Source: https://www.nrc.gov/materials/miau/med-use-toolkit.html
Timestamp: 2019-06-19 03:00:31
Document Index: 392295792

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Home > Nuclear Materials > Medical, Industrial, & Academic Uses of Nuclear Materials > Licensee Toolkit
Medical Uses Licensee Toolkit
Patients Administered Radioactive Iodine
Consolidated Guidance About Material Licenses (NUREG 1556)
FDA–NRC Memorandum of Understanding
FAQs on Licensing Medical Use of Byproduct Material
NMSS Newsletters (Discontinued)
This toolkit is designed to help licensees find key information easily. Contact Us to submit medical-related inquiries.
High Dose-Rate Remote Afterloader Brachytherapy Devices
Instructions for submitting training and experience information for the January 14, 2019, revisions to 10 CFR Part 35
Medical use applicants, licensees and Master Material License (MML) permittees need to submit information for Item 7, "Individual(s) Responsible for Radiation Safety Program and Their Training and Experience" of the NRC Form 313, "Applications for a Materials License." This information is reviewed by NRC and MML reviewers when approving individuals as a Radiation Safety Officer, Associate Radiation Safety Officers, Authorized Users, Authorized Nuclear Pharmacists, Authorized Medical Physicists, and Ophthalmic Physicists on medical use licenses and permits.
Usually, licensees would submit this information using the NRC Form 313 A series to provide the necessary information. However, the Office of Management and Budget (OMB) has not yet approved the revised NRC Form 313 A series of forms that comport with the final rule, "Medical Use of Byproduct Material – Medical Event Definitions, Training and Experiences, and Clarifying Amendments," 83 FR 33046 (July 16, 2018). Therefore, these forms should not be used by applicants, licensees, or permittees in submissions to either the NRC or an MML. Further, the current NRC Form 313 A series should not be used because they do not comport with the final rule.
Applicants, licensees, and permittees should follow the instructions on the NRC Medical Uses Licensee Toolkit under Forms, to provide training and experience information to the NRC and MMLs. These instructions are from pages 30 through 49 of "Guidance for the Final Rule, "Medical Use of Byproduct Material – Medical Event Definitions, Training and Experiences, and Clarifying Amendments". These instructions comport with the training and experience requirements in 10 CFR Part 35 that went into effect on January 14, 2019.
Issuance of SECY-18-0084: Staff Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals in Response to SRM-M170817
SECY-18-0084 was publicly released on September 12, 2018. The paper provides the initial results, status, and next steps related to the NRC staff's evaluation of training and experience requirements for administering different categories of radiopharmaceuticals for which a written directive is required in accordance with 10 CFR Part 35, "Medical Use of Byproduct Material," Subpart E, "Unsealed Byproduct Material—Written Directive Required." The paper also presents results of preliminary outreach on the matter and draft comments on the SECY from the Advisory Committee on the Medical Use of Isotopes. For more information on this matter, please see the NRC's Training and Experience Evaluation site.
Changes to Part 35 Became Effective in January 2019
The Final Rule, "Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments," was published on July 16, 2018 and became effective on January 14, 2019. Guidance for the 2019 Final Rule (83 FR 32759) may help licensees with implementation of the changes.
NRC maintains a medical list server for automatic e-mail notifications of medical-related information, and Federal Register Notices. All interested stakeholders are welcome to subscribe.
The NRC is evaluating the training and experience requirements for administering different categories of radiopharmaceuticals for which a written directive is required in accordance with 10 CFR Part 35, "Medical Use of Byproduct Material," Subpart E, "Unsealed Byproduct Material – Written Directive Required." For additional information on this evaluation, including activities, public involvement, and schedule, please see Training and Experience Evaluation.
The NRC's regulations are found in Chapter I of Title 10, "Energy," of the Code of Federal Regulations (CFR). Chapter I is divided into Parts 1 through 199. The following parts contain the requirements most relevant to medical use of nuclear materials:
Part 19 – Notices, Instructions and Reports to Workers: Inspection and Investigations
Part 30 – Rules of General Applicability to Domestic Licensing of Byproduct Material
Part 32 – Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material
Part 33 – Specific Domestic Licenses of Broad Scope for Byproduct Material
Part 37 – Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material
Part 40 – Domestic Licensing of Source Material
Part 70 – Domestic Licensing of Special Nuclear Material
Supporting information for the regulations and rulemaking activities are found in Background Information for Medical Licensees.
NUREG-1556; "Consolidated Guidance About Materials Licenses"
Volume 5, Rev. 1, Program-Specific Guidance About Self-Shielded Irradiator Licenses
Volume 6, Rev. 1, Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses
Volume 7, Rev. 1, Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope, Including Electron Capture Devices and X-Ray Fluorescence Analyzers
Volume 9, Rev. 2, Program-Specific Guidance About Medical Use Licenses
Volume 10, Rev. 1, Program-Specific Guidance About Master Materials Licenses
Volume 13, Revision 2, Program-Specific Guidance About Commercial Radiopharmacy Licenses
Volume 17, Rev. 1, Program-Specific Guidance About Licenses for Special Nuclear Material of Less than Critical Mass
Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator
NUREG-2155, "Implementation Guidance for 10 CFR Part 37, "Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material"
NUREG-2166, "Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material"
NUREG/CR-6345; Radiation Dose Estimates for Radiopharmaceuticals
To understand the basis for the NRC's medical-use regulations, background information can be found in the Federal Register Notices Related to Medical Licensees.
Regulatory Guides (RGs) are issued in 10 divisions and are intended to aid licensees in implementing regulations. The RGs most applicable to medical use can be found in Medical, Industrial, Academic Uses of Nuclear Materials Regulations, Guidance, and Communications.
Generic Communcations
Regulatory Issue Summaries of interest to medical-use licensees
Information Notices of interest to medical-use licensees
NRC’s regional offices (Region I – East, Region III – Midwest, and Region IV – West/Southwest) typically conduct unannounced, periodic inspection of licensed activities using guidance from NRC's Inspection Manual, Chapter 2800. The frequency of inspection is based on the hazard of materials used. More information can be found on Inspection of Medical, Industrial, and Academic Uses of Nuclear Material. The following Inspection Procedures are directly related to medical use.
IP 87130 – Nuclear Medicine Programs, Written Directive Not Required
IP 87131 – Nuclear Medicine Programs, Written Directive Required
IP 87132 – Brachytherapy Programs
IP 87133 – Medical Gamma Stereotactic Radiosurgery and Teletherapy Programs
IP 87134 – Medical Broad-Scope Programs
Records of NRC inspection, including a description of applicable enforcement, are available in NRC's Agencywide Documents Access and Management System (ADAMS). In order to obtain electronic copies of publicly-available inspection reports by using the Sample Search Template, the license number is required. Publicly-available inspection reports can also be obtained from the NRC Public Document Room. Agreement state inspection reports will not be found in ADAMS or the NRC Public Document Room.
To ensure transparency with our stakeholders, the NRC also maintains descriptions of Significant Enforcement Actions for Material Licensees, sorted by date and a database of Significant Enforcement Actions for Material Licensees, sorted alphabetically. For additional information on how the NRC enforces applicable regulations, see Enforcement.
Operating experience is an essential element in the regulatory process for ensuring that licensed activities are conducted safely. The reporting and analysis of medical events helps to identify deficiencies in the safe use of radioactive material and to help ensure that corrective actions are taken to prevent recurrence. A medical event may indicate a potential problem in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. Medical event reporting also allows the NRC to follow up on events and determine if other licensees might be experiencing the same or similar challenges. The NRC assesses trends or patterns, identifies generic issues or concerns, and recognizes any inadequacy or unreliability of specific equipment or procedures. When the NRC identifies similarities in the problems reported from multiple facilities, the NRC issues generic communications that may help prevent additional incidents.
Medical licensees are required to report medical events in accordance with:
In addition to medical events, licensees are required to report events in accordance with 10 CFR Part 20, Subpart M, "Reports," 10 CFR Part 21, "Reporting of Defects and Noncompliance," and 10 CFR 30.50, "Reporting requirements."
The secure database which contains the reported events is not accessible by the public. However, the NRC's Advisory Committee on the Medical Uses of Isotopes conducts semiannual meetings in which the NRC staff and ACMUI give presentations on the medical events from the past fiscal year. Included in the presentation are the causes of those events if known. Below are the presentation slides:
FY18 – NRC Staff Medical Event Slides
FY17 – ACMUI Medical Event Slides (Trend Review for FY14-FY17)
FY17 – NRC Staff Medical Event Slides
FY16 – ACMUI Medical Event Slides
FY16 – NRC Staff Medical Event Slides
FY15 – ACMUI Medical Event Slides
FY15 – NRC Staff Medical Event Slides
FY14 – ACMUI Medical Event Slides
FY14 – NRC Staff Medical Event Slides
The NRC and the Food and Drug Association (FDA) co-regulate high dose-rate remote afterloader brachytherapy devices. A list of high dose-rate remote afterloader brachytherapy devices that are FDA-cleared for patient treatment using sources exceeding 10 Curies is provided for your convenience. The NRC will not authorize the use of sources exceeding 10 Curies in afterloaders unless the FDA has cleared them.
Licensees and applicants should consult NUREG 1556 Volume 9, Rev. 2, "Program-Specific Guidance About Medical Use Licenses," for the information that should be submitted to support a new license, amendment, or renewal of a medical use.
NRC assigns a five-digit code to each license to designate the major activity or principal use authorized in the license. These codes may be used to identify the appropriate NUREG-1556 guidance documents and secondary activities or uses authorized in the license. NRC uses approximately 100 program codes to classify the primary and secondary activities of thousands of active licenses.
Licenses with multiple activities may be assigned multiple program codes. When a licensee has more than one program code, the code with the shortest inspection cycle is designated as the highest priority. This code is designated as the primary code.
Additional information provided in the description of each license type may be used to identify the fee categories information in the schedules in 10 CFR Part 170 and 10 CFR Part 171. To learn more about the license category and the associated fee and inspection categories, see "Consolidated Guidance About Materials Licenses: Guidance About Administrative Licensing Procedures" (NUREG-1556, Vol. 20, Appendix G: LTS Program Code Descriptions).
License Types (Program Codes) for Medical Facilities, Practices, Laboratories
The code used depends upon whether the licensee is a medical facility, private practice, mobile service, or laboratory.
License Type (Program Code)
NUREG-1556 Vol.
Medical Institution Broad 02110 9 & 11
Medical Institution – Written Directive Required 02120 9
Medical Institution – Written Directive Not Required 02121 9
Medical Private Practice – Written Directive Required 02200 9
Medical Private Practice – Written Directive Not Required 02201 9
Mobile Medicine Service – Written Directive Not Required 02220 9
Mobile Medical Service – Written Directive Required 02231 9
Medical Therapy – Other Emerging Technology 02240 9
In Vitro Testing Laboratories* 02410 9
* not medical use but may be used for medical facilities and practices when it is the only byproduct material used
Additional License Types (Program Codes) Associated with Medical Use
The code used depends upon the medical device used.
Eye Applicators Strontium-90 02210 9
High Dose Rate Remote Afterloader 02230 9
Teletherapy 02300 9
Gamma Stereotactic Radiosurgery 02310 9
Pacemaker Byproduct and/or SNM – Medical Institution 22160 17
Pacemaker Byproduct and/or SNM – Individual 22161 17
Source Material Shielding 11210 17
The code used depends upon radiation program authorizations.
Research and Development Type A Broad* 03610 11
Research and Development Type B Broad* 03611 11
Research and Development Type C Broad* 03612 11
Research and Development Other* 03620 7
Measuring Systems Analytic Gauges 03122 7
Measuring Systems Gas Chromatographs 03123 7
Measuring Systems Other 03124 7
Irradiators Self-Shielded Less than or Equal to 10,000 Curies 03510 5
Irradiators Other Less than or Equal to 10,000 Curies 03511 6
Irradiators Self Shielded Greater than 10,000 Curies 03520 5
Waste Disposal (Burial) 03231
Incineration - Noncommercial (Secondary Code) 03235
Byproduct Material Possession Only - Permanent Shutdown 03800
Byproduct Material Standby - No Operations 03810
Decommissioning of Byproduct Material Facilities 03900
Low Level Waste Storage - Other (Secondary Code) 06101
* does not include research on human subjects
Medical use licensees are required to pay an annual license fee to the NRC. Refer to the schedule of materials fees for the fees required for each category of license and each type of fee. Program Codes are provided in the section above.
The following Forms and Instructions are to be used by medical use licensees.
Reciprocity Form 214
Training and Experience NRC Form 313A Series of Forms and Guidance
Instructions – Radiation Safety Officer and Associate Radiation Safety Officer
Instructions – Authorized Medical Physicist and Ophthalmic Physicist
Instructions – Authorized Nuclear Pharmacist
Instructions – Authorized User 35.100, 35.200, 35.500 uses
Instructions – Authorized User 35.300 uses
Instructions – Authorized User 35.400, 35.600 uses
NRC Form 3, Notice to Employees
NRC Form 4, Cumulative Occupational Dose History