ML24338A041
| ML24338A041 | |
| Person / Time | |
|---|---|
| Issue date: | 02/04/2025 |
| From: | NRC/NMSS/DMSST/MSEB |
| To: | |
| Shared Package | |
| ML24338A044 | List: |
| References | |
| Download: ML24338A041 (11) | |
Text
1 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 regulations and conditions which the NRC has determined are necessary for the medical use of Alpha DaRT. Applicants may submit alternative list of regulations and specific conditions to be reviewed on a case-by-case basis by NRC staff.
Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance Subpart A - General Information 35.1 Purpose and scope Yes No N/A 35.2 Definitions Yes No N/A 35.5 Maintenance of records Yes No N/A 35.6 Provisions for the protection of human research subjects Yes No N/A 35.7 FDA, other Federal, and State requirements Yes No N/A 35.8 Information collection requirements: OMB approval Yes No N/A 35.10 Implementation Yes No N/A 35.11 License required Yes No N/A 35.12 Application for license, amendment, or renewal Yes No N/A 35.13 License amendments Yes No N/A 35.14 Notifications Yes No N/A 35.15 Exemptions regarding Type A specific licenses of broad scope Yes No N/A 35.18 License issuance Yes No N/A 35.19 Specific exemptions Yes No N/A Subpart B - General Administrative Requirements
2 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance 35.24 Authority and responsibilities for the radiation protection program Yes No N/A 35.26 Radiation protection program changes Yes No N/A Section 6.7, Radiation Protection Program Changes. The Alpha DaRT licensing guidance maybe revised as the industry gains more experience about the technology. 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 35.40 Written directives (WDs)
Yes No N/A Section 7.2, Written Directives. 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 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
3 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance 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 35.50 Training for Radiation Safety Officer (RSO) and Associate RSO Yes No N/A While a new condition is not necessary, the guidance reminds licensees of the requirement in 10 CFR 35.50(d) which 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 Use of Alpha DaRT does not require AMP.
35.55 Training for an authorized nuclear pharmacist (ANP)
Yes No N/A Use of Alpha DaRT does not require ANP.
35.57 Training for experienced RSO, teletherapy or medical physicist, AMP, authorized user (AU), nuclear pharmacist, and ANP Yes No N/A 35.59 Recentness of training Yes No N/A 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 As licensees are not required to determine dosages in accordance with 10 CFR 35.63, no additional condition is necessary here. Calibration is
4 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance described further in the table under 10 CFR 35.432.
35.61 Calibration of survey instruments Yes No N/A 35.63 Determination of dosages of unsealed byproduct material for medical use Yes No N/A Section 6.5, Calibration. 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 35.67 Requirements for possession of sealed sources and brachytherapy sources Yes No N/A 35.69 Labeling of vials and syringes Yes No N/A Section 6.3, Labeling. Alpha DaRT is not a radioactive drug and does not require labeling per 10 CFR 35.69.
Licensees shall commit to label applicators in accordance with the sealed source and device registry (SS&DR) 35.70 Surveys of ambient radiation exposure rate Yes No N/A Section 6.4, Surveys. 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. Personnel surveys should be performed and should include surveys of the hands for AU and the hands of supporting staff.
5 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance Contamination surveys must also include the packaging (sterile bag) of the Alpha DaRT applicator 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material Yes No N/A Section 7.3, Patient Release. While there are no additional commitments, the guidance gives additional radiation safety items licensees should consider ensuring 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 35.92 Decay-in-storage Yes No N/A Subpart D - Unsealed Byproduct Material - Written Directive Not Required 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a WD is not required Yes No N/A 35.190 Training for uptake dilution, and excretion studies Yes No N/A 35.200 Use of unsealed byproduct material for imaging and localization studies for which a WD is not required Yes No N/A 35.204 Permissible Mo-99, Sr-82, Sr-85 concentrations Yes No N/A 35.290 Training for imaging and localization studies Yes No N/A Subpart E - Unsealed Byproduct Material - WD Required 35.300 Use of unsealed byproduct material for which a WD is required Yes No N/A 35.310 Safety instruction Yes No N/A 35.315 Safety precautions Yes No N/A
6 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance 35.390 Training for use of unsealed byproduct material for which a WD is required Yes No N/A 35.392 Training for the oral administration of NaI I-131 requiring a WD in quantities <= 1.22 GBq (33 mCi)
Yes No N/A 35.394 Training for the oral administration of NaI I-131 requiring a WD in quantities > 1.22 GBq (33 mCi)
Yes No N/A 35.396 Training for the parenteral administration of unsealed byproduct material requiring a WD Yes No N/A Subpart F - Manual Brachytherapy 35.400 Use of sources for manual brachytherapy Yes No N/A While there are no additional commitments, additional guidance is given to use the applicators as listed in the SS&DR as the applicators are specific to radiation safety.
35.404 Surveys after source implant and removal Yes No N/A 35.406 Brachytherapy sources accountability Yes No N/A Section 7.5, Brachytherapy Source Accountability. 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 35.415 Safety precautions Yes No N/A Section 6.6, Contamination Control. 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 As permitted by 10 CFR 35.432, it is expected that licensees will use
7 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance measurements provided by the source manufacturer instead of making their own calibration measurements.
35.433 Sr-90 sources for ophthalmic treatments Yes No N/A 35.457 Therapy-related computer systems Yes No N/A 35.490 Training for use of manual brachytherapy sources Yes No N/A Similar to 10 CFR 35.490 but specific for Alpha DaRT.
35.491 Training for ophthalmic use of Sr-90 Yes No N/A Subpart G - Sealed Sources for Diagnosis 35.500 Use of sealed sources and medical devices for diagnosis Yes No N/A 35.590 Training for use of sealed sources and medical devices for diagnosis Yes No N/A Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery (GSR) Units 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or GSR unit Yes No N/A 35.604 Surveys of patients and human research subjects treated with a remote afterloader unit Yes No N/A 35.605 Installation, maintenance, adjustment, and repair Yes No N/A 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and GSR units Yes No N/A 35.615 Safety precautions for remote afterloader units, teletherapy units, and GSR units Yes No N/A 35.630 Dosimetry equipment Yes No N/A 35.632 Full calibration measurements on teletherapy units Yes No N/A 35.633 Full calibration measurements on remote afterloader units Yes No N/A 35.635 Full calibration measurements on GSR units Yes No N/A
8 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance 35.642 Periodic spot-checks for teletherapy units Yes No N/A 35.643 Periodic spot-checks for remote afterloader units Yes No N/A 35.645 Periodic spot-checks for GSR units Yes No N/A 35.647 Additional technical requirements for mobile remote afterloader units Yes No N/A 35.652 Radiation surveys Yes No N/A 35.655 Full-inspection servicing for teletherapy and GSR units Yes No N/A 35.657 Therapy-related computer systems Yes No N/A 35.690 Training for use of remote afterloader units, teletherapy units, and GSR units Yes No N/A Subpart L - Records 35.2024 Records of authority and responsibilities for radiation protection programs Yes No N/A 35.2026 Records of radiation protection program changes Yes No N/A 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 35.2041 Records for procedure for administrations requiring a WD Yes No N/A 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
9 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance 35.2061 Records of radiation survey instrument calibrations Yes No N/A 35.2063 Records of dosages of unsealed byproduct material for medical use Yes No N/A As 10 CFR 35.63 is not required, these records are not applicable for Alpha DaRT.
35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources Yes No N/A 35.2070 Records of surveys for ambient radiation exposure rate Yes No N/A 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 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 35.2092 Records of decay-in-storage Yes No N/A 35.2204 Records of Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A 35.2310 Records of safety instruction Yes No N/A 35.2404 Records of surveys after source implant and removal Yes No N/A 35.2406 Records of brachytherapy source accountability Yes No N/A While there is no additional commitments, additional guidance is given on how licensees can maintain accountability and document the location of use.
35.2432 Records of calibration measurements of brachytherapy sources Yes No N/A 35.2433 Records of decay of Sr-90 sources for ophthalmic treatments Yes No N/A
10 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance 35.2605 Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and GSR units Yes No N/A 35.2610 Records of safety procedures Yes No N/A 35.2630 Records of dosimetry equipment used with remote afterloader units, teletherapy units, and GSR units Yes No N/A 35.2632 Records of teletherapy, remote afterloader, and GSR full calibrations Yes No N/A 35.2642 Records of periodic spot-checks for teletherapy units Yes No N/A 35.2643 Records of periodic spot-checks for remote afterloader units Yes No N/A 35.2645 Records of periodic spot-checks for GSR units Yes No N/A 35.2647 Records of additional technical requirements for mobile remote afterloader units Yes No N/A 35.2652 Records of surveys of therapeutic treatment units Yes No N/A 35.2655 Records of full-inspection servicing for teletherapy and GSR units Yes No N/A Subpart M - Reports 35.3045 Report and notification of a medical event Yes No N/A 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 35.3067 Report of a leaking source Yes No N/A
11 Section Description Regulation Applicable to Alpha DaRT Deviation Explanation and Specifics for Licensing Guidance 35.3204 Report and notification for an eluate exceeding permissible Mo-99, Sr-82, and Sr-85 concentrations Yes No N/A Subpart N - Enforcement 35.4001 Violations Yes No N/A 35.4002 Criminal penalties Yes No N/A Additional Considerations