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{{#Wiki_filter:C. Einberg UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 26, 2022 MEMORANDUM TO: | {{#Wiki_filter:C. Einberg | ||
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 | |||
January 26, 2022 | |||
MEMORANDUM TO: Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards | |||
FROM: Sarah L. Lopas, Project Manager Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards | |||
==SUBJECT:== | ==SUBJECT:== | ||
==SUMMARY== | |||
OF JANUARY 5, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS C-SCAN SYSTEM INFORMATION AND RADIATION DOSE ASSESSMENT | |||
On January 5, 2022, the U.S. Nuclear Regulatory Commission (NRC) staff met with representatives from Check-Cap, Ltd. (Check -Cap) during a closed meeting to hear updates from Check-Cap on the C -Scan system design and results of Check-Caps radiation dose assessment of disposal of the C-Scan system to the sanitary sewerage. | |||
=== | |||
Background=== | |||
Check-Cap is a medical diagnostics company that is developing the C -Scan system, an ingestible scanning capsule-based system for the prevention of colorectal cancer through the x-ray detection of precancerous polyps. On March 15, 2020, Check -Cap requested interpretation of NRC regulations to confirm that Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applied to the dis posal of the C-Scan system in excreta (see Agencywide Documents Access and Management System [ADAMS] Accession No. ML21007A278). The NRC responded to Check-Caps request in a {{letter dated|date=January 27, 2021|text=letter dated January 27, 2021}} (ADAMS Accession No. ML21011A218), determining that the C-Scan system is not excreta in the form identified under 10 CFR 20.2003(b) that can disposed of in the sanitary sewerage. | |||
Meeting Summary | |||
During the January 5, 2022 closed meeting with the NRC, Check -Cap presented commercial proprietary information about the radioactive source in the C -Scan system and results from a radiation dose assessment of disposal of the C -Scan system to the sanitary sewerage. The | |||
CONTACT: Sarah Lopas, NMSS/MSST (301) 415-6360 | |||
C. Einberg 2 | |||
dose assessment estimated potential radiation doses that may be encountered by members of the public once C -Scan systems are excreted by patients and released in to the sanitary sewerage. Because the NRC staff has determined that the C -Scan system is not excreta that can be disposed of in the sanitary sewerage, Check -Cap conducted the public dose assessment to support potential regulatory actions related to sanitary sewerage disposal, such as exemption requests or a petition for rulemaking. The meeting concluded after Check -Cap provided its updates. Check -Cap may request additional meetings, but these meetings have not been scheduled as of the date of this meeting summary. | |||
The enclosure lists the closed meeting attendees. No written materials were prepared or distributed by the NRC staff for this meeting. | |||
C. Einberg 2 | |||
==SUBJECT:== | |||
==SUMMARY== | ==SUMMARY== | ||
OF JANUARY 5, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS C-SCAN SYSTEM INFORMATION AND RADIATION DOSE ASSESSMENT | OF JANUARY 5, 2022, CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS C-SCAN SYSTEM INFORMATION AND RADIATION DOSE ASSESSMENT | ||
DATE: January 26, 2022 | |||
C. | ENCLOSURE: | ||
As stated | |||
DISTRIBUTION: | |||
PUBLIC CFlannery, NMSS/MSST/MSEB VHolahan, NMSS/MSST ASchwartzman, NMSS/DUWP/RTAB CMcKenney, NMSS/DUWP/RTAB | |||
ADAMS Accession No.: ML22026A164 *via email NMSS/MSST/MSEB: NMSS/MSST/MSEB: NMSS/MSST/MSEB: NMSS/MSST/MSEB: | |||
OFFICE PM TL BC PM NAME SLopas CValentin-Rodriguez* CEinberg* SLopas DATE 01/24/2022 01/25/2022 01/25/2022 01/26/2022 OFFICIAL RECORD COP Y CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS C-SCAN IOION AADIIOSE ASSESSME | |||
y 5 M 10:MST | |||
Meeting Attendees | |||
Name Affiliation Chris tian Einberg U.S. NRC, Office of Nuclear Material Safety and Safeguards, Division of Materials Safety, Security, State, and Tribal Programs, Medical Safety and Events Assessment Branch (NRC/NMSS/MSST/MSEB) | |||
Celimar Valentin -Rodriguez NRC/NMSS/MSST/MSEB Cindy Flannery NRC/NMSS/MSST/MSEB Sarah Lopas NRC/NMSS/MSST/MSEB Vincent Holahan NRC/NMSS/MSST Chris McKenney NRC/NMSS, Division of Decommissioning, Uranium Recovery, and Waste Programs, Risk and Technical Analysis Branch Adam Schwartzman NRC/NMSS, Division of Decommissioning, Uranium Recovery, and Waste Programs, Risk and Technical Analysis Branch Ian Irvin NRC, Office of the General Counsel Angela Coggins NRC, Office of the General Counsel Yevgeny Zigelman Check -Cap, Ltd. | |||
Israel Hershko Check -Cap, Ltd. | |||
Yoav Kimchy Check -Cap, Ltd. | |||
Alex Ovadia Check -Cap, Ltd. | |||
Amy Roma Hogan Lovells US, LLP Stephanie Fishman Hogan Lovells US, LLP Jack Buddenbaum Plexus Scientific Corporation Dan Brague Brague Consulting, LLC | |||
Enclosure}} | |||
Latest revision as of 19:17, 18 November 2024
| ML22026A164 | |
| Person / Time | |
|---|---|
| Issue date: | 01/26/2022 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | Christian Einberg Office of Nuclear Material Safety and Safeguards |
| Sarah Lopas | |
| References | |
| Download: ML22026A164 (4) | |
Text
C. Einberg
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
January 26, 2022
MEMORANDUM TO: Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
FROM: Sarah L. Lopas, Project Manager Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF JANUARY 5, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS C-SCAN SYSTEM INFORMATION AND RADIATION DOSE ASSESSMENT
On January 5, 2022, the U.S. Nuclear Regulatory Commission (NRC) staff met with representatives from Check-Cap, Ltd. (Check -Cap) during a closed meeting to hear updates from Check-Cap on the C -Scan system design and results of Check-Caps radiation dose assessment of disposal of the C-Scan system to the sanitary sewerage.
=
Background===
Check-Cap is a medical diagnostics company that is developing the C -Scan system, an ingestible scanning capsule-based system for the prevention of colorectal cancer through the x-ray detection of precancerous polyps. On March 15, 2020, Check -Cap requested interpretation of NRC regulations to confirm that Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applied to the dis posal of the C-Scan system in excreta (see Agencywide Documents Access and Management System [ADAMS] Accession No. ML21007A278). The NRC responded to Check-Caps request in a letter dated January 27, 2021 (ADAMS Accession No. ML21011A218), determining that the C-Scan system is not excreta in the form identified under 10 CFR 20.2003(b) that can disposed of in the sanitary sewerage.
Meeting Summary
During the January 5, 2022 closed meeting with the NRC, Check -Cap presented commercial proprietary information about the radioactive source in the C -Scan system and results from a radiation dose assessment of disposal of the C -Scan system to the sanitary sewerage. The
CONTACT: Sarah Lopas, NMSS/MSST (301) 415-6360
C. Einberg 2
dose assessment estimated potential radiation doses that may be encountered by members of the public once C -Scan systems are excreted by patients and released in to the sanitary sewerage. Because the NRC staff has determined that the C -Scan system is not excreta that can be disposed of in the sanitary sewerage, Check -Cap conducted the public dose assessment to support potential regulatory actions related to sanitary sewerage disposal, such as exemption requests or a petition for rulemaking. The meeting concluded after Check -Cap provided its updates. Check -Cap may request additional meetings, but these meetings have not been scheduled as of the date of this meeting summary.
The enclosure lists the closed meeting attendees. No written materials were prepared or distributed by the NRC staff for this meeting.
C. Einberg 2
SUBJECT:
SUMMARY
OF JANUARY 5, 2022, CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS C-SCAN SYSTEM INFORMATION AND RADIATION DOSE ASSESSMENT
DATE: January 26, 2022
ENCLOSURE:
As stated
DISTRIBUTION:
PUBLIC CFlannery, NMSS/MSST/MSEB VHolahan, NMSS/MSST ASchwartzman, NMSS/DUWP/RTAB CMcKenney, NMSS/DUWP/RTAB
ADAMS Accession No.: ML22026A164 *via email NMSS/MSST/MSEB: NMSS/MSST/MSEB: NMSS/MSST/MSEB: NMSS/MSST/MSEB:
OFFICE PM TL BC PM NAME SLopas CValentin-Rodriguez* CEinberg* SLopas DATE 01/24/2022 01/25/2022 01/25/2022 01/26/2022 OFFICIAL RECORD COP Y CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS C-SCAN IOION AADIIOSE ASSESSME
y 5 M 10:MST
Meeting Attendees
Name Affiliation Chris tian Einberg U.S. NRC, Office of Nuclear Material Safety and Safeguards, Division of Materials Safety, Security, State, and Tribal Programs, Medical Safety and Events Assessment Branch (NRC/NMSS/MSST/MSEB)
Celimar Valentin -Rodriguez NRC/NMSS/MSST/MSEB Cindy Flannery NRC/NMSS/MSST/MSEB Sarah Lopas NRC/NMSS/MSST/MSEB Vincent Holahan NRC/NMSS/MSST Chris McKenney NRC/NMSS, Division of Decommissioning, Uranium Recovery, and Waste Programs, Risk and Technical Analysis Branch Adam Schwartzman NRC/NMSS, Division of Decommissioning, Uranium Recovery, and Waste Programs, Risk and Technical Analysis Branch Ian Irvin NRC, Office of the General Counsel Angela Coggins NRC, Office of the General Counsel Yevgeny Zigelman Check -Cap, Ltd.
Israel Hershko Check -Cap, Ltd.
Yoav Kimchy Check -Cap, Ltd.
Alex Ovadia Check -Cap, Ltd.
Amy Roma Hogan Lovells US, LLP Stephanie Fishman Hogan Lovells US, LLP Jack Buddenbaum Plexus Scientific Corporation Dan Brague Brague Consulting, LLC
Enclosure