ML22018A223
| ML22018A223 | |
| Person / Time | |
|---|---|
| Issue date: | 03/10/2022 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| K Tapp, NMSS/MSST/MSEB | |
| References | |
| Download: ML22018A223 (10) | |
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 Alpha DaRT. Licensees shall comply with all regulations which address use of Alpha DaRT. The table also provides specific conditions which the NRC has determined are necessary for the medical use of Alpha DaRT. 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 Alpha DaRT Guidance Section Comment 35.1 Purpose and scope Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2 Definitions Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.5 Maintenance of records Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.6 Provisions for the protection of human research subjects Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.7 FDA, other Federal, and State requirements Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.8 Information collection requirements: OMB approval Yes No N/A 1566 Vol 9 Alpha DaRT Other
Appendix Consolidated Technical Analysis 2
35.10 Implementation Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.11 License required Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.12 Application for license, amendment, or renewal Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.13 License amendments Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.14 Notifications Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.15 Exemptions regarding Type A specific licenses of broad scope Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.18 License issuance Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.19 Specific exemptions Yes No N/A 1566 Vol 9 Alpha DaRT Other Subpart B - General Administrative Requirements 35.24 Authority and responsibilities for the radiation protection program Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.26 Radiation protection program changes Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.9 The Alpha DaRT licensing guidance maybe revised as the industry gains more experience more about the technology.
Appendix Consolidated Technical Analysis 3
Licensees should be authorized to make radiation protection program changes to follow future revisions of the guidance.
Licensees need to evaluate all aspects of its radiation safety program when adding a new use and make commensurate changes, i.e., area surveys, emergency procedures, radiation safety training, etc.
35.27 Supervision Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.40 Written directives (WDs)
Yes No N/A 1566 Vol 9 Alpha DaRT Other 7.2 While a new requirement is not necessary, total source strength recorded on the written directive need to only include the Ra-224 activity.
35.41 Procedures for administrations requiring a WD Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.1 Requirements in 10 CFR 35.41 can be followed but additional commitments are needed. Due to the potential for leakage outside the patients body, licensees need to commit to verify that seeds are fully contained without leakage outside the patients body after administration. In addition, as seeds could be dislodged, licensees shall commit to evaluating the location of the seeds prior to removal for temporary implant brachytherapy to determine if the seeds moved during treatment to determine if a medical event occurred.
35.49 Suppliers for sealed sources or devices for medical use Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.50 Training for Radiation Safety Officer (RSO) and Associate RSO Yes No N/A 1566 Vol 9 Alpha DaRT 5.2.2 While a new condition is not necessary, the guidance reminds licensees of the requirement in 10 CFR 35.50(d) which
Appendix Consolidated Technical Analysis 4
Other requires RSOs to have training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval 35.51 Training for an authorized medical physicist (AMP)
Yes No N/A 1566 Vol 9 Alpha DaRT Other Use of Alpha DaRT does not require AMP.
35.55 Training for an authorized nuclear pharmacist (ANP)
Yes No N/A 1566 Vol 9 Alpha DaRT Other Use of AlphaDaRT does not require ANP.
35.57 Training for experienced RSO, teletherapy or medical physicist, AMP, authorized user, nuclear pharmacist, and ANP Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.59 Recentness of training Yes No N/A 1566 Vol 9 Alpha DaRT Other 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 1566 Vol 9 Alpha DaRT Other As licensees are not required to determine dosages in accordance with 10 CFR 35.63, no additional condition is necessary here.
Calibration is described further in the table under 10 CFR 35.432.
35.61 Calibration of survey instruments Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.63 Determination of dosages of unsealed byproduct material for medical use Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.7 As Alpha DaRT is a brachytherapy device, licensees do not need to comply with 10 CFR 35.63.
35.65 Authorization for calibration, transmission, and reference sources Yes No N/A 1566 Vol 9 Alpha DaRT Other
Appendix Consolidated Technical Analysis 5
35.67 Requirements for possession of sealed sources and brachytherapy sources Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.69 Labeling of vials and syringes Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.4 Alpha DaRT is not a radioactive drug and does not require labeling per 10 CFR 35.69 is not required. Licensees shall commit to label applicators in accordance with the sealed source and device registry.
35.70 Surveys of ambient radiation exposure rate Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.5 As Alpha DaRT has a higher potential for contamination, licensees shall commit to performing surveys after every administration, not just once per day. Both ambient radiation and contamination surveys should be performed.
35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1566 Vol 9 Alpha DaRT Other 7.3 While there are no additional commitments, the guidance gives additional radiation safety items licensees should consider to ensure patient release limits are not exceeded. See Regulatory Guide 8.39, Release of Patients Administered Radioactive Materials. for more guidance.
35.80 Provision of mobile medical service Yes No N/A 1566 Vol 9 Alpha DaRT Other Decay-in-storage Yes No N/A 1566 Vol 9 Alpha DaRT Other Subpart F - Manual Brachytherapy 35.400 Use of sources for manual brachytherapy Yes No N/A 1566 Vol 9 Alpha DaRT Other 7.4 While there are no additional commitments, additional guidance is given to use the applicators as listed in the Sealed Source and Device registry as the applicators are specific to radiation safety.
Appendix Consolidated Technical Analysis 6
35.404 Surveys after source implant and removal Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.406 Brachytherapy sources accountability Yes No N/A 1566 Vol 9 Alpha DaRT Other 7.5 While there is no additional commitments, additional guidance is given on how licensees can maintain accountability and document the location of use.
35.410 Safety instruction Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.415 Safety precautions Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.8 In addition to the commitments in 10 CFR 35.415, use of sealed container is necessary for all waste and unsealed sources to control contamination.
35.432 Calibration measurements of brachytherapy sources Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.7 As permitted by 10 CFR 35.432, it is expected that licensees will use measurements provided by the source manufacturer instead of making their own calibration measurements. However, as there is a potential that the applicator could leak, licensees shall commit to ensure the integrity of the applicator seal prior to administering seeds to a patient in addition to following 10 CFR 35.432.
35.433 Sr-90 sources for ophthalmic treatments Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.457 Therapy-related computer systems Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.490 Training for use of manual brachytherapy sources Yes No N/A 1566 Vol 9 Alpha DaRT Other 5.2 Similar to 10 CFR 35.490 but specific for Alpha DaRT.
Appendix Consolidated Technical Analysis 7
35.491 Training for ophthalmic use of Sr-90 Yes No N/A 1566 Vol 9 Alpha DaRT Other Subpart L - Records 35.2024 Records of authority and responsibilities for radiation protection programs Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2026 Records of radiation protection program changes Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.9 Records of radiation protection program changes made per the commitment which replaced 10 CFR 35.26 must be kept for 5 years similar to the requirements in 10 CFR 35.2026.
35.2040 Records of WDs Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2041 Records for procedure for administrations requiring a WD Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.1 As a commitment for additional procedures for administration is necessary, licensees must commit to maintain a record of these procedures for the duration of the license similar to the requirement in 10 CFR 35.2041.
35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct materials Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2061 Records of radiation survey instrument calibrations Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2063 Records of dosages of unsealed byproduct material for medical use Yes No N/A 1566 Vol 9 Alpha DaRT Other As 10 CFR 35.63 is not required, these records are not applicable for Alpha DaRT.
Appendix Consolidated Technical Analysis 8
35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2070 Records of surveys for ambient radiation exposure rate Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.5 In addition to 10 CFR 35.2070, licensees should also keep a record in a similar manner as 10 CFR 35.2070 of surveys after each administration.
35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A 1566 Vol 9 Alpha DaRT Other 7.3 See Regulatory Guide 8.39, Release of Patients Administered Radioactive Materials. for more guidance.
35.2080 Records of mobile medical services Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2092 Records of decay-in-storage Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2204 Records of Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2404 Records of surveys after source implant and removal Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.2406 Records of brachytherapy source accountability Yes No N/A 1566 Vol 9 Alpha DaRT Other 7.5 While there is no additional commitments, additional guidance is given on how licensees can maintain accountability and document the location of use.
Appendix Consolidated Technical Analysis 9
35.2432 Records of calibration measurements of brachytherapy sources Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.7 35.2433 Records of decay of Sr-90 sources for ophthalmic treatments Yes No N/A 1566 Vol 9 Alpha DaRT Other Subpart M - Reports 35.3045 Report and notification of a medical event Yes No N/A 1566 Vol 9 Alpha DaRT Other 6.2 As Alpha DaRT seeds are unsealed brachytherapy sources, not all medical event criteria listed in 10 CFR 35.3045 is applicable. Therefore, use of Alpha DaRT needs unique medical event reporting criteria such as that described in the Alpha DaRT guidance.
35.3047 Report and notification of a dose to an embryo/fetus or a nursing child Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.3067 Report of a leaking source Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.3204 Report and notification for an eluate exceeding permissible Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 1566 Vol 9 Alpha DaRT Other Subpart N - Enforcement 35.4001 Violations Yes No N/A 1566 Vol 9 Alpha DaRT Other 35.4002 Criminal penalties Yes No N/A 1566 Vol 9 Alpha DaRT Other
Appendix Consolidated Technical Analysis 10 Additional Considerations