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 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 Guidance Alpha Comment Addressed DaRT in Regulation Guidance Section 35.1 Purpose and scope Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.2 Definitions Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.5 Maintenance of records Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.6 Provisions for the Yes No 1566 Vol 9 protection of human N/A Alpha DaRT research subjects Other 35.7 FDA, other Federal, and Yes No 1566 Vol 9 State requirements N/A Alpha DaRT Other 35.8 Information collection Yes No 1566 Vol 9 requirements: OMB N/A Alpha DaRT approval Other 1
Appendix Consolidated Technical Analysis 35.10 Implementation Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.11 License required Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.12 Application for license, Yes No 1566 Vol 9 amendment, or renewal N/A Alpha DaRT Other 35.13 License amendments Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.14 Notifications Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.15 Exemptions regarding Yes No 1566 Vol 9 Type A specific licenses N/A Alpha DaRT of broad scope Other 35.18 License issuance Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.19 Specific exemptions Yes No 1566 Vol 9 N/A Alpha DaRT Other Subpart B - General Administrative Requirements 35.24 Authority and Yes No 1566 Vol 9 responsibilities for the N/A Alpha DaRT radiation protection Other program 35.26 Radiation protection Yes No 1566 Vol 9 6.9 The Alpha DaRT licensing guidance maybe program changes N/A Alpha DaRT revised as the industry gains more Other experience more about the technology.
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Appendix Consolidated Technical Analysis 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 1566 Vol 9 N/A Alpha DaRT Other 35.40 Written directives (WDs) Yes No 1566 Vol 9 7.2 While a new requirement is not necessary, N/A Alpha DaRT total source strength recorded on the Other written directive need to only include the Ra-224 activity.
35.41 Procedures for Yes No 1566 Vol 9 6.1 Requirements in 10 CFR 35.41 can be administrations requiring N/A Alpha DaRT followed but additional commitments are a WD Other 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 Yes No 1566 Vol 9 sources or devices for N/A Alpha DaRT medical use Other 35.50 Training for Radiation Yes No 1566 Vol 9 5.2.2 While a new condition is not necessary, the Safety Officer (RSO) and N/A Alpha DaRT guidance reminds licensees of the Associate RSO requirement in 10 CFR 35.50(d) which 3
Appendix Consolidated Technical Analysis 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 Yes No 1566 Vol 9 Use of Alpha DaRT does not require AMP.
medical physicist (AMP) N/A Alpha DaRT Other 35.55 Training for an authorized Yes No 1566 Vol 9 Use of AlphaDaRT does not require ANP.
nuclear pharmacist N/A Alpha DaRT (ANP) Other 35.57 Training for experienced Yes No 1566 Vol 9 RSO, teletherapy or N/A Alpha DaRT medical physicist, AMP, Other authorized user, nuclear pharmacist, and ANP 35.59 Recentness of training Yes No 1566 Vol 9 N/A Alpha DaRT Other Subpart C - General Technical Requirements 35.60 Possession, use, and Yes No 1566 Vol 9 As licensees are not required to determine calibration of instruments N/A Alpha DaRT dosages in accordance with 10 CFR 35.63, used to measure the Other no additional condition is necessary here.
activity of unsealed Calibration is described further in the table byproduct material under 10 CFR 35.432.
35.61 Calibration of survey Yes No 1566 Vol 9 instruments N/A Alpha DaRT Other 35.63 Determination of dosages Yes No 1566 Vol 9 6.7 As Alpha DaRT is a brachytherapy device, of unsealed byproduct N/A Alpha DaRT licensees do not need to comply with material for medical use Other 10 CFR 35.63.
35.65 Authorization for Yes No 1566 Vol 9 calibration, transmission, N/A Alpha DaRT and reference sources Other 4
Appendix Consolidated Technical Analysis 35.67 Requirements for Yes No 1566 Vol 9 possession of sealed N/A Alpha DaRT sources and Other brachytherapy sources 35.69 Labeling of vials and Yes No 1566 Vol 9 6.4 Alpha DaRT is not a radioactive drug and syringes N/A Alpha DaRT does not require labeling per 10 CFR 35.69 Other is not required. Licensees shall commit to label applicators in accordance with the sealed source and device registry.
35.70 Surveys of ambient Yes No 1566 Vol 9 6.5 As Alpha DaRT has a higher potential for radiation exposure rate N/A Alpha DaRT contamination, licensees shall commit to Other performing surveys after every administration, not just once per day. Both ambient radiation and contamination surveys should be performed.
35.75 Release of individuals Yes No 1566 Vol 9 7.3 While there are no additional commitments, containing unsealed N/A Alpha DaRT the guidance gives additional radiation byproduct material or Other safety items licensees should consider to implants containing ensure patient release limits are not byproduct material exceeded. See Regulatory Guide 8.39, Release of Patients Administered Radioactive Materials. for more guidance.
35.80 Provision of mobile Yes No 1566 Vol 9 medical service N/A Alpha DaRT Other Decay-in-storage Yes No 1566 Vol 9 N/A Alpha DaRT Other Subpart F - Manual Brachytherapy 35.400 Use of sources for Yes No 1566 Vol 9 7.4 While there are no additional commitments, manual brachytherapy N/A Alpha DaRT additional guidance is given to use the Other applicators as listed in the Sealed Source and Device registry as the applicators are specific to radiation safety.
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Appendix Consolidated Technical Analysis 35.404 Surveys after source Yes No 1566 Vol 9 implant and removal N/A Alpha DaRT Other 35.406 Brachytherapy sources Yes No 1566 Vol 9 7.5 While there is no additional commitments, accountability N/A Alpha DaRT additional guidance is given on how Other licensees can maintain accountability and document the location of use.
35.410 Safety instruction Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.415 Safety precautions Yes No 1566 Vol 9 6.8 In addition to the commitments in 10 CFR N/A Alpha DaRT 35.415, use of sealed container is Other necessary for all waste and unsealed sources to control contamination.
35.432 Calibration Yes No 1566 Vol 9 6.7 As permitted by 10 CFR 35.432, it is measurements of N/A Alpha DaRT expected that licensees will use brachytherapy sources Other 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 Yes No 1566 Vol 9 ophthalmic treatments N/A Alpha DaRT Other 35.457 Therapy-related computer Yes No 1566 Vol 9 systems N/A Alpha DaRT Other 35.490 Training for use of Yes No 1566 Vol 9 5.2 Similar to 10 CFR 35.490 but specific for manual brachytherapy N/A Alpha DaRT Alpha DaRT.
sources Other 6
Appendix Consolidated Technical Analysis 35.491 Training for ophthalmic Yes No 1566 Vol 9 use of Sr-90 N/A Alpha DaRT Other Subpart L - Records 35.2024 Records of authority and Yes No 1566 Vol 9 responsibilities for N/A Alpha DaRT radiation protection Other programs 35.2026 Records of radiation Yes No 1566 Vol 9 6.9 Records of radiation protection program protection program N/A Alpha DaRT changes made per the commitment which changes Other 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 1566 Vol 9 N/A Alpha DaRT Other 35.2041 Records for procedure for Yes No 1566 Vol 9 6.1 As a commitment for additional procedures administrations requiring N/A Alpha DaRT for administration is necessary, licensees a WD Other 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 Yes No 1566 Vol 9 instruments used to N/A Alpha DaRT measure the activity of Other unsealed byproduct materials 35.2061 Records of radiation Yes No 1566 Vol 9 survey instrument N/A Alpha DaRT calibrations Other 35.2063 Records of dosages of Yes No 1566 Vol 9 As 10 CFR 35.63 is not required, these unsealed byproduct N/A Alpha DaRT records are not applicable for Alpha DaRT.
material for medical use Other 7
Appendix Consolidated Technical Analysis 35.2067 Records of leaks tests Yes No 1566 Vol 9 and inventory of sealed N/A Alpha DaRT sources and Other brachytherapy sources 35.2070 Records of surveys for Yes No 1566 Vol 9 6.5 In addition to 10 CFR 35.2070, licensees ambient radiation N/A Alpha DaRT should also keep a record in a similar exposure rate Other manner as 10 CFR 35.2070 of surveys after each administration.
35.2075 Records of the release of Yes No 1566 Vol 9 7.3 See Regulatory Guide 8.39, Release of individuals containing N/A Alpha DaRT Patients Administered Radioactive unsealed byproduct Other Materials. for more guidance.
material or implants containing byproduct material 35.2080 Records of mobile Yes No 1566 Vol 9 medical services N/A Alpha DaRT Other 35.2092 Records of decay-in- Yes No 1566 Vol 9 storage N/A Alpha DaRT Other 35.2204 Records of Mo-99, Sr-82, Yes No 1566 Vol 9 and Sr-85 concentrations N/A Alpha DaRT Other 35.2404 Records of surveys after Yes No 1566 Vol 9 source implant and N/A Alpha DaRT removal Other 35.2406 Records of brachytherapy Yes No 1566 Vol 9 7.5 While there is no additional commitments, source accountability N/A Alpha DaRT additional guidance is given on how Other licensees can maintain accountability and document the location of use.
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Appendix Consolidated Technical Analysis 35.2432 Records of calibration Yes No 1566 Vol 9 6.7 measurements of N/A Alpha DaRT brachytherapy sources Other 35.2433 Records of decay of Sr- Yes No 1566 Vol 9 90 sources for N/A Alpha DaRT ophthalmic treatments Other Subpart M - Reports 35.3045 Report and notification of Yes No 1566 Vol 9 6.2 As Alpha DaRT seeds are unsealed a medical event N/A Alpha DaRT brachytherapy sources, not all medical Other 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 Yes No 1566 Vol 9 a dose to an N/A Alpha DaRT embryo/fetus or a nursing Other child 35.3067 Report of a leaking Yes No 1566 Vol 9 source N/A Alpha DaRT Other 35.3204 Report and notification for Yes No 1566 Vol 9 an eluate exceeding N/A Alpha DaRT permissible Mo-99, Sr- Other 82, and Sr-85 concentrations Subpart N - Enforcement 35.4001 Violations Yes No 1566 Vol 9 N/A Alpha DaRT Other 35.4002 Criminal penalties Yes No 1566 Vol 9 N/A Alpha DaRT Other 9
Appendix Consolidated Technical Analysis Additional Considerations 10