United States Nuclear Regulatory Commission - Protecting People and the Environment

ACMUI Subcommittees

The Advisory Committee on the Medical Uses of Isotopes (ACMUI) advises the U.S. Nuclear Regulatory Commission (NRC) on policy and technical issues that arise in the regulation of the medical uses of radioactive material in diagnosis and therapy.  The ACMUI's recommendations and comments to the NRC come through formal reports submitted by Subcommittees. Below is a list of Subcommittees, including their charges, members, established dates, deactivated dates, and any final, draft or interim reports. Subcommittee reports may also be found on the Subcommittee Reports Web Page.

Subcommittee Name Subcommittee
Charge
Subcommittee Members Status
Xcision® GammaPod™ Licensing Guidance Subcommittee To review and comment on the draft Revision 1 of the 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
Institutional Memory Subcommittee To evaluate the ACMUI’s institutional memory and provide recommendations for improvement

Dr. Ronald Ennis
Dr. Michael O’Hara
Dr. A. Robert Schleipman (chair)
Ms. Megan Shobver
Ms. Laura Weil

NRC staff resource:  Ms. Kellee Jamerson
Subcommittee
established
4/04/19
Infiltrations Subcommittee To evaluate the NRC’s 1980 infiltration policy decision and provide comments and recommendations

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

NRC staff resource amended 8/12/19:  Dr. Said Daibes
Subcommittee
established
4/03/19
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:
[ML19058A598]

Interim Report Submitted 2/19/18:
[ML18051A725]

Status Report (35.190)
[ML17138A365]
Submitted 4/26/17

Status Report
[ML17066A442]
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 [ML19091A256] Submitted 11/30/2018

Final Report
[ML19126A296]
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
[ML19143A367]
Submitted 5/23/19

Phase 1 Final Report
[ML19171A222]
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
[ML19091A240]
Submitted 3/11/19

Final Report
[ML19130A103]
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
[ML19091A238]
Submitted 3/7/19

Final Report
[ML19126A297]
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

Interim Report
[ML19091A242]
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
[ML18033B034]
Submitted 2/01/18

Final Report
[ML18177A451]
Submitted 6/26/18

Final Report,
Table Revised
[ML19038A498]
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 7/1/18:
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
[ML18253A124]
Submitted 8/31/18
(for comments on draft licensing guidance)

Final Report
[ML18071A413]
Submitted 2/27/18
(for original charge)

Medical Event Report and Impact on Safety Culture Subcommittee The charge of the subcommittee is to:
  1. explore the impact of ME reporting and its impact on self-reporting (safety culture);
  2. identify potential ways to improve effectiveness of self-reporting in support of a culture of safety; and
  3. 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
[ML17281A001]
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
[ML17138A383]
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 [ML17281A001] 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:
  1. the removal of the AU manufacturer training Pathway 2
  2. update the waste and disposal section on long-lived impurities; and
  3. 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
[ML17138A352]
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
[ML17138A379]
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
[ML16196A005]
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
[ML16089A271]
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:
  1. 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
  2. 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
[ML14177A218]
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 [ML14300A138]
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:

  1. To estimate the number of potential Ge/Ga-68 generator licensees; and
  2. 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 [ML15231A047] Submitted 8/12/15

Subcommittee deactivated 7/29/16 when exemption memo was issued [ML16082A415]

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 [ML15030A149] Submitted 1/29/15

Subcommittee deactivated 1/29/15

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Page Last Reviewed/Updated Monday, August 26, 2019