ML23257A264
| ML23257A264 | |
| Person / Time | |
|---|---|
| Issue date: | 09/29/2023 |
| From: | Maryann Ayoade NRC/NMSS/DMSST/MSEB |
| To: | Christian Einberg Office of Nuclear Material Safety and Safeguards |
| Shared Package | |
| ML23257A262 | List: |
| References | |
| Download: ML23257A264 (7) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 MEMORANDUM TO: Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards FROM:
Maryann Ayoade, Medical Radiation Safety Team Member Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF AUGUST 29, 2023, PUBLIC MEETING ON REGULATORY BASIS FOR RULEMAKING ON RB-82 GENERATORS, EMERGING TECHNOLOGIES, AND OTHER MEDICAL USE OF BYPRODUCT MATERIAL Meeting Identifier: 20230877 Date of Meeting: Tuesday, August 29, 2023; 2:00 p.m. EDT Location: Webinar Meeting Participation Level: Information meeting with Question-and-Answer Session Meeting Notice: ML23212A385 Purpose of the Meeting: To provide an overview of and facilitate stakeholder feedback on the U.S. Nuclear Regulatory Commission (NRC) staffs regulatory basis document and questions included in the Federal Register notice (88 FR 42654) for the planned rulemaking on Rubidium-82 Generators, Emerging Medical Technologies, and Other Uses of Byproduct Material, under Title 10 of the Code of Federal Regulations (10 CFR), Part 35, Medical Uses of Byproduct Material.
Background:
On July 3, 2023, the NRC published the Federal Register notice (FRN) announcing the availability of the regulatory basis document (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23122A356), for a 120-day public comment period. The document summarizes the current regulatory framework, describes the regulatory issues and proposed changes to the regulations in 10 CFR Part 35, includes specific questions for feedback to better inform the proposed changes, and evaluates alternatives for September 29, 2023 Signed by Ayoade, Maryann on 09/29/23
C. Einberg establishing requirements for rubidium-82 generators, EMTs, and other medical uses of byproduct material. The regulatory basis also includes preliminary cost estimates for the NRC, Agreement States, and licensees for each alternative. The regulatory basis document, along with public comments received, will inform the NRC staffs development of a proposed rule to revise certain requirements in Part 35.
General Details: The NRC published the official public meeting notice on July 31, 2023, providing the agenda and webinar registration instructions for attendees (ML23212A385). The staff gave detailed presentations on the contents of the regulatory basis document and the questions included in the document and in the FRN. The staff also explained that the purpose of the meeting was not to receive comments on the regulatory basis document. The staff described how to provide comments on the document and outlined the next steps in the rulemaking process. The staffs presentations are available at ML23240A718. At designated points during the presentations, the staff provided opportunities for meeting attendees to ask questions. The meeting was attended by about 122 people, including NRC staff, medical community representatives, Agreement State representatives, and members of the public. The meeting concluded at 3:32 p.m. EDT. A list of NRC and external meeting participants is enclosed. Below is a summary of the questions and comments received, and a transcript of the meeting is available at ML23257A263.
Summary of Questions and Comments Received:
During the meeting, the NRC received the following questions or comments:
Questions about the availability and current use of GliaSite radiation therapy system, which is currently identified in the regulatory basis as an emerging medical technology;
A question about whether the NRC would maintain or change the current guidelines for germanium-68/gallium-68 breakthrough testing;
A question about the source of the statement in the regulatory basis that interventional radiologists receive only 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training to use microspheres; and
A question about whether the rulemaking will allow for decay-in-storage of radionuclides with half-lives greater than 120 days.
Next Steps: The regulatory basis comment period closes on October 31, 2023. The NRC staff will consider the comments received as we develop the proposed rule package, recognizing the delay in this rulemaking to accommodate another ongoing rulemaking to address nuclear medicine injection extravasations. The staff expects to have more dialogue with the medical community in the second half of 2024 as we prepare the proposed rule. The staff expects to submit the proposed rule package to the Commission in January 2026.
ENCLOSURE:
NRC Meeting Participants
SUMMARY
OF AUGUST 29, 2023, PUBLIC MEETING ON REGULATORY BASIS FOR PART 35 RULEMAKING ON RB-82 GENERATORS, EMERGING TECHNOLOGIES, AND OTHER MEDICAL USE OF BYPRODUCT MATERIAL DATE: XXXXXX ENCLOSURE:
NRC Meeting Participants DISTRIBUTION:
Public NMSS/MSST/MSEB ACarrera, NMSS/REFS ADAMS Accession Nos.: Package ML23257A262; Meeting Summary ML23257A264; Slides ML23240A718; Transcript ML23257A263; Meeting Notice ML23212A385
Enclosure ENCLOSURE MEETING ATTENDEES Public Meeting on the Regulatory Basis for Part 35 Rulemaking on Rb-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material August 29, 2023 U.S. Nuclear Regulatory Commission Maryann Ayoade Antonio Gomez Ken Brenneman Anita Gray Laura Cender Vincent Holahan Andrew Carrera Sarah Lopas Theresa Clark Jan Nguyen Daniel Dimarco Christine Pineda Lisa Dimmick Daniel Shaw Christian Einberg Jill Shepherd Robin Elliott Sarah Spence Linda Eusebio Katie Tapp Monica Ford Elizabeth Tindle-Engelmann Farrah Gaskins Celimar Valentin Rodriguez Public Name Affiliation (if provided)
Logan Allen Mouaz Al-mallah Janell D. Anderson Kristin Anson Julia Bellinger James Blacker Michael Boutwell Jared Brokke Emily A Brower Judi Buckalew Molly E Buffington Janet Bryant Ashley Cockerham Willie M. Crawford Corey Creveling David Crowley Cathy S. Cutler Karen M. Deibert Christine Dobert Nick Dorrell Cheri Douglas Stephen C. Dragotakes Michele Egberts Adam Ekstedt Bassem A. Elshahat Brian S. Fairchild Teresa Fisher National Institutes of Health Mary C Furan S. Gabriel Tianliang Gu Andrew Halloran Kaylie Hammersborg Defense Health Agency Stanley D Hampton Barbara Hamrick Megan Harkins Ahmad Hatami Matt Hendrickson Oregon Department of Energy Kathleen Hintenlang Andrew Holcomb Lauren James Friederike Keating Brian M Kelley Nathaniel A Kishbasugh Sue Kurgatt Florentina Kurti Ian P. Lake Olusegun Akano Larinde Jerry Lee Ramon Li Ralph Lieto David Luechtefeld Melissa Martin Undria McCallum Candi McDowell Kasey McGinty Lawrence McKenzie Josh McIlvain Tara Medich Douglas L. Miller Emine Ocak Akin Ogretici Jonathan J. Otten Reiko Oyama Ron Parsons John Pavlica Texas Department of State Health Services Lawrence Phillips Ronald Raunikar Gloria Romanelli Emily C Rostel Daniel J Samson Tim Sanchez Amber L. Schmidt Kansas Department of Health and Environment Todd Senglaub Roger C Sit Dr. Smith Defense Health Agency Jill Southerland Kansas Department of Health and Environment David W. Stradinger Kaci Studer Cindy Tomlinson Paul Wallner Kara Duncan Weatherman Karen Wheeler Steven Whitesides Melonie Wissing Aaron Short Kansas Department of Health and Environment Jimmy Uhlemeyer Michael Welling Carol Wen Brandi Woods Note: The attendance list is based on the Microsoft Teams attendance report. This list does not include individuals who called in and individuals who did not provide their last name when signing into the meeting.
ML23257A262; ML23257A264 OFFICE NMSS/MSST/MSEB
/MRST NMSS/REFS/MRPB NMSS/MSST/MSEB NMSS/MSST/MSEB
/MRST NAME MAyoade JShepherd CEinberg MAyoade DATE Sep 22, 2023 Sep 25, 2023 Sep 28, 2023 Sep 29, 2023