ML18361A919
| ML18361A919 | |
| Person / Time | |
|---|---|
| Issue date: | 03/14/2019 |
| From: | Andrea Kock NRC/NMSS/DMSST |
| To: | Palestro C Advisory Committee on the Medical Uses of Isotopes |
| K Jamerson | |
| References | |
| Download: ML18361A919 (5) | |
Text
March 14, 2019 MEMORANDUM TO: Christopher J. Palestro, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes FROM: Andrea L. Kock, Director Division of Materials Safety, Security, State, and Tribal Programs /RA Kevin Williams for/
Office of Nuclear Material Safety and Safeguards
SUBJECT:
U.S. NUCLEAR REGULATORY COMMISSION ACTIONS IN RESPONSE TO THE SEPTEMBER 20-21, 2018, MEETING AND FEBRUARY 26, 2019, TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Below are the U.S. Nuclear Regulatory Commission (NRC) staffs actions in response to the recommendations and requests from the September 20-21, 2018 and February 26, 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI or Committee) meetings.
September 20-21, 2018 Fall Meeting ITEM (1): The Committee recommended adding the following language into the report of the Subcommittee on the Nursing Mother Guidelines for the Medical Administration of Radioactive Materials: the U.S. Food and Drug Administration approved radiopharmaceuticals currently on the market and that licensees are obligated to carefully evaluate radiopharmaceuticals that are not encompassed in the report to keep exposures as low as reasonably achievable to patients, staff, and members of the public.
The recommendation passed unanimously with thirteen votes. This report was provided to the Regulatory Guide 8.39 working group for consideration in their development of revisions to the patient release instructions in the regulatory guide.
CONTACT: Kellee Jamerson, MSST/MSEB (301) 415-7408
C. Palestro 2 ITEM (2): The Committee endorsed the Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' Licensing Guidance Subcommittee report.
The recommendation passed unanimously with thirteen votes. The Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' Licensing Guidance, Revision 1, was issued on January 11, 2019.
ITEM (3): The NRC staff will provide the Committee with a copy of the Briefing on Results of the Agency Action Review Meeting presentation slides on Yttrium-90 microspheres; SECY-18-0048, Annual Report to the Commission on Licensee Performance in the Nuclear Materials and Waste Safety Program Fiscal Year 2017; and the Strategic Programmatic Overview of the Fuel Facilities and Nuclear Materials Users Business Lines Commission meeting slides related to Yttrium-90.
The requested materials will be provided to the Committee prior to the spring 2019 meeting.
ITEM (4): Dr. Palestro amended the membership of the Training and Experience for All Modalities Subcommittee. Subcommittee membership now includes Dr. Ennis, Dr. Metter (chair), Dr. Schleipman, Mr. Sheetz, Ms. Shober, and Ms. Weil. Ms. Maryann Ayoade remains the NRC resource.
No action required at this time.
ITEM (5): Dr. Palestro formed a subcommittee to review the Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance. Subcommittee membership includes Ms. Martin, Dr. Metter, Mr. Sheetz, and Ms. Shober (chair). Dr. Said Daibes is the NRC resource.
No action required at this time. This subcommittee will present at the spring 2019 meeting.
ITEM (6): Dr. Palestro formed a subcommittee to review the revisions to Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.
Subcommittee membership includes Dr. Dilsizian, Ms. Martin, Dr.
Schleipman, Mr. Sheetz (chair), Ms. Shober, and Ms. Weil. Dr. Said Daibes is the NRC resource.
No action required at this time. The NRC staff intends to provide draft Regulatory Guide 8.39 to the subcommittee in spring 2019. The Committee will hold a summer teleconference to receive and discuss the subcommittees comments, recommendations and report.
ITEM (7): Dr. Palestro formed a subcommittee to review the Yttrium-90 Microspheres Brachytherapy Sources and Devices TheraSphere and SIR_Spheres Licensing Guidance. Subcommittee membership includes Dr. Dilsizian, Ms. Martin, Dr. Metter, Dr. OHara (chair), Mr. Ouhib, and Dr. Schleipman. Dr. Katie Tapp is the NRC resource.
No action required at this time. This subcommittee will present at the spring 2019 meeting.
C. Palestro 3 ITEM (8): Dr. Palestro formed a subcommittee to review and update the ACMUI Bylaws, as needed, including a review of the role of the ACMUI Chair and his or her participation on subcommittees. Subcommittee membership includes Dr. Schleipman, Mr. Sheetz, Ms. Shober, and Ms. Weil (chair).
Ms. Sophie Holiday is the NRC resource.
No action required at this time. This subcommittee will present at the spring 2019 meeting.
ITEM (9): Dr. Palestro formed a subcommittee to review the appropriateness of the required elements of medical event reporting, the adherence to these requirements, and the recommended actions to improve reporting.
Subcommittee membership includes Dr. Dilsizian, Dr. Ennis (chair),
Ms. Martin, Mr. Ouhib, Ms. Shober, and Ms. Weil. Ms. Lisa Dimmick is the NRC resource.
No action required at this time. This subcommittee will present at the spring 2019 meeting.
ITEM (10): The Committee recommended that the NRC staff develop an Information Notice on the best practices that could help prevent medical events.
Staff will develop a generic communication to address the best practices that could help prevent medical events, pending resource availability.
ITEM (11): The Committee requested a list of all the current ACMUI members, their contact information, term information, and the subcommittee(s) each member serves on. The Committee also requested that the NRC staff update the ACMUI webpage to include a list of the active subcommittees and subcommittees that have culminated, their members with term expiration, NRC staff resource, and the specific charge of the subcommittee.
Ms. Jamerson will distribute the listing of all current ACMUI members, contact information, term information, and their respective subcommittee(s) prior to the spring 2019 meeting. Staff will create an ACMUI Web page that includes a list of active subcommittees and deactivated subcommittees, NRC staff resource, and the specific charge for each subcommittee. The Web page will go live prior to the spring 2019 meeting.
ITEM (12): The Committee tentatively scheduled the spring 2019 meeting for April 15-16, 2019. The alternative meeting date is April 3-4, 2019, subject to Commission availability.
The ACMUI will hold its meeting on April 3-4, 2019, with a Commission meeting scheduled for April 4, 2019.
C. Palestro 4 February 26, 2019 Teleconference Meeting ITEM (13): The Committee recommended adding language into the draft Training and Experience Requirements (T&E) for All Modalities Subcommittee Report regarding the Committees desire to work with the NRC staff to develop a curriculum for limited-scope authorized user (AU) pathway.
The recommendation to add the above language to the report passed unanimously with 12 votes. If and when the NRC pursues a limited-scope AU pathway, the NRC will engage the ACMUI to develop a curriculum, as appropriate.
ITEM (14): The Committee endorsed the Training and Experience Requirements for All Modalities Subcommittee Report, and the recommendations included therein.
The recommendation passed with 11 affirming votes and one dissenting vote. The Committees final report (ML19058A598) has been provided to the NRC staff for consideration in its development of the Commission paper to determine whether the staff should establish tailored T&E requirements for different categories of radiopharmaceuticals for which a written directive is required and whether significant regulatory changes to the NRC's T&E requirements for AUs are warranted.
C. Palestro 5
SUBJECT:
NRC ACTION IN RESPONSE TO THE SEPTEMBER 20-21, 2018 MEETING AND FEBRUARY 26, 2019 TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES DATE: MARCH 14, 2019 DISTRIBUTION:
ACMUI ML18361A919 *via email OFC MSST/MSEB MSST/MSEB MSST/MSEB MSST NAME KJamerson LDimmick* CEinberg* KWilliams for:
AKock DATE 2/28/2019 3/01/2019 3/01/2019 3/14/2019 OFFICIAL RECORD COPY