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. 1, 2021 MEMORANDUM TO: Christian E. Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards Signed by Wu, Irene FROM: Irene Wu, Project Manager , on 02/01/21 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 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 On January 5, 2021, the U.S. Nuclear Regulatory Commission (NRC) staff held a closed meeting with representatives from Check-Cap, Ltd. (Check-Cap) to discuss their request (Agencywide Documents Access and Management System [ADAMS] ADAMS Accession No. ML21007A278) to seek an interpretation of NRCs regulations to confirm that Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applies to the disposal of the C-Scan (C-Scan) system in excreta. In total, 17 people participated in the meeting. The meeting attendance list is enclosed. | |||
NRC staff opened up the meeting with an overview of its evaluation, including whether the colon-imaging capsule from the C-Scan system is considered excreta, information from past statements of consideration related to the promulgation and revision of 10 CFR Part 20, and the prospects associated with disposing of the C-Scan capsule in the sanitary sewer system. NRC staff then discussed how the disposal of the capsule to the sanitary sewer is not permissible under the current regulatory framework because staff does not consider the C-Scan system as excreta and past statements of consideration for 10 CFR Part 20 included a discussion of why nonbiological insoluble materials are not permitted for disposal into the sanitary sewers. NRC staff discussed that they have additional concerns about the ultimate disposal because they could be found in the public domain. Check-Cap provided some additional information on their upcoming planned clinical trial and detailed technical information on the battery life and how the CONTACT: Irene Wu, NMSS/MSST (301) 415-1951 | |||
C. Einberg 2 sensors on the back signal when the C-Scan system is eliminated from the body. Check-Cap then asked about whether they could submit an exemption request. NRC staff indicated that the licensee would be the entity to request an exemption from the appropriate regulatory agency and that pursuing exemptions would not be the preferred path forward for the pivotal trial nor for commercial distribution. NRC staff then discussed the possibility of Check-Cap submitting a petition for rulemaking to request a change to the existing regulations. Check-Cap also raised the question of whether they could perform a limited trial to see what happens to the C-Scan system if they dispose of it in the sanitary sewer. NRC staff indicated that Check-Cap would need to provide a concrete proposal for the NRC to evaluate before determining if a controlled test could be performed. NRC staff concluded the meeting by informing Check-Cap that the staffs formal response is being developed and will be issued by the end of the month. | |||
==Enclosure:== | |||
Meeting Attendees | |||
Meeting Attendees 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 January 5, 2021 11:00 AM - 12:00 PM ET Name Organization 1 Irene Wu NRC 2 Christian Einberg NRC 3 Ian Irvin NRC 4 Adam Schwartzman NRC 5 Theresa Clark NRC 6 Vincent Holahan NRC 7 Lisa Dimmick NRC 8 Chris McKenney NRC 9 Yevgeny Zigelman Check-Cap Ltd. | |||
10 Yaara Tirosh Check-Cap Ltd. | |||
11 Alex Ovadia Check-Cap Ltd. | |||
12 Michael Smirnov Check-Cap Ltd. | |||
13 Israel Hershko Check-Cap Ltd. | |||
14 Boaz Shpigelman Check-Cap Ltd. | |||
15 Yoav Kimchy Check-Cap Ltd. | |||
16 Sachin Desai Hogan Lovells US LLP 17 Amy Roma Hogan Lovells US LLP Enclosure | |||
Memo ML21028A502 NMSS/MSST NMSS/MSST/MSEB NMSS/MSST OFFICE NMSS/MSST/MSEB | |||
/MSEB /MRST /MSEB NAME IWu IW LDimmick LD CEinberg CE IWu IW DATE Jan 28, 2021 Feb 1, 2021 Feb 1, 2021 Feb 1, 2021}} | |||
Latest revision as of 19:59, 20 January 2022
| ML21028A502 | |
| Person / Time | |
|---|---|
| Issue date: | 02/01/2021 |
| From: | Irene Wu Office of Nuclear Material Safety and Safeguards |
| To: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| WU, I/NMSS/MSST | |
| References | |
| Download: ML21028A502 (4) | |
Text
February
. 1, 2021 MEMORANDUM TO: Christian E. Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards Signed by Wu, Irene FROM: Irene Wu, Project Manager , on 02/01/21 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 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 On January 5, 2021, the U.S. Nuclear Regulatory Commission (NRC) staff held a closed meeting with representatives from Check-Cap, Ltd. (Check-Cap) to discuss their request (Agencywide Documents Access and Management System [ADAMS] ADAMS Accession No. ML21007A278) to seek an interpretation of NRCs regulations to confirm that Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applies to the disposal of the C-Scan (C-Scan) system in excreta. In total, 17 people participated in the meeting. The meeting attendance list is enclosed.
NRC staff opened up the meeting with an overview of its evaluation, including whether the colon-imaging capsule from the C-Scan system is considered excreta, information from past statements of consideration related to the promulgation and revision of 10 CFR Part 20, and the prospects associated with disposing of the C-Scan capsule in the sanitary sewer system. NRC staff then discussed how the disposal of the capsule to the sanitary sewer is not permissible under the current regulatory framework because staff does not consider the C-Scan system as excreta and past statements of consideration for 10 CFR Part 20 included a discussion of why nonbiological insoluble materials are not permitted for disposal into the sanitary sewers. NRC staff discussed that they have additional concerns about the ultimate disposal because they could be found in the public domain. Check-Cap provided some additional information on their upcoming planned clinical trial and detailed technical information on the battery life and how the CONTACT: Irene Wu, NMSS/MSST (301) 415-1951
C. Einberg 2 sensors on the back signal when the C-Scan system is eliminated from the body. Check-Cap then asked about whether they could submit an exemption request. NRC staff indicated that the licensee would be the entity to request an exemption from the appropriate regulatory agency and that pursuing exemptions would not be the preferred path forward for the pivotal trial nor for commercial distribution. NRC staff then discussed the possibility of Check-Cap submitting a petition for rulemaking to request a change to the existing regulations. Check-Cap also raised the question of whether they could perform a limited trial to see what happens to the C-Scan system if they dispose of it in the sanitary sewer. NRC staff indicated that Check-Cap would need to provide a concrete proposal for the NRC to evaluate before determining if a controlled test could be performed. NRC staff concluded the meeting by informing Check-Cap that the staffs formal response is being developed and will be issued by the end of the month.
Enclosure:
Meeting Attendees
Meeting Attendees 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 January 5, 2021 11:00 AM - 12:00 PM ET Name Organization 1 Irene Wu NRC 2 Christian Einberg NRC 3 Ian Irvin NRC 4 Adam Schwartzman NRC 5 Theresa Clark NRC 6 Vincent Holahan NRC 7 Lisa Dimmick NRC 8 Chris McKenney NRC 9 Yevgeny Zigelman Check-Cap Ltd.
10 Yaara Tirosh Check-Cap Ltd.
11 Alex Ovadia Check-Cap Ltd.
12 Michael Smirnov Check-Cap Ltd.
13 Israel Hershko Check-Cap Ltd.
14 Boaz Shpigelman Check-Cap Ltd.
15 Yoav Kimchy Check-Cap Ltd.
16 Sachin Desai Hogan Lovells US LLP 17 Amy Roma Hogan Lovells US LLP Enclosure
Memo ML21028A502 NMSS/MSST NMSS/MSST/MSEB NMSS/MSST OFFICE NMSS/MSST/MSEB
/MSEB /MRST /MSEB NAME IWu IW LDimmick LD CEinberg CE IWu IW DATE Jan 28, 2021 Feb 1, 2021 Feb 1, 2021 Feb 1, 2021