ML18099A280

Advisory Committee on the Medical Uses of Isotopes (ACMUI) 2012 Recommendations and Actions Chart - April 2018

ML18099A280
Person / Time
Issue date:	04/09/2018
From:	Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards
To:
Holiday, Sophie
References
Download: ML18099A280 (2)

Text

2012 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI recommended the following two changes to the PIBS Report: 1) the addition of the word "final" to the recommendation B, paragraph 1, the last sentence, to read ACMUI 1 as "in accordance with the final planned distribution." and 2) the word 2/7/12 Closed 2/7/12 Action

"(contiguously)" be dropped and, instead, using it as an adjective with the word "contiguous," preceding the "centimeters" in both subheadings 2(a) and 2(b).

ACMUI Closed 2 ACMUI approved the Electronics Subcommittee Report, as written. 4/16/12 Action 4/16/12 Dr. Thomadsen created a subcommittee to provide a recommendation on licensing for alpha-emitters, including Ra-223, The subcommittee will submit its report by ACMUI 3 6/15/12. Subcommittee members include: Dr. Zanzonico (chair), Ms. Bailey, Dr. 4/17/12 Closed Action Langhorst, Mr. Mattmuller, Dr. Palestro, Dr. Suleiman, Dr. Thomadsen, Dr. Welsh.

The NRC Staff resource person will be Ms. Ashley Cockerham.

ACMUI has planned to hold the Fall 2012 ACMUI Meeting on October 18-19, 2012.

The back-up date is September 20-21, 2012. However, if a Commission Meeting ACMUI 4 cannot be planned for the October meeting date, the preference for the ACMUI 4/17/12 Closed Action Meeting is reversed. The first choice then becomes September 20-21, 2012, with the October 18-19, 2012 dates as the back-up ACMUI approved the Draft Subcommitee Report on Licensing Ra-223 Chloride with ACMUI 5 7/9/12 Closed minor modifications to be made. Action Dr. Malmud asked NRC staff to find data on events in which the radiopharmacy has 6 dispensed the incorrect amount of a radiopharmaceutical or the incorrect 9/20/12 NRC Action Closed radiopharmaceutical.

ACMUI recommends licensing of Ra-223 dichloride under 10 CFR 35.300 and ACMUI 7 recommends (but does not recommend requiring ) direct measurement of activity 9/20/12 Closed Action before/after administration.

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2012 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS ACMUI endorses the subcommittee report submitted on July 16, 2012 with the following changes: 1) recommend licensing of Ra-223 dichloride under 10 CFR 35.300 and recommend (but not require) direct measurement of activity before/after ACMUI 8 administration; 2) remove statement regarding applicability of report for all future 9/20/12 Closed Action alpha-emitting particles; and 3) remove statement regarding Ra-223 dichloride significantly prolonging survivial. ACMUI will submit a report to NRC staff with the aforementioned changes.

Open 9 ACMUI requested that reporting structure reviews remain on an annual basis. 9/20/12 Accepted Indefinitely Dr. Malmud created a subcommittee to review the refined Abnormal Occurrence criteria and provide recommendations to NRC staff. The subcommittee includes: ACMUI 10 9/21/12 Closed Dr. Langhorst (chair), Ms. Bailey, Ms. Weil, Dr. Palestro, Dr. Welsh, Dr. Action Thomadsen, and Mr. Mattmuller. NRC staff resource will be Angela McIntosh.

Dr. Langhorst asked NRC staff to provide direction as to whether or not the trigger 11 criteria needs to be a part of the Abnormal Occurrence criteria or if the trigger 9/21/12 NRC Action Closed criteria could be used separately ACMUI proposed the next meeting be on April 15-16, 2013 with a backup date of ACMUI 12 April 29-30, 2013. The ACMUI will meet separately with the Commission, if 9/21/12 Closed Action requested.

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