ML25051A034

Interim Staff Guidance NMSS-ISG-03, Guidance for Implementation of 10 CFR 35 Training and Experience Requirements

ML25051A034
Person / Time
Issue date:	04/04/2025
From:	Maryann Ayoade, Cindy Flannery, Ong A, Shaw D, Tindle-Engelmann E NRC/NMSS/DMSST/MSEB, State of NH, Dept of Health & Human Services
To:
References
NMSS-ISG-03
Download: ML25051A034 (1)

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OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS INTERIM STAFF GUIDANCE NMSS-ISG-03 GUIDANCE FOR THE IMPLEMENTATION OF 10 CFR PART 35 TRAINING AND EXPERIENCE REQUIREMENTS Manuscript Completed: April 2025 Date Published: April 2025 Prepared by:

Ayoade, Maryann Flannery, Cindy Ong, Augustinus*

Shaw, Daniel Tindle-Engelmann, Elizabeth U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards Washington, DC 20555

• New Hampshire Department of Health & Human Services Radiological Health Section 29 Hazen Drive Concord, NH 03301

ii TABLE OF CONTENTS TABLE OF CONTENTS.................................................................................................................ii PAPERWORK REDUCTION ACT................................................................................................iv PUBLIC PROTECTION NOTIFICATION......................................................................................iv ABBREVIATIONS..........................................................................................................................v 1.0 PURPOSE......................................................................................................................1 2.0 APPLICABILITY AND USE.............................................................................................2

3.0 BACKGROUND

..............................................................................................................3 4.0 GUIDELINES..................................................................................................................3 4.1 Authorized Individuals and Other Individuals Involved in Implementing the Program....4 4.1.1 Purpose of an Authorized Individual........................................................................4 4.1.2 Roles and Responsibilities.......................................................................................5 4.2 Supervision...................................................................................................................12 4.2.1 Purpose of Supervision..........................................................................................13 4.2.2 Roles and Responsibilities.....................................................................................13 4.3 Training.........................................................................................................................14 4.3.1 Pathways for Authorized Individual Approval........................................................15 4.3.1.1 Board Certification Pathway...........................................................................15 4.3.1.2 Alternate Pathway..........................................................................................16 4.3.1.3 Prior Approval on a License...........................................................................16 4.3.2 Types of Training...................................................................................................17 4.3.2.1 Classroom and Laboratory Training...............................................................17 4.3.2.2 Supervised Work Experience.........................................................................17 4.3.2.3 Supervised Clinical Casework........................................................................18 4.3.2.4 Device-Specific Training.................................................................................18 4.3.3 Recentness of Training..........................................................................................19 4.4 Authorized Individuals Seeking to Become an RSO/ARSO..........................................20 4.5 Documentation of T&E to Identify Proposed Authorized Individuals on a License.......20 4.5.1 Adding New Authorized Individuals.......................................................................21 4.5.2 Adding Experienced Authorized Individuals..........................................................22 4.5.3 Adding Experienced Authorized Individuals Who Only Used Accelerator-Produced Nuclear Materials, or Discrete Sources of Radium226, or Both, for Medical or Nuclear Pharmacy Uses........................................................................................23 4.5.4 Recognition of Foreign-Trained Physicians and Physicists...................................23 4.6 General Instructions for Completing the NRC Form 313A Series of Forms.................24 4.6.1 NRC Form 313A (RSO) for Radiation Safety Officers and Associate Radiation Safety Officers.......................................................................................................25

iii 4.6.2 NRC Form 313A (AMP) for Authorized Medical Physicists and Ophthalmic Physicists..............................................................................................................27 4.6.3 NRC Form 313A (ANP) for Authorized Nuclear Physicists....................................29 4.6.4 NRC Forms 313A (AUD), (AUT), (AUS) for Authorized Users..............................31 4.6.5 Training and Experience Documentation for 10 CFR 35.1000..............................33 4.7 Preceptor Attestation....................................................................................................33 4.7.1 Preceptor...............................................................................................................35 REFERENCES............................................................................................................................37 APPENDIX.................................................................................................................................A-1 Guidance for Completing NRC Form 313A and Documentation of Training and Experience..................................................................................................................A-1 Case Scenario for Radiation Safety Officer (RSO) - Board-Certified Medical Physicist Pathway......................................................................................................................A-2 Case Scenario for Radiation Safety OfficerAlternate Pathway.........................................A-10 Case Scenario for Authorized Medical PhysicistAlternate Pathway.................................A-19 Case Scenario for Authorized Nuclear PharmacistAlternate Pathway.............................A-27 Case Scenario for Authorized UserAlternate Pathway.....................................................A-32

iv PAPERWORK REDUCTION ACT This interim staff guidance contains voluntary guidance for implementing the mandatory information collections in 10 CFRPart 35 and NRC Form 313 that are subject to the Paperwork Reduction Act of 1995 (44U.S.C.3501 et. seq.). These information collections were approved by the Office of Management and Budget (OMB), under control numbers 3150-0010 and 3150-0120 respectively. Send comments regarding these information collections to the FOIA, Library, and Information Collections Branch (T6-A10M), U.S.Nuclear Regulatory Commission, Washington, DC 205550001, or by e-mail to Infocollects.Resource@nrc.gov, and to the OMB reviewer at: OMB Office of Information and Regulatory Affairs (3150-0010 and 3150-0120), Attn:

Desk Officer for the Nuclear Regulatory Commission, 725 17th Street, NW Washington, DC 20503.

PUBLIC PROTECTION NOTIFICATION The U.S. Nuclear Regulatory Commission (NRC) may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.

v ABBREVIATIONS 10 CFR Title 10 of the Code of Federal Regulations ADAMS Agencywide Documents Access and Management System AMP authorized medical physicist ANP authorized nuclear pharmacist ARSO associate radiation safety officer AU authorized user AUD authorized user diagnostic AUS authorized user for sealed source AUT authorized user therapy CFR Code of Federal Regulations EMT emerging medical technologies FR Federal Register ISG interim staff guidance MML master materials license Mo99 molybdenum-99 NRC U.S. Nuclear Regulatory Commission OP ophthalmic physicist RSC radiation safety committee RSO radiation safety officer Ra226 radium-226 Rb82 rubidium-82 Sr82 strontium-82 Sr90 strontium-90 SRM staff requirements memorandum Tc99m technetium-99m T&E training and experience WD written directive

1 1.0 PURPOSE This document provides guidance for implementing the training and experience (T&E) requirements in Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material. This interim staff guidance (ISG) is intended for use by licensees or applicants that are seeking to add individuals to their license as authorized individuals, including authorized users (AUs), radiation safety officers (RSOs), associate radiation safety officers (ARSOs), authorized nuclear pharmacists (ANPs), authorized medical physicists (AMPs), and ophthalmic physicists (OPs).

This ISG also provides criteria for the U.S. NRC staff and Agreement State regulators to evaluate such applications or license amendment requests. It clarifies the roles and responsibilities of individuals subject to T&E requirements, and it outlines the information needed to demonstrate the necessary T&E for individuals being listed on the license.

Additionally, it explains expectations for how these individuals fulfill the T&E requirements.

This ISG does the following:

Identifies the information needed to demonstrate necessary T&E for individuals to be listed as AUs, RSOs, ARSOs, ANPs, AMPs, and OPs on an NRC license Provides step-bystep instructions for adding authorized individuals to a medical-use license Details certain specialty board certifications recognized by the NRC Identifies the information and supporting documentation needed to complete the NRC Forms 313A series of forms Provides completed sample NRC Forms 313A and examples of supporting documents that licensees and applicants may refer to when developing their license requests Offers examples of recommended responses for various blocks on the NRC Forms 313A series of forms As stated in the NRCs Medical Policy Statement, the agency regulates the use of radionuclides in medicine to ensure radiation safety of workers and the general public. The NRC minimizes intrusion into medical judgments, except when necessary to ensure radiation safety for workers and the general public. When justified by the risk to patients, the NRC will regulate the radiation safety of patients, primarily to ensure that the use of radionuclides is in accordance with the physicians directions. In developing specific regulatory approaches, the NRC considers industry and professional standards that define acceptable methods to achieve radiation safety.

2.0 APPLICABILITY AND USE This ISG does not contain new expectations for implementing the T&E requirements. Rather, it consolidates the guidance previously contained in various referenced sources into a streamlined format to improve efficiency, clarity, and accessibility.

2 The NRC issues guidance to describe methods that the staff considers acceptable for implementing and complying with specific parts of the agencys regulations. This ISG is not a substitute for NRC or Agreement State regulations. Therefore, licensees are free to demonstrate approaches and solutions that differ from those described in this guidance that may also be deemed acceptable if they satisfy 10 CFR Part 35 T&E requirements and provide a suitable basis for licensing staff to make the necessary determinations for approving individuals as AUs, RSOs, ARSOs, ANPs, AMPs, and OPs.

Applicants and staff should use this ISG in addition to the existing applicable guidance (e.g., NUREG1556, Consolidated Guidance About Materials Licenses, Volume 9, Revision 3, Program-Specific Guidance About Medical Use Licenses, issued September 2019 (NRC, 2019)) until it is superseded by or incorporated in other guidance or rulemaking. Currently, the NRC staff intends to update guidance on the implementation of 10 CFR Part 35 T&E requirements when the rulemaking to establish requirements for rubidium (Rb)-82 generators and emerging medical technologies (EMT) is completed. The NRC staff intends to further review the guidance and make necessary revisions to enhance licensing efficiencies in the future. This will involve a thorough evaluation of comments received outside the scope of this ISG development, incorporating feedback and lessons learned, and further public engagement.

An individual who accesses an electronic version of this guidance document can navigate its contents by clicking on the hyperlinks for each section listed in the table of contents. Hyperlinks also appear throughout the guidance to enable the reader to go directly to the reference material or relevant section of the rule.

Certain States, called Agreement States, have entered into agreements with the NRC that give them the authority to license and inspect byproduct, source, and special nuclear materials in quantities not sufficient to form a critical mass, which are used or possessed within their borders. Any applicant or licensee, other than a Federal entity, that wishes to possess or use licensed material in one of these Agreement States, should contact the responsible officials in that State for guidance on implementing these regulations.

A licensee may seek NRC staff input for clarification on what is required under existing regulations and for the basis for the regulations. NRC staff will not draft or develop text for licensing requests or advise on decisions by the licensee related to license amendment or application submittals.

Sources of basic information about T&E for use by applicants and licensees for the medical use of byproduct material include the following:

10 CFR Part 35 NUREG1556, Volume 9, Revision 3 (NRC, 2019)

NUREG1516, Management of Radioactive Material Safety Programs at Medical Facilities, issued May 1997 (NRC, 1997)

Medical Uses Licensee Toolkit NRC Forms 313A series of forms Specialty Board Certifications Recognized by NRC Under 10 CFR Part 35

3 Final Rule, Medical Use of Byproduct MaterialMedical Event Definitions, Training and Experience, and Clarifying Amendments, published as a final rule on July 16, 2018 (83 FR 33046) (NRC, 2018b)

Final Rule, Medical Use of Byproduct Material, published as a final rule on April 24, 2002 (67 FR 20250) (NRC, 2002)

SECY200005, Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35), dated January 13, 2020 (NRC, 2020)

Staff Requirements Memorandum (SRM)-SECY-200005, dated January 27, 2022 (NRC, 2022)

3.0 BACKGROUND

The NRCs regulations require that individuals complete T&E criteria to be authorized for the medical use of byproduct material and to independently fulfill the radiation-safety-related duties of an AU, RSO, ARSO, ANP, AMP, or OP.

The T&E requirements have evolved over the years in response to changes in medical practice and to ensure that access to patient care is not affected by changes in the medical arena. In SRM-SECY200005, the Commission directed the staff to develop implementation guidance to clarify expectations on how individuals fulfill T&E requirements and clarify the roles and responsibilities of persons subject to the T&E requirements. Guidance on medical T&E criteria found in NUREG1556, Volume 9, Revision 3, is periodically updated concurrent with any regulatory changes. However, given the types of questions that the NRC and Agreement States routinely receive about T&E requirements, the NRC staff has determined that, until the next update to NUREG1556, Volume 9,, supplemental guidance would benefit individuals applying for authorized individual status. The NRC staff determined that this ISG should address the following in response to the Commissions direction:

Expectations for individuals who are subject to the T&E requirements (e.g., supervision)

Training, including equivalency of hours, recentness of training, and vendor-and device-specific training; preceptors and their role in T&E requirements Multiple authorizations (e.g., AUs or AMPs who can also serve as RSOs)

Completion of NRC Forms 313A series of forms and supporting documentation 4.0 GUIDELINES To ensure high levels of radiation safety, medical use licensees are required to have highly qualified and experienced personnel who are knowledgeable about the technical and administrative radiation safety requirements. The following guidelines are designed to help individuals who are interested in becoming an AU, AMP, OP, ANP, RSO, or ARSO.

4 4.1 Authorized Individuals and Other Individuals Involved in Implementing the Program REGULATORY REQUIREMENTS:

10 CFR 35.2, 35.12, 35.24, 35.26, 35.27, 35.50, 35.51, 35.55, 35.57, 35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.400, 35.490, 35.491, 35.690 OTHER

REFERENCES:

NUREG1516 NUREG1556, Volume 9, Revision 3, Section 8.7, Item 7: Individual(s) Responsible for the Radiation Safety Program and Their Training and Experience NUREG1556, Volume 9, Revision 3, Section 8.7.1, Radiation Safety Officer (RSO) and Associate Radiation Safety Officers (ARSOs)

NUREG1556, Volume 9, Revision 3, Figure 82, Licensing Examples of Potential Radiation Safety Officer (RSO) and Associate Radiation Safety Officer (ARSO)

Arrangements NUREG1556, Volume 9, Revision 3, Appendix I, Radiation Safety Officer Duties, Responsibilities, and Delegation EXPLANATION:

An authorized individual is a person (i.e., an AU, AMP, ANP, RSO, ARSO, or OP as defined in 10 CFR 35.2, Definitions,) who meets either of the following criteria:

Has T&E that meets the applicable regulatory training requirements in 10 CFR Part 35 and has been reviewed and approved by the NRC or Agreement States Is identified as an authorized individual on an NRC or Agreement State radioactive materials medical use license, or permit issued by an NRC master materials license (MML) (that authorizes the medical use of byproduct material), or nuclear pharmacy license or permit (that authorizes the medical use or the practice of nuclear pharmacy) and is able to independently fulfill specific radiation-safety-related duties Although the regulations in 10 CFR 35.2 do not specifically define the term authorized individual, they do define each specific type of authorized individual (AU, AMP, ANP, RSO, ARSO, and OP) who may be listed on a license or permit. The term Authorized Individuals generally refers to these specific individuals.

4.1.1 Purpose of an Authorized Individual An authorized individual is responsible for ensuring that radioactive materials are handled and used safely and in accordance with NRC or Agreement State regulations and the terms and conditions of the license or permit. An authorized individual is also responsible for carrying out the applicable duties and functions associated with the license or permit.

5 An authorized individual may have multiple authorizations and may serve as more than one type of authorized individual.

4.1.2 Roles and Responsibilities The regulations in 10 CFR 35.24, Authority and responsibilities for the radiation protection program, provide the requirements for the authority and responsibilities for the licensees radiation protection program, including the licensees management, the RSO, and other personnel who have a role in the radiation protection program (i.e., ARSOs, AUs, AMPs, ANPs, OPs, and members of the Radiation Safety Committee (RSC) if an RSC is required).

Licensees are responsible for their radiation protection programs and the conduct of licensed activities. Each authorized individual has a role and is responsible for implementing certain aspects of the radiation protection program in accordance with the authorizations on the approved license or permit. Section 8.7, Item 7: Individual(s) Responsible for the Radiation Safety Program and Their Training and Experience, of NUREG1556, Volume 9, Revision 3, includes a detailed description of the responsibilities of the licensee and licensee management, as well as the roles and responsibilities of each authorized individual.

Licensee and Licensee Management The licensee is responsible for the conduct of licensed activities and the licensee's management has the ultimate responsibility for the radiation protection program.

Licensee management shall ensure that licensed activities are in accordance with the regulations and the licensees procedures. The regulations in 10 CFR 35.2 define management as the chief executive officer or other individual who has the authority to manage, direct, or administer the licensees activities, or those persons delegate or delegates. The responsibilities and duties of management are included in certain other regulations in 10 CFR Part 35 (e.g., 10 CFR 35.12, 35.24, and 35.26).

Licensee management can delegate tasks or duties, but not the responsibility, to a management delegate. Appendix I to NUREG1556, Volume 9, Revision 3, includes a sample delegation of authority.

Licensee management must approve requests (in writing) for a license application, renewal, or amendment before submittal to the NRC of (1) any individual before allowing that individual to work as an RSO or ARSO, AU, ANP, AMP, or OP and (2) radiation protection program changes that do not require a license amendment and are permitted under 10 CFR 35.26, Radiation protection program changes. The NRC requires that the information in the application be complete and accurate in all material aspects, in accordance with 10 CFR 30.9, Completeness and Accuracy of Information. This includes preceptor attestations for authorized individuals.

The licensees management must appoint an RSO, who agrees in writing to be responsible for implementing the radiation protection program. Licensee management must provide the RSO sufficient authority, organizational freedom, time, resources, and management prerogative to communicate with personnel and direct personnel regarding NRC regulations and license provisions, including (1) identifying radiation safety problems, (2) initiating, recommending, or providing corrective actions, (3) stopping

6 unsafe operations, and (4) verifying the implementation of corrective actions. Although not required, the licensees management may appoint one or more ARSOs to support the RSO.

The licensee is responsible for ensuring that individuals working under the supervision of an AU or ANP have or are provided adequate T&E in accordance with 10 CFR 35.27, Supervision.

Licensees may contract for medical use services, including those involving patient services. However, the licensee should not assume that, by hiring a contractor (e.g., consultant) to provide certain services, it has satisfied all regulatory requirements or that it has transferred responsibility for the licensed program to the contractor.

Licensee management should ensure that mechanisms for oversight are adequate to determine that the radiation protection program, including the training of contractor staff, is effectively implemented by the appropriate individuals.

Radiation Safety Committee Not all licensees are required to have an RSC. Licensees that are authorized for two or more different types of uses of byproduct material under 10 CFR Part 35, Subpart E, Unsealed Byproduct MaterialWritten Directive Required; Subpart F, Manual Brachytherapy; and Subpart H, Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units; or two or more types of units under Subpart H, are required under 10 CFR 35.24(f) to establish an RSC to oversee all uses of byproduct material permitted by the license. EMT under 10 CFR Part 35, Subpart K, Other Medical Uses of Byproduct Material or Radiation from Byproduct Material, are not considered in the requirement to establish an RSC, nor are AUs for EMT required to be part of the RSC unless specified as a license condition. Membership of the committee must include an AU for each type of use permitted by the license (except AUs for EMT unless specified as a license condition), the RSO, a representative of the nursing service, and a representative of management who is neither an AU nor the RSO. The committee may include other members that the licensee considers appropriate such as an AU for an EMT.

If 10 CFR 35.24(f) does not require the creation of an RSC, but the licensee still decides to establish this committee, then the RSC functions as management directs, and its duties are as assigned.

Radiation Safety Officer A licensee is required to have an RSO who has been appointed by licensee management and agrees in writing to be responsible for implementing the radiation protection program in accordance with 10 CFR 35.24. The licensee must provide the RSO sufficient authority, organizational freedom, time, resources, and management prerogative to perform his or her duties. Appendix I to NUREG1556, Volume 9, Revision 3, includes a sample delegation of authority. Additionally, the RSO must have a sufficient commitment from management to fulfill the duties and responsibilities specified in 10 CFR 35.24 to ensure that radioactive materials are used safely.

7 The RSO identified on a license or permit is responsible for overseeing and ensuring the safe operation of the licensees entire radiation protection program and ensuring that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. The NRC requires the name of the current RSO to be listed on the license to ensure that licensee management always has a responsible, qualified person identified and that the named individual knows of their designation as RSO.

Every license is limited to one RSO, but there may be more than one ARSO, or more than one temporary RSO in accordance with 10 CFR 35.24. As required by 10 CFR 35.14(b)(2) and 10 CFR 35.24, licensees must notify the NRC within 30 days of a temporary RSO performing the duties of an RSO.

If the RSO is placed in the licensee management structure and meets the criteria of management as defined in the regulations in 10 CFR 35.2, then actions of the RSO may be considered actions of management. However, if the licensee has an RSC, the RSO is prohibited by 10 CFR 35.24(f) from serving as the management representative on the committee.

The RSO, with written agreement from licensee management, may delegate or assign duties and tasks to each ARSO, but these duties and tasks are limited to the types of use for which the ARSO is listed on the license. The RSO shall not delegate the authority or responsibilities for implementing the radiation protection program (10 CFR 35.24(b)).

An AU, AMP, or ANP listed on a license or permit may be designated and can serve as the RSO or ARSO on the license if the individual has experience with the radiation safety aspects of similar types of byproduct material use for which that individual will have RSO responsibilities or ARSO duties and tasks and as required by 10 CFR 35.24.

Nuclear medicine technologists can be an RSO if they have successfully completed all of the T&E requirements in 10 CFR 35.50, Training for Radiation Safety Officer and Associate Radiation Safety Officers, and agree in writing to be responsible for implementing the radiation protection program.

The RSO is often directly employed by the licensed facility. However, the NRC allows authorized individuals who are not directly employed by the licensee, such as consultants or contractors, to fill the role of RSO (if qualified in accordance with criteria in 10 CFR 35.50 or 10 CFR 35.57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist, and 10 CFR 35.59, Recentness of training) or to provide support to the facility RSO. To fulfill the duties and responsibilities, the RSO should be on site periodically to conduct meaningful person-to-person interactions with licensee staff, commensurate with the scope of licensed activities, to satisfy the requirements of 10 CFR 35.24. The licensee should, in its license amendment request or license application, identify other commitments of the consultant-RSO for other licensees, a description of how they will allocate time to permit the performance of RSO duties, the minimum amount of onsite time, and an in-house representative who will serve as the point of contact during the RSOs absence.

8 A licensee must apply for and receive approval through a license amendment, before an individual can begin duties as a permanent RSO for an existing license in accordance with 10 CFR 35.13, License amendments. A licensee may also appoint individuals as temporary RSOs under the license for up to 60 days each year without prior NRC approval in accordance with 10 CFR 35.14(b)(2) and 10 CFR 35.24(c). A license amendment is not needed for a temporary RSO to begin performing the duties of the RSO, but the licensee must notify the NRC no later than 30 days after permitting a qualified individual to function as the temporary RSO. To be so appointed, an individual must either be qualified to be an RSO or be an AMP, ANP, or AU identified on the license and have experience with the radiation safety aspects of similar types(s) of use(s) of byproduct material for which the individual will have RSO responsibilities. If necessary, for complete radiation safety coverage of activities conducted under the license, the licensee may simultaneously appoint more than one temporary RSO to be responsible for assigned program areas.

The RSO is responsible for the day-today oversight of the entire radiation safety program and has independent authority to stop operations that the RSO considers unsafe. The RSO must have adequate training to understand the hazards associated with radioactive material and be familiar with all applicable regulatory requirements. The RSO duties and responsibilities include ensuring radiological safety, security, and compliance with both the NRC and the U.S. Department of Transportation (DOT) regulations and the conditions of the license. Typically, these duties and responsibilities include, but are not limited to, the following:

Stop unsafe activities involving licensed material.

Ensure that radiation exposures are kept as low as is reasonably achievable.

Oversee all activities involving radioactive material, including monitoring and surveying all areas in which radioactive material is used or stored.

Ensure that upto-date operating, emergency, and security procedures are developed, implemented, maintained, and distributed, as appropriate.

Maintain an inventory of all radioactive material, as required. Ensure that possession, use, and storage of licensed material are consistent with the limitations in the license, the regulations, the sealed source and device registration certificate(s), and the manufacturers recommendations and instructions.

Oversee and coordinate the receipt, opening, and delivery of all packages of radioactive material arriving at the facility. This includes radiation surveys of all shipments arriving or leaving the facility, as well as packaging and labeling of radioactive material leaving the facility.

Ensure that individuals installing, relocating, maintaining, adjusting, or repairing devices containing sealed sources are trained and authorized by an NRC or Agreement State licensee.

Ensure that personnel training is conducted and is commensurate with the individuals duties regarding licensed material.

9

Ensure that documentation is maintained to demonstrate that individuals are not likely to receive, in 1 year, a radiation dose more than 10 percent of the allowable limits or that personnel monitoring devices are provided.

Ensure that personnel monitoring devices are used and exchanged at the proper intervals, and personnel radiation exposure and bioassay records are monitored, reviewed, and maintained, when necessary. Individuals are notified when radiation exposures are approaching established limits, and appropriate corrective actions are taken.

Properly secure radioactive material from unauthorized use or access.

Support development and implementation of a security program for radioactive material in accordance with 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, if the licensee possesses an aggregated Category 1 or Category 2 quantity of radioactive material.

Ensure that documentation is maintained to demonstrate, by measurement or calculation, that the total effective dose equivalent to the individual member of the public likely to receive the highest dose from the licensed operation does not exceed the annual limit in 10 CFR 20.1301, Dose limits for individual members of the public.

Notify proper authorities of incidents, such as damage to or malfunction of sources/devices, excess breakthrough values for molybdenum (Mo)-99/technetium (Tc)-99m or strontium (Sr)-82/Rb-82 generators, loss of licensed material, fire, or theft.

Serve as a point of contact for the NRCs and licensees management during routine operations, emergencies, or incidents.

Investigate and report to the NRC medical events and precursor events, identify cause(s) and appropriate corrective action(s), and ensure that timely corrective action(s) are taken.

Perform and document periodic audits, at least annually, of the radiation safety program to ensure that the licensee is complying with all applicable NRC regulations and the terms and conditions of the license.

Ensure that the results of audits, identification of deficiencies, and recommendations for change are documented (and maintained for 3 years after the record is made) and provided to management for review; ensure that prompt action is taken to correct deficiencies.

Ensure that the audit results and corrective actions are communicated to all personnel who use licensed material.

Ensure corrective action(s) are developed, implemented, and documented when the licensee identifies violation(s) of regulations or license conditions or program weaknesses.

10

Ensure that all incidents, accidents, and personnel exposure to radiation more than the limits in 10 CFR Part 20, Standards for Protection Against Radiation, and 10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, are investigated, their cause(s) are identified, appropriate corrective action(s) are taken, and reports are submitted to the NRC and other appropriate authorities, if required, within the stated time limits.

Ensure that licensed material is transported, or offered for transport, in accordance with all applicable NRC and DOT requirements.

Ensure that radioactive waste is disposed of in accordance with NRC regulations and license conditions. Supervise and coordinate the radioactive waste disposal program, including effluent monitoring and recordkeeping on waste storage and disposal records. Oversee the storage of radioactive material not in current use, including waste.

Perform/oversee the inventory and leak testing on all sealed sources.

Oversee the calibration of radiation survey instruments.

Supervise decontamination operations.

Maintain upto-date copies of NRC regulations, the license, and revised licensee procedures, and ensure that the license is amended whenever there are changes in licensed activities, responsible individuals, or information or commitments provided to the NRC during the licensing process.

Submit amendment and renewal requests in a timely manner.

Assign tasks and duties to an ARSO, if applicable.

Associate Radiation Safety Officer A licensee may appoint one or more ARSOs to support the RSO. Consistent with 10 CFR 35.24(b), ARSOs can be named on a medical license.

An ARSO identified on a license or permit is responsible for duties and tasks as assigned by the RSO, with written agreement from the licensees management.

Licensees with multiple program operating locations or multiple types of use can appoint a qualified ARSO at each location or for each type of byproduct material used. ARSOs are named on medical-use licenses to avoid confusion between individuals named on a license as opposed to individuals working in a radiation program. This allows the individual to be recognized as an ARSO by the NRC and Agreement States as an RSO or ARSO for the same medical uses on another license without resubmitting T&E documentation.

The ARSO cannot assume any RSO responsibilities unless the licensee designates, in writing, the ARSO as a temporary RSO. As required by 10 CFR 35.14(b)(2) and 10 CFR 35.24, licensees must notify the NRC within 30 days of a temporary RSO performing the duties of an RSO.

11 An ARSO may supervise and serve as a preceptor for an individual seeking to be named as the RSO or ARSO, but only for those medical uses for which the preceptor is authorized. For an individual to be named on a license as an ARSO, the individual must have experience in the radiation safety aspects of similar types of medical byproduct material use for which the applicant seeks the approval of the ARSO.

The term assistant RSO is not recognized by the NRC under 10 CFR Part 35.

Authorized User An AU involved in medical use is responsible for radiation safety commensurate with use of byproduct material, administration of a radiation dose or dosage and how it is prescribed, direction of individuals under the AUs supervision in the preparation of byproduct material for medical use and in the medical use of byproduct material, and preparation of written directives (WDs), if required.

There is no NRC requirement that an AU must interpret a diagnostic image or results of a therapeutic procedure. The NRC recognizes that the AU may or may not be the physician who interprets such studies. Additionally, NRC regulations do not restrict who can read and interpret diagnostic scans or the results of therapeutic procedures involving the administration of byproduct material to individuals.

Medical use, as defined under 10 CFR 35.2, is the intentional internal or external administration of byproduct material or radiation from byproduct material to patients or human research subjects under the supervision of an AU (see Section 4.2, Supervision). Individuals authorized for nonmedical uses are sometimes called nonmedical AUs. Nonmedical uses are those not intended for intentional exposure of humans (e.g., nonhuman uses such as in vitro and animal research, certain types of calibration, and other types of uses under 10 CFR 35.65, Authorization for calibration, transmission, and reference sources). A nonmedical AU is not an AU as defined in 10 CFR 35.2, although an individual could serve as both a medical AU and a nonmedical AU.

Authorized Medical Physicist An AMP identified on a license or permit is responsible for calculations and tasks associated with the administration of the radiation dose, including required tasks as described under 10 CFR Part 35, Subpart H, and required tasks associated with performing ophthalmic radiation therapy treatments as described in 10 CFR 35.433(b).

An AMP may assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the WD.

Ophthalmic Physicist An OP identified on a license or permit is responsible for calculating the activity of each Sr-90 source that is used to determine treatment times (10 CFR 35.433(b)(1)).

12 An OP is responsible for assisting the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the WD (10 CFR 35.433(b)(2)).

Although an OP performs the same tasks as an AMP as described in 10 CFR 35.433(b),

the OP and AMP have different T&E requirements.

Authorized Nuclear Pharmacist An ANP identified on a license or permit is responsible for the preparation of radiopharmaceuticals in accordance with the provisions of 10 CFR 35.100(b), 35.200(b),

35.300(b), or 35.1000 licensing guidance found on the NRCs Medical Uses Licensee Toolkit website.

4.2 Supervision REGULATORY REQUIREMENTS:

10 CFR 19.12, 10 CFR 35.2, 35.11, 35.27 OTHER

REFERENCES:

NUREG1556, Volume 9, Revision 3, Section 8.8, Training for Individuals Working in or Frequenting Restricted Areas NUREG1556, Volume 9, Revision 3, Appendix J, Model Training Program "Supplementary Information,"Section III, Summary of Public Comments and Responses to Comments, for 10 CFR 35.27, as published in the Federal Register on April 24, 2002 (67 FR 20250)

Revised 10 CFR Part 35, published as a proposed rule on August 13, 1998 (63 FR 43516), and as a final rule on April 24, 2002 (67 FR 20250)

EXPLANATION:

Only AUs and ANPs identified on a medical use license under 10 CFR Part 35, or individuals working under the supervision of either an ANP or AU, are authorized to use or prepare byproduct material in the practice of medicine. Medical use, as defined in 10 CFR 35.2, must be under the supervision of an AU in accordance with 10 CFR 35.27. All medical preparation of byproduct material for medical use must be under the supervision of an ANP or an AU.

The regulations in 10 CFR 35.11, License required, permit licensees to allow individuals who are neither AUs nor ANPs to perform certain tasks under the supervision of an AU or an ANP who is named on the license or permit. The regulations in 10 CFR 35.27 provide training and oversight requirements for individuals working under the supervision of either an ANP or AU.

The licensee is responsible for ensuring that all supervised individuals have been properly trained and instructed in accordance with direction, instruction, and oversight provided by the AU or ANP. The requirements for supervision do not require the authorized individual or that the authorized individual be physically present at all times during the use or preparation of such materials.

13 AUs and ANPs should assign tasks they determine that supervised individuals can safely perform and provide the degree of supervision that each individual needs. It is frequently necessary for an AU or ANP to delegate specific tasks to others who are not authorized individuals for the use or preparation of byproduct material for medical use. Federal regulations do not require licensees to notify the NRC that an AU has delegated tasks associated with the medical use of byproduct material to another individual under the AUs supervision (e.g., tasks such as package receipt, radiopharmaceutical preparation and administration, and disposal of the radioactive waste). The supervisor or supervising individual is referred to as the supervising AU or supervising ANP, and the individual being supervised is referred to as the supervised individual or individual under the supervision of an AU or ANP.

In addition to the requirements in 10 CFR 19.12, Instruction to workers, the regulations in 10 CFR 35.27 require that supervised individuals be instructed in written radiation protection procedures, WD procedures, regulations, and license conditions with respect to the use of byproduct material. The instructions may be provided in various ways, including inperson training, online training, online protocol review, and other informal training. Additionally, 10 CFR 35.27 requires the supervised individual to comply with the following:

Instructions of the supervising AU for medical uses of byproduct material Instructions of the supervising ANP or supervising AU for preparation of byproduct material for medical uses Written radiation protection procedures and WD procedures established by the licensee 4.2.1 Purpose of Supervision The requirements for supervision allow supervised individuals to receive, possess, prepare, use, and transfer byproduct material under the supervision of an authorized individual (i.e., an AU or ANP). The requirements also ensure that individuals working under the supervision of an AU or ANP receive adequate training.

4.2.2 Roles and Responsibilities Licensee The licensee must instruct supervised individuals in, and require supervised individuals to follow, the licensees written radiation protection procedures, WD procedures, applicable medical regulations, license conditions, and procedures for preparing byproduct material for medical use (10 CFR 35.27). The supervising authorized individual is also expected to have been instructed in these same procedures, regulations, and license conditions.

The licensee is responsible for ensuring that both supervised and supervising individuals receive adequate and applicable training.

The licensee is not only responsible for the acts and omissions of the supervised individual, but also for the acts and omissions of the supervising individual.

14 The licensee is responsible for ensuring that the T&E of supervised individuals is adequate for the duties performed by the individual.

Supervising AU or Supervising ANP An AU or ANP may delegate specific tasks to others who are not authorized individuals for the use or preparation of byproduct material for medical use.

A supervising individual who provides supervised work experience for a potential authorized individual may also serve as the preceptor. The preceptor does not have to be the supervising individual, as long as the preceptor directs or verifies that the required T&E was completed.

Supervised Individual or Individual Under the Supervision of the AU or ANP Nuclear medicine technologists, radiation therapists, or other personnel may use byproduct material for medical use under an AUs supervision, in accordance with 10 CFR 35.27.

Technologists or other personnel may prepare byproduct material for medical use under an ANPs supervision, in accordance with 10 CFR 35.27. Byproduct material for medical use may also be prepared under the supervision of a physician who is an AU.

4.3 Training REGULATORY REQUIREMENTS:

10 CFR 30.33(a)(3), 35.50, 35.51, 35.55, 35.57, 35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.590, 35.690 OTHER

REFERENCES:

NUREG1556, Volume 9, Revision 3 Medical Uses Licensee Toolkit Specialty Board Certifications Recognized by NRC Under 10 CFR Part 35 Supplementary Information,Section IV, Summary of Public Comments and Responses to Comments, Part II, General Issues, Issue 7, Should the term laboratory training be defined? as published in the Federal Register on March 30, 2005 (70 FR 16336)

Supplementary Information,Section III, Summary of Public Comments and Responses to Comments, Part II, General Issues, Item E, Training and Experience, Issue 6, How Long Should the Training Programs Be for Individuals Who Would Like To Become AUs Under §§35.190, 35.290, and 35.390? as published in the Federal Register on April 24, 2002 (67 FR 20250)

EXPLANATION:

15 4.3.1 Pathways for Authorized Individual Approval The regulations in 10 CFR Part 35 provide three primary pathways for individuals seeking to satisfy the T&E requirements and be approved and listed as an authorized individual for uses identified on a medical use radioactive materials license:

Board certification pathway Alternate T&E pathway (hereafter referred to as the alternate pathway)

Prior approval on an NRC or Agreement State license Licensees or applicants should provide documentation for each individual under one pathway.

4.3.1.1 Board Certification Pathway The applicant or licensee may use a board certification pathway if the proposed new authorized individual is (1) certified by a board recognized by the NRC and listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website as provided in 10 CFR 35.50(a), 35.51(a), 35.55(a), 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a),

35.396(a), 35.490(a), 35.590(a), or 35.690(a), or (2) certified before October 24, 2005, by a board listed in 10 CFR 35.57.

The applicable regulatory requirements in 10 CFR Part 35 allow the NRC to recognize specialty board certifications. The certifying board is responsible for reviewing the board applicants qualifications to determine whether the applicant has met the applicable requirements of 10 CFR Part 35. This pathway allows the applicant or licensee to submit a copy of the individuals board certificate rather than detailed information on each T&E element.

Note: An individual who is board eligible will not be considered for this pathway until the individual is board-certified. The NRC does not recognize examination status letters from specialty boards in lieu of an NRC-recognized specialty board certificate. If an individual has passed the examination of a board that is recognized by the NRC but has not yet received a certificate, the individual has the option of submitting the applicable required documentation of T&E using the alternate pathway.

Individuals seeking authorization through the board certification must have a certificate from a specialty board that is recognized by the NRC. To ensure that the board certification is current, the applicant or licensee should review the sample certificate for a recognized specialty board on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website to verify consistency with the proposed individuals certificate. Board certificates should contain prescribed language and show issuance within specified dates as described on the website.

The applicant or licensee will need to provide a copy of the board certification along with other necessary documentation of T&E (e.g., clinical casework, device-specific training), as indicated on the specific form of the NRC Forms 313A series of forms.

4.3.1.2 Alternate Pathway The required T&E under the alternate pathway is essentially equivalent to the board certification pathway for the same type of licensed use, with the exception that T&E must be acquired

16 through a residency training program under the board certification pathway for certain types of uses. Also, the alternate pathway requires a written attestation except for individuals qualifying as AUs for sealed source for diagnosis. OPs can qualify only under the alternate pathway as the NRC does not have a regulation that recognizes OP boards.

The regulatory requirements refer to two main categories of training: (1) classroom and laboratory training and (2) supervised work experience. T&E also includes supervised clinical casework and device-specific training for some types of use. The applicable regulatory requirements in 10 CFR Part 35 define the required hours or number of cases for each element.

All hours credited to classroom and laboratory training must relate directly to radiation safety and safe handling of byproduct material and be allocated to one of the topics in the regulations.

Each hour of training involving performance of radiation safety tasks or hands-on use of byproduct material may be credited to either (1) classroom and laboratory training or (2) supervised work experience. Note that a single hour of training may be counted only once and may not be credited to both categories.

The specific number of hours needed for each T&E element will depend on the type of approval sought. Tables providing the minimum number of hours of T&E required for the alternate pathway for each of the authorized individuals can be found on the NRCs Medical Uses Licensee Toolkit website. On NRC Form 313A, the licensee/applicant should provide the number of clock hours spent on the topics listed in the regulatory requirements, ensuring to document hours in each of the topics listed in the regulations. If an individual seeks to credit more than 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> for a workweek, then supplemental information should be provided to illustrate the total number of hours spent on the T&E element.

The proposed authorized individual may receive the required classroom and laboratory training, supervised work experience, and clinical casework at a single training facility or at multiple training facilities; therefore, space is provided to identify each location and date of training or experience on the NRC Form 313A. The date should be provided in the month/day/year (mm/dd/yyyy) format.

4.3.1.3 Prior Approval on a License Adding an authorized individual to a medical use license or application requires only documentation (i.e., NRC license number or a copy of the Agreement State license) that the individual is listed on a medical use license issued by the NRC or Agreement State; permit issued by an NRC MML; permit issued by an NRC or Agreement State broad-scope licensee; or permit issued by an NRC MML broad-scope permittee. Adding an authorized individual is also contingent on having the same authorization for the same types of use(s) requested in the medical use license or application and the individual meeting the recentness of training criteria described in 10 CFR 35.59.

4.3.2 Types of Training There are four elements of T&E for a proposed authorized individual:

Classroom and laboratory training Supervised work experience Supervised clinical casework Device-specific training

17 4.3.2.1 Classroom and Laboratory Training The proposed authorized individual may obtain the required classroom and laboratory training in any number of settings, locations, and educational situations. For example, at some medical teaching/university institutions, a course may be provided for that specific need and taught in consecutive days. In other training programs, the period may be a semester or quarter as part of the formal curriculum.

Also, the classroom and laboratory training may be obtained using a variety of other instructional methods. Therefore, the NRC will broadly interpret classroom and laboratory training to include various types of instruction, including online training, when it meets the specific clock hour requirements, and the subject matter relates to radiation safety and safe handling of byproduct material for the uses requested:

Formal education (e.g., undergraduate coursework, graduate coursework, medical school coursework)

Coursework offered by an entity such as a licensee, hospital, or vendor Classroom learning activities such as lectures, seminars, or laboratory learning For online or other training programs, the NRC may contact the training entity to discuss the training program components (course outline, test, mechanism to ensure that the proposed individual completed the training and test) and to ensure that the program satisfies the required elements.

For the regulatory body to determine whether the classroom and laboratory training requirements are met, the applicant should provide information such as a transcript, completion certificate, course description, syllabus, outline, or learning objectives. The number of hours is based on time engaged in the learning activity. For a typical collegiate course, the total number of hours of class time may be counted rather than the credit hours received for the course.

4.3.2.2 Supervised Work Experience Supervised work experience must be performed under the supervision of an individual who is currently authorized for the type of activities for which the individual is seeking authorization.

Specifically, the supervising individual must meet specific requirements and have authorization for the same use or device categories that the proposed authorized individual is seeking. The supervising individual may be employed at a different facility than the proposed authorized individual (e.g., previous place of work or someone from the proposed individuals educational program). Applicants should include a copy of the license to demonstrate the materials and uses for which the supervising individual is authorized.

The supervised work experience for proposed physician AUs must include, but is not limited to, the subject areas listed in the applicable T&E requirements. The NRC recognizes that physicians in training may not dedicate all of their supervised work experience time specifically to the subject areas listed in the regulatory requirements (e.g., 10 CFR 35.290(c)(1)(ii) and 10 CFR 35.390(b)(1)(ii)) and will be attending to other clinical matters involving the medical use of the material (e.g., reviewing case histories or interpreting scans). Even though the NRC does not specifically require these clinical activities, this type of supervised clinical experience may be

18 credited toward the supervised work experience category to obtain the required total of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E, but not to the classroom and laboratory training category. The applicable sections of 10 CFR Part 35 describe the specific elements required for each type of authorized individual supervised work experience may be remote (e.g., reviewing case histories or interpreting scans) or in person, depending on the clinical activity (e.g., hands-on medical use of the licensed material or delivery device). For supervised work experience, a standard workweek of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 52 weeks per year is used to demonstrate the number of work experience hours that have been completed by an individual. Clear justification and support for claiming more than 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week should be provided to support a deviation from a standard workweek.

For RSOs, ARSOs, and ANPs, all the hours of applicable supervised experience should be allocated to the topics specified in the regulations. If the individual has other duties during this period, those hours should be omitted from the summation of the work experience hours.

Note: If the proposed new authorized individual had more than one supervisor, the requested information must be provided for each supervising individual.

4.3.2.3 Supervised Clinical Casework Individuals seeking certain authorization may be required to complete supervised clinical casework. This is considered a sub-element of the supervised work experience. In this case, a supervisor is an individual who provides frequent direction, instruction, and direct oversight of the supervised individuals as they complete the required work experience in the clinical use of byproduct material. Supervision may occur at various licensed facilities, from a large teaching university hospital to a small private practice.

The individual seeking authorization may submit a list of dates and procedure types performed under the supervision of an AU. Casework should be presented for each type of use for which the individual is seeking authorization. Casework should be completed in person. A physician who has experience with at least three cases in oral administration of greater than 33 millicuries (mCi) (1.22 gigabecquerels (GBq)) of sodium iodide I-131 also satisfies the requirement in oral administrations of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131. The applicant or licensee should submit a copy of the license for which the supervising AU is listed.

4.3.2.4 Device-Specific Training Individuals seeking certain authorizations may need to complete device-specific training. This element refers to training that the individuals have completed with the specific type of therapeutic medical unit for which they are seeking authorization. There is not a specified number of hours that must be completed. Device-specific training allows for the individual to receive training on the type of therapeutic medical unit and does not require that the training be specific to the model of the device. For example, individuals seeking authorization for a high-dose-rate remote afterloader need not have training on the specific model for which they are seeking authorization but simply training with a high-dose-rate remote afterloader to meet NRC T&E criteria. In some cases, 10 CFR 35.610(d) and/or 10 CFR 35.610(e) may require model-specific training.

The scope of the training may differ for each type of therapeutic medical unit. The training shall cover operating procedures, safety procedures, emergency procedures, operation of the device, safety of the device, and clinical use of the device. This element must be hands-on training with

19 the device for AMPs (10 CFR 35.51(c)) and for AUs of some of the EMT. The vendor of the device, an AU of the device, or an AMP of the device may provide this training. The regulatory body will likely verify authorizations for the supervising AU, so the applicant or licensee should submit a copy of the license for which the supervising AU or AMP is listed.

When device manufacturer training for units under 10 CFR 35.600, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit, has been completed at the facility, the licensee can train its own staff under the provisions of 10 CFR 35.610(d)(2) if there are no additional manufacturer upgrades that affect the operation and safety of the unit. In accordance with 10 CFR 35.610(d)(2), all individuals who operate the unit at the facility must receive operational and safety instruction, as appropriate to the individual's assigned duties, initially and at least annually. If there are additional manufacturer upgrades that affect the operation and safety of the unit, the provisions of 10 CFR 35.610(d)(1) apply, and only the device manufacturer or an individual certified by the device manufacturer to provide the training can train the licensees staff. If the device manufacturer certifies someone on the licensees staff to provide the training, that individual can provide the training to other licensee staff members.

4.3.3 Recentness of Training The required T&E, including the board certification pathway, alternate pathway, and prior approval on a license, must be obtained within the 7 years preceding the date of the application, or the individual must document having completed related continuing education and experience since obtaining the required T&E as described in 10 CFR 35.59. The NRC does not specify a certain number of hours or elements that must be included in the continuing education and experience. However, the continuing education and experience must be relevant to the duties associated with the activities for which the individual is seeking authorization. License applications and amendment requests should contain information that would support a determination that the proposed authorized individuals continuing education demonstrates competency in the topics specified in the applicable regulations. The required number of hours of continuing education and clinical experience depends on the period of time the individual has not been involved in licensed activities and how closely the individuals recent educational and work experience are related to the proposed area of medical use and is reviewed on a case-bycase basis. Acceptable continuing education and experience may include the following:

Successful completion of classroom and laboratory review courses that include radiation safety practices related to the proposed type of authorized medical use (this review may include various instruction, including online training, as long as the subject matter relates to radiation safety and safe handling of byproduct material for the uses requested)

Practical and laboratory experience with patient procedures using radioactive material for the same use(s) for which the applicant is requesting authorization Practical and laboratory experience under the supervision of an AU at the same or another licensed facility that is authorized for the same use(s) for which the applicant is requesting authorization

20 For therapy devices, experience with the therapy unit, comparable linear accelerator experience, or both, and completion of an in-service review of operating and emergency procedures relative to the therapy unit to be used by the applicant Maintaining active certifications may not be sufficient documentation to demonstrate meeting the recentness of training requirements since the training must be relevant to the duties associated with the activities for which the individual is seeking authorization. Supplementary documentation is typically necessary for maintenance of certification to be used for this requirement.

4.4 Authorized Individuals Seeking to Become an RSO/ARSO REGULATORY REQUIREMENTS:

10 CFR 35.13, 35.24, 35.50, 35.51, 35.55, 35.57, 35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.433, 35.490, 35.590, 35.690 OTHER

REFERENCES:

Authorized Individuals section of the Medical Uses Licensee Toolkit NUREG1556, Volume 9, Revision 3 EXPLANATION:

Regulations in 10 CFR 35.50 provide pathways by which authorized individuals may become an RSO or ARSO. A medical physicist who is certified by a specialty board recognized by the NRC under 10 CFR 35.51, Training for an authorized medical physicist, may request authorization as the RSO or ARSO on a license or permit (10 CFR 35.50(c)(1)). Regulations found in 10 CFR 35.50(c)(2) allow an individual who is an AU, AMP, or ANP identified on a medical license or permit to request authorization as the RSO or ARSO on a license or permit.

An individual who has not yet been named as an AU on a medical license or permit, but is qualified to be an AU, may apply for and be authorized simultaneously as the RSO and the AU on the same new medical-use license (10 CFR 35.50(c)(3)).

All individuals seeking approval under 10 CFR 35.50(c) must have experience with the radiation safety aspects of all the types of use of byproduct material for which the individual will have RSO responsibilities or ARSO duties and tasks, and they must have training in radiation safety, regulatory issues, and emergency procedures for all the types of use for which a licensee seeks approval (10 CFR 35.50(d)). These individuals must also meet the recentness of training criteria described in 10 CFR 35.59.

4.5 Documentation of T&E to Identify Proposed Authorized Individuals on a License REGULATORY REQUIREMENTS:

10 CFR 35.2, 35.13, 35.50, 35.51, 35.55, 35.57, 35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, 35.590, 35.690

21 OTHER

REFERENCES:

NUREG1556, Volume 9, Revision 3 Medical Uses Licensee Toolkit NRC Forms 313A series of forms Emerging Medical Technologies website EXPLANATION:

Multiple individuals may be involved in the process of demonstrating T&E for an individual seeking authorization. The proposed authorized individual should be responsible for gathering relevant documentation that demonstrates fulfillment of the requirements, preparing the necessary paperwork, and working with other individuals such as preceptors, residency coordinators, and supervising individuals, as necessary. Some institutions may rely on the RSO, a physicist, or management to assist and guide the proposed authorized individual.

It is important for preceptors, residency coordinators, and supervising individuals to note that the NRC does not assess the medical competency of any authorized individual. The NRC only reviews T&E related to the radiation safety responsibilities of authorized individuals.

4.5.1 Adding New Authorized Individuals Pursuant to 10 CFR 35.12, licensees are to use NRC Form 313, Application for Materials License for license applications, and may use NRC Form 313 or a letter containing all of the information required by NRC Form 313 for license amendments or renewals. Licensees should use the most current version of the applicable NRC Form 313A to document T&E for adding an authorized individual to its license. Refer to the NRC Medical Uses Licensee Toolkit website or the NRC Forms website for the most current version of the forms and their associated instructions. Verify that the most current version of NRC Form 313A is being used by checking the Expires date in the top right-hand corner of the form. Additionally, the appendix to this ISG includes five different case scenarios along with completed sample NRC Forms 313A that shows the information and supplemental documentation that should be submitted by the applicant or licensee. The following are the six forms in the 313A series which a licensee can use to document T&E to request authorization for different roles:

NRC Form 313A (RSO)Radiation Safety Officer or Associate Radiation Safety Officer NRC Form 313A (AMP)Authorized Medical Physicist and Ophthalmic Physicist NRC Form 313A (ANP)Authorized Nuclear Pharmacist NRC Form 313A (AUD)Authorized User requesting authorization for diagnostic uses defined under 10 CFR 35.100, Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required; 10 CFR 35.200, Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required; or 10 CFR 35.500, Use of sealed sources and medical devices for diagnosis NRC Form 313A (AUT)Authorized User requesting authorization for use of unsealed radioactive material for therapy defined under 10 CFR 35.300, Use of unsealed byproduct material for which a written directive is required

22 NRC Form 313A (AUS)Authorized User requesting authorization for use of sealed sources defined under 10 CFR 35.400, Use of sources for manual brachytherapy, or 10 CFR 35.600, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit The forms are specific to medical use licensees.

At the time of this guidance, there is not a specific NRC Form 313A for an AU requesting authorization use for radioactive material defined under 10 CFR 35.1000, Other medical uses of byproduct material or radiation from byproduct material. The T&E requirements for 10 CFR 35.1000 medical uses are determined on a case-bycase basis. The NRC has developed licensing guidance, including T&E guidance, for certain 10 CFR 35.1000 medical uses, which is available on the NRCs Emerging Medical Technologies website.

It is important to note that the communication to the regulatory authority must come from the license holder (or licensee), not the individual seeking approval as an authorized individual. The licensee is the responsible entity and is accountable for authorized individuals working under its license. NUREG-1556, Volume 9, Revision 3, includes guidance on preparing amendment requests and notifications.

4.5.2 Adding Experienced Authorized Individuals An applicant or licensee that is adding an experienced AU for medical uses, AMP, OP, ANP, RSO, or ARSO to its medical use application or license should provide a copy of the license or permit listing the applicant. This may be a medical use license issued by the NRC or an Agreement State, a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC master material broad-scope permittee, provided that the individual is authorized for the same types of use(s) requested in the application under review, and that the individual meets the recentness of training criteria in 10 CFR 35.59.

When adding an experienced ANP to the license, an applicant or licensee also may provide evidence that the individual is listed on an NRC or Agreement State commercial nuclear pharmacy license or is identified as an ANP by a commercial nuclear pharmacy authorized to identify ANPs. For individuals who have been previously authorized by, but are not currently listed on, the commercial nuclear pharmacy license, medical broad-scope license, or MML medical broad-scope permit, the applicant should submit either verification of previous authorizations granted or evidence of acceptable T&E.

Some situations may require only a notification by the licensee to the regulatory authority. For example, if a proposed authorized individual is identified as an AMP, OP, ANP, or AU for medical use on an Agreement State license, a license amendment is not needed to permit the individual to begin work as an authorized individual under the NRC license for the same types of use (see 10 CFR 35.13(b) and 10 CFR 35.57). For licensees other than those possessing a Type A specific license of broad-scope for medical use (issued under 10 CFR Part 33, Specific Domestic Licenses of Broad-Scope for Byproduct Material), the licensee is required by 10 CFR 35.14(a) to notify and provide to the NRC within 30 days of the individual beginning work for the licensee as an AMP, OP, ANP, or AU, a copy of the license or permit, or the board certification. For approval of additional uses or devices, documentation verifying completion of additional training must also be provided under 10 CFR 35.51(c) for an AMP; additional case

23 experience required in 10 CFR 35.390(b)(1)(ii)(G) for an AU under 10 CFR 35.300; or device-specific training in 10 CFR 35.690(c) for an AU under 10 CFR 35.600.

4.5.3 Adding Experienced Authorized Individuals Who Only Used Accelerator-Produced Nuclear Materials, or Discrete Sources of Radium-226, or Both, for Medical or Nuclear Pharmacy Uses Regulations in 10 CFR 35.57(a)(4) and 10 CFR 35.57(b)(3) allow grandfathering of RSOs, physicians, podiatrists, dentists, medical physicists, and nuclear pharmacists who used only accelerator-produced radioactive materials, discrete sources of radium (Ra)-226, or both for medical or nuclear pharmacy uses at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, when using these materials for the same uses. The applicant or licensee that is adding one of these experienced individuals to its medical use license should document that the individual used only accelerator-produced radionuclides, or discrete sources of Ra-226, or both, for medical or nuclear pharmacy uses before or during the dates specified and that the materials were used for the same uses requested. This documentation may be, but is not restricted to, evidence that the individual was listed on an Agreement State or NRC license or permit authorizing these materials for the requested uses. The applicant or licensee should submit evidence of recentness of training in accordance with 10 CFR 35.59.

4.5.4 Recognition of Foreign-Trained Physicians and Physicists For foreign-trained physicians, the following must be provided to the regulator as evidence of meeting the T&E requirements.

Current license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine Documentation of the work experience that was completed under the supervision of an AU who meets the applicable T&E requirements in 10 CFR Part 35 o

A copy of the license or permit that lists the supervisor as an AU for the uses requested A written attestation signed by a preceptor AU who meets the applicable T&E requirements in 10 CFR Part 35 o

A copy of the license or permit that lists the preceptor as an AU for the uses requested The supervising AU and the preceptor AU must be a physician licensed to practice medicine in the United States, or a U.S. Territory, or Puerto Rico.

For foreign-trained physicists, the following must be provided to the regulator as evidence of meeting the T&E requirements:

The masters and/or doctoral degrees from outside of the United States are from an accredited college or university. This should include submission of the diploma and transcript demonstrating that the degree was issued. The licensee should verify that the

24 college or university was accredited at the time that the degree was granted. The licensee should also ensure that the graduate education program is accredited by referring to the website for the International Organization for Medical Physicists, which provides a global listing of graduate education programs in medical physics and the associated accreditation status.

The applicants transcript (or equivalent documentation), provided in English. The licensee should ensure that foreign degrees other than physics, medical physics, other physical science, engineering, and applied mathematics are equivalent to one of these listed degrees.

The work experience completed under the supervision of an individual who meets the requirements for an AMP in 10 CFR 35.51 for the type(s) of use for which the individual is seeking authorization is documented.

A written attestation, signed by a preceptor AMP who meets the applicable T&E requirements in 10 CFR 35.51 for each type of therapeutic medical unit for which the individual is requesting to become an AMP.

A copy of the license or permit that lists the supervising individual and preceptor is included.

4.6 General Instructions for Completing the NRC Form 313A Series of Forms REGULATORY REQUIREMENTS:

10 CFR 35.50, 35.51, 35.55, 35.57, 35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.590, 35.433, 35.491, 35.690 OTHER

REFERENCES:

NRC Forms 313A series of forms Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 EXPLANATION:

Name of Proposed Authorized Individual:

Provide the individuals complete legal name so that the NRC can distinguish the individual from others with a similar name. Include terminal degree designation(s) and documentation as applicable to the review of the proposed authorized individual. Note: Do not include personal or private information (e.g., date of birth, social security number, home address, personal telephone number) as part of the qualification documentation. As a reminder, licensees have 30 days to inform the NRC of an authorized individuals name change per 10 CFR 35.14(b)(1).

Requested Authorization(s):

Indicate authorizations requested and fill in the blanks as provided.

25 T&E Documentation:

Indicate the applicable T&E pathway (i.e., board certification pathway, alternate pathway, or authorization on another license), as documented on the form.

Additional Considerations for Completing the NRC Form 313A Series of Forms:

If the applicant or licensee is proposing an individual for more than one type of authorization, the applicant may need to either submit multiple forms in the NRC Forms 313A series of forms or fill out some sections more than once. For example, an applicant requesting that a physician be authorized for 10 CFR 35.200 and 10 CFR 35.300 medical uses and as the RSO should complete three forms of the 313A series (i.e., NRC Form 313A (RSO), NRC Form 313A (AUD) and NRC Form 313A (AUT))). If the applicant or licensee has multiple supervising individuals, more than one form or page may be used to document supervised work experience.

To identify any individual (i.e., proposed individual or supervising individual or preceptor) currently or previously listed on a license, provide the license on which the individual was identified.

Provide a complete copy of the permit issued by the NRC MML, broad-scope licensee, or MML broad-scope permittee to identify an individual who is authorized under any of the following:

Medical use permit issued by an NRC MML Permit issued by an NRC or Agreement State broad-scope medical use licensee Permit issued by an NRC MML broad-scope medical use permittee Personal information about employees or other individuals should not be submitted. Examples of private information are social security number, home address, home telephone number, date of birth, radiation dose information, patient records, clinical records or resident summaries.

4.6.1 NRC Form 313A (RSO) for Radiation Safety Officers and Associate Radiation Safety Officers The T&E requirements for the RSO and ARSOs, as described in 10 CFR 35.50, provide multiple pathways that applicants or licensees can use to demonstrate that individuals are qualified as an RSO or ARSO. Applicants should provide documentation that each individual is qualified under one of the three pathways. The appendix to this ISG includes two proposed RSO case scenarios along with completed sample NRC Form 313A (RSO) that shows the information and supplemental documentation that should be submitted by the applicant or licensee.

When an applicant wants to identify one or more ARSOs, the applicant must identify the types of use (e.g., 10 CFR 35.200, 10 CFR 35.300) of byproduct material for which the proposed authorized individual may be assigned duties and tasks under the licensees program in the oversight of the radiation safety program.

26 Prior Approval on a License:

An applicant or licensee that is adding an experienced RSO/ARSO for medical uses to its license needs to provide only an NRC license number or a copy of the license (if issued by an Agreement State), a copy of a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC MML broad-scope permittee on which the individual is authorized for the same types of use(s) requested.

Alternatively, the applicant or licensee may provide a statement signed by the RSO or chairperson of the RSC similar to the following:

(Name of authorized individual) was authorized under (name of license/permit) broad-scope license number (license number) to use (materials authorized to use) during (time frame).

The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet the recentness of training requirements described in 10 CFR 35.59, if applicable.

All RSOs who are listed on a license after January 14, 2019, are required to meet the training requirements of 10 CFR 35.50(d) if they are seeking authorizations for new materials and medical uses for which they were not authorized before this date.

Board Certification Pathway:

The board certification pathway, as provided in 10 CFR 35.50(a), requires certification by a specialty board whose certification process has been recognized and is listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website or included in 10 CFR 35.57(a)(2) and has training in radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval.

Qualification may also be demonstrated by a medical physicist who has been certified by a specialty board whose certification process has been recognized for AMPs by the NRC and is listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website. The medical physicist should have experience with the radiation safety aspects of similar types of byproduct material and training in radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval (10 CFR 35.50(d)).

Board-certified individuals that were not named as an RSO may be grandfathered for those materials and uses that they performed on or before October 24, 2005, if the individual was board-certified by any of the boards listed in 10 CFR 35.57(a)(2) on or before October 24, 2005.

The applicant must provide documentation that the individual used the materials and performed the medical uses before October 24, 2005, to meet the requirements to be an RSO or ARSO for those materials and uses. This documentation will be reviewed on a case-bycase basis to verify that the time period of use, the materials used, and the types of medical use meet the criteria in the regulation.

Supporting documentation for NRC Form 313A (RSO) would include a copy of a board certificate listed on the NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website. Additional training may also need to be documented under

27 10 CFR 35.50(d). The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet the recentness of training requirements described in 10 CFR 35.59, if applicable. Proposed RSOs who are board-certified do not need to provide a preceptor attestation.

Alternate Pathway:

The alternate pathway requires the proposed RSO to meet a structured educational program of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training (10 CFR 35.50(b)(1)(i)), 1 year of full-time supervised radiation safety work experience (10 CFR 35.50(b)(1)(ii)), a preceptor attestation (10 CFR 35.50(b)(2)), and completion of training as specified in 10 CFR 35.50(d). For example, for supervised work experience, a standard workweek of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 52 weeks per year is considered full-time. If the proposed RSO is not obtaining supervised work experience on a full-time basis (i.e., 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> a week), the licensee should demonstrate that the equivalent of 1 year full-time is obtained (e.g., multiple entries of supervised work experience that add up to 1 year full-time).

Supporting documentation for NRC Form 313A (RSO) may include some of the following:

National Registry of Radiation Protection Technicians certificate Diploma or transcripts Continuing education and experience records Documentation of specific radiation safety training for each use on the license Documentation of device-specific training (10 CFR 35.600 and possibly 10 CFR 35.1000 uses), such as training records from the vendor A list of prior health physics/RSO occupational positions and duty descriptions Certificates or a syllabus from formal courses (examples)

Health Physics Course

Radiation Safety Officer Course

Medical RSO Course

DOT Course

HAZMAT Course

Radiation Instrumentation Course

Multi-Agency Radiation Survey and Site Investigation Manual

Medical Effects of Ionizing Radiation

Air Sampling for Radionuclides Other/additional documents provided (i.e., for 10 CFR 35.1000 uses)

Memorandum from a vendor listing radiation safety training course completion

List of patient case involvement A copy of the license or permit from preceptor attestation (supporting documentation for Part II, Fourth Section, of NRC Form 313A (RSO))

28 4.6.2 NRC Form 313A (AMP) for Authorized Medical Physicists and Ophthalmic Physicists T&E requirements for AMPs described in 10 CFR 35.51 allow multiple pathways that applicants can use to demonstrate that individuals are qualified as an AMP. Applicants should provide documentation that each individual is qualified under one of the three pathways. The appendix to this ISG includes a proposed AMP case scenario along with a completed sample NRC Form 313A (AMP) that shows the information and supplemental documentation that should be submitted by the applicant or licensee.

Prior Approval on a License:

An applicant or licensee that is adding an experienced AMP to its license needs to provide only an NRC license number or a copy of the license (if issued by an Agreement State), a copy of a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC MML broad-scope permittee on which the individual is authorized for the same types of use(s) requested.

Alternatively, the applicant or licensee may provide a statement signed by the RSO or chairperson of the RSC similar to the following:

(Name of authorized individual) was authorized under (name of license/permit) broad-scope license number (license number) to use (materials authorized to use) during (time frame).

The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet the recentness of training requirements in 10 CFR 35.59, if applicable.

All AMPs listed on a license after January 14, 2019, are required to meet the training requirements of 10 CFR 35.51(c) if they are seeking authorizations for new materials and medical uses for which they were not authorized before this date.

Board Certification Pathway:

The board certification pathway, as provided in 10 CFR 35.51(a), requires certification by a specialty board whose certification process has been recognized and is listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website or included in 10 CFR 35.57(a)(3). The individual should have training in hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system.

Board-certified individuals who were not named as an AMP may be grandfathered for those materials and uses that they performed on or before October 24, 2005 if the individual was certified by any of the boards listed in 10 CFR 35.57(a)(3) on or before October 24, 2005. The applicant must provide documentation that the individual used the materials and performed the medical uses before October 24, 2005, to meet the requirements to be an AMP for those materials and uses. This documentation will be reviewed on a case-by-case basis to verify that the time period of use, the materials used, and the types of medical use meet the criteria in the regulation.

29 Supporting documentation for NRC Form 313A (AMP) would include a copy of a board certificate recognized as listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website. Additional training may also need to be documented under 10 CFR 35.51(c). The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet recentness of training requirements described in 10 CFR 35.59, if applicable. Proposed AMPs who are board-certified do not need to provide a preceptor attestation.

Alternate Pathway:

The alternate pathway requires the proposed AMP to meet a structured educational program of a masters or doctors degree in physics, medical physics, other physical science, engineering or applied mathematics from an accredited college or university as required in 10 CFR 35.51(b)(1)); 1 year of full-time training in medical physics and an additional year of full-time supervised work experience (10 CFR 35.51(b)(1)); a preceptor attestation (10 CFR 35.51(b)(2)); and completion of training as specified in 10 CFR 35.51(c). For example, for supervised work experience, a standard workweek of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 52 weeks per year is considered full-time. If the proposed AMP is not obtaining training or supervised work experience on a full-time basis (i.e., 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> a week), the licensee should demonstrate that the equivalent of 1 year full-time is obtained (e.g., multiple entries of training or supervised work experience that add up to 1 year full-time).

OPs can qualify only under this pathway as the NRC does not have a regulation that recognizes ophthalmic physicist boards. The T&E requirements for OPs are described in 10 CFR 35.433(a)(2). NRC Form 313A (AMP) may be used to document T&E for individuals seeking authorization to use Sr-90 for ophthalmic treatments.

Supporting documentation for NRC Form 313A (AMP) would include the following:

Diploma or transcripts Continuing education and experience records Documentation of specific radiation safety training for each use on the license Documentation of device-specific training (10 CFR 35.600 and possibly 10 CFR 35.1000 uses), such as training records from vendor Certificates or a syllabus from formal courses Other/additional documents provided (i.e., for 10 CFR 35.1000 uses)

Memorandum from a vendor listing radiation safety training course completion

List of patient case involvement A copy of the license or permit from preceptor attestation (supporting documentation for Part II, Fourth Section, of NRC Form 313A (AMP))

4.6.3 NRC Form 313A (ANP) for Authorized Nuclear Physicists

30 The T&E requirements for ANPs, as described in 10 CFR 35.55, Training for an authorized nuclear pharmacist, allow multiple pathways for applicants to demonstrate that individuals are qualified as an ANP. Applicants should provide documentation that each individual is qualified under one of the three pathways. The appendix to this ISG includes a proposed ANP case scenario along with a completed sample NRC Form 313A (ANP) that shows the information and supplemental documentation that should be submitted by the applicant or licensee.

Prior Approval on a License:

An applicant or licensee that is adding an experienced ANP to its license needs to provide only an NRC or Agreement State license number or a copy of one of the following on which the individual is authorized for the same types of use(s) requested:

Medical use license (if issued by an Agreement State)

Commercial nuclear pharmacy license (if issued by an Agreement State)

Permit issued by an NRC MML Permit issued by an NRC or Agreement State broad-scope licensee Permit issued by an NRC MML broad-scope permittee Authorization from a commercial nuclear pharmacy authorized to identify ANPs Alternatively, the applicant or licensee may provide a statement signed by the RSO or chairperson of the RSC similar to the following:

(Name of authorized individual) was authorized under (name of license/permit) broad-scope license number (license number) to use (materials authorized to use) during (time frame).

The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet the recentness of training requirements in 10 CFR 35.59, if applicable.

Board Certification Pathway:

The board certification pathway, as provided in 10 CFR 35.55(a), requires certification by a specialty board whose certification process has been recognized and is listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website or included in 10 CFR 35.57(a)(2).

Supporting documentation for NRC Form 313A (ANP) would include a copy of a board certificate recognized as listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website. The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet the recentness of training requirements described in 10 CFR 35.59, if applicable. Proposed ANPs who are board-certified do not need to provide a preceptor attestation.

Alternate Pathway:

The alternate pathway requires the proposed ANP to meet a structured educational program of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training (10 CFR 35.55(b)(1)(i)), supervised practical

31 experience in nuclear pharmacy (10 CFR 35.55(b)(1)(ii)), and a preceptor attestation (10 CFR 35.55(b)(2)).

Supporting documentation for NRC Form 313A (ANP) includes the following:

A copy of the State license to practice pharmacy (in accordance with 10 CFR 35.55(a)(2))

Diploma or transcripts Continuing education and experience records Certificates or a syllabus from formal courses by their employer or an educational institution Vendor-specific training certificates for radioactive drug preparation 4.6.4 NRC Forms 313A (AUD), (AUT), (AUS) for Authorized Users T&E requirements for AUs, described in 10 CFR 35.57, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, 35.590, and 35.690, allow multiple pathways for applicants to use to demonstrate that individuals are qualified as an AU. Applicants should provide documentation that each individual is qualified under one of the three pathways: prior approval on a license, board certification pathway, or the alternate pathway.

The NRC requires physicians, dentists, podiatrists, and pharmacists to be licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine, as well as licensed in the practice of dentistry, podiatry, or pharmacy, respectively (see definitions of physician, dentist, podiatrist, and pharmacist in 10 CFR 35.2).

The following NRC Forms 313A may be used to document T&E for proposed AUs:

NRC Form 313A (AUD) for uses defined under 10 CFR 35.100, 35.200, and 35.500 NRC Form 313A (AUT) for uses defined under 10 CFR 35.300 NRC Form 313A (AUS) for uses defined under 10 CFR 35.400 and 10 CFR 35.600 The appendix to this ISG includes a proposed AU case scenario along with a completed sample NRC Form 313A (AUT) that shows the information and supplemental documentation that should be submitted by the applicant or licensee.

Prior Approval on a License:

An applicant or licensee that is adding an experienced AU to its license needs only to provide the NRC license number or a copy of the license (if issued by an Agreement State), a copy of a permit issued by an NRC MML, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC MML broad-scope permittee on which the individual is authorized for the same types of use(s) requested.

Alternatively, the applicant or licensee may provide a statement signed by the RSO or chairperson of the RSC similar to the following:

32 (Name of authorized individual) was authorized under (name of license/permit) broad-scope license number (license number) to use (materials authorized to use) during (time frame).

The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet the recentness of training requirements in 10 CFR 35.59, if applicable.

Board Certification Pathway:

The board certification pathway, as provided in 10 CFR 35.190(a), 35.290(a), 35.390(a),

35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a), requires certification by a specialty board whose certification process has been recognized and is listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website or included in 10 CFR 35.57(a)(3).

Board-certified individuals (i.e., physicians, dentists, or podiatrists) who were not named as an AU may be grandfathered for those materials and uses that they performed on or before October 24, 2005, if they were board-certified by any of the boards listed in 10 CFR 35.57(b)(2) on or before October 24, 2005. The applicant must provide documentation that the individual used the materials and performed the medical uses before October 24, 2005, to meet the requirements to be an AU for those materials and uses. This documentation will be reviewed on a case-bycase basis to verify that the time period of use, the materials used, and the types of medical use meet the criteria in the regulation. For example, a physician who was authorized to use sodium iodide (I131) for imaging and localization involving greater than 30 microcuries

(µCi) (1.11 megabecquerels) (a quantity for which 10 CFR 35.40, Written directives, requires a WD) would continue to be authorized for imaging and localization involving greater than 30 µCi, even though after 2002 the physician was authorized under 10 CFR 35.300.

Supporting documentation for NRC Forms 313A (AUD), (AUT), (AUS) would include a copy of a board certificate recognized as listed on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website. The applicant or licensee would also need to provide evidence that the individual completed continuing education to meet the recentness of training requirements described in 10 CFR 35.59, if applicable. Proposed AUs who are board-certified do not need to provide a preceptor attestation.

Alternate Pathway:

The alternate pathway requires the proposed AU physician to have completed a specified number of hours of classroom and laboratory training, supervised work experience, case experience, and a preceptor attestation (10 CFR 35.190(b), 35.290(b), 35.390(b), 35.392(b),

35.394(b), 35.490(b), 35.590(b), and 35.690(b)).

Supporting documentation for Forms NRC Forms 313A (AUD), (AUT), (AUS), would include the following:

State license License or permit listing preceptor as AU (except in cases where the residency program director serves as the preceptor)

33 License or permit listing supervising AU Continuing education and experience records Documentation of specific radiation safety training for each use on the license Certificates or a syllabus from formal courses Other/additional documents provided (i.e., for 10 CFR 35.1000 uses)

Memorandum from a vendor listing radiation safety training course completion

List of patient case involvement Vendor-specific training certificates for device-specific training 4.6.5 Training and Experience Documentation for 10 CFR 35.1000 The regulations in 10 CFR 35.1000 describe the process to obtain a license, or an amendment to a license, for a new medical use of byproduct material or radiation from byproduct material that is not addressed in other parts of 10 CFR Part 35 (i.e., an EMT). It does not include specific T&E requirements for AUs of emerging technologies because the training requirements necessary for the safe use of byproduct material in new technologies are not known in advance.

Applicants and licensees are required to submit T&E information for individuals who are to serve as authorized individuals (RSOs, ARSOs, AUs, AMPs, OPs, and ANPs) in accordance with 10 CFR 35.12(b)(1), for the purpose(s) for which licensed material will be used. The NRC has developed licensing guidance, including T&E guidance, for certain 10 CFR 35.1000 medical uses. This information is available on the NRC public website Emerging Medical Technologies.

The NRC will evaluate alternative T&E for 10 CFR 35.1000 uses other than those listed in guidance on a case-bycase basis to determine whether the T&E of the identified individuals is appropriate for the proposed use.

4.7 Preceptor Attestation REGULATORY REQUIREMENTS:

10 CFR 35.2, 35.50, 35.51, 35.55, 35.57, 35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, 35.690 OTHER

REFERENCES:

NUREG1556, Volume 9, Revision 3, Appendix D, Documentation of Training and Experience to Identify Individuals on a License, pages D-5 and D-6 Guidance for the Final Rule, Medical Use of Byproduct MaterialMedical Event Definitions, Training and Experience, and Clarifying Amendments Effective January 2019, and Comment Resolution for Proposed Guidance on the Proposed Rule Medical Use of Byproduct MaterialMedical Event Definitions, Training and Experience, and Clarifying Amendments (NRC, 2018a)

34 SECY080179, Recommendations on Amending Preceptor Attestation Requirements in 10 CFR Part 35, Medical Use of Byproduct Material, dated November 20, 2008 (NRC, 2008)

Final Rule, Medical Use of Byproduct MaterialRecognition of Specialty Boards, dated March 30, 2005, 70 FR 16336 (NRC, 2005)

EXPLANATION:

A preceptor attestation, also referred to as a preceptor statement, is included in certain T&E requirements in 10 CFR Part 35. It is a signed statement provided by a preceptor that vouches for an individuals qualifications and completion of appropriate T&E and ability to function independently.

Some of the T&E requirements for authorized individuals in 10 CFR Part 35 require that an individual seeking authorization obtain a written attestation signed by a preceptor with that same authorization, stating that the individual has satisfactorily completed the necessary T&E requirements and is able to independently fulfill the radiation-safety-related duties of the position for which authorization is sought.

Effective January 19, 2019, and in accordance with the final rule Medical Use of Byproduct MaterialMedical Event Definitions, Training and Experience, and Clarifying Amendments (83 FR 33046) (NRC, 2018b), the regulations were amended to eliminate the requirement for preceptor attestations for almost all individuals certified by specialty boards recognized by the NRC or Agreement States on NRCs Specialty Board Certifications Recognized by the NRC Under 10 CFR Part 35 website or listed in 10 CFR 35.57. The NRC determined that preceptor attestations are unnecessary for individuals certified by the currently recognized boards or for grandfathered boards listed in 10 CFR 35.57, provided that the provisions of 10 CFR 35.59 are met. Individuals applying under the alternate pathway and all physicians applying to be AUs under the provisions of 10 CFR 35.396, Training for the parenteral administration of unsealed byproduct material requiring a written directive, will continue to need a preceptor attestation.

The regulations were also amended to incorporate the new language to clarify that the written attestation must verify that the individual is able to independently fulfill the radiation-safety-related duties, rather than state the individual has achieved a level of competency to function independently as an authorized individual. The purpose of the written attestations is to affirm the individuals ability to perform radiation-safety-related duties; they do not attest to the individuals clinical or medical competency. Medical competency is addressed by each states medical board.

The following scenarios require a written and signed preceptor attestation:

All individuals seeking authorization using the alternate pathway, except for individuals qualifying as AUs for sealed source for diagnosis Board-certified individuals seeking AU authorization under the provisions of 10 CFR 35.396 Medical uses that are or have been licensed under 10 CFR 35.1000, as applicable

35 AUs, RSOs, and AMPs who have received additional training for new medical uses and who initially qualified under the alternate pathway seeking authorization for a new medical use (An attestation statement is not needed if these authorized individuals initially qualified under the board certification pathway.)

Specialty boards are required to give an examination that assesses knowledge and competency in areas that include radiation safety to be recognized by the NRC. Therefore, the NRC finds that preceptor attestations are unnecessary for individuals certified by the currently recognized boards or for grandfathered boards listed in 10 CFR 35.57, as long as the provisions of 10 CFR 35.59 are met.

In the NRC Forms 313A series of forms, Part IIPreceptor Attestation, may be used to document what the preceptor is attesting to and the preceptor qualifications. The preceptor must complete an attestation of the proposed users training, experience, and ability to independently fulfill the duties of the position in areas that include radiation safety, as well as provide information concerning his or her own qualifications, and sign the attestation. Because there are a number of different pathways to obtain the required T&E for different authorized individuals, specific instructions are provided for each form in the NRC Forms 313A series of forms.

The preceptor attestation page (Part II of the NRC Forms 313A series of forms) has different sections to be completed:

Attestation to the proposed authorized individuals training Attestation for the device-specific training, as applicable Attestation for clinical casework, as applicable Attestation of the individuals ability to independently fulfill the radiation-safety-related duties as an authorized individual for the specific types of uses requested by the applicant Specific information about the preceptors authorizations to use licensed material, in addition to the preceptors signature The preceptor for a proposed new authorized individual must fill out all applicable sections of this page. The preceptor for an authorized individual seeking additional authorizations must complete the applicable preceptor information sections.

Detailed information on documenting the required T&E and written preceptor attestation for the NRC Forms 313A series of forms can be found in NUREG1556, Volume 9, Revision 3.

A description of the specific changes to the requirements for written attestations, as well as related questions and answers are included in Part 3, Medical Use Questions and Answers Effective January 2019, of Guidance for the Final Rule, Medical Use of Byproduct Material Medical Event Definitions, Training and Experience, and Clarifying Amendments (83 FR 33046).

36 4.7.1 Preceptor A preceptor is defined in 10 CFR 35.2 as an individual who provides, directs, or verifies the T&E required for an individual to become an AU, AMP, ANP, RSO, or ARSO. A preceptor may be either of the following:

An authorized individual who meets specific requirements and has authorization for the same use or device categories that the proposed authorized individual is seeking A residency program director who may provide attestation for physicians seeking to become AUs by affirming in writing that the attestation represents the consensus of the residency program faculty of which at least one faculty member is an AU for the uses requested and concurs with the attestation provided by the residency program director The preceptor must attest in writing that the proposed authorized individual has satisfactorily completed the appropriate T&E requirements and is able to independently fulfill the radiation-safety-related duties of an authorized individual. The preceptor must meet specific requirements and have authorization for the same use or device categories that the proposed authorized individual is seeking. The preceptor may be employed at a different facility than the proposed authorized individual (e.g., previous place of work or someone from the proposed individuals educational program). Applicants should include a copy of the license to demonstrate the materials and uses for which the preceptor is authorized.

A preceptor authorized individual that meets the applicable requirements may serve as a supervising individual (see Section 4.2, Supervision). The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies the required T&E. If more than one preceptor is necessary to document the T&E, the licensee must provide a separate written attestation from each preceptor.

In accordance with the preceptor attestation requirements in 10 CFR Part 35, Subparts B, D, E, F, G, and H RSOs and ARSOs may serve as preceptors for an individual seeking to be named as the RSO or ARSO on a license if they have experience with the radiation safety aspects of similar types of use of byproduct material for which the RSO/ARSO is providing the attestation. (See 10 CFR 35.50(b)(2)).

AUs may serve as preceptors for an individual seeking to be named as an AU on a license in accordance with 10 CFR 35.190(c)(2), 35.290(c)(2), 35.390(b)(2),

35.392(c)(3), 35.394(c)(3), 35.396(b)(3), 35.490(b)(3), and 35.690(b)(3).

AMPs may serve as preceptors for an individual seeking to be named as an AMP on a license in accordance with 10 CFR 35.51(b)(2).

ANPs may serve as preceptors for an individual seeking to be named as an ANP on a license in accordance with 10 CFR 35.55(b)(2).

37 REFERENCES U.S. Code of Federal Regulations, Notices, Instructions and Reports to Workers: Inspection and Investigations, Part 19, Chapter I, Title 10, Energy.

U.S. Code of Federal Regulations, Standards for Protection Against Radiation, Part 20, Chapter I, Title 10, Energy.

U.S. Code of Federal Regulations, Rules of General Applicability to Domestic Licensing of Byproduct Material, Part 30, Chapter I, Title 10, Energy.

U.S. Code of Federal Regulations, Specific Domestic Licenses of Broad Scope for Byproduct Material, Part 33, Chapter I, Title 10, Energy.

U.S. Code of Federal Regulations, Medical Use of Byproduct Material, Part 35, Chapter I, Title 10, Energy.

U.S. Code of Federal Regulations, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, Part 37, Chapter I, Title 10, Energy.

U.S. Nuclear Regulatory Commission (NRC), 1997. NUREG-1516, Management of Radioactive Material Safety Programs at Medical Facilities, May 1997, available at https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1516/index.html.

NRC, 2002. Medical Use of Byproduct Material, Federal Register, Vol. 67, p. 20250 (67 FR 20250), April 24, 2002, available at https://www.federalregister.gov/documents/2002/04/24/02-9663/medical-use-of-byproduct-material.

NRC, 2005. Medical Use of Byproduct MaterialRecognition of Specialty Boards, Federal Register, Vol. 70, p. 16336 (70 FR 16336), March 30, 2005, available at https://www.federalregister.gov/documents/2005/03/30/05-6103/medical-use-of-byproduct-material-recognition-of-specialty-boards.

NRC, 2008. SECY-08-0179, Recommendations on Amending Preceptor Attestation Requirements in 10 CFR Part 35, Medical Use of Byproduct Material, November 20, 2008, ML083170176.

NRC, 2009. Staff Requirements Memorandum (SRM)-SECY-08-0179, Staff Requirements SECY-08-0179Recommendations on Amending Preceptor Attestation Requirements in 10 CFR Part 35, Medical Use of Byproduct Material, January 16, 2009, ML090160275.

NRC, 2018a. Guidance for the Final Rule Medical Use of Byproduct MaterialMedical Event Definitions, Training and Experience, and Clarifying Amendments Effective January 2019 and Comment Resolution for Proposed Guidance on the Proposed Rule Medical Use of Byproduct MaterialMedical Event Definitions, Training and Experience, and Clarifying Amendments, July 3, 2018, Agencywide Documents Access and Management System (ADAMS) Accession No. ML18176A377.

38 NRC, 2018b. Medical Use of Byproduct MaterialMedical Event Definitions, Training and Experience, and Clarifying Amendments, Federal Register, Vol. 83, p. 33046 (83 FR 33046),

July 16, 2018, ML18242A169.

NRC, 2019. NUREG-1556, Consolidated Guidance About Materials Licenses, Volume 9, Rev. 3, Program-Specific Guidance About Medical Use Licenses, September 2019, ML19256C219.

NRC, 2020. SECY-20-0005, Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35), January 13, 2020, ML19217A318.

NRC, 2022. SRM-SECY-20-0008, Staff RequirementsSECY-20-0005Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35),

January 27, 2022, ML22027A519.

NRC. Authorized Individuals. NRC Public Webpage available at https://www.nrc.gov/materials/miau/med-use-toolkit/auth-individuals.html; last accessed on May 24, 2023.

NRC. Emerging Medical Technologies. NRC Public Webpage available at https://www.nrc.gov/materials/miau/med-use-toolkit/emerg-licensed-med-tech.html; last accessed on February 15, 2024.

NRC. Frequently Asked Questions About Licensing Medical Uses of Byproduct Material Under Revised 10 CFR Part 35. NRC Public Webpage available at http://www.nrc.gov/materials/miau/med-use-toolkit/faqs-part35.html; last accessed on August 2, 2023.

NRC. Medical Uses Licensee Toolkit. NRC Public Webpage available at https://www.nrc.gov/materials/miau/med-use-toolkit.html; last accessed on May 7, 2024.

NRC. NRC Form 313A. NRC Public Webpage available at https://www.nrc.gov/reading-rm/doc-collections/forms/index.html; last accessed on August 6, 2024.

NRC. Specialty Board Certifications Recognized by NRC Under 10 CFR Part 35. NRC Public Webpage available at https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html; last accessed on January 24, 2024.

A-1 APPENDIX Guidance for Completing NRC Form 313A and Documentation of Training and Experience An applicant or licensee may provide a copy of the board certificate and other documentation of training, experience, or clinical casework as indicated on the specific form of the NRC Forms 313A series for proposed authorized individuals to be listed on a medical use license. An Agreement State may require use of its own forms that are equivalent to the NRC Forms 313A. Applicants and licensees should contact the responsible officials in the Agreement State for guidance on the required form.

There are numerous pathways and unique scenarios to become an authorized individual; therefore, not all scenarios are presented in this guidance. However, the following case scenarios and associated NRC Forms 313A are provided to illustrate the necessary documentation needed to complete the forms, and the supporting documentation to be submitted by licensees (see NUREG-1556, Consolidated Guidance About Materials Licenses, Volume 9, Revision 3, Program-Specific Guidance About Medical Use Licenses, Appendix D, Documentation of Training and Experience to Identify Individuals on a License, issued September 2019).

A-2 Case Scenario for Radiation Safety Officer - Board-Certified Medical Physicist Pathway An NRC licensee is requesting that Niels Bohr, a medical physicist certified in July 2023 by the American Board of Medical Physics (ABMP), an NRC-recognized specialty board, to be added to its license as an RSO. Niels Bohr has never been listed on a radioactive materials license as an AMP or RSO. The licensee is authorized for medical uses under Title 10 of the Code of Federal Regulations (10 CFR) 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000 (SIR-Spheres use). Enrico Fermi was Niels Bohrs supervising individual providing the training in radiation safety, regulatory issues and emergency procedures for the types of medical uses on the license. Supporting documentation to be provided by the licensee includes the following:

Copy of Niels Bohrs medical physics certification from ABMP Copies of the NRC or Agreement State licenses for the supervising individual providing the training in radiation safety, regulatory issues and emergency procedures (i.e., license number CA-123456 that lists Enrico Fermi as authorized for 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000 materials in this case scenario) 313A NRC Form 313A (RSO) HEADER:

Insert the full name of the applicant and select the requested authorization (RSO or ARSO) and medical uses (e.g., 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000). Since many materials are EMT regulated under 10 CFR 35.1000, Other medical uses of byproduct material or radiation from byproduct material (e.g., Y-90 microspheres, gamma stereotactic radiosurgery), the licensee should annotate the type of use(s) requested in the license amendment request or application (e.g., SIR Spheres).

313A NRC Form 313A (RSO) PART ITRAINING AND EXPERIENCE Niels Bohr is certified by the ABMP (Block 1 selected).

313A (RSO) Part I, Section 5.a. Classroom and Laboratory Training Since Niels Bohr is a medical physicist certified by a specialty board that is recognized by the NRC, this section does not need to be completed.

313A (RSO) Part I, Section 5.b. Supervised Radiation Safety Experience Since Niels Bohr is a medical physicist certified by a specialty board that is recognized by the NRC, this section does not need to be completed.

313A (RSO) Part I, Section 5.c. Training in Radiation Safety, Regulatory Issues, and Emergency Procedures Document the name of the individual who provided training and the location and dates of the training. In this case, Niels Bohr did not receive any training for teletherapy uses

A-3 under 10 CFR 35.600, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit, and this section is left blank as she is not applying for this medical use.

Completion of section 5.c. of Form 313A (RSO) demonstrates that the requirements of 10 CFR 35.50(d) are met.

Enter the name of the supervising individual providing the training; the license number on which the supervising individual is listed as an RSO, ARSO, AMP, ANP, or AU; and the medical uses for which the supervising individual is authorized.

Note: Enrico Fermi provided all the training in this case scenario. Training can be obtained from more than one authorized individual (RSO, ARSO, AMP, ANP, or AU), as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval, to supervise completion of the required training.

313A (RSO) Part IIPRECEPTOR ATTESTATION Since Niels Bohr is board-certified by a specialty board recognized by the NRC, the preceptor attestation section does not need to be completed.

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A-10 Case Scenario for Radiation Safety OfficerAlternate Pathway An NRC licensee is asking that Isaac Newton be added to its license as an RSO. Isaac Newton is not board-certified and has never been listed on a radioactive materials license as an RSO.

The licensee is authorized for medical uses under 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000 (SIR-Spheres use). Albert Einstein was Isaac Newtons supervising individual providing the training in radiation safety, regulatory issues and emergency procedures for the types of medical uses on the license. Albert Einstein also served as Isaac Newtons preceptor. Supporting documentation to be provided by the licensee for Isaac Newton includes the following:

Course completion certificates for courses that apply toward the classroom and laboratory training requirements (e.g., the 40-hour medical RSO course (divided over four topics) and the DOT course in Isaac Newtons example)

College transcripts showing completion of applicable college credits

Any personal information such as date of birth, student ID number, etc. should be redacted before submission to the NRC.

Copies of the NRC or Agreement State licenses for the supervising individual and the preceptor (i.e., license number CA-123456 that lists Albert Einstein (who is serving as both the supervising individual and the preceptor) as authorized for 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000 materials in this case scenario) 313A (RSO) HEADER Insert the full name of the applicant and select the requested authorization (RSO or ARSO) and medical uses (e.g., 10 CFR 35.100, 35.200, 35.300, 35.400, 35.600, and 35.1000). Since many materials are EMT regulated under 10 CFR 35.1000 (e.g., Y-90 microspheres, gamma stereotactic radiosurgery), the licensee should annotate the type of use(s) requested in the license amendment request or application (e.g., SIR-Spheres).

313A (RSO) PART ITRAINING AND EXPERIENCE Isaac Newton is seeking authorization using the alternate pathway (Block 5 selected).

313A (RSO) Part I, Section 5.a. Classroom and Laboratory Training Demonstrate completion of at least 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in five key radiation protection areas (radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry).

Include the location of training, number of hours per topic, and dates of training.

It is acceptable to list a course over several topics. However, hours may be counted in only one category.

A-11 313A (RSO) Part I, Section 5.b. Supervised Radiation Safety Experience Demonstrate completion of at least 1 year of full-time radiation safety experience under the supervision of an individual identified as an RSO/ARSO on an NRC or an Agreement State license or permit issued by an NRC MML that authorizes similar type(s) of use(s) of byproduct material.

The supervised work experience must cover all seven of the listed categories.

Supervised work experience can be obtained at more than site and by more than one individual. In this case, multiple copies of this section of Form 313A(RSO) can be provided.

Include the location of experience, license/permit number of the facility, and dates of experience.

Provide the name of the supervising individual, the license number on which the supervising individual is listed as an RSO (or ARSO), and the medical uses for which the supervising individual is authorized.

313A (RSO) Part I, Section 5.c. Training in Radiation Safety, Regulatory Issues, and Emergency Procedures Document the name of the individual who provided training and the location and dates of the training.

Completion of section 5.c. of Form 313A (RSO) demonstrates that the requirements of 10 CFR 35.50(d) are met.

Provide the name of the supervising individual providing the training; the license or permit number on which the supervising individual is listed as an RSO, ARSO, AMP, ANP, or AU; and the medical uses for which the supervising individual is authorized.

Note: Albert Einstein provided all the training in this case scenario. Training can be obtained by more than one authorized individual (RSO, ARSO, AMP, ANP, or AU), as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval, to supervise the required training.

313A (RSO) Part II - PRECEPTOR ATTESTATION The preceptor should attest to the following:

The applicant has completed the 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training.

The applicant has completed training in radiation safety, regulatory issues, and emergency procedures for the requested medical applications. This section must match the header section on page 1.

The applicant is able to independently fulfill the radiation-safety-related duties as an RSO.

A-12 Select the preceptors authorization (RSO or ARSO), and provide the name of the preceptors facility, the license/permit number on which the preceptor is listed as an RSO (or ARSO), the name of the preceptor, and telephone number.

Have the preceptor sign and date the preceptor section.

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A-19 Case Scenario for Authorized Medical PhysicistAlternate Pathway An NRC licensee is asking that Nikola Tesla, a medical physicist, be added to its license as an AMP. Nikola Tesla is not board-certified and has never been listed on a radioactive materials license as an AMP. Nikola Tesla is seeking authorization for remote afterloaders under 10 CFR 35.600, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit. Marie Curie was Nikola Teslas supervising individual for the medical physics training and work experience. Marie Curie also served as Nikola Teslas preceptor. Supporting documentation to be provided by the licensee includes the following:

College diploma or transcripts demonstrating completion of relevant degree (physics, medical physics, other physical science, engineering, or applied mathematics)

Any personal information such as date of birth, student ID number, etc. should be redacted before submission to the NRC.

Copies of the NRC or Agreement State licenses for the supervising individual and the preceptor (i.e., license number NC-001001 that lists Marie Curie as authorized for remote afterloaders under 35.600 in this case scenario) 313A (AMP) HEADER Insert the full name of the proposed AMP (or OP), select the requested authorization (AMP or OP) and the medical use(s) (e.g., 35.600 remote afterloader unit(s)).

In this example, Nikola Tesla is requesting authorization for the use of remote afterloader units.

313A (AMP) PART ITRAINING AND EXPERIENCE Nikola Tesla is seeking authorization using the alternate pathway (Block 3 selected).

313A (AMP) Part I, Section 3.a. Education List the degree, major, and college or university at which the degree was obtained.

313A (AMP) Part I, Section 3.b. Supervised Full-Time Medical Physics Training and Work Experience Verify 1 year of full-time training in medical physics and 1 year of full-time work experience in medical physics.

The training and work experience must have been acquired in clinical radiation facilities that provide high-energy external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services.

Name the individual(s) who provided the training in medical physics and who supervised the work experience.

A-20 Document the location of the training facility, NRC or Agreement State license number or permit number, medical devices used, and dates of the training and work experience.

The supervised work experience must cover all applicable listed categories.

The 1 year of full-time medical physics training and 1 year of full-time work experience cannot be concurrent.

Supervised work experience can be obtained at more than one site and from more than one individual. In this case, multiple copies of this section of Form 313A(AMP) can be provided.

Name the supervising individual, the license or permit number on which the supervising individual is listed as an AMP, and the medical uses for which the supervising individual is authorized.

If the individual supervising the applicant is not identified as an AMP on an NRC or an Agreement State license or permit issued by an NRC MML, evidence that the supervising medical physicist meets the T&E requirements for the types of use for which the applicant is seeking authorization must be submitted.

313A (AMP) Part I, Section 3.c. Training in Radiation Safety, Regulatory Issues, and Emergency Procedures Document the name of the individual or vendor who provided training and the location and dates of the training.

Completion of section 3.c. of Form 313A (RSO) demonstrates that the requirements of 10 CFR 35.51(c) are met.

Provide the name of the supervising individual providing the training; the license or permit number on which the supervising individual is listed as an AMP; and the medical uses for which the supervising individual is authorized.

Note: Marie Curie provided all the training in this case scenario. Training can be obtained from more than one AMP who is authorized for the type(s) of use for which the licensee is seeking approval.

313A (AMP) Part I, Section 4. Education, Training, and Experience for Proposed Ophthalmic Physicist Since Nikola Tesla is not seeking authorization as an OP, this section does not need to be completed.

313A (AMP) PART IIPRECEPTOR ATTESTATION Have the preceptor attest to the following:

Completion of 1 year of full-time training in medical physics and an additional year of full-time work experience

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Completion of training for the uses for which authorization is sought

Ability to independently fulfill the radiation-safety-related duties as an AMP in the uses for which authorization is sought Select the preceptors authorization and provide the name of the preceptors facility, the license/permit number on which the preceptor is listed as an AMP, the name of the preceptor, and the telephone number.

Have the preceptor sign and date the preceptor section.

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A-27 Case Scenario for Authorized Nuclear PharmacistAlternate Pathway An NRC licensee is requesting that Lise Meitner, a nuclear pharmacist, be added to its license as an ANP. Lise Meitner is not board-certified and has never been listed on a radioactive materials license as an ANP. Rolf Sievert was Lise Meitners supervising individual for the nuclear pharmacy work experience. Robert Oppenheimer was Lise Meitners preceptor.

Supporting documentation to be provided by the licensee includes the following:

A copy of the State/territory license to practice pharmacy Copies of the NRC or Agreement State licenses for the supervising individual and the preceptor (i.e., license number CO-ABC123 that authorizes Rolf Sievert and Robert Oppenheimer as ANPs in this case scenario) 313A (ANP) HEADER Insert the full name of the proposed ANP and the State or territory where licensed.

A copy of the state/territory license to practice pharmacy should be provided with the application.

313A (ANP) PART ITRAINING AND EXPERIENCE Lise Meitner is seeking authorization using the alternate pathway (Block 2 selected).

313A (ANP) Part I, Section 2.a. Classroom and Laboratory Training Demonstrate completion of at least 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in five key radiation protection areas (radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, chemistry of byproduct material for medical use, and radiation biology).

Include the location of training, number of hours per topic, and dates of training.

It is acceptable to list a course over several topics. Hours may be counted only in one category.

313A (ANP) Part 1, Section 2.b. Supervised Practical Experience in a Nuclear Pharmacy Demonstrate completion of at least 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured educational program, which includes a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training (section 2.a. of Form 313A (ANP)).

Include the location of experience, license/permit number of the facility, number of hours per topic, and dates of experience.

The supervised work experience must cover all five of the listed categories.

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Supervised work experience can be obtained at more than site and from more than one individual. In this case, multiple copies of this section of Form 313A(RSO) can be provided.

Provide the name of the supervising individual and the license number on which the supervising individual is listed.

313A (ANP) PART IIPRECEPTOR ATTESTATION Have the preceptor attest that the proposed ANP has completed the 700-hour structured educational program, consisting of both practical experience in nuclear pharmacy and 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training, and is able to independently fulfill the radiation safety duties as an ANP.

Provide the name of the preceptor, the name of the facility, and the license/permit number on which the preceptor is listed, and the telephone number.

Have the preceptor sign and date the preceptor section.

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A-32 Case Scenario for Authorized UserAlternate Pathway An NRC licensee is requesting that Henri Becquerel, a physician, be added to its license as an AU. Henri Becquerel is not board-certified and has never been listed on a radioactive materials license as an AU. Henri Becquerel is seeking authorization for medical uses under 10 CFR 35.300, Use of unsealed byproduct material for which a written directive is required.

Wilhelm Roentgen was Henri Becquerels supervising individual for the supervised work experience and clinical case experience. Wilhelm Roentgen also served as Henri Becquerels preceptor. Supporting documentation to be provided by the licensee includes the following:

A copy of the State/territory license to practice Copies of the NRC or Agreement State licenses for the supervising individual and the preceptor (i.e., license number AL-123456 that lists Wilhelm Roentgen (who is serving as both the supervising individual and the preceptor) as authorized for 10 CFR 35.390 materials in this case scenario)

Casework 313A (AUT) HEADER Insert the full name of the proposed AU, the State or territory where licensed, and requested authorizations (e.g., 10 CFR 35.300).

Under Requested Authorization(s), a licensee/applicant has several options:

Authorization for sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (GBq) (33 millicuries (mCi))

Authorization for both sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 GBq (33 mCi) AND quantities greater than or equal to 1.22 GBq (33 mCi)

Authorization for parenteral administrations (e.g., Xofigo, Lutathera, Pluvicto')

In this example, Henri Becquerel would select 35.300 Use of unsealed byproduct material for which a written directive is required as Henri Becquerel is seeking approval for all medical uses that fall under 10 CFR 35.300.

313A (AUT) PART ITRAINING AND EXPERIENCE Henri Becquerel is seeking authorization using the alternate pathway (Block 3 selected).

A-33 313A (AUT) Part I, Section 3.a. Classroom and Laboratory Training Select the requested authorizations (e.g., 10 CFR 35.590, Training for use of sealed sources and medical devices for diagnosis).

Demonstrate completion of at least 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E, including a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in five key radiation protection areas (radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, chemistry of byproduct material, and radiation biology).

Include the location of training, number of hours per topic, and dates of training.

Hours may be counted only in one category.

313A (AUT) Part I, Section 3.b. Supervised Work Experience Select the requested authorizations (e.g., 10 CFR 35.390).

Document the location of the training facility, NRC or Agreement State license number or permit number, confirmation, and dates of the work experience.

The supervised work experience e must cover all five of the listed categories.

Supervised work experience can be obtained at more than site. In this case, multiple copies of this section of Form 313A(AUT) can be provided.

Provide the name of the supervising individual, the license or permit number on which the supervising individual is listed as an AU, and the medical uses for which the supervising individual is authorized.

The supervising AU must have experience in administering dosages in the same dosage category or categories as the individual requesting AU status.

313A (AUT) Part I, Section 3.c. Supervised Clinical Case Experience Document the number of supervised clinical cases in each category, location of the training facility, NRC or Agreement State license number or permit number, and dates of the experience.

The clinical case work experience must cover all three of the listed categories.

Supervised work experience can be obtained at more than one site. In this case, multiple copies of this section of Form 313A(AUT) can be provided.

Provide the name of the supervising individual, the license or permit number on which the supervising individual is listed as an AU, and the medical uses for which the supervising individual is authorized.

The supervising AU must have experience in administering dosages in the same dosage category or categories as the individual requesting AU status.

A-34 313A (AUT) PART IIPRECEPTOR ATTESTATION For the first, second, and third sections, have the preceptor attest to the following:

The applicant has completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E, including 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training for 10 CFR 35.390 authorization.

The applicant has acquired clinical case experience in the categories for which the individual is requesting AU status.

The applicant can independently fulfill the radiation-safety-related duties as an AU in the uses for which authorization is sought.

For the fourth section, since Henri Becquerel is not seeking authorization for use of 10 CFR 35.396, Training for the parenteral administration of unsealed byproduct material requiring a written directive, byproduct material, this section does not need to be completed.

For the fifth section, select the preceptors authorization, and provide the name of the preceptors facility, the license/permit number on which the preceptor is listed as an AU, the name of the preceptor, and telephone number.

Have the preceptor sign and date the preceptor section.

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ML25051A034 OFFICE NMSS/MSST/SLPB NMSS/MSST

/MSEB NMSS/MSST/MSEB RES/DSA/AAB NAME CFlannery KTapp CEinberg TBloomer DATE Feb 21, 2025 Mar 10, 2025 Mar 25, 2025 Apr 3, 2025