ML18099A310
| ML18099A310 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18099A310 (4) | |
Text
2014 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS Dr. Thomadsen created a subcommittee to review the NRC Medical Policy Statement. The subcommittee was charged with determining 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 ACMUI 1 permanent implant brachytherapy procedures because of NRC's current regulations in 10 1/30/14 Closed Action 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? Subcommittee members include: Dr. Thomadsen (chair), Dr. Guiberteau, Dr. Palestro, and Dr. Suh.
ACMUI 2 Dr. Thomadsen added Dr. Philip Alderson to the Medical Policy Statement Subcommittee. 3/24/14 Closed Action The ACMUI recommended to endorse the Medical Policy Statement Subcommittee Report.
ACMUI 3 This included a recommendation to make no changes to the current Medical Policy 5/8/14 Closed Action Statement.
Dr. Thomadsen formed a subcommittee to review the medical event reporting criteria of the yttrium-90 microspheres (35.1000) guidance. Subcommittee members include: Dr.
ACMUI 4 Guiberteau (chair), Mr. Costello, Dr. Langhorst, Dr. Palestro, Dr. Thomadsen, and Dr. 5/8/14 Closed Action Welsh. The subcommittee will present their recommendations at the Fall 2014 meeting.
The NRC staff resource is Dr. Howe.
No Action 5 Dr. Thomadsen added Mr. Frank Costello to the Medical Events Subcommittee. 5/8/14 Closed Required Dr. Thomadsen formed a subcommittee on May 8, 2014 to provide staff with the background information to justify the recommendation for the regulatory relief from the DFP of Ge-68. The subcommittee is specifically charged with evaluating the cost of a DFP for ACMUI 6 5/8/14 Closed the use of Ge-68, its effect on the future clinical use of new Ga-68 radiopharmaceuticals Action and how appropriate regulatory relief may be gained. Subcommittee members include Mr.
Mattmuller (chair), Dr. Langhorst, Mr. Costello, Dr. Palestro and Dr. Zanzonico.
1
2014 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS Staff will provide the Ge-68 DFP Subcommittee with the NRC guidelines for developing a 7 5/8/14 NRC action Closed Regulatory Basis.
The ACMUI will hold the fall 2014 ACMUI Meeting in T2-B3 on September 29-30, 2014.
8 5/9/14 NRC action Closed The back-up date is October 20-21, 2014.
The ACMUI recommended to table the discussion and vote on the revisions to the ACMUI ACMUI 9 8/20/14 Closed Bylaws until the September 29-30, 2014 meeting. Action The ACMUI recommended that the total treatment activity of yttrium-90 microspheres to be 10 administered should be the required compliance measure for organs and tissues other than 9/29/14 NRC action Closed the treatment site.
The ACMUI recommended that the implantation of the microsphere brachytherapy sources is considered to be in accordance with the written directive if the total administered/infused 11 activity does not vary from the activity prescribed in the written directive by 20% or more; 9/29/14 NRC action Closed except in situations in which the activity administered is limited by the termination of procedure due to stasis.
The ACMUI recommended that (a) these recommendations be incorporated into the NRC guidance for yttrium-90 microsphere brachytherapy and that (b) the NRC staff, in 12 consultation with ACMUI, compose and disseminate explanation of these recommended 9/29/14 NRC action Closed revisions in a manner best suited to both the NRC as well as to AUs and other stakeholders tasked with compliance.
2
2014 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The ACMUI endorsed the yttrium-90 microsphere brachytherapy medical event reporting ACMUI 13 9/29/14 Closed criteria subcommittee report. Action The ACMUI endorsed the revisions to the ACMUI Bylaws presented on September 29, ACMUI 14 which includes the proposed language in section 1.3.5 and 3.1 and changes to reflect the 9/29/14 Closed Action new office structure.
The ACMUI requested that staff provide them with a contact list for the NRC 15 9/29/14 NRC action Closed Commissioners.
Ms. Holiday committed to providing the memorandum sent to the Commissioners regarding 16 9/29/14 NRC action Closed the international practices of patient release.
Dr. Thomadsen tasked Dr. Langhorst and Mr. Costello with creating a proposal to present to ACMUI 17 the Committee and staff regarding the costs and logistics for an additional face-to-face 9/29/14 Closed Action meeting and/or a medical regulatory information conference.
The ACMUI have tentatively scheduled the Spring 2015 Meeting for March 19-20, 2015. ACMUI 18 9/30/14 Closed The back-up date is March 24-25, 2015 Action Dr. Thomadsen formed a subcommittee to review the advanced notice of proposed rulemaking for Title 10 Code of Federal Regulations Part 20, Standards for Protection ACMUI 19 Against Radiation. Subcommittee members include: Dr. Langhorst (chair), Mr. Costello, 9/30/14 Closed Action Dr. Dilsizian, Mr. Mattmuller, and Dr. Zanzonico. The subcommittee will present their recommendations at a future teleconference.
3
2014 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS Dr. Thomadsen tasked Dr. Suh and Dr. Welsh to work with the American Society for Radiation Oncology for their proposed changes to the language in the Draft FY15 Water and Energy Bill. Dr. Ennis will serve as a consultant to Drs. Suh and Welsh until he ACMUI 20 9/30/14 Closed assumes the role of the ACMUIs Brachytherapy Radiation Oncologist in February 2015. Action Drs. Ennis, Suh, and Welsh will present the language to the Committee at the spring 2015 meeting.
ACMUI 21 The ACMUI endorsed the ANPR for Part 20 subcommittee report. 12/10/14 Closed Action 4