ML18099A280
| 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 ITEMSITEMDATE 1 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
as "in accordance with the final planned distribution." and 2) the word
"(contiguously)" be dropped and, instead, using it as an adjective with the word "conti g uous ," p recedin g the "centimeters" in both subheadin g s 2 (a) and 2 (b).2/7/12 ACMUI Action Closed 2/7/122ACMUI approved the Electronics Subcommittee Report, as written.4/16/12 ACMUI Action Closed 4/16/12 3 Dr. Thomadsen created a subcommittee to provide a recommendation on licensing for alpha-emitters, including Ra-223, The subcommittee will submit its report by
6/15/12. Subcommittee members include: Dr. Zanzonico (chair), Ms. Bailey, Dr.
Langhorst, Mr. Mattmuller, Dr. Palestro, Dr. Suleiman, Dr. Thomadsen, Dr. Welsh.
The NRC Staff resource person will be Ms. Ashley Cockerham.
4/17/12 ACMUI Action Closed 4 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
cannot be planned for the October meeting date, the preference for the ACMUI
Meeting is reversed. The first choice then becomes September 20-21, 2012, with
the October 18-19, 2012 dates as the back-up 4/17/12 ACMUI Action Closed 5 ACMUI approved the Draft Subcommitee Report on Licensing Ra-223 Chloride with minor modifications to be made.
7/9/12 ACMUI Action Closed 6 Dr. Malmud asked NRC staff to find data on events in which the radiopharmacy has dispensed the incorrect amount of a radiopharmaceutical or the incorrect
radiopharmaceutical.9/20/12NRC ActionClosed 7 ACMUI recommends licensing of Ra-223 dichloride under 10 CFR 35.300 and recommends (but does not recommend requiring) direct measurement of activity before/after administration.
9/20/12 ACMUI Action Closed STATUS 1 2012 ACMUI RECOMMENDATIONS AND ACTION ITEMSITEMDATE STATUS 8 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
administration; 2) remove statement regarding applicability of report for all future
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.
9/20/12 ACMUI Action Closed9ACMUI requested that reporting structure reviews remain on an annual basis.9/20/12Accepted Open Indefinitely 10 Dr. Malmud created a subcommittee to review the refined Abnormal Occurrence criteria and provide recommendations to NRC staff. The subcommittee includes:
Dr. Langhorst (chair), Ms. Bailey, Ms. Weil, Dr. Palestro, Dr. Welsh, Dr.
Thomadsen, and Mr. Mattmuller. NRC staff resource will be Angela McIntosh.
9/21/12 ACMUI Action Closed 11 Dr. Langhorst asked NRC staff to provide direction as to whether or not the trigger criteria needs to be a part of the Abnormal Occurrence criteria or if the trigger
criteria could be used separately9/21/12NRC ActionClosed 12 ACMUI proposed the next meeting be on April 15-16, 2013 with a backup date of April 29-30, 2013. The ACMUI will meet separately with the Commission, if
requested.
9/21/12 ACMUI Action Closed 2