| Subcommittee Name |
Subcommittee
Charge |
Subcommittee Members |
Status |
| Akesis Galaxy RTi |
To review and comment on the U.S. Nuclear Regulatory Commission (NRC) staff’s draft Akesis Galaxy® RTi Licensing Guidance. |
Rebecca Allen
Richard Harvey PhD
Zoubir Ouhib, MS
Megan Shober, MS
Harvey Wolkov, MD (Chair)
NRC Staff Resource: Daniel Shaw |
Subcommittee was established on 12/08/23
Final Report submitted on 04/15/24
Draft Report Submitted on
03/06/24 |
| Emerging Medical Technologies/Rubidium-82 Generator Rulemaking Subcommittee |
To review and comment on the staff’s regulatory basis for the Emerging Medical Technologies/Rubidium-82 Generator rulemaking. |
Ms. Megan Shober (chair)
Dr. Ronald Ennis
Dr. Harvey Wolkov
Dr. Richard Harvey
Dr. Hossein Jadvar
Non-voting subcommittee consultant: Dr. John F. Angle
NRC staff resource: Ms. Maryann Ayoade
|
Subcommittee established 08/18/22
Final Report Submitted 12/19/22
Draft Report Submitted 11/18/2022
|
| Y-90 Medical Event Subcommittee |
To evaluate the issue of Y-90 microspheres medical events in more depth and, in consultation with vendors, propose methods to decrease the number of Y-90 microsphere-related medical events. |
Dr. Vasken Dilsizian
Dr. John F. Angle,
Dr. Michael O’Hara (chair)
Ms. Megan Shober
Mr. Josh Mailman
Ms. Melissa Martin
Non-voting subcommittee consultant: Dr. John F. Angle
NRC staff resource: Dr. Katie Tapp |
Subcommittee established 10/04/21
Final Report Submitted 12/19/22
Draft Report Submitted 11/18/2022
|
| Liberty Vision Subcommittee |
To review the Liberty Vision
technology and comment on the NRC staff’s draft Liberty Vision Y-90 Eye Brachytherapy Source Licensing Guidance. |
Mr. Zoubir Ouhib (chair)
Dr. Harvey Wolkov
Ms. Megan Shober
Dr. Michael O’Hara
Ms. Rebecca Allen
NRC staff resource: Ms. Maryann Ayoade |
Subcommittee established 10/04/21 |
| Alpha Dart Subcommittee |
To review the Alpha Dart
technology and comment on the NRC staff’s draft Alpha Dart Licensing Guidance. |
Dr. Ronald Ennis (chair)
Dr. Hossein Jadvar
Dr. Michael O’Hara
Ms. Megan Shober
Ms. Becky Allen
Mr. Zoubir Ouhib
NRC staff resource: Dr. Katie Tapp |
Subcommittee established May 2021
Final Report Submitted 1/21/22
Draft Report Submitted 11/29/21 |
| Subcommittee on Medical Events |
To annually review the medical events (MEs) with an eye to
advising the ACMUI and NRC about emerging trends needing regulatory attention. |
Mr. Richard Green
Dr. Ronald D. Ennis (Chair)
Dr. Darlene F. Metter
Mr. Zoubir Ouhib
Mr. Michael Sheetz
Dr. Harvey Wolkov
NRC staff resource: Daniel Dimarco |
Subcommittee established 03/19/15
Final Report Submitted 10/14/21
Draft Report Submitted 10/04/21 |
| Subcommittee on Emerging Radiopharmaceutical Therapy Knowledge Requirements in Theranostics |
To outline the knowledge and specific or specialized practice or policy requirements needed for the safe use and handling of emerging radiopharmaceuticals in theranostics. |
Dr. Vasken Dilsizian
Dr. Ronald Ennis
Dr. Hossein Jadvar (Chair)
Mr. Josh Mailman
Dr. Michael O’Hara
Mr Zoubir Ouhib
NRC staff resource: Ms. Maryann Ayoade |
Subcommittee established May 2021
Final Report Submitted 10/14/21
Draft Report Submitted 9/20/21 |
Subcommittee on Radionuclide Generator
Knowledge and Practice Requirements |
- To review and evaluate the knowledge and practice requirements for eluting, measuring and testing, and processing the eluate from radionuclide generator systems based on the evolution of radionuclide generator distribution.
- To evaluate and determine the appropriateness of the requirements and how best to obtain the required knowledge and practice.
- To evaluate whether and how additional knowledge and practice should be obtained as necessary to supervise the use of any radionuclide generator system.
|
Dr. Vasken Dilsizian
Mr. Richard Green (Chair)
Ms. Melissa Martin
Ms. Megan Shober
Dr. Harvey Wolkov
NRC staff resource: Ms. Maryann Ayoade |
Subcommittee established May 2021
Final Report Submitted 10/14/2021
Draft Report Submitted 9/8/21 |
| Subcommittee on Regulatory Guide 8.39, “Release of Patients Administered Radioactive Material” |
To review the revisions to Regulatory Guide 8.39, “Release of Patients Administered Radioactive Material”
*Charge expanded 10/4/2021
Review the CivaDerm technology and comment on the NRC staff’s draft CivaDerm additional licensing considerations memo. |
*Membership Amended 10/28/2021:
Dr. Hossein Jadvar
Dr. Vasken Dilsizian
Ms. Melissa Martin
Ms. Megan Shober (Chair)
Mr. Josh Mailman
Non-voting subcommittee consultant: Mr. Michael Sheetz
NRC staff resource: Dr. Katie Tapp |
Subcommittee established 09/21/18
CivaDerm Final Report submitted 01/21/22
CivaDerm Draft Report Submitted 12/01/21
Phase 2 Final Report Submitted 01/21/22
Phase 2 Draft Report Submitted 12/01/21
Phase 1 Final Report Submitted 06/19/19
Phase 1 Draft Report Submitted 05/23/19 |
| Subcommittee on Extravasation |
To review the U.S. Nuclear Regulatory Commission (NRC) staff’s Memorandum “Preliminary Evaluation of Radiopharmaceutical Extravasation and Medical Event Reporting” dated April 1, 2021 and provide feedback and recommendations. |
Vasken Dilsizian
Richard Green
Melissa Martin (Chair)
Michael Sheetz
Megan Shober
NRC staff resource: Ms. Lisa Dimmick |
Subcommittee established on 04/03/19
Final Report Submitted 09/16/2021
Draft Report Submitted 07/30/2021 |
| Abnormal Occurrence Subcommittee |
- To define patient harm in abnormal occurrence (AO)
- To reassess the current AO criteria
- To define the goals of AO criteria reporting
- To determine if AO criteria is adequate for public health and safety
|
*Membership amended
Chair (TBD)
Dr. Ronald Ennis
Dr. Hossein Jadvar
Ms. Megan Shober
Mr. Zoubir Ouhib
NRC staff resource: Dr. Katie Tapp |
Subcommittee established 03/30/20
Final Report Submitted 9/16/21
Draft Report Submitted 7/30/21 |
| ACMUI COVID-19 Subcommittee |
To review the impacts of COVID-19 on the medical community and provide recommendations for any regulatory relief measures in the areas of nuclear medicine and radiation oncology during the COVID-19 pandemic. |
Dr. Vasken Dilsizian
Mr. Richard Green
Dr. Hossein Jadvar (chair)
Ms. Melissa Martin
Ms. Megan Shober
Dr. Harvey Wolkov
Non-voting subcommittee consultants: Mr. Gary Bloom and Mr. Zoubir Ouhib
NRC staff resource: Ms. Lisa Dimmick |
Subcommittee established 3/30/20
Final Report Submitted 5/4/20
Draft Report Submitted 4/27/20 |
|
Interventional Radiologist Subcommittee
|
To investigate the need for an interventional radiologist (IR) on the ACMUI, including whether an IR should be a non-voting consultant or full ACMUI member.
|
Dr. Vasken Dilsizian
Dr. Ronald Ennis
Dr. Hossein Jadvar
Dr. Darlene Metter
Ms. Megan Shober (chair)
NRC staff resource: Dr. Katie Tapp
|
Subcommittee established 9/11/19
Final Report Submitted 4/6/20
Draft Report Submitted 2/25/20
|
|
ACMUI Bylaws (2019)
|
*Charge Amended 9/11/19:
To determine (1) Should there be term limits for the ACMUI Chair and Vice Chair? If so, how long? and (2) Should the ACMUI Vice Chair automatically become the ACMUI Chair?
|
*Membership Amended 9/11/19:
Mr. Michael Sheetz
Ms. Megan Shober
Dr. Harvey Wolkov (chair)
NRC staff resource amended 9/11/19: Ms. Kellee Jamerson
|
Subcommittee established 9/21/18
Final Report Submitted 4/6/20
Draft Report Submitted 3/2/20
|
|
Patient Intervention Subcommittee
(re-established)
|
To evaluate the definition of patient intervention and other actions and circumstances that are exclusive of medical events.
|
Dr. Vasken Dilsizian
Dr. Ronald Ennis
Mr. Michael Sheetz (chair)
Mr. Gary Bloom
NRC staff resource: Ms. Maryann Ayoade
|
Subcommittee established 9/11/19
Final Report Submitted 4/6/20
Draft Report Submitted 3/5/20
|
|
Training and Experience Requirements for All Modalities Subcommittee
|
To review and evaluate the training and experience requirements for all modalities in 10 CFR Part 35.
*Charge Expanded 8/6/19:
To review and comment on the staff's draft evaluation of training and experience requirements for radiopharmaceuticals requiring a written directive.
|
*Membership Amended 9/10/2019:
Dr. Ronald Ennis
Dr. Darlene Metter
Dr. A. Robert Schleipman (chair)
Mr. Michael Sheetz
Ms. Megan Shober
NRC staff resource: Ms. Maryann Ayoade
|
Subcommittee established 2/25/16
Draft Report (Staff evaluation) Submitted 10/6/19
Final Report (Staff evaluation) Submitted 10/23/19
|
| Xcision® GammaPod™ Licensing Guidance Subcommittee |
To review the draft Xcision® GammaPod™ Licensing Guidance |
Mr. Zoubir Ouhib
Mr. Mike Sheetz
Ms. Megan Shober
Dr. Harvey Wolkov (chair)
NRC staff resource: Dr. Katie Tapp |
Subcommittee established 5/16/19
Final Report Submitted 10/23/19
|
|
ACMUI Medical Events Subcommittee
|
To review the Medical Events reported in the prior FY and provide any comments or recommendations for action
|
*Membership Amended 7/18/19:
Dr. Ronald Ennis (Chair)
Mr. Richard Green
Dr. Darlene Metter
Mr. Michael Sheetz
Dr. Harvey Wolkov
NRC staff resource: Dr. Donna-Beth Howe
|
Subcommittee established 3/19/15
Final FY18 Report Submitted 10/23/19
|
| ACMUI Institutional Memory Subcommittee |
To improve the ACMUI's institutional memory and provide possible recommendations for methods of tracking and/or retrieving ACMUI documents. |
Dr. Ronald Ennis
Dr. Michael O’Hara
Dr. A. Robert Schleipman (chair)
Ms. Megan Shober
Ms. Laura Weil
NRC staff resource: Ms. Kellee Jamerson |
Subcommittee
established
4/03/19
Final Report Submitted 10/23/19
|
| Infiltrations and Medical Event Reporting Subcommittee |
To review the NRC's 1980 determination related to infiltrations and medical event reporting [45 FR 31703]. |
Dr. Vasken Dilsizian
Mr. Richard Green
Ms. Melissa Martin (chair)
Mr. Michael Sheetz
Ms. Megan Shober
Ms. Laura Weil
NRC staff resource: Ms. Maryann Ayoade
|
Subcommittee
established
4/03/19
Final Report Submitted 10/23/19
|
| Training and Experience Requirements for All Modalities Subcommittee |
To review and evaluate the training and experience requirements for all modalities in 10 CFR Part 35. |
Membership Amended 9/20/2018:
Dr. Ronald Ennis
Dr. Darlene Metter (chair)
Dr. A. Robert Schleipman
Mr. Michael Sheetz
Ms. Megan Shober
Ms. Laura Weil
NRC staff resource:
Ms. Maryann Ayoade
|
Subcommittee
established
2/25/16
Final Report (35.390)
Submitted 2/27/19
Interim Report Submitted 2/19/18
Status Report (35.190)
Submitted 4/26/17
Status Report
Submitted 9/16/17 |
| Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance, Revision 1 |
To review and provide comments on the the Draft Revision 1 to the Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance |
Ms. Melissa Martin
Dr. Darlene Metter
Mr. Michael Sheetz
Ms. Megan Shober (chair)
NRC staff resource:
Dr. Said Daibes
|
Subcommittee
established
9/21/18
Draft Report
Submitted 11/30/2018
Final Report
Submitted 5/06/19
|
| Regulatory Guide 8.39, "Release of Patients Administered Radioactive Material" |
Review the revisions to Regulatory Guide 8.39, "Release of Patients Administered Radioactive Material"
*Note: Regulatory Guide 8.39 is being revised in two phases. Phase 1 updates the patient release guidance, including information for patient instructions and updates to Table 3. Phase 2 will include updates to the dosimetric equations, methodologies, and tables used to calculate dose to members of the public from released patients. |
Dr. Vasken Dilsizian
Ms. Melissa Martin
Dr. A. Robert Schleipman
Mr. Michael Sheetz (chair)
Ms. Megan Shober
Ms. Laura Weil
NRC staff resource:
Dr. Said Daibes
|
Subcommittee
established
9/21/18
Phase 1 Draft Report
Submitted 5/23/19
Phase 1 Final Report
Submitted 6/19/19
|
| Yttrium-90 Microspheres Brachytherapy Sources and Devices TheraSphere® and SIR_Spheres ® Licensing Guidance, Rev. 10 |
To review the draft Revision 10 of the Yttrium-90 Microspheres Brachytherapy Sources and Devices TheraSphere® and SIR_Spheres ® Licensing Guidance |
Dr. Vasken Dilsizian
Ms. Melissa Martin
Dr. Darlene Metter
Dr. Michael O'Hara (chair)
Mr. Zoubir Ouhib
Dr. A. Robert Schleipman
NRC staff resource:
Dr. Katie Tapp
|
Subcommittee
established
9/21/18
Draft Report
Submitted 3/11/19
Final Report
Submitted 5/9/19
|
| ACMUI Bylaws (2019) |
To review and update the ACMUI Bylaws, as needed, including a review of the role of the ACMUI Chair and his/her participation on subcommittees |
Dr. A. Robert Schleipman
Mr. Michael Sheetz
Ms. Megan Shober
Ms. Laura Weil (chair)
NRC staff resource:
Ms. Sophie Holiday
|
Subcommittee
established
9/21/18
Draft Report
Submitted 3/7/19
Final Report
Submitted 4/10/19
|
| Appropriateness of Medical Event Reporting Subcommittee |
To review the appropriateness of the required elements of medical event reporting, the adherence to these requirements, and the recommended actions to improve reporting |
Dr. Vasken Dilsizian
Dr. Ronald Ennis (chair)
Ms. Melissa Martin
Mr. Zoubir Ouhib
Ms. Megan Shober
Ms. Laura Weil
NRC staff resource:
Ms. Lisa Dimmick
|
Subcommittee
established
9/20/18
Final Report Submitted 10/23/19
Interim Report
Submitted 3/25/19
|
| Nursing Mother Guidelines Subcommittee |
To review the radiation exposure from diagnostic and therapeutic radiopharmaceuticals including brachytherapy to the nursing mother and child |
Dr. Vasken Dilsizian
Dr. Darlene Metter (chair)
Dr. Christopher Palestro
Dr. Pat Zanzonico
NRC staff resource:
Dr. Said Daibes |
Subcommittee
established 4/26/17
Draft Report
Submitted 2/01/18
Final Report
Submitted 6/26/18
Final Report,
Table Revised
Submitted 1/31/19
|
| Physical Presence Requirements for the Leksell Gamma Knife® Icon ™ Subcommittee |
To propose the appropriate physical presence requirements for the Leksell Gamma Knife® Icon ™ radiosurgery unit
Charge Expanded 7/01/18:
To review the draft revision of the Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon Licensing Guidance
|
Dr. Ronald Ennis
Dr. John Suh (chair)
Ms. Laura Weil
Membership Amended 7/1/18 to add: Ms. Megan Shober and Mr. Zoubir Ouhib
NRC staff resource:
Ms. Sophie Holiday
|
Subcommittee
established
4/26/17
Draft Report
Submitted 8/31/18
(for comments on draft licensing guidance)
Final Report
Submitted 2/27/18
(for original charge)
|
| Medical Event Report and Impact on Safety Culture Subcommittee |
The charge of the subcommittee is to:
- explore the impact of ME reporting and its impact on self-reporting (safety culture);
- identify potential ways to improve effectiveness of self-reporting in support of a culture of safety; and
- suggest ways to share ME reports and lessons-learned with the medical community to promote safety
|
Mr. Frank Costello
Dr. Vasken Dilsizian
Dr. Ronald Ennis
Dr. Sue Langhorst (chair)
Ms. Laura Weil
Mr. Zoubir Ouhib will serve as a consultant to the subcommittee
NRC staff resource: Dr. Katie Tapp
|
Subcommittee
established
3/18/16
Final Report
Submitted on 9/11/17
|
|
Patient Intervention Subcommittee
(Re-established)
|
The new charge was to clarify Issue II (passive vs. active patient intervention) from the 10/8/15 ACMUI presentation on "Unintentional Treatment Outcome" |
Mr. Frank Costello
Dr. Vasken Dilsizian (chair)
Dr. Ronald Ennis
Dr. John Suh
Ms. Laura Weil
NRC staff resource:
Ms. Maryann Ayoade
|
Subcommittee
re-established
10/6/16
Draft Report
Submitted 4/27/17
Final Report was incorporated as an addendum to the Medical Event Reporting and Impact on Medical Licensee Patient Safety Culture Final Report
on 9/11/17.
Subcommittee
deactivated
9/11/17
|
Yttrium‐90 Microsphere Brachytherapy Sources and Devices TheraSpheres
and SIR‐Spheres Licensing Guidance |
To provide comments on the following:
- the removal of the AU manufacturer training Pathway 2
- update the waste and disposal section on long-lived impurities; and
- addition of a section on autopsy and cremation of Y-90 microsphere patients
|
Mr. Frank Costello
Dr. Sue Langhorst
Dr. Darlene Metter (chair)
Dr. Chris Palestro |
Subcommittee
established
7/25/16
Final Report
Submitted on 10/07/16
Subcommittee was superseded by the Draft Rev. 10 Subcommittee established on 9/21/18
|
| Medical Event Report for All Modalities Excluding Permanent Implant Brachytherapy |
To propose appropriate
criteria for Medical Event Reporting for events other than permanent implant brachytherapy |
Dr. Vasken Dilsizian
Dr. Ronald Ennis
Mr. Zoubir Ouhib
Dr. Chris Palestro
Dr. John Suh (Chair)
Dr. Pat Zanzonico
NRC staff resource:
Dr. Katie Tapp
Membership Amended 10/6/16: Dr. Pat Zanzonico stepped down from the subcommittee. Mr. Frank Costello was appointed to the subcommittee.
|
Subcommittee
established
10/9/15
Final Report
Submitted 4/27/17
|
| Patient Intervention Subcommittee |
To review and evaluate the phrase "patient intervention" |
Dr. Alderson
Mr. Frank Costello
Dr. Vasken Dilsizian (Chair)
Dr. Ronald Ennis
Dr. John Suh
Ms. Laura Weil
NRC staff resource:
Dr. Sandy Gabriel
|
Subcommittee
established
3/19/15
No formal report provided.
|
| Subcommittee on Radioactive Seed Localization for Non-Palpable Breast Lesions |
To review the existing 10 CFR 35.1000 licensing guidance for radioactive seed localization and make recommendations for revisions to the guidance |
Dr. Philip Alderson
Mr. Frank Costello
Dr. Ronald Ennis (Chair)
Dr. Darlene Metter
Dr. Pat Zanzonico
NRC staff resource:
Ms. Sophie Holiday
|
Subcommittee
established
3/19/15
Final Report
Submitted 6/24/16
|
| Training and Experience for Alpha and Beta Emitters Subcommittee |
To evaluate if the required 700 hours for training and experience for authorized users of alpha and beta emitters places hardship on the patient community. If so, the subcommittee should make recommendations for potential changes (rulemaking). |
Dr. Vasken Dilsizian
Dr. Ronald Ennis
Dr. Sue Langhorst
Dr. Chris Palestro (Chair)
Ms. Laura Weil
Dr. Pat Zanzonico |
Subcommittee
established
6/16/15
Final Report
Submitted 3/16/16
Subcommittee
deactivated
3/16/16
|
| Medical Policy Statement Subcommittee |
To determine if the Policy Statement needed revision(s). In addition, the subcommittee was asked to address the following two questions:
- Stakeholders in the medical community have suggested that physicians are not performing permanent implant brachytherapy procedures because of NRC's current regulations in 10 CFR Part 35. Does the subcommittee believe this to be true; and
- Does the subcommittee believe the regulations in 10 CFR Part 35, as amended in the proposed rule, address this real or perceived issue?
|
Dr. Philip Alderson
Dr. Milton Guiberteau
Dr. Chris Palestro
Dr. John Suh
Dr. Bruce Thomadsen (chair) |
Subcommittee
established
1/30/14
Final Report
Submitted 5/8/14
Subcommittee deactivated 12/5/14 when the Commission agreed not to update the Medical Policy Statement at this time
|
| Medical Event Reporting Criteria of the Yttrium-90 Microspheres (35.1000) Guidance |
To review the medical event reporting criteria of the yttrium-90 microspheres (35.100) guidance and recommend any changes. |
Mr. Frank Costello
Dr. Milton Guiberteau (chair)
Dr. Sue Langhorst
Dr. Chris Palestro
Dr. Bruce Thomadsen
Dr. James Welsh |
Subcommittee
established
5/8/14
Final Report
Submitted 9/29/14
Subcommittee deactivated 9/29/14
|
| Germanium-68 Decommissioning Funding Plan Subcommittee |
To evaluate the cost of a decommissioning funding plan (DFP) for the use of Ge-68, its effect on the future clinical use of new
Ga-68 radiopharmaceuticals and how appropriate regulatory relief may be gained.
Charge amended 3/19/15:
- To estimate the number of potential Ge/Ga-68 generator licensees; and
- To make a recommendation to the Committee on which route of action it believes NRC should pursue to address the decommissioning funding plan issue.
|
Mr. Frank Costello
Dr. Sue Langhorst
Mr. Mattmuller (chair)
Dr. Chris Palestro
Dr. Pat Zanzonico. |
Subcommittee established 5/8/14
Final Report Submitted 8/12/15
Subcommittee deactivated 7/29/16 when exemption memo was issued
|
| Advanced Notice for Proposed Rulemaking for 10 CFR Part 20 Subcommittee |
To review the advanced notice of proposed rulemaking for Title 10 Code of Federal Regulations Part 20, "Standards for Protection Against Radiation" |
Mr. Frank Costello
Dr. Vasken Dilsizian
Dr. Sue Langhorst (chair)
Mr. Mattmuller
Dr. Pat Zanzonico |
Subcommittee established 9/30/14
Final Report
Submitted 1/29/15
Subcommittee deactivated 1/29/15
|