ML18099A309
| ML18099A309 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18099A309 (5) | |
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2013 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI recommended NRC staff allow use of total source strength as a Closed 1 substitute for total dose for determining medical events for permanent 3/5/13 NRC Action 3/7/18 implant brachytherapy until the Part 35 rulemaking is complete.
ACMUI recommended that NRC staff solicit feedback from stakeholders, in Supplementary Information section IV.D, on whether the proposed ME definition for permanent implant brachytherapy would discourage Closed 2 3/5/13 NRC Action licensees from using this form of therapy. This recommendation was 3/7/18 modified the caveat that NRC may utilize the language that they think is appropriate for gaining this type of information from its stakeholders ACMUI recommended the draft rule re-defining medical events in 3/5/13 Closed 3 permanent implant brachytherapy be designated as Compatibility NRC Action 3/12/13 3/7/18 Category B.
ACMUI recommended replacing the phrasing in the literature in terms of Closed 4 support for the 5 cubic centimeters of contiguous normal tissue provision 3/5/13 NRC Action 3/7/18 of the ME definition, to the specific reference cited as, Nag, et al 2004 ACMUI recommended that licensees approved to use generator systems show specific training on the requirement now listed under 35.290 (c)(1)(ii)(G) for those individuals (Authorized Users and others) who are responsible for proper operation and testing of the generator as part of Closed 5 3/5/13 NRC Action their license conditions. ACMUI further recommended that Authorized 3/7/18 Nuclear Pharmacists who have the adequate training and experience (T&E) are able to provide the supervised work experience for Authorized Users on the elution of generators.
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2013 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI endorsed the language in the proposed rule for preceptor Closed 6 attestations that states a candidate is able to independently fulfill the 3/5/13 NRC Action 3/7/18 radiation safety related duties for which authorization is being sought.
ACMUI recommended that the work experience for parenteral administrations under Sections 35.390 (b)(1)(2)(g), and 35.396 not be Closed 7 separated between parenteral administrations of a beta gamma emitting 3/12/13 NRC Action 3/7/18 radiopharmaceutical versus an alpha emitting radiopharmaceutical, as proposed in the proposed rule.
ACMUI recommended that the date of recognition of a certifying board should not impact individuals seeking to be named as an Authorized Closed 8 3/12/13 NRC Action User, Authorized Radiation Safety Officer, Authorized Medical Physicist, 3/7/18 or Authorized Nuclear Pharmacist through the certification pathway.
ACMUI recommended that the NRC adopt the FDA approved package Closed 9 3/12/13 NRC Action insert for breakthrough limits for radioisotope generators 3/7/18 ACMUI recommended licensee reporting of out-of-tolerance generator Closed 10 3/12/13 NRC Action breakthrough results to the NRC 3/7/18 ACMUI recommended requiring testing of molybdenum breakthrough on Closed 11 every elution of a molybdenum-technetium generator, rather than after 3/12/13 NRC Action 3/7/18 only the first elution.
ACMUI recommended that the addition of Associate Radiation Safety Closed 12 Officers (ARSOs), and Temporary RSOs also be included in these 3/12/13 NRC Action 3/7/18 exemptions in the same manner as AUs, ANPs, and AMPs.
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2013 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS In reference to the plain language requirement, the ACMUI suggested that the rule could be shortened and improved by eliminating redundancies and consolidating related sections and eliminating Closed 13 identical or nearly identical passages appearing multiple times 3/12/13 NRC Action 3/7/18 throughout the draft rule. A further improvement would be the inclusion of a detailed executive summary-style section summarizing, perhaps in a bullet format, the key changes introduced in the draft rule.
ACMUI recommended approval of the Second Draft ACMUI Rulemaking Subcommittee Report (ML13071A690) with the caveat that all 14 3/12/13 NRC Action Closed modifications discussed during the teleconference would be incorporated before submission to NRC staff.
The ACMUI recommended tabling the discussion of amendments to the 15 4/15/13 NRC Action Closed ACMUI Bylaws to the Fall 2013 ACMUI Meeting.
Dr. Langhorst requested if NRC staff could add the Draft Guidance for the Draft Expanded Part 35 Rulemaking into the same docket number as 16 the Rulemaking document. If this is not possible, she requests that the 4/15/13 NRC Action Closed location (docket number) of the draft guidance be clearly identified in the Draft Expanded Part 35 Rulemaking docket and vice versa.
The ACMUI have planned to hold a summer teleconference to discuss the Medical Events Subcommittee analysis of Yttrium-90 microspheres ACMUI 17 4/15/13 Closed medical events. The dates are June 18, 2013 from 2-4pm EDT or June Action 20, 2013 from 2-4pm EDT (back-up).
The ACMUI endorsed the Abnormal Occurrence Criteria Subcommittee ACMUI 18 4/15/13 Closed Report. Action The ACMUI have planned to hold the Fall 2013 ACMUI Meeting at NRC ACMUI 19 Headquarters on September 9-10, 2013 or September 16-17, 2013 4/16/13 Closed Action (back-up).
Dr. Guiberteau requested that NRC staff provide a link to the abstract 20 4/16/13 NRC Action Closed cited in Ms. Weil's ThyCa presentation to the full ACMUI.
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2013 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The ACMUI recommended that NRC provides regulatory relief from the 21 decommissioning funding plan requirements for the use of a Germanium- 4/16/13 NRC action Closed 68/Gallium-68 generator.
The ACMUI endorsed the Draft ACMUI Yttrium-90 Microsphere ACMUI 22 6/18/13 Closed Brachytherapy Medical Events Analysis Report (ML13162A113). Action Dr. Thomadsen added Dr. Christopher Palestro to the Medical Events Subcommittee. Dr. Palestro will review the I-131 medical events. ACMUI 23 9/9/13 Closed Subcommittee Members: Welsh (Chair), Langhorst, Mattmuller, Suh, Action Suleiman, Thomadsen Dr. Thomadsen created a subcommittee to review the Proposed Amendments to the ACMUI Bylaws. The recommendations will be ACMUI 24 presentation in the spring 2014 meeting. Subcommittee members 9/9/13 Closed Action include: Dr. Chris Palestro, Dr. John Suh, Dr. Orhan Suleiman, Ms.
Laura Weil, and Dr. Pat Zanzonico (chair).
The ACMUI recommended to reestablish the Rulemaking Subcommittee to review and address staff's response to the subcommittee's ACMUI 25 9/10/13 Closed recommendations for the draft proposed expanded 10 CFR Part 35 Action Rulemaking.
Dr. Thomadsen added Mr. Steve Mattmuller to the ACMUI Bylaws ACMUI 26 9/10/13 Closed Subcommittee Action Dr. Thomadsen added the following additional charges to the ACMUI Bylaws Subcommittee: 1) Discuss, address and make a recommendation for the reporting structure (to the MSSA Director versus ACMUI 27 the Commission); 2) Discuss, address, and make a recommendation for 9/10/13 Closed Action the consideration of budgeting for an additional face-to-face meeting at Headquarters; 3) Consider the feasibility of conducting meetings using the Go-To-Meeting or Go-To-Webinar function.
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2013 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS Dr. Thomadsen requested that staff provide the Committee with the 28 SECY Paper transmitted to the Commission in 2011 that discussed the 9/10/13 NRC Action Closed pros and cons of restructuring the reporting structure of the ACMUI.
Dr. Welsh recommended to add the topic of physical presence ACMUI 29 requirements of Authorized Users for the Gamma Knife and Perfexion 9/10/13 Closed Action for discussion at the spring 2014 meeting.
The ACMUI planned the spring 2014 meeting for May 8-9, 2013. The ACMUI 30 9/10/13 Closed back-up dates are May 12-13, 2013. Action 5