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{{#Wiki_filter: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.
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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}}

Revision as of 23:49, 18 November 2024

Alphadart 35.10000 Consolidated Technical Analysis
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)
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