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{{#Wiki_filter:MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 21-22, 2020 WEBEX 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.
{{#Wiki_filter:1 MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 21-22, 2020 WEBEX 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.
Monday, September 21, 2020 OPEN SESSION
Monday, September 21, 2020 OPEN SESSION
: 1. Opening Remarks                                                                           C. Einberg, NRC Mr. Einberg will formally open the meeting and provide opening remarks.
: 1. Opening Remarks Mr. Einberg will formally open the meeting and provide opening remarks.
: 2. Old Business                                                                           K. Jamerson, NRC Ms. Jamerson will review past ACMUI actions and recommendations 10:00 - 11:30                and provide NRC responses.
C. Einberg, NRC 10:00 - 11:30
: 3. Open Forum                                                                                         ACMUI The ACMUI will identify medical topics of interest for further discussion.
: 2. Old Business Ms. Jamerson will review past ACMUI actions and recommendations and provide NRC responses.
: 4. Medical Events Subcommittee Report                                                       R. Ennis, ACMUI Dr. Ennis will provide an analysis of FY19 medical events.
: 3. Open Forum The ACMUI will identify medical topics of interest for further discussion.
11:30 - 12:15                                             BREAK/LUNCH
K. Jamerson, NRC ACMUI
: 5. Non-Medical Events                                                                     M. Sheetz, ACMUI Mr. Sheetz will provide an analysis of FY19 non-medical events reported by medical use facilities and commercial pharmacies.
: 4. Medical Events Subcommittee Report Dr. Ennis will provide an analysis of FY19 medical events.
: 6. New Drug Development and Labeling                                                      F. Lutterodt, FDA 12:15 - 2:00                 Mr. Lutterodt will discuss the U.S. Food and Drug Administrations regulatory process for new drug development and labeling.
R. Ennis, ACMUI 11:30 - 12:15 BREAK/LUNCH
: 7. Dosimetry Methodology Update for Regulatory Guide 8.39,                                        D. Hamby, Phase 2 Revision                                                                       RCD Radiation Dr. Hamby will discuss the dosimetry methodology update for the                     Protection Assoc.
: 5. Non-Medical Events Mr. Sheetz will provide an analysis of FY19 non-medical events reported by medical use facilities and commercial pharmacies.
Regulatory Guide 8.39, Phase 2 revision.
M. Sheetz, ACMUI 12:15 - 2:00
2:00                                                   ADJOURN FOR THE DAY Tuesday, September 22, 2020 CLOSED SESSION
: 6. New Drug Development and Labeling Mr. Lutterodt will discuss the U.S. Food and Drug Administrations regulatory process for new drug development and labeling.
: 8. INFOSEC Training                                                                         R. Norman, NRC 10:00 - 12:00          9. Ethics Training                                                                           C. Safford, NRC
F. Lutterodt, FDA
: 10. Allegations Training                                                                   S. Hawkins, NRC 1
: 7. Dosimetry Methodology Update for Regulatory Guide 8.39, Phase 2 Revision Dr. Hamby will discuss the dosimetry methodology update for the Regulatory Guide 8.39, Phase 2 revision.
D. Hamby, RCD Radiation Protection Assoc.
2:00 ADJOURN FOR THE DAY Tuesday, September 22, 2020 CLOSED SESSION 10:00 - 12:00
: 8. INFOSEC Training
: 9. Ethics Training
: 10. Allegations Training R. Norman, NRC C. Safford, NRC S. Hawkins, NRC  


12:00 - 12:15                                 BREAK Tuesday, September 22, 2020 OPEN SESSION
2 12:00 - 12:15 BREAK Tuesday, September 22, 2020 OPEN SESSION
: 11. Medical Team Updates                                                     L. Dimmick, NRC Ms. Dimmick will provide an update on Medical Radiation Safety Team activities.
: 11. Medical Team Updates Ms. Dimmick will provide an update on Medical Radiation Safety Team activities.
12:15 - 1:45 12. Open Forum                                                                         ACMUI The ACMUI will discuss medical topics of interest previously identified.
L. Dimmick, NRC 12:15 - 1:45
: 13. Administrative Closing                                                   K. Jamerson, NRC Ms. Jamerson will provide a meeting summary and propose dates for the spring 2021 meeting.
: 12. Open Forum The ACMUI will discuss medical topics of interest previously identified.
1:45                                         ADJOURN 2}}
ACMUI
: 13. Administrative Closing Ms. Jamerson will provide a meeting summary and propose dates for the spring 2021 meeting.
K. Jamerson, NRC 1:45 ADJOURN}}

Latest revision as of 05:27, 4 December 2024

Advisory Committee on the Medical Uses of Isotopes (ACMUI) September 21-22, 2020 Meeting Agenda
ML20212L863
Person / Time
Issue date: 07/30/2020
From:
Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards
To:
Jamerson, Kellee NMSS/MSST
References
Download: ML20212L863 (2)
v • d • e


Text

1 MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES September 21-22, 2020 WEBEX 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.

Monday, September 21, 2020 OPEN SESSION

1. Opening Remarks Mr. Einberg will formally open the meeting and provide opening remarks.

C. Einberg, NRC 10:00 - 11:30

2. Old Business Ms. Jamerson will review past ACMUI actions and recommendations and provide NRC responses.
3. Open Forum The ACMUI will identify medical topics of interest for further discussion.

K. Jamerson, NRC ACMUI

4. Medical Events Subcommittee Report Dr. Ennis will provide an analysis of FY19 medical events.

R. Ennis, ACMUI 11:30 - 12:15 BREAK/LUNCH

5. Non-Medical Events Mr. Sheetz will provide an analysis of FY19 non-medical events reported by medical use facilities and commercial pharmacies.

M. Sheetz, ACMUI 12:15 - 2:00

6. New Drug Development and Labeling Mr. Lutterodt will discuss the U.S. Food and Drug Administrations regulatory process for new drug development and labeling.

F. Lutterodt, FDA

7. Dosimetry Methodology Update for Regulatory Guide 8.39, Phase 2 Revision Dr. Hamby will discuss the dosimetry methodology update for the Regulatory Guide 8.39, Phase 2 revision.

D. Hamby, RCD Radiation Protection Assoc.

2:00 ADJOURN FOR THE DAY Tuesday, September 22, 2020 CLOSED SESSION 10:00 - 12:00

8. INFOSEC Training
9. Ethics Training
10. Allegations Training R. Norman, NRC C. Safford, NRC S. Hawkins, NRC

2 12:00 - 12:15 BREAK Tuesday, September 22, 2020 OPEN SESSION

11. Medical Team Updates Ms. Dimmick will provide an update on Medical Radiation Safety Team activities.

L. Dimmick, NRC 12:15 - 1:45

12. Open Forum The ACMUI will discuss medical topics of interest previously identified.

ACMUI

13. Administrative Closing Ms. Jamerson will provide a meeting summary and propose dates for the spring 2021 meeting.

K. Jamerson, NRC 1:45 ADJOURN

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