ML21028A502: Difference between revisions

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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}}

Revision as of 08:20, 18 January 2022

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
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)


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