ML24325A441
| ML24325A441 | |
| Person / Time | |
|---|---|
| Issue date: | 12/10/2024 |
| From: | Adelaide Giantelli NRC/NMSS/DMSST/MSEB |
| To: | State of CT, State of IN, State, Agreement States |
| Shared Package | |
| ML24325A436 | List: |
| References | |
| Download: ML24325A441 (1) | |
Text
Appendix Consolidated Technical Analysis 1
The following table provides a list of 10 CFR Part 35 regulations and conditions the NRC has determined are applicable for use of Eye90 microspheres. Licensees shall comply with all regulations which address use of Eye90 microspheres. The table also provides specific conditions which the NRC has determined are necessary for the medical use of Eye90 microspheres. In addition, the table lists where licensees and applicants can find additional guidance. Applicants may submit alternative list of regulations and specific conditions to be reviewed on a case-by-case basis by NRC staff.
Section Description Use Addressed in Regulation Guidance Eye90 microspheres Guidance Section Comment 35.1 Purpose and scope Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2 Definitions Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.5 Maintenance of records Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.6 Provisions for the protection of human research subjects Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.7 FDA, other Federal, and State requirements Yes No N/A 1556 Vol 9 Eye90 microspheres Other
Appendix Consolidated Technical Analysis 2
Section Description Use Addressed in Regulation Guidance Eye90 microspheres Guidance Section Comment 35.8 Information collection requirements: OMB approval Yes No N/A 1556 Vol 9 Eye90 microspheres Other
Appendix Consolidated Technical Analysis 3
35.10 Implementation Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.11 License required Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.12 Application for license, amendment, or renewal Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.13 License amendments Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.14 Notifications Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.15 Exemptions regarding Type A specific licenses of broad scope Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.18 License issuance Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.19 Specific exemptions Yes No N/A 1556 Vol 9 Eye90 microspheres Other
Appendix Consolidated Technical Analysis 4
Subpart B - General Administrative Requirements 35.24 Authority and responsibilities for the radiation protection program Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.26 Radiation protection program changes Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.27 Supervision Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.40 Written directives (WDs)
Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.2 35.40(b)(6) details written directive requirements for permanent implant brachytherapy. 35.40(b)(6)(ii) requires a record of the number of sources implanted, which is not possible due to the small size and large number of microspheres involved in Eye90 therapy. Therefore there are different items required by the written directive.
35.41 Procedures for administrations requiring a WD Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.2 The guidance document provides additional information specific to Eye90 Microspheres.
35.49 Suppliers for sealed sources or devices for medical use Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.50 Training for Radiation Safety Officer (RSO) and Associate RSO Yes No N/A 1556 Vol 9 Eye90 microspheres 5.2 The guidance document provides additional information specific to Eye90 Microspheres.
Appendix Consolidated Technical Analysis 5
Other 35.51 Training for an authorized medical physicist (AMP)
Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.55 Training for an authorized nuclear pharmacist (ANP)
Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.57 Training for experienced RSO, teletherapy or medical physicist, AMP, authorized user (AU),
nuclear pharmacist, and ANP Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.59 Recentness of training Yes No N/A 1556 Vol 9 Eye90 microspheres Other 5
The guidance document provides additional information specific to Eye90 microspheres.
Subpart C - General Technical Requirements 35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.1 Although Eye90 microspheres are not considered unsealed byproduct material, their pre-treatment activity is measured as per 35.60.
35.61 Calibration of survey instruments Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.63 Determination of dosages of unsealed byproduct material for medical use Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.1 Although Eye90 microspheres are not considered unsealed byproduct material, their pre-treatment activity is measured as per 35.60.
Appendix Consolidated Technical Analysis 6
35.65 Authorization for calibration, transmission, and reference sources Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.67 Requirements for possession of sealed sources and brachytherapy sources Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.5 Microspheres are not managed as individual discrete sources and Y-90 is short-lived. 35.406, 20.1906, 20.1904, 35.69, 20.1801, and 35.92 are sufficient.
35.69 Labeling of vials and syringes Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.70 Surveys of ambient radiation exposure rate Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.8 The guidance document provides additional information specific to Eye90 microspheres.
35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.80 Provision of mobile medical service Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.92 Decay-in-storage Yes No N/A 1556 Vol 9 Eye90 microspheres Other 7.3 The guidance document provides additional information specific to Eye90 microspheres, including concerns specific to isotopic impurities inherent in the production of Y-90.
Subpart F - Manual Brachytherapy
Appendix Consolidated Technical Analysis 7
35.400 Use of sources for manual brachytherapy Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.404 Surveys after source implant and removal Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.8 The guidance document provides additional information specific to Eye90 microspheres. Eye90 microspheres are permanent implants, therefore post-removal surveys are not applicable.
35.406 Brachytherapy sources accountability Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.5 The guidance document provides additional information specific to Eye90 microspheres.
35.410 Safety instruction Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.415 Safety precautions Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.432 Calibration measurements of brachytherapy sources Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.1 Microspheres are too small to be calibrated in accordance with 35.432, therefore 35.63 and 35.60 are used for measuring each dosage.
35.433 Sr-90 sources for ophthalmic treatments Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.457 Therapy-related computer systems Yes No N/A 1556 Vol 9 Eye90 microspheres Other
Appendix Consolidated Technical Analysis 8
35.490 Training for use of manual brachytherapy sources Yes No N/A 1556 Vol 9 Eye90 microspheres Other 5
The guidance document provides additional information specific to Eye90 microspheres.
35.491 Training for ophthalmic use of Sr-90 Yes No N/A 1556 Vol 9 Eye90 microspheres Other Subpart L - Records 35.2024 Records of authority and responsibilities for radiation protection programs Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2026 Records of radiation protection program changes Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2040 Records of WDs Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2041 Records for procedure for administrations requiring a WD Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct materials Yes No N/A 1566 Vol 9 Eye90 microspheres Other 35.2061 Records of radiation survey instrument calibrations Yes No N/A 1556 Vol 9 Eye90 microspheres
Appendix Consolidated Technical Analysis 9
Other 35.2063 Records of dosages of unsealed byproduct material for medical use Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources Yes No N/A 1556 Vol 9 Eye90 microspheres Other 4.4, 6.5 Microspheres are not managed as individual discrete sources and Y-90 is short-lived. 35.406, 20.1906, 20.1904, 35.69, 20.1801, and 35.92 are sufficient.
35.2070 Records of surveys for ambient radiation exposure rate Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2080 Records of mobile medical services Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.2092 Records of decay-in-storage Yes No N/A 1556 Vol 9 Eye90 microspheres Other 7.3 The guidance document provides additional information specific to Eye90 microspheres.
35.2204 Records of Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 1556 Vol 9 Eye90 microspheres Other
Appendix Consolidated Technical Analysis 10 35.2404 Records of surveys after source implant and removal Yes No N/A 1556 Vol 9 Eye90 Microspheres Other 6.8 The guidance document provides additional information specific to Eye90 microspheres. Eye90 microspheres are permanent implants, therefore post-removal surveys are not applicable.
35.2406 Records of brachytherapy source accountability Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.5 Microspheres are not managed as individual discrete sources and Y-90 is short-lived. 35.406, 20.1906, 20.1904, 35.69, 20.1801, and 35.92 are sufficient.
35.2432 Records of calibration measurements of brachytherapy sources Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.1 Microspheres are too small to be calibrated in accordance with 35.432, therefore 35.63 and 35.60 are used for measuring each dosage.
35.2433 Records of decay of Sr-90 sources for ophthalmic treatments Yes No N/A 1556 Vol 9 Eye90 microspheres Other Subpart M - Reports 35.3045 Report and notification of a medical event Yes No N/A 1556 Vol 9 Eye90 microspheres Other 6.3 The guidance document provides additional information specific to Eye90 microspheres.
35.3047 Report and notification of a dose to an embryo/fetus or a nursing child Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.3067 Report of a leaking source Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.3204 Report and notification for an eluate exceeding permissible Mo-99, Sr-Yes No N/A 1556 Vol 9 Eye90 microspheres
Appendix Consolidated Technical Analysis 11 82, and Sr-85 concentrations Other Subpart N - Enforcement 35.4001 Violations Yes No N/A 1556 Vol 9 Eye90 microspheres Other 35.4002 Criminal penalties Yes No N/A 1556 Vol 9 Eye90 microspheres Other Additional Considerations