ML19067A239

Advisory Committee on the Medical Uses of Isotopes (ACMUI) April 3-4, 2019 Meeting Agenda

ML19067A239
Person / Time
Issue date:	03/08/2019
From:	Advisory Committee on the Medical Uses of Isotopes
To:
Jamerson, Kellee
References
Download: ML19067A239 (2)

Text

MEETING AGENDA ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES April 3-4, 2019 Three White Flint North Building, 11601 Landsdown Street, Room 1-C03/1-C05, North Bethesda, Maryland 20852 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.

Wednesday, April 3, 2019 OPEN SESSION

1. Opening Remarks C. Einberg, NRC Mr. Einberg will formally open the meeting and Ms. Kock will provide opening A. Kock, NRC remarks.

2. Old Business S. Holiday, NRC Ms. Holiday will review past ACMUI recommendations and provide NRC responses.

8:30 - 10:30 3. Open Forum ACMUI The ACMUI will identify medical topics of interest for further discussion.

4. Yttrium-90 Microspheres Brachytherapy Licensing Guidance M. OHara, ACMUI Subcommittee Report Dr. OHara will discuss the subcommittees recommendations on the NRCs draft Revision 10 to the Yttrium-90 Microspheres Brachytherapy Licensing Guidance.

5. Lucerno Dynamics LARA Infiltration Detection R. Lattanze, Mr. Lattanze will provide an overview about a product that can assist with Lucerno Dynamics detecting nuclear medicine injection infiltrations.

10:30 - 10:45 BREAK

6. Summary of Changes to 10 CFR Part 35 L. Dimmick, NRC Ms. Dimmick will discuss the changes to the final rule 10 CFR Part 35 that went into effect January 2019.

10:45 - 12:00

7. Germanium-68/Gallium-68 Subcommittee Report M. Shober, ACMUI Ms. Shober will discuss the subcommittees recommendations on the NRCs draft revision to the Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance.

12:00 - 1:00 LUNCH

8. Medical Related Events DB. Howe, NRC Dr. Howe will provide an update on recent medical events.

1:00 - 2:45 9. Appropriateness of Medical Event Reporting Subcommittee Report R. Ennis, ACMUI Dr. Ennis will discuss the subcommittees recommendations on the appropriateness of the required medical event reporting in accordance with 10 CFR 35.3045.

2:45 - 3:15 BREAK (public portion ends)

WEDNESDAY, APRIL 3, 2019 CLOSED SESSION 3:15 - 5:00 10. ACMUI Working Session: Biennial Evaluations and Commission ACMUI Meeting Presentation Development THURSDAY, APRIL 4, 2019 OPEN SESSION

11. ACMUI Reporting Structure K. Jamerson, NRC Members will discuss the reporting structure of the Committee and provide feedback to the NRC staff.

8:30 - 9:30 12. Special Presentation to Ms. Weil S. Moore, NRC Mr. Moore will make a special presentation to Ms. Laura Weil

13. Thoughts on Leaving the ACMUI L. Weil, ACMUI Ms. Weil will share her thoughts on leaving the ACMUI, after serving two full terms (8 years).

9:30 - 10:00 BREAK

14. Commission Meeting with the ACMUI ACMUI The ACMUI will brief the Commission on various topics in a public meeting.

10:00 - 12:15

15. Group Photo ACMUI The ACMUI will take a group photo with and without the Commission.

12:15 - 1:15 LUNCH

16. ACMUI Bylaws Subcommittee Report L. Weil, ACMUI Ms. Weil will discuss the subcommittees recommendations for changes to the ACMUIs Bylaws - with particular focus on the ACMUI Chairs role with respect to subcommittees.

1:15 - 2:45 17. Open Forum ACMUI The ACMUI will discuss medical topics of interest previously identified.

18. Administrative Closing K. Jamerson, NRC Ms. Jamerson will provide a meeting summary and propose dates for the fall 2019 meeting.

2:45 ADJOURN