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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 31, 2022 MEMORANDUM TO: | {{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 | ||
March 31, 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== | ==SUMMARY== | ||
OF FEBRUARY 22, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS THE U.S. NUCLEAR REGULATORY COMMISSIONS PETITION FOR RULEMAKING PROCESS | OF FEBRUARY 22, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS THE U.S. NUCLEAR REGULATORY COMMISSIONS PETITION FOR RULEMAKING PROCESS | ||
===Background=== | === | ||
Check-Cap Ltd. (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 U.S. Nuclear Regulatory Commission (NRC) regulations to determine whether Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applied to the disposal of the C-Scan system in excreta (Agencywide Documents Access and Management System | Background=== | ||
[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. | Check-Cap Ltd. (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 U.S. Nuclear Regulatory Commission ( NRC) regulations to determine whether Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applied to the disposal of the C-Scan system in excreta (Agencywide Documents Access and Management System | ||
Meeting Summary On February 22, 2022, NRC staff met with representatives from Check-Cap during a closed meeting to discuss the NRCs petition for rulemaking process. The NRC staff informed Check-Cap that NRC regulations related to petitions for rulemaking can be found in Subpart H, Rulemaking, of 10 CFR Part 2, Agency Rules of Practice and Procedure. The NRC staff | [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. Subs equently, during a 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 Check-Caps radiation dose assessment of disposal of the C-Scan system to the sanitary sewerage (ADAMS Accession No. ML22026A164). Following the January 5, 2022 meeting, Check -Cap had additional questions for NRC staff regarding potential regulatory actions r elated to sanitary sewerage disposal of the C-Scan system. | ||
Meeting Summary | |||
On February 22, 2022, NRC staff met with representatives from Check -Cap during a closed meeting to discuss the NRCs petition for rulemaking process. The NRC staff informed Check-Cap that NRC regulations related to petitions for rulemaking can be found in Subpart H, Rulemaking, of 10 CFR Part 2, Agency Rules of Practice and Procedure. The NRC staff C. Einberg 2 | |||
described the process for filing, docketing, tracking, closing, amending, withdrawing, and resolving a petition for rulemaking; discussed the regulatory basis for 10 CFR 20.2003(b), which is documented in the statements of consideration in the 1991 final rule amending 10 C FR Part 20, Standards for Protection Against Radiation ( May 21, 1991; 56 FR 23381) ; and discussed compatibility of Agreement State regulations with certain NRC regulations. | |||
The staff provided Check-Cap with the following links for additional information: | The staff provided Check-Cap with the following links for additional information: | ||
* The NRCs petition for rulemaking process at https://www.nrc.gov/about-nrc/regulatory/rulemaking/petition-rule.html | * The NRCs petition for rulemaking process at https://www.nrc.gov/about-nrc/regulatory/rulemaking/petition-rule.html | ||
* State Agreements Procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements (ADAMS Accession No. ML20183A325) at https://www.nrc.gov/docs/ML2018/ML20183A325.pdf | * State Agreements Procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements (ADAMS Accession No. ML20183A325) at https://www.nrc.gov/docs/ML2018/ML20183A325.pdf | ||
* Review summary sheets for regulation adoption for | * Review summary sheets for regulation adoption for n ew Agreement States/p rograms at https://scp.nrc.gov/regsumsheets_newregs.html | ||
The enclosure lists the closed meeting attendees. No written materials were prepared or distributed by the NRC staff for this meeting. | |||
C. Einberg 3 | |||
==SUBJECT:== | |||
==SUMMARY== | |||
OF FEBRUARY 22, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS THE U.S. NUCLEAR REGULATORY COMMISSIONS PETITION FOR RULEMAKING PROCESS | |||
DATE: March 31, 2022 | |||
ENCLOSURE: | |||
As stated | |||
DISTRIBUTION: | |||
PUBLIC CFlannery, NMSS/MSST/MSEB VHolahan, NMSS/MSST ASchwartzman, NMSS/DUWP/RTAB CMcKenney, NMSS/DUWP/RTAB CBladey, NMSS/REFS/RASB | |||
ADAMS Accession No.: ML 22090A096 *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 03/31/2022 03/31/2022 03/31/2022 03/31/2022 OFFICIAL RECORD COP Y CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS THE PETITION FOR RULEMAKING PROCESS | |||
February 22, 2022 9:00 AM - 10:00 AM EST | |||
Meeting Attendees | |||
Name Affiliation Christian 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 Cindy Bladey NRC, Division of Rulemaking, Environmental, and Financial Support, Regulatory Analysis and Rulemaking Support 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 | |||
ENCLO SURE}} | |||
Revision as of 12:31, 18 November 2024
| ML22090A096 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/2022 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| Sarah Lopas, X6360 | |
| References | |
| Download: ML22090A096 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
March 31, 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 FEBRUARY 22, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS THE U.S. NUCLEAR REGULATORY COMMISSIONS PETITION FOR RULEMAKING PROCESS
=
Background===
Check-Cap Ltd. (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 U.S. Nuclear Regulatory Commission ( NRC) regulations to determine whether Title 10 of the Code of Federal Regulations (10 CFR) 20.2003(b) applied to the disposal of the C-Scan system in excreta (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. Subs equently, during a 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 Check-Caps radiation dose assessment of disposal of the C-Scan system to the sanitary sewerage (ADAMS Accession No. ML22026A164). Following the January 5, 2022 meeting, Check -Cap had additional questions for NRC staff regarding potential regulatory actions r elated to sanitary sewerage disposal of the C-Scan system.
Meeting Summary
On February 22, 2022, NRC staff met with representatives from Check -Cap during a closed meeting to discuss the NRCs petition for rulemaking process. The NRC staff informed Check-Cap that NRC regulations related to petitions for rulemaking can be found in Subpart H, Rulemaking, of 10 CFR Part 2, Agency Rules of Practice and Procedure. The NRC staff C. Einberg 2
described the process for filing, docketing, tracking, closing, amending, withdrawing, and resolving a petition for rulemaking; discussed the regulatory basis for 10 CFR 20.2003(b), which is documented in the statements of consideration in the 1991 final rule amending 10 C FR Part 20, Standards for Protection Against Radiation ( May 21, 1991; 56 FR 23381) ; and discussed compatibility of Agreement State regulations with certain NRC regulations.
The staff provided Check-Cap with the following links for additional information:
- The NRCs petition for rulemaking process at https://www.nrc.gov/about-nrc/regulatory/rulemaking/petition-rule.html
- State Agreements Procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements (ADAMS Accession No. ML20183A325) at https://www.nrc.gov/docs/ML2018/ML20183A325.pdf
- Review summary sheets for regulation adoption for n ew Agreement States/p rograms at https://scp.nrc.gov/regsumsheets_newregs.html
The enclosure lists the closed meeting attendees. No written materials were prepared or distributed by the NRC staff for this meeting.
C. Einberg 3
SUBJECT:
SUMMARY
OF FEBRUARY 22, 2022 CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS THE U.S. NUCLEAR REGULATORY COMMISSIONS PETITION FOR RULEMAKING PROCESS
DATE: March 31, 2022
ENCLOSURE:
As stated
DISTRIBUTION:
PUBLIC CFlannery, NMSS/MSST/MSEB VHolahan, NMSS/MSST ASchwartzman, NMSS/DUWP/RTAB CMcKenney, NMSS/DUWP/RTAB CBladey, NMSS/REFS/RASB
ADAMS Accession No.: ML 22090A096 *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 03/31/2022 03/31/2022 03/31/2022 03/31/2022 OFFICIAL RECORD COP Y CLOSED MEETING WITH CHECK-CAP LTD. TO DISCUSS THE PETITION FOR RULEMAKING PROCESS
February 22, 2022 9:00 AM - 10:00 AM EST
Meeting Attendees
Name Affiliation Christian 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 Cindy Bladey NRC, Division of Rulemaking, Environmental, and Financial Support, Regulatory Analysis and Rulemaking Support 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
ENCLO SURE