACMUI The ACMUI will brief the Commission on various topics in a public meeting.

10:00 - 12:15

15. Group Photo ACMUI The ACMUI will take a group photo with and without the Commission.

12:15 - 1:15 LUNCH

16. ACMUI Bylaws Subcommittee Report L. Weil, ACMUI Ms. Weil will discuss the subcommittees recommendations for changes to the ACMUIs Bylaws - with particular focus on the ACMUI Chairs role with respect to subcommittees.

1:15 - 2:45 17. Open Forum ACMUI The ACMUI will discuss medical topics of interest previously identified.

18. Administrative Closing K. Jamerson, NRC Ms. Jamerson will provide a meeting summary and propose dates for the fall 2019 meeting.

2:45 ADJOURN