ML18288A691
| ML18288A691 | |
| Person / Time | |
|---|---|
| Issue date: | 09/20/2018 |
| From: | Dapas M Office of Nuclear Material Safety and Safeguards |
| To: | |
| Dimmick L | |
| References | |
| Download: ML18288A691 (7) | |
Text
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 20-21, 2018 MEETING
SUMMARY
PURPOSE To discuss issues related to 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 endorsed the report of the Subcommittee on the Nursing Mother Guidelines for the Medical Administration of Radioactive Materials with added language that this document reflects the FDA approved radiopharmaceuticals on the market at this time and that licensees are obligated to carefully evaluate radiopharmaceuticals that are not encompassed in this report to keep exposures ALARA to patients, staff, and members of the public. The recommendation passed unanimously with thirteen votes.
The Committee endorsed the Leksell Gamma Knife PerfexionTM and Leksell Gamma Knife IconTM Licensing Guidance Subcommittee Report. The recommendation passed unanimously with thirteen votes.
The NRC staff will provide the Committee with a copy of the Briefing on Results of the Agency Action Review Meeting presentation slides on Yttrium-90 microspheres; SECY-18-0048, Annual Report to the Commission on Licensee Performance in the Nuclear Materials and Waste Safety Program Fiscal Year 2017, which includes a discussion on medical events involving Yttrium-90 microsphere brachytherapy; and the Strategic Programmatic Overview of the Fuel Facilities and Nuclear Materials Users Business Lines Commission meeting slides related to Yttrium-90.
2 Dr. Palestro amended the membership of the Training and Experience for All Modalities Subcommittee. Subcommittee membership now includes Dr. Metter (chair), Dr. Ennis, Dr.
Schleipman, Ms. Weil, Ms. Shober, and Mr. Sheetz. The NRC staff resource continues to be Ms. Maryann Ayoade.
Dr. Palestro formed a subcommittee to review the Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance. Subcommittee membership includes Ms. Shober (chair), Dr.
Metter, Mr. Sheetz, and Ms. Martin. The NRC staff resource is Dr. Said Daibes.
Dr. Palestro formed a subcommittee to review the revisions to Regulatory Guide 8.39, Release of Patients Administered Radioactive Material. Subcommittee membership includes Mr.
Sheetz (chair), Ms. Shober, Dr. Dilsizian, Dr. Schleipman, Ms. Martin, and Ms. Weil. The NRC staff resource is Dr. Said Daibes.
Dr. Palestro formed a subcommittee to review the Yttrium-90 Microspheres Brachytherapy Sources and Devices TheraSphere and SIR_Spheres Licensing Guidance. Subcommittee membership includes Dr. OHara (chair), Dr. Dilsizian, Mr. Ouhib, Ms. Marin, Dr. Metter, and Dr.
Schleipman. The NRC staff resource is Dr. Katie Tapp.
Dr. Palestro formed a subcommittee to review and update the ACMUI Bylaws as needed, including a review of the role of the ACMUI Chair and his or her participation on subcommittees.
Subcommittee membership includes Ms. Weil (chair), Dr. Schleipman, Ms. Shober, and Mr.
Sheetz. The NRC staff resource is Ms. Sophie Holiday.
Dr. Palestro formed a subcommittee to review the appropriateness of the required elements of medical event reporting, the adherence to these requirements, and recommend actions to improve reporting. Subcommittee membership includes Dr. Ennis (chair), Ms. Weil, Ms. Martin, Mr. Ouhib, Dr. Dilsizian, and Ms. Shober. The NRC staff resource is Ms. Lisa Dimmick.
The Committee recommended for the NRC to draft an Information Notice on the best practices that could help prevent medical events.
The Committee requested a list of all the current ACMUI members, their contact information, information regarding each members term, and the subcommittee(s) they serve on. The Committee also requested that the NRC staff create a web page that lists the active subcommittees and subcommittees that have been sunset, their members with term expiration, NRC staff resource, and the specific charge of the subcommittee.
The Committee tentatively scheduled the spring 2019 meeting for April 15-16, 2019. The alternate meeting dates are April 3-4, 2019, subject to Commission availability.
Enclosures:
- 1. Meeting Attendees
- 2. Meeting Agenda
MEETING ATTENDEES ACMUI Vasken Dilsizian, M.D. Member Ronald D. Ennis, M.D. Member Richard L. Green Member Melissa Martin Member Darlene F. Metter, M.D. Vice Chairman Michael D. OHara, Ph.D. Member Zoubir Ouhib Member Christopher J. Palestro, M.D. Chairman A. Robert Schleipman, M.D. Member Michael Sheetz Member Megan L. Shober Member John H. Suh, M.D. Member Laura M. Weil Member NRC Marc Dapas Director, Office of Nuclear Material Safety and Safeguards (NMSS)
Sabrina Atack Acting Deputy Director, Division of Materials Safety, State, and Tribal Programs (MSST)
Douglas Bollock Chief, Medical Safety and Events Assessment Branch and Designated Federal Officer Lisa Dimmick Medical Radiation Safety Team Leader and Alternate Designated Federal Officer Maryann Ayoade NMSS/MSST Russell Chazell Office of the Secretary Said Daibes, Ph.D. NMSS/MSST Christian Einberg NMSS/MSST Vincent Holahan, Ph.D. NMSS/MSST Sophie Holiday Office of Enforcement Esther Houseman Office of the General Counsel (OGC)
Donna-Beth Howe, Ph.D. NMSS/MSST Ian Irvin OGC Janelle Jessie Office of Commissioner Jeff Baran Kathy Modes NMSS/MSST Katie Tapp, Ph.D. NMSS/MSST Irene Wu NMSS/MSST MEMBERS OF THE PUBLIC Philip O. Alderson, M.D. Unaffiliated Bette Blankenship American Association of Physicists in Medicine (AAPM)
Ashley Cockerham Sirtex Medical Limited Munir Ghesani, M.D. Society for Nuclear Medicine & Molecular Imaging (SNMMI)
Enclosure 1
2 Michael Guastella Council on Radionuclides and Radiopharmaceuticals (CORAR)
Caitlin Kubler SNMMI Akio Hori Japan Nuclear Regulation Authority Susan Lohman Elekta Richard Martin AAPM Michael Peters American College of Radiology (ACR)
Aria Razmaria, M.D. SNMMI Glora Romanelli ACR Daichi Saito Japan Nuclear Regulation Authority Cindy Tomlinson American Society for Radiation Oncology (ASTRO)
MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 20-21, 2018 One White Flint North Building (Commission Hearing Room), Rockville, Maryland 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.
Thursday, September 20, 2018 CLOSED SESSION
- Badging and Enrollment PERSEC, NRC 7:30 - 10:30
- INFOSEC Training R. Norman, NRC
- Ethics Training J. Suttenberg & J. Ezell, NRC
- Allegations Training D. Willis, NRC 10:30 - 11:00 BREAK OPEN SESSION
- Opening Remarks D. Bollock & S. Atack, NRC Mr. Bollock will formally open the meeting and Ms. Atack will provide opening comments.
11:00 - 11:45
- Old Business L. Dimmick, NRC Ms. Dimmick will review past ACMUI recommendations and provide NRC responses.
11:45 - 12:45 LUNCH
- Medical Events Subcommittee Report R. Ennis, ACMUI Dr. Ennis will present the subcommittees analysis of medical events for fiscal year 2017.
- Non-Medical Events M. Sheetz, ACMUI 12:45 - 2:30 Mr. Sheetz will did non-medical events reported by medical use facilities and commercial pharmacies.
- ABS Medical Event Case Study Program Z. Ouhib, ACMUI Mr. Ouhib will discuss the American Brachytherapy Societys effort to reach out to the brachytherapy community for creative corrective actions regarding events that have taken place.
2:30 - 2:45 BREAK Enclosure 2
2
- T&E for All Modalities Subcommittee Update D. Metter, ACMUI Dr. Metter will provide an update on the actions of the training and experience for all modalities subcommittee and the planned path forward.
- T&E Stakeholder Outreach Plan M. Ayoade, NRC Ms. Ayoade will present the staffs outreach plan for the continued evaluation of training and experience.
- ACMUI-SNMMI Session at the 2018 SNMMI Annual C. Palestro, ACMUI 2:45 - 5:00 Meeting Dr. Palestro will provide an overview of the topics discussed by ACMUI at the 2018 SNNMI meeting in Philadelphia, PA.
- Nursing Mother Guidelines Subcommittee Report D. Metter, ACMUI Dr. Metter will discuss the subcommittees final report on the nursing mother guidelines for exposure from diagnostic and therapeutic radiopharmaceuticals.
- ACMUI Comments on the Draft Revision of the J. Suh, ACMUI Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' Licensing Guidance Dr. Suh will discuss the subcommittees comments on the draft revision of the Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' licensing guidance.
Friday, September 21, 2018 OPEN SESSION
- Special Presentation to Dr. Suh M. Dapas, NRC Mr. Dapas will make a special presentation to Dr. Suh.
- Dr. Suhs Thoughts on Leaving ACMUI J. Suh, ACMUI Dr. Suh will share his thoughts on leaving the ACMUI.
- Special Presentation to Dr. Alderson M. Dapas, NRC 8:30 - 10:15 Mr. Dapas will make a presentation to Dr. Alderson.
- Dr. Aldersons Thoughts on Leaving ACMUI P. Alderson, ACMUI Dr. Alderson will share his thoughts on leaving the ACMUI.
- Y-90 Microspheres Brachytherapy Licensing K. Tapp, NRC Guidance Dr. Tapp will discuss the current status of the yttrium-90 working groups revised guidance and planned actions.
10:15 - 10:45 BREAK 10:45 - 11:15
- Compounding of Sterile and Non-Sterile R. Green, ACMUI Radiopharmaceuticals Mr. Green will discuss the establishment of an Expert Panel by USP to develop USP Standards of sterile and non-sterile radiopharmaceutical preparation.
3
- Medical Team Highlights L. Dimmick, NRC Ms. Dimmick will recap the work of the Medical Radiation Safety Team for fiscal year 2018.
11:15 - 12:00
12:00 - 1:00 LUNCH
- ACMUI, Subcommittees, NRC staff, NRC R. Chazell & D. Bollock, NRC management: How the Team Works Under FACA Mr. Chazell and Mr. Bollock will discuss the roles and responsibilities of each under the Federal Advisory Committee Act (FACA).
1:00 - 3:00
- ACMUI Subcommittees, Subcommittee Membership, C. Palestro, ACMUI and the ACMUI Chair Dr. Palestro will discuss the possible need for ACMUI bylaw changes and the need to update subcommittee membership, form new subcommittees and sunset other subcommittees.
- Administrative Closing L. Dimmick, NRC Ms. Dimmick will provide a meeting summary and propose dates for the spring 2019 meeting.
3:00 ADJOURN