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Category:Meeting Summary
MONTHYEARML23355A1422024-02-0505 February 2024
Summary of Public Meeting with Fusion Systems - Proposed Rule
ML23305A0092023-11-0909 November 2023
Summary of the October 26, 2023 Meeting with Tennessee Historical Commission Regarding Section 106 Consultations
ML23258A1822023-11-0909 November 2023
November 9, 2023 Public Meeting Summary - Fusion Systems Proposed Rule
ML23331A0042023-11-0808 November 2023
Meeting Summary of November 8, 2023, Cer Public Meeting on Renewing Nuclear Power Plant Operating Licenses - Environmental Review
ML23258A1692023-11-0101 November 2023
November 1, 2023 Summary of Public Meeting - Fusion Systems Proposed Rule
ML23319A2592023-10-25025 October 2023
10-25-2023 Public Meeting Summary - Increased Enrichment Rulemaking
ML23319A2602023-10-25025 October 2023
10-25-2023 Public Meeting Transcript - Increased Enrichment Regulatory Basis
ML23100A2112023-06-16016 June 2023
Meetings Summary: Public Meetings on Proposed Rule Renewing Nuclear Power Plant Operating Licenses Environmental Review
ML23100A2082023-04-0606 April 2023
Meeting Summary: Public Meeting on Proposed Rule Renewing Nuclear Power Plant Operating Licenses - Environmental Review
ML23100A2072023-04-0404 April 2023
Meeting Summary: Public Meeting on Proposed Rule Renewing Nuclear Power Plant Operating Licenses - Environmental Review
ML23100A2032023-03-30030 March 2023
Meeting Summary: Public Meeting on Proposed Rule Renewing Nuclear Power Plant Operating Licenses Environmental Review
ML23100A2132023-03-28028 March 2023
Meeting Summary: Public Meeting on Proposed Rule Renewing Nuclear Power Plant Operating Licenses - Environmental Review
ML23062A5052023-03-0303 March 2023
TRISO-X Fuel Fabrication Facility Scoping Meetings and Audit Summary - January 2023
ML23054A0022023-01-23023 January 2023
Summary of Public Meeting Regarding the Alternatives to the Use of Credit Ratings
ML22309A0062022-12-12012 December 2022
Public Non-Sensitive Meeting Summary on Clarification Call with Holtec Regarding Request for Additional Information for Indian Point Unit 2 Master Decommissioning Trust Agreement as Per Indian Point Nuclear Generating Facility Unit 1 and 2
ML22318A0862022-10-26026 October 2022
Public Meeting Summary - Proposed Rule - Harmonization of Transportation Safety Requirements with International Atomic Energy Agency Standards (Rin 3150-AJ85; NRC-2016-0179);
ML22298A2712022-10-0303 October 2022
NRC-TVA Public Meeting Summary
ML22206A1172022-08-18018 August 2022
Summary of July 21, 2022 Meeting with the National Marine Fisheries Service on Endangered Species Act Consultation for the San Onofre Nuclear Generating Station, Units 2 and 3, Decommissioning
ML21285A0412021-10-13013 October 2021
Summary of September 29, 2021 Meeting with the U.S. Fish and Wildlife Service Regarding Crocodile Monitoring at Turkey Point
ML21322A3172021-09-16016 September 2021
September 16, 2021 DOE-NRC Teleconference Summary for Hanford Vitrified Low Activity Waste (Vlaw) Draft Wir Evaluation
ML21267A0212021-09-0202 September 2021
September 02 2021 - ACMUI Teleconference Meeting Summary
ML21201A0702021-08-0505 August 2021
Summary of July 20, 2021, Meeting with the National Marine Fisheries Service Regarding Incidental Take of Kemps Ridley Sea Turtles at Salem Nuclear Generating Station, Units 1 and 2
ML21180A3632021-06-21021 June 2021
Rhode Island Department of Health Quarterly Monitoring Call Summary
ML21158A0572021-06-0707 June 2021
Summary of May 3, 2021, Teleconference with the U.S. Fish and Wildlife Service and Florida Power & Light Company Regarding Injured American Crocodile at Turkey Point Nuclear Generating Unit Nos. 3 and 4
ML21158A0582021-06-0707 June 2021
Summary of May 20, 2021, Teleconference with the Florida Power & Light Company Regarding Endangered and Threatened Species Reporting at Turkey Point Nuclear Generating Unit Nos. 3 and 4
ML21123A0622021-05-0505 May 2021
Summary of Public Meeting with Holtec International to Discuss Upcoming Application for Certificate of Compliance No. 1032 for the HI-STORM Flood/Wind, Amendment No. 7
ML21104A4032021-04-14014 April 2021
Summary of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Spring 2021 Meeting, March 16, 2021
ML21091A0242021-03-30030 March 2021
Call Between NRC and LES 2021-03-30
ML21089A0052021-03-0101 March 2021
Public Meeting Summary - Alternative Criteria for Postulating High-Energy Pipe Break Locations
ML21028A5022021-02-0101 February 2021
Summary of the January 5, 2021 Closed Meeting with Check-Cap Ltd. to Discuss the Applicability of 10 CFR 20.2003(b) for the Disposal of the C-Scan System to the Sanitary Sewer
ML20335A1122020-12-0707 December 2020
Summary of November 30, 2020, Meeting with the National Marine Fisheries Service and Dominion Energy, Inc. Regarding Atlantic Sturgeon Capture at Surry Power Station
ML20264E6912020-08-27027 August 2020
Summary of 8-27-2020 Retrospective Review of Administrative Requirements (Rroar) Initiative Public Meeting
ML20140A0062020-06-0303 June 2020
Summary of Meeting with Exubrion Therapeutic'S to Discuss Staff'S Request for Additional Information
ML20140A3572020-05-19019 May 2020
Summary of the Teleconference Meeting of the Advisory Committee on the Medical Uses of Isotopes (Acmui), April 30, 2020
ML20125A1652020-05-0404 May 2020
Summary of April 23, 2020, Teleconference with NMFS Regarding Incidental Take of Atlantic Sturgeon at Salem Nuclear Generating Station
ML20121A2592020-04-30030 April 2020
Westinghouse License Renewal - ISA Review- Conference Call Summary Dec 2017
ML20108F0652020-04-17017 April 2020
Summary of April 15, 2020, Teleconference with PSEG Nuclear, LLC Regarding Incidental Take of Atlantic Sturgeon at Salem
ML20106F0742020-04-16016 April 2020
Summary of the Closed Telephone Meeting with Check-Cap to Discuss Proprietary Information Related to Use and Marketing of Check-Cap in the United States
ML20091P5532020-03-31031 March 2020
Summary of Teleconference Meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI)
ML20083F5962020-03-23023 March 2020
Summary of Teleconference with the National Marine Fisheries Service for Indian Point Biological Opinion
ML20034F2862020-02-0303 February 2020
Summary of January 29, 2020, NRC-NMFS Teleconference Regarding St. Lucie Endangered Species Act Consultation
ML19340A4142019-12-18018 December 2019
Public Meeting Summary for November 18, 2019, Meeting - Public Meeting to Discuss the Issues Contained in PRM 72 7 and Additional Staff Identified Changes to 10 CFR Part 72
ML19336A0032019-12-0505 December 2019
11/7/2019 - Meeting Summary for Fitness for Duty Drug Testing Requirements Rulemaking
ML19319A4652019-11-15015 November 2019
Summary of Nov 6, 2019, Pre-Submittal Public Meeting with Exubrion Therapeutics
ML19322A6922019-10-30030 October 2019
Summary of 10-30-2019 Public Meeting
ML19273A9572019-10-0101 October 2019
Meeting Summary of Public Teleconference with Euxbrion Therapeutics to Discuss Options for Continued Discussions on the Use of Sn-117m in Dogs for the Treatment of Osteoarthritis
ML19274B8622019-09-11011 September 2019
September 10-11, 2019 Summary Meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Fall 2019 Meeting,
ML19221B6112019-08-14014 August 2019
Public Meeting Summary of 08082019, Physical Security for Advanced Reactors Rulemaking
ML19176A1432019-06-26026 June 2019
Category 3 Public Meeting Summary for Enhanced Weapons Supplemental Commission Paper
ML19163A2772019-06-20020 June 2019
Enclosure 1 - Public Meeting Summary: Brainstorming and Scoping Workshop on the NRC Initiatives for Building a Smarter Fuel Cycle Licensing and Oversight Program
2024-02-05
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TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES March 11, 2020 MEETING
SUMMARY
PURPOSE To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Regulatory Guide 8.39 Subcommittees draft report on the final recommendations for the draft final Phase 1 revision to Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.
OUTCOME The ACMUI Regulatory Guide 8.39 Subcommittee provided a draft report for discussion with the full Committee. Subcommittee members include: Mr. Gary Bloom, Dr. Vasken Dilsizian, Ms.
Melissa Martin, Dr. A. Robert Schleipman, Mr. Michael Sheetz (Chair), and Ms. Megan Shober.
The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the ACMUIs comments while finalizing Phase 1 of the draft proposed Regulatory Guide 8.39, which will be issued in April 2020. A full transcript and handout for the ACMUI teleconference meeting can be found on the NRCs public web site at:
https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2020.html.
The ACMUI Regulatory Guide 8.39 Subcommittee report is available on the NRCs public web site under ACMUI Subcommittee Reports: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.
AGENDA TOPIC Draft Final Phase 1 revisions to Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.
SUMMARY
The ACMUI Regulatory Guide 8.39 Subcommittee presented its draft report (Agencywide Documents and Access Management System (ADAMS) Accession No. ML20056D823), which focused on final recommendations that only pertained to the final draft Phase 1 revision to Regulatory Guide 8.39. In its report, the Subcommittee provided for consideration, several specific comments and recommendations which directed changes pertaining to wording, items of emphasis, and formatting. The draft subcommittee report was endorsed by the full Committee.
RECOMMENDATIONS AND ACTIONS The Regulatory Guide 8.39 Subcommittee discussed the following recommendations from the Subcommittee report.
- 1. In the Patient Precautions and Instructions Sections, it should be emphasized that the major source of radiation dose to other individuals will be from external exposure from
the patient. Therefore, the most important precautions to take are measures to reduce or avoid the external radiation exposure from the patient, especially in the early time period after administration of the radionuclide therapy.
- 2. The patient instructions should be simple, clear, and concise.
- 3. Discussions on the radionuclide therapy procedure and release instructions should also include a caregiver or family member, if possible.
- 4. Instructions should also be provided on how long the precautions should be followed.
As a guideline, the licensee may consider using several (3-5) effective half-lives of the radionuclide therapy.
- 5. The Regulatory Guide should not include instructions that are excessive, likely to cause patient anxiety, and not likely to reduce public exposures.
- 6. Table 1, 2, and A1 should be updated to include the new and potential radionuclides used in medicine.
- 7. In Table 3, Activities of Radiopharmaceuticals That Require Instructions and Records When Administered to Patients Who Are Breastfeeding an Infant or Child, the subcommittee supports the guidance for a standardized interruption time period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for all Tc-99m radionuclides, and the recommended interruption period to limit the dose to the nursing infant to 1 millisievert (mSv), and not the regulatory limit of 5 mSv.
The ACMUI unanimously approved the draft Regulatory Guide 8.39 Subcommittee Report, as presented, during its public teleconference meeting on March 11, 2020. The recommendations above can be viewed, in their entirety, in the final Regulatory Guide 8.39 Subcommittee Report (ADAMS Accession No. ML20085H267) on the NRCs ACMUI Subcommittee Reports webpage.
Enclosures:
- 1. Meeting Attendees
- 2. Teleconference Agenda
MEETING PARTICIPANTS ACMUI Darlene F. Metter, M.D. Chairman A. Robert Schleipman, PhD Vice Chairman Gary Bloom Member Vasken Dilsizian, M.D. Member Richard Green Member Melissa Martin Member Michael D. OHara, M.D. Member Zoubir Ouhib Member Michael Sheetz Member Megan Shober Member Harvey B. Wolkov, M.D. Member NRC STAFF Christian Einberg Chief, Medical Safety and Events Assessment Branch (MSEB)/Designated Federal Officer Lisa Dimmick Medical Radiation Safety Team Leader, NMSS/MSST/MSEB Kellee Jamerson Designated Federal Officer/ACMUI Coordinator Said Daibes Figueroa, Ph.D. NMSS/MSST/MSEB Daniel Dimarco NMSS/MSST/MSEB Jennifer Fisher NMSS/MSST/MSEB Anita Gray, Ph.D. NMSS/MSST/SMPB Vincent Holahan, Ph.D. NMSS/MSST Esther Houseman OGC/GCLR/RMR Donna-Beth Howe, Ph.D. NMSS/MSST/MSEB Penny Lanzisera R-I/DNMS/MLAB Sarah Lopas NMSS/MSST/MSEB Jeffery Lynch NMSS/MSST/SLPB Minh-Thuy Nguyen RES/DSA/RPB Vered Shaffer RES/DSA/RPB Katherine Tapp, Ph.D. NMSS/MSST/MSEB John Tomon RES/DSA/RPB Irene Wu NMSS/MSST/MSEB MEMBERS OF THE PUBLIC Jaime Barnes Cook Childrens Medical Center Roland Benke Renaissance Code Development, LLC Lisa Bruedigan Texas Department of State Health Services Tina Buehner Unaffiliated David Crowley North Carolina Department of Health and Human Services, Radiation Protection Section Elizabeth Franklin Atrium Health Noelle Geier Froedtert & The Medical College of Wisconsin Jennifer Gersman Northwestern Medicine Enclosure 1
Phil Goble Utah Division of Waste Management and Radiation Control Miguel de la Guardia Cook Childrens Medical Center Stanley Hampton Eli Lilly Curtis Hicks, Jr. Scripps Health Bill Hinchcliffe Yale New Haven Health Mary Ellen Jafari Gundersen Health Tyler Kruse Minnesota Radioactive Materials Unit Ralph Lieto St. Joseph Mercy Health System Carol Marcus, Ph.D., M.D. University of California at Los Angeles Steven Marsh Baystate Health Richard Martin American Association of Physicists in Medicine Jeffrey Mason Department of Veterans Affairs Candi McDowell University of Pennsylvania Mary Moore CMC Veterans Affairs Medical Center Lora Moyle North Carolina State University Michael Peters American College of Radiology Carmine Plott Novant Health Daniel Samson New York State Department of Health Jeffry Siegel, Ph.D. Nuclear Physics Enterprises Eric Skotak Texas Department of State Health Services Cindy Tomlinson American Society for Radiation Oncology Brian Vamvakias Texas Department of State Health Services Karen Wheeler Bio-Med Associates William White Rush University Matthew Williamson Memorial Sloan Kettering Cancer Center Melonie Wissing Department of Veterans Affairs 2
Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Wednesday, March 11, 2020 2:00 PM - 4:00 PM (ET)
OPEN SESSION 2:00 pm - 4:00 pm Discuss the Draft ACMUI Subcommittee Report for the Final Draft of Regulatory Guide 8.39, Release of Patients Administered Radioactive Material Phase 1 Revisions Enclosure 2