ML25050A035
| ML25050A035 | |
| Person / Time | |
|---|---|
| Issue date: | 02/19/2025 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| References | |
| Download: ML25050A035 (1) | |
Text
PROGRAM ELEMENTS: REGULATION AND NON-REGULATION 2015-PRESENT The Agreement State Program Policy Statement defines program element as any component or function of a radiation control regulatory program, including regulations or other legally binding requirements imposed on regulated persons, which contributes to implementation of that program. It identifies those NRC program elements required for adequacy and having a particular health and safety component as those that are designated as Compatibility Categories A, B, C, D, NRC, and H&S: and those required for compatibility include those regulations and other legally binding requirements designated as Compatibility Categories A, B and C.
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments STC-24-068 Availability of Final Revisions to Procedure SA-300 and the Handbook on Nuclear Material Event Reporting for the Agreement States December 17, 2024 December 17, 2024 C
STC-24-065 Notification Of Issuance of Eye90 Microspheres Licensing Guidance December 10, 2024 June 10, 2025 C
STC-24-051 Notification Of Issuance of Akesis Galaxy Rti Gamma Stereotactic Radiotherapy Licensing Guidance August 29, 2024 February 28, 2025 C
STC-24-006 Licensing Guidance Memo for Technegas Aerosol and Technegas Plus System January 24, 2024 July 24, 2024 C
STC-24-005 Issuance of Materials inspection Procedures Associated with January 19, 2024 January 19, 2025 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments inspection Manual Chapter 2800, Materials inspection Program STC-23-056 Licensing Guidance Memo for Superficial Manual Brachytherapy Civaderm Device' July 28, 2023 January 28, 2024 C*
- The SSC determined that Civaderm Device' should be licensed under 10 CFR 35.400, but additional guidance for patient release considerations be provided.
STC-23-044 Notification of Revisions to inspection Manual Chapter (IMC) 2800, Materials inspection Program June 20, 2023 June 20, 2024 C
STC-23-029 Notification of the Issuance of Procedure SA-900, Termination of Uranium Milling Licenses in Agreement States April 26, 2023 October 26, 2023 C
STC-22-054 Issuance of NUREG-1757, Volume 2, Revision 2, Consolidated Decommissioning
- Guidance, Characterization, Survey, and Determination of Radiological Criteria.
September 1, 2022 March 2, 2023 C*
- The Standing Committee on Compatibility noted that since some Agreement States do not allow for license termination under restricted conditions as stated in
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments 10 CFR 20.1403, certain parts of this NUREG may not apply.
(06/18/2020)
STC-22-028 Issuance of Materials inspection Procedures Associated with IMC 2800-Materials inspection Program May 5, 2022 May 5, 2023 C
Agreement State due date was extended to one year.
STC-22-016 Notification of Issuance of Alpha Tau Alpha DartTM Manual Brachytherapy Licensing Guidance March 14, 2022 September 14, 2022 C
STC-21-085 Issuance of Revision 2 of the Northstar Medical Radioisotopes, LLC Radiogenix Molybdenum-99/Technetium-99m Generator System Licensing Guidance for Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies December 17, 2021 June 17, 2022 C
STC-21-082 Revision of the Chronology of the U.S.
Nuclear Regulatory Commission (NRC)
Amendments including December 30, 2021 December 30, 2024 Various-See Summary of Change Document
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Summary of Change Document for Miscellaneous Corrections [RATS ID 2021-2]
STC-21-060 Revision of the Chronology of the U.S.
Nuclear Regulatory Commission (NRC)
Amendments including Summary of Change Document for Miscellaneous Corrections [RATS ID 2021-1]
September 8, 2021 September 8, 2024 Various-See Summary of Change Document STC-21-020 Notification of Issuance of Revision 10.2 of Yttrium-90 Microsphere Brachytherapy Sources and Devices Therasphere and Sir-Spheres Licensing Guidance April 21, 2021 October 21, 2021 C
STC-20-082 Notification that Major Revision to inspection Manual Chapter (IMC) 2800, Materials inspection Program Is a Matter of Compatibility and to Provide Additional information As December 4, 2020 June 4, 2021 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Recommended By the Standing Committee on Compatibility STC-20-081 Publication of NUREG-1556, Volume 20, Revision 1, Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures December 4, 2020 June 4, 2021 C
STC-20-073 Revision of the Chronology of the U.S.
Nuclear Regulatory Commission (NRC)
Amendments including Summary of Change Document for Miscellaneous Corrections [RATS ID 2020-3]
October 16, 2020 November 16, 2023 VARIOUS-SEE
SUMMARY
OF CHANGE DOCUMENT STC-20-057 Revision of the Chronology of the U.S.
Nuclear Regulatory Commission (NRC)
Amendments including Summary of Change Document for Social Security Number Fraud Prevention, 10 CFR June 2, 2020, August 17, 2023 Part 35 regulations included in this rulemaking are a C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Parts 9, and 35 [RATS ID 2020-2]
STC-20-042 Notification of Issuance of an Addendum to State and Tribal Communications (STC)
Letter STC-20-035 Regarding the Document, Guidance for the Reviews of Proposed Disposal Procedures and Transfers of Radioactive Material Under 10 CFR 20.2002 and 10 CFR 40.13(A)
June 5, 2020 December 5, 2020 C
STC-20-035 Notification Of Issuance of The Document, Guidance for the Reviews Of Proposed Disposal Procedures and Transfers of Radioactive Material Under 10 CFR 20.2002 And 10 CFR 40.13(A)
April 30, 2020 December 5, 2020*
C
- Due date extended; see STC-20-042 STC-20-034 Revision of the Chronology of the U.S.
Nuclear Regulatory Commission Amendments including Summary of Change Document for individual April 23, 2020 June 16, 2023 VARIOUS-SEE
SUMMARY
OF CHANGE DOCUMENT
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Monitoring Devices, 10 CFR Parts 34, 36, and 39 [RATS ID 2020-1]
Medical generic communication Revision I to Regulatory Guide 8.39, Release of Patients Administered Radioactive Material April 8, 2020 NA D
STC-20-023 Notification of Major Revision to inspection Manual Chapter (IMC) 2800, Materials inspection Program and Canceling of IMC 1220, Processing of NRC form 241, Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and offshore Waters, and inspection of Agreement State Licensees Operating Under 10 CFR 150.20 March 13, 2020 September 13, 2020 C
STC-20-006 Availability of Revision 1 of the Northstar Medical Radioisotopes, LLC, Radiogenix' Molybdenum-99/Technetium-99m Generator System, Licensing Guidance for January 16, 2020 July 16, 2020 C
NOTE: on 09/30/2020 the NRC issued a Temporary Addendum to the NorthStar Medical Radioisotopes, LLC, RadioGenix Molybdenum-99/Technetium-99m
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies (STC 006)
Generator System Licensing Guidance for Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies, Revision 1(See ML20268A919)
STC-19-080 Revision of the Chronology of the U.S.
Nuclear Regulatory Commission (NRC)
Amendments including Summary of Change Document for organizational Changes and Conforming Amendments to 10 CFR Parts 1, 2, 37, 40, 50, 51, 52, 55, 71, 72, 73, 74, 100, 140, and 150
[RATS ID 2019-2]
December 23, 2019 December 30, 2022 VARIOUS-SEE
SUMMARY
OF CHANGE DOCUMENT STC-19-077 and STC 20-003 (issuing corrected version of Summary of Revision of the Chronology of the U.S.
Nuclear Regulatory Commission (NRC)
Amendments including Summary of Change November 26, 2019 July 30, 2022 VARIOUS-SEE
SUMMARY
OF CHANGE DOCUMENT the due date was extended because the Agreement States were not notified timely.
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Change document)
Document for Miscellaneous Corrections to 10 CFR PARTS 1, 2, 34, 37, 50, 71, 73, and 140 [RATS ID 2018-3]
This RATS ID was issued out of chronological order.
STC-19-076 Revision of the Chronology of the U.S.
Nuclear Regulatory Commission (NRC)
Amendments including Summary of Change Document for Miscellaneous Corrections to 10 CFR Parts 2, 21, 37, 50, 52, 73, and 110 [Rats Id 2019-1]
November 21, 2019 December 18, 2022 VARIOUS-SEE
SUMMARY
OF CHANGE DOCUMENT STC-19-073 Notification of Issuance of Yttrium-90 Microsphere Brachytherapy Licensing Guidance, Revision 10 Revision 10.1 November 8, 2019 April 21, 2020
- November 6, 2020 C
- Date was extended from May to November This revision made a slight update to the training and experience section as NRC has been alerted of concerns that requiring future Authorized User (AU) case work to be
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments conducted in the physical presence of an AU is a significant change from past revisions and if implemented immediately, could cause a delay in training future physicians.
therefore, the NRC is allowing clinical casework to be conducted in the physical presence of a manufacturer representative until November 8, 2021.
STC-19-061 Publication of NUREG-1556, Volume 9, Revision 3, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses October 3, 2019 April 3, 2020 C
STC-19-048 Notification of Issuance of Germanium-68/Gallium-68 Pharmaceutical Grade July 25, 2019 January 25, 2020 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Generators Licensing Guidance STC-19-019 Publication of NUREG-1556, Volume 13, Revision 2, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses March 28, 2019 September 28, 2019 C
STC-19-001 Notification of Issuance of Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' Licensing Guidance, Revision 1 January 10, 2019 July 10, 2019 C
STC-18-071 Publication of the Draft Revision of instructions for Completing NRCs Uniform Low-Level Radioactive Waste Manifest November 30, 2018 May 30, 2019 C
STC-18-054 Publication of NUREG-1556, Volume 17, Revision 1, Consolidated Guidance About Materials Licenses: Program-July 23, 2018 January 23, 2019 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Specific Guidance About Special Nuclear Material of Less Than Critical Mass Licenses STC-18-050 Publication of NUREG-1556, Volume 16, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees July 10, 2018 January 10, 2019 C
STC-18-046 Publication of NUREG-1556, Volume 5, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator Licenses June 28, 2018 December 28, 2018 C
STC-18-042 Licensing of Lutetium-177 June 21, 2018 December 21, 2018 C
STC-18-040 Publication of NUREG-1556, Volume 8, Revision 1, Consolidated Guidance June 19, 2018 December 19, 2018 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses STC-18-036 Publication of NUREG-1556, Volume 21, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator May 29, 2018 November 29, 2018 C
STC-18-034 Publication of NUREG-1556, Volume 12, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution May 25, 2018 November 25, 2018 C
STC-18-035 Issuance of Revision to Management Directive 5.9 Adequacy and Compatibility of Program May 25, 2018 November 25, 2018 D
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Elements for Agreement State Programs STC-18-029 Publication of NUREG-1556, Volume 14, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Well Logging, Tracer, and Field Flood Study Licenses May 8, 2018 November 8, 2018 C
STC-18-020 Publication of NUREG-1556, Volume 7, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope including Electron Capture Devices and X-Ray Fluorescence Analyzers March 9, 2018 September 9, 2018 C
STC-18-006 Publication of NUREG-1556, Volume 6, Revision 1, Consolidated Guidance February 7, 2018 August 7, 2018 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments About Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses STC-17-060 Clarification of Title 10 of the Code of Federal Regulations Part 71 Requirements Identified in Regulation Amendment Tracking System Identification Number RATS ID 2015-3 August 15, 2017 August 15, 2020 VARIOUS FOR PART 71 REQUIREMENTS This correspondence extended the Agreement State adoption date of the regulation amendments identified in RATS ID 2015-3 to August 15, 2020.
STC-17-068 Publication of NUREG-1556, Volume 18, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Service Provider Licenses September 19, 2017 March 19, 2018 C
STC-17-057 Notification of Clarification That Granting an Exemption from the Decommissioning Funding Plan Requirements in Title 10 of the Code of August 1, 2017 February 1, 2018 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Federal Regulations Part 30 Does Not Exempt Licensees from Other Financial Assurance Requirements, Update of Licensing Guidance, and Compatibility Determination for Germanium-68/Gallium-68 Generators STC-17-029 Issuance of SA-111, formal Qualifications for integrated Materials Performance Evaluation Program (IMPEP) Team Members and Team Leaders March 2, 2017 NA D
STC-17-028 Publication of NUREG-1556, Volume 11, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope March 17, 2017 September 17, 2017 C
STC-16-083 Notification of Issuance of a Revision to the Eckert and Ziegler GalliapharmTM Germanium-68/Gallium-October 19, 2016 April 19, 2017 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments 68 Pharmacy Grade Generator Licensing Guidance STC-16-082 Notification of Issuance of the Radioactive Seed Localization Licensing Guidance, Rev. 1 October 13, 2016 April 13, 2017 C
STC-16-065 Notification of Issuance of Authorization for Granting Specific Exemption from Decommissioning Funding Plan Requirement for Germanium-68/Gallium-68 Generators August 18, 2016 February 18, 2017 C
STC-16-079 Issuance of Eckert and Ziegler GalliapharmTM Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance October 5, 2016 April 5, 2017 C
STC-16-058 Publication of NUREG-1556, Volume 1, Revision 2, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Portable Gauge Licenses, Volume 10, July 18, 2016 January 18, 2017 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Master Material Licenses, Volume 15, Revision 1, Consolidated Guidance About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials
- Licenses, and Volume 19, Revision 1, Consolidated Guidance About Materials Licenses:
Guidance for Agreement State Licensees About NRC form 241 Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, or offshore Waters and Guidance for NRC
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments Licensees Proposing to Work in Agreement State Jurisdiction (Reciprocity)
STC-16-057 Publication of NUREG-1556, Volume 4, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Fixed Gauge Licenses July 18, 2016 January 18, 2017 C
STC-16-042 Notification of Issuance of Leksell Gamma Knife Perfexion' and Leksell Gamma Knife Icon' Licensing Guidance May 25, 2016 November 25, 2016 C
STC-16-030 Publication of NUREG-1556, Volume 2, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Industrial Radiography Licenses April 1, 2016 October 1, 2016 C
STC-16-005 Publication of NUREG-1556 Series on the Consolidated Guidance About Materials Licenses January 14, 2016 NA NA informational.
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments STC-15-085 Publication of NUREG-1556, Volume 3, Revision 2, Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration December 15, 2015 June 15, 2015 C
STC-15-069 Refresher Training for Agreement State Staff September 1, 2015 March 1, 2016 C
RCPD LETTERS RCPD-19-003 Request to Implement the Revised Pre-Licensing Guidance January 29, 2017 July 29, 2017 C
RCPD-18-011 Request to Implement the Risk-Significant Radioactive Material Checklist and Guidance December 18, 2018 June 18, 2019 C
RCPD-18-005 Request to Implement the Revised Pre-Licensing Guidance, Notification of Upcoming Webinar Training, and Discontinuance of a Licensing Practice August 9, 2018 February 9, 2019 C
Type/ID No. of Communication/
Issuance Subject Date of Issuance Due Date for Agreement State Implementation Compatibility Category Comments RCPD-18-002 Notification of Issuance of Northstar Medical Radioisotopes, LLC Radiogenix' Molybdenum-99/Technetium-99m Generator System Licensing Guidance April 27, 2018 October 27, 2018 C
RCPD-17-012 Notification of Issuance of Procedure for Implementing the 15 Year Materials Licenses Term August 22, 2017 February 22, 2018 C
RCPD-17-007 Request to Implement the Risk-Significant Radioactive Material Checklist and Guidance (RCPD-17-007)
June 30, 2017 December 30, 2017 C
RCPD-15-010 the Importance of Using Pre-Licensing Guidance and Site Visits During the Licensing Process October 23, 2015 April 23, 2016 C