ML22019A068
| ML22019A068 | |
| Person / Time | |
|---|---|
| Issue date: | 01/21/2022 |
| From: | Don Lowman NRC/NMSS/DMSST/MSEB |
| To: | |
| D. Lowman, NMSS/MSST/MSEB | |
| References | |
| Download: ML22019A068 (4) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
December 15, 2021
MEETING
SUMMARY
PURPOSE
To discuss (1) the Subcommittee on Alpha Dart s review and com ment on the U.S Nuclear Regulatory Commission (NRC) staffs draft Alpha Tau Alpha DaRT' Manual Brachytherapy licensing guidance; (2) the Subcommittee on CivaDerms review a nd comment on the NRC staffs memorandum, Draft Licensing Guidance for Superficial M anual Brachytherapy CivaDerm Device; and (3) the Subcommittee on Regulatory Guide 8.39s review and comment on the NRC staffs proposed revision 2 of Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.
OUTCOME
The Advisory Committee on the Medical Uses of Isotopes (ACMUI) subcommittees provided feedback and recommendations on the three documents developed b y the NRC staff: draft Alpha Tau Alpha DaRT' Manual Brachytherapy licensing guidance; NRC staffs memorandum, Draft Licensing Guidance for Superficial Manual Brachytherapy CivaDerm Device; and the proposed revision 2 of Regulatory Guide 8.39, Release of Patie nts Administered Radioactive Material. The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the ACMUIs comments an d recommendations prior to finalizing the three documents.
Full transcripts and handouts from the ACMUI meeting can be fou nd on the NRCs ACMUI Meetings and Related Documents webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2021.html
SUMMARY
AND RECOMMENDATIONS
Subcommittee on Alpha Dart
Members: Dr. Ronald Ennis (chair), Dr. H ossein Jadvar, Dr. Michael OHa ra, Ms. Megan Shober, Ms. Becky Allen, Mr. Zoubi r Ouhib, Dr. Katherine Tapp ( NRC Staff Resource)
The Alpha Dart Subcommittee provided an overview and recommenda tions on the NRC staffs Alpha Tau Alpha DaRT' Manual Brachytherapy licensing guidance. The Subcommittee discussed licensing of Alpha DaRT' under 10 CFR 35.1000, roles of the authorized medical physicist and nuclear pharmacist, source leakage and integrity, contamination of procedure room, patient release, definition of medical event, and documen tation of patient location.
The subcommittee report was unani mously approved by the ACMUI. The final report can be accessed at the ADAMS Accession No. ML22021B298.
Subcommittee on Regulatory Guide 8.39, Revision 2 (CivaDerm)
Members: Megan Shober (Chair), Dr. Vasken Dilsizian, Dr. Hossein Jadvar, Josh Mailman, Melissa Martin, Michael Sheetz (Consultant), Dr. Katherine Tapp (NRC Staff Resource)
The Subcommittee provided an overview and its recommendations o n the NRC staffs memorandum, Draft Licensing Guidance for Superficial Manual Br achytherapy CivaDerm Device. The Subcommittee recommended that CivaDerm should be licensed under 10 CFR 35.400 and recommended that the NRC staff develop a shorter gui dance document that focuses on the consequences of loose or dislodged sources. Add itionally, the Subcommittee believes it is unlikely that public dose limits will be exceede d if the Palladium-103 source is dislodged.
The subcommittee report was unani mously approved by the ACMUI. The final report can be accessed at the ADAMS Accession No. ML22021B299.
Subcommittee on Regulatory Guide 8.39, Revision 2
Members: Megan Shober (Chair), Dr. Vasken Dilsizian, Dr. Hossein Jadvar, Josh Mailman, Melissa Martin, Michael Sheetz (Consultant), Dr. Katherine Tapp (NRC Staff Resource)
The Subcommittee provided an overview and its recommendations o n the NRC staffs proposed revision 2 to RG 8.39, Release of Patients Administered Radioa ctive Materials. In Revision 2, the staff updated the dosimetric equations/methodologies used t o calculate public dose from the released patient. Additionally, the staff made changes to the patient instructions and recommends analysis of public exposures from patient body crema tion. The Subcommittee made six recommendations and provided specific comments on the NRC staffs draft RG 8.39.
The recommendations were related to the patient instructions, o ccupancy factors, hold times, and calculation methodologies.
The subcommittee report was unani mously approved by the ACMUI. The final report can be accessed at the ADAMS Accession No. ML22021B300.
The final reports can be viewed, in their entirety, on the NRC s ACMUI Subcommittee Reports webpage, located at: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda MEETING PARTICIPANTS ACMUI
Darlene F. Metter, M.D. Chairman Vasken Dilsizian, M.D. Vice Chairman Rebecca Allen Member Ronald D. Ennis, M.D. Member Richard Green Member Hossein Jadvar, M.D. Member Josh Mailman Member Melissa Martin Member Michael D. OHara, Ph.D. Member Megan Shober Member Harvey B. Wolkov, M.D. Member
NRC STAFF Chris Einberg Chief, Medical Safety and Events Assessment Branch (MSEB) and Designated Federal Officer Maryann Ayoade NMSS/MSST/MSEB Angela Coggins OGC/LHE/MFW Daniel Dimarco NMSS/MSST/MSEB Robin Elliott RI/DRSS/MLB Cindy Flannery NMSS/MSST/MSEB Vincent Holahan NMSS/MSST Donna-Beth Howe, Ph.D. NMSS/MSST/MSEB Ian Irvin OGC/GCRPS/RMR Harriet Karagiannis RES/DE/RGPMB Erin Kennedy RIII/DNMS/MLB Penny Lanzisera RI/DRSS/MLAB Sarah Lopas NMSS/MSST/MSEB Don Lowman NMSS/MSST/MSEB Joan Olmstead OGC/LRAA/RASFP Vered Shaffer RES/DSA/RPB Michael Sheetz ACMUI Consultant Katherine Tapp, Ph.D. NMSS/MSST/MSEB Elizabeth Tindle-Engelman RIII/DNMS/MIB John Tomon RES/DSA/RPB Celimar Valentin-Rodriguez, Ph.D. NMSS/MSST Kevin Williams NMSS/MSST
MEMBERS OF THE PUBLIC Matthew Williamson Ralph Lieto Peter Crane Dr. Michael Schuster Jeffrey Brunette Steven Frank - MD Anderson Cancer Center, Houston Dr. Lisa Aldape - Seattle Childrens Hospital Dr. Firas Mourtada - Christian Care, Newark, DE Mike Welling - University of Virginia
Enclosure 1 TELECONFERENCE MEETING AGENDA Advisory Committee on The Medical Uses Of Isotopes
December 15, 2021 2:00 PM - 4:00 PM EST
OPEN SESSION
- 1. Opening Statements C. Einberg, NRC Mr. Chris Einberg will formally open the meeting.
- 2. Alpha Dart Licensing Guidance R. Ennis, M.D.,
Dr. Ronald Ennis will present the ACMUI Subcommittee on Alpha ACMUI Dart draft report on the NRC staffs draft licensing guidance.
- 3. CivaDerm M. Shober, ACMUI Ms. Megan Shober will present the ACMUI Subcommittee on Civaderm draft report on the NRC staffs additional considerations memo for CivaDerm.
- 4. Revision to Regulatory Guide 8.39 M. Shober, ACMUI Ms. Megan Shober will present the ACMUI Subcommittee on Regulatory Guide 8.39, Release of Patients Administered Radioactive Material draft report on the NRC staffs draft revision of the regulatory guide.
- 5. Closing and Adjournment D. Metter, M.D.,
Dr. Darlene Metter will close the meeting. ACMUI
Enclosure 2