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{{#Wiki_filter:Guidance for the Final Rule Medical Use of Byproduct Material - Medical 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 Material -
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Medical Event Definitions, Training and Experience, and Clarifying Amendments
 
Introduction Guidance for the Final Rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments The guidance developed to implement the Final Rule 10 CFR Parts 30, 32 and 35 - Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments is provided in three parts. The guidance will be effective January 2019. The first two parts consist of revisions to the guidance already provided in the NUREG-1556, Consolidated Guidance About Materials Licenses series of volumes for medical uses and commercial nuclear pharmacies. These guidance documents primarily provide guidance to applicants in the completion and submission of materials license applications. They also include model procedures that an applicant may want to use as models when developing its radiation safety program, as well as tools that licensees may employ when completing the corresponding material license applications. Because the rulemaking is not limited to elements associated with obtaining a license, the third part of this guidance document includes supplemental questions and answers that will be added to the NRCs Medical Uses Licensee Toolkit website, to assist licensees in understanding and implementing the new regulatory changes. The fourth part addresses the comments received on the proposed guidance.
Part 1 consists of the Supplemental Guidance for NUREG-1556, Volume 9, Revision 2, Consolidated Guidance About Materials Licenses: Program - Specific Guidance About Medical Use Licenses.
Part 2 consists of the Supplemental Guidance for NUREG-1556, Volume 13, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses.
For Part 1 and Part 2, the NRC extracted only those NUREG sections and appendices that it changed as part of the revised supplementary guidance documents. For each revised section and/or appendix, the NRC inserted an introductory notation describing and changes and identifying the relevant revised regulation. Red line format was used to show new text and black strikeout format was used to show eliminated text. In general, entire sections were included to put the proposed changes in proper context. If the entire appendix was not included, the NUREG-1556 page numbers were included in the introductory notation.
Part 3 includes questions and answers grouped by topic.
4 includes responses to comments received on the proposed guidance.
There were five commenters. Three provided comments only on the proposed rule. The fourth commenter provided comments on both the proposed rule and the guidance and the fifth only commented on the guidance. The comments on the rule were addressed in the Federal Register notice publishing the rule. The summary of the comments provided on the proposed guidance document and NRCs response to those comments is provided in Part 4 of this document.
 
PART 1 Supplemental Guidance Effective January 2019, for NUREG-1556, Volume 9, Revision 2, Consolidated Guidance About Materials Licenses: Program - Specific Guidance About Medical Use Licenses.
 
[The following redline addition to the Abbreviations section reflects the change to 10 CFR 35.2, adding an Associate Radiation Safety Officer.]
ABBREVIATIONS AAPM        American Association of Physicists in Medicine ACMUI      Advisory Committee on the Medical Use of Isotopes ACR        American College of Radiology ALARA      as low as is reasonably achievable ALI        annual limit on intake AMP        Authorized Medical Physicist ANP        Authorized Nuclear Pharmacist ANSI        American National Standards Institute ARSO        Associate Radiation Safety Officer AU          Authorized User bkg        background BPR        Business Process Redesign Bq          becquerel CFR        Code of Federal Regulations Ci          curie cc          centimeter cubed cm2        square centimeter Co-57      cobalt-57 Co-60      cobalt-60 cpm        counts per minute Cs-137      cesium-137 DAC        derived air concentration DOT        United States Department of Transportation dpm        disintegrations per minute EPAct      Energy Policy Act of 2005 F-18        fluorine-18 1
 
FDA    United States Food and Drug Administration GM      Geiger-Mueller GPO    Government Printing Office GSR    gamma stereotactic radiosurgery HDR    high dose-rate I-125  iodine-125 I-131  iodine-131 IN      Information Notice IP      Inspection Procedure Ir-192  iridium-192 LDR    low dose-rate mCi    millicurie ml      milliliter Mo-99  molybdenum-99 mR      milliroentgen mrem    millirem mSv    millisievert N-13    nitrogen-13 NaI(Tl) sodium iodide (thallium doped)
NARM    Naturally Occurring and Accelerator-Produced Material NCRP    National Council on Radiation Protection and Measurements NIST    National Institute of Standards and Technology NRC    United States Nuclear Regulatory Commission NVLAP  National Voluntary Laboratory Accreditation Program O-15    oxygen-15 OCFO    Office of the Chief Financial Officer OCR    optical character reader OMB    Office of Management and Budget OSL    optically stimulated luminescence dosimeters PET    Positron Emission Tomography P-32    phosphorus-32 2
 
Pd-103 palladium-103 PDR    pulsed dose-rate P&GD  Policy and Guidance Directive QA    quality assurance Ra-226 radium-226 Ru-82  rubidium-82 RG    Regulatory Guide RIS    Regulatory Issue Summary RSC    Radiation Safety Committee RSO    Radiation Safety Officer SDE    shallow-dose equivalent SI    International System of Units (abbreviated SI from the French Le Systme Internationale dUnités)
Sr-82  strontium-82 Sr-85  strontium-85 Sr-90  strontium-90 SSDR  Sealed Source and Device Registry std    standard Sv    Sievert TAR    Technical Assistance Request Tc-99m technetium-99m TEDE  total effective dose equivalent TI    Transport Index TLD    thermoluminescent dosimeters U-235  uranium-235 WD    written directive Xe-133 xenon-133 Y-90  yttrium-90
µCi    microcurie
%      percent 3
 
[The following redline additions to Table 1.1 reflect the changes to 10 CFR 35.2 and 35.433 adding an Associate Radiation Safety Officer and an ophthalmic physicist.]
Table 1.1      Sections of NUREG-1556, Volume 9, Revision 2, that Applicants for a Particular Type of Use Should Review Type of Use NUREG-1556 - Volume 9, Rev. 2 Section:
100  200 300    400      500 600 1000 8.1  License Action Type 8.2  Applicant's Name and Mailing
 
Address 8.3  Address(es) Where Licensed Material
 
Will Be Used or Possessed 8.4  Person to Be Contacted about This
 
Application 8.5  Radioactive Material 8.6  Sealed Sources and Devices (including
 
Ra-226 Sealed Sources and Devices) 8.7  Discrete Source of Ra-226 (other than
 
Sealed Sources) 8.8  Recordkeeping for Decommissioning
 
and Financial Assurance 8.9  Purpose(s) for which Licensed
 
Material Will Be Used 8.10 Individual(s) Responsible for Radiation Safety Program and their Training and Experience 8.11 Radiation Safety Officer (RSO) and Associate Radiation Safety Officer (ARSO) 8.12 Authorized User (AU) 8.13 Authorized Nuclear Pharmacist (ANP) 4
 
Table 1.1        Sections of NUREG-1556, Volume 9, Revision 2, that Applicants for a Particular Type of Use Should Review Type of Use NUREG-1556 - Volume 9, Rev. 2 Section:
100  200 300    400      500 600  1000 8.14a Authorized Medical Physicist (AMP) 8.14b Ophthalmic Physicist 8.15 Facilities and Equipment 8.16 Facility Diagram 8.17 Radiation Monitoring Instruments 8.18 Dose Calibrator and Other Equipment Used to Measure Dosages of Unsealed Byproduct Material 8.19 Therapy Unit - Calibration and Use 8.20 Other Equipment and Facilities 8.21 Radiation Protection Program 8.22 Safety Procedures and Instructions 8.23 Occupational Dose 8.24 Area Surveys 8.25 Safe Use of Unsealed Licensed
 
Material 8.26 Spill/Contamination Procedures 8.27 Installation, Maintenance, Adjustment, Repair, and Inspection of
 
Therapy Devices Containing Sealed Sources 8.28 Minimization of Contamination 8.29 Waste Management 8.30 Fees 8.31 Certification 5
 
Table 1.1      Sections of NUREG-1556, Volume 9, Revision 2, that Applicants for a Particular Type of Use Should Review Type of Use NUREG-1556 - Volume 9, Rev. 2 Section:
100  200 300    400      500 600  1000 AA  Authorization under 10 CFR 30.32(j) to Prepare PET Radioactive Drugs for Noncommercial Transfer PROGRAM-RELATED GUIDANCE - NO RESPONSE FROM APPLICANTS ON NRC FORM 313 8.32 Safety Instruction for Individuals Working In or Frequenting Restricted Areas 8.33 Public Dose 8.34 Opening Packages 8.35 Procedures for Administrations When
 
a Written Directive Is Required 8.36 Release of Patients or Human
 
Research Subjects 8.37 Mobile Medical Service 8.38 Audit Program 8.39 Operating and Emergency Procedures 8.40 Material Receipt and Accountability 8.41 Ordering and Receiving 8.42 Sealed Source Inventory 8.43 Records of Dosages and Use of
 
Brachytherapy Source 8.44 Recordkeeping 8.45 Reporting 8.46 Leak Tests 8.47 Safety Procedures for Treatments
 
When Patients Are Hospitalized 8.48 Transportation 6
 
[The following redline additions to Section 3 reflect the changes to 10 CFR 35.2 and 35.24 adding an Associate Radiation Safety Officer.]
Part 35  Applicability 100 3    MANAGEMENT RESPONSIBILITY                                              200 300 Regulations: 10 CFR 30.9, 10 CFR 35.12, 10 CFR 35.24.                        400 500 The NRC endorses the philosophy that effective Radiation                      600 Protection Program management is vital to safe operations that 1000 comply with NRC regulatory requirements (see 10 CFR 35.24).
Management refers to the chief executive officer or other individual having the authority to manage, direct, or administer the licensees activities or that persons delegate or delegates (see 10 CFR 35.2).
To ensure adequate management involvement in accordance with 10 CFR 35.12(a) and 35.24(a), a management representative (i.e., chief executive officer or delegate) must sign the submitted application acknowledging managements commitments to and responsibility for the following:
Radiation protection, security and control of radioactive materials, and compliance with regulations; Completeness and accuracy of the radiation protection records and all information provided to NRC (10 CFR 30.9);
Knowledge about the contents of the license application; Compliance with current NRC and United States Department of Transportation (DOT) regulations and the licensees operating and emergency procedures; Provision of adequate financial and other resources (including space, equipment, personnel, time, and, if needed, contractors) to the Radiation Protection Program to ensure that patients, the public, and workers are protected from radiation hazards; Appointment of a qualified individual who has agreed in writing to work as the RSO; If applicable, appointment of one or more qualified as an ARSO; Approval of qualified individual(s) to serve as authorized medical physicists (AMPs), an ophthalmic physicist, ANPs, and AUs for licensed activities.
For information on NRC inspection, investigation, enforcement, and other compliance programs, see the following:
The NRC Enforcement Policy which is included on the NRCs Web site at http://www.nrc.gov/what-we-do/regulatory/enforcement/enforce-pol.html 7
 
The NRC Inspection Manual, Chapter 2800, Materials Inspection Program, and Inspection Procedures:
83822 - Radiation Protection, 84850 - Radioactive Waste Management - Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61, 84900 - Low-Level Radioactive Waste Storage, 87130 - Nuclear Medicine Programs  Written Directive Not Required, 87131 - Nuclear Medicine Programs  Written Directive Required, 87132 - Brachytherapy Programs, 87133 - Medical Gamma Stereotactic Radiosurgery and Teletherapy Programs, and 87134 - Medical Broad-Scope Programs.
For availability of these documents, see the Notice of Availability on the inside front cover of this report. In addition, the Inspection Manual and procedures are available at http://www.nrc.gov/materials/miau/med-use-toolkit.html.
8
 
[The following redline/strike out revisions to Section 5.1 reflect a change to 10 CFR 35.12 to require submission of only the original license application.]
5.1        PREPARING AN APPLICATION Applicants for an NRC materials license should do the following:
Part 35      Applicability 100 Use the most recent guidance in preparing an application, including Appendix AA of this document, if appropriate;                  200 300 Complete NRC Form 313 (Appendix A), Items 1 through 4,                  400 12, and 13, on the form itself;                                          500 600 Complete NRC Form 313, Items 5 through 11, on 1000 supplementary pages, or use Appendix C; Complete the appropriate NRC Form 313A series of forms (Appendix B) to document training and experience, if electing to complete this optional form; Provide sufficient detail for NRC to determine that equipment, facilities, training, experience, and the Radiation Safety Program are adequate to protect health and safety and minimize danger to life and property; 3333          For each separate sheet, other than the NRC Form 313A series of forms or Appendix C, that is submitted with the application, identify and cross-reference it to the item number on the application or the topic to which it refers; Submit all documents, typed, on 8-1/2 x 11-inch paper; Avoid submitting proprietary information unless it is absolutely necessary; If submitted, proprietary information and other sensitive information must be clearly identified (see Section 5.2 below);
Submit the an original signed application and one copy; and Retain one copy of the license application for future reference.
Applications must be signed by the applicants or licensees management as required by 10 CFR 35.12(a); see Section 8.31, Certification.
9
 
[The following redline additions to Section 8 reflect changes to 10 CFR 35.2 and 35.433 adding an Associate Radiation Safety Officer and an ophthalmic physicist.]
8      CONTENTS OF AN APPLICATION This section explains, item by item, the information that medical use applicants must provide on NRC Form 313 (see Appendix A) and should provide on the appropriate NRC Form 313A series of forms if electing to use this optional form (see Appendices B and D). If an application contains security-related sensitive information (see Section 5.2), the cover letter should state that the attached documents contain security-related sensitive information. If a cover letter is not used, NRC Form 313 should include this statement. The information needed to complete Items 5 through 11 on Form 313 describes the applicants proposed medical use Radiation Safety Program. To assist the applicant in submitting complete information on these items, the applicable regulations are referenced in the discussion of each item. Appendix AA explains additional information the applicant must provide on NRC Form 313 when requesting authorization under 10 CFR 30.32(j) for preparing PET radioactive drugs for noncommercial distribution to medical use licensees within its consortium.
Table 1 in Appendix C is provided to help applicants determine which procedures must be developed, implemented, and maintained for the type of medical use requested. Several appendices in this report present sample procedures that applicants may use in developing their procedures. Suggested responses for each block on the NRC Form 313 appear under Response from Applicant in this guide.
If a particular part of a section does not apply, simply note N/A for not applicable. If a particular section applies, but a procedure does not have to be developed, simply note N for no response required. N/A, N, or short sentence responses to Items 5 through 11 should run consecutively on one or more sheets separate from responses provided on NRC Form 313.
Lengthy responses should be appended as attachments.
As indicated on NRC Form 313 (see Appendix A), responses to Items 5 through 11 should be submitted on separate sheets of paper. Applicants may use the appropriate NRC Form 313A series of forms (see Appendix B) to document training and experience for new AUs, medical physicists, ophthalmic physicists, nuclear pharmacists, ARSOs and RSOs. The NRC Form 313A series of forms may also be used by experienced individuals seeking additional authorizations. Applicants may use Appendix C to assist with completion of the application.
10
 
[The following redline/strikeout revisions to Item 5 reflect changes to 10 CFR 35.65 to prohibit bundling of single sources or use of calibration, transmission, or reference sources for medical use under the provisions of 10 CFR 35.65; and to clarify that certain calibration, transmission, or reference sources may not have to be listed on the license when used under the provisions of 10 CFR 35.500.]
8.5        ITEM 5: RADIOACTIVE MATERIAL Regulations: 10 CFR 30.32, 10 CFR 32.210, 10 CFR 35.65, 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 35.400,                Part 35  Applicability 10 CFR 35.500, 10 CFR 35.600, 10 CFR 35.1000.                                  100 200 Criteria: Byproduct material for medical use in 10 CFR Part 35                300 is divided into seven types of use (10 CFR 35.100, 35.200, 35.300,            400 35.400, 35.500, 35.600, and 35.1000).                                          500 600 Discussion: The applicant should indicate the byproduct material              1000 requested. The amount and type of information necessary will vary according to the type of use and material requested.
Under Section 651c of the EPAct, the NRC now has regulatory authority over accelerator-produced byproduct material as well as discrete sources of Ra-226. Although sealed Ra-226 sources (e.g., Ra-226 needles) were once used for manual brachytherapy and are no longer believed to be used for medical uses, the medical use of discrete sources of Ra-226 is included in this guidance because its use for this purpose is not prohibited. The guidance also distinguishes between discrete sources of Ra-226 and sealed sources of Ra-226 because not all discrete sources are sealed sources.
The medical uses of the other new byproduct materials are essentially the same as the uses of the previously defined byproduct materials. However, some of the radionuclides now included in the expanded definition of byproduct material have significantly shorter half-lives and higher energy levels (e.g., PET radionuclides) that may result in delivery of the unsealed material by direct transfer tube from the accelerator production facility to the 35.100 and 35.200 medical use areas. This may result in higher potential radiation doses to workers and the public if additional handling and shielding precautions are not implemented, and licensees should consider this in evaluating their equipment, facilities, and programs.
35.100 and 35.200 Use: For 10 CFR 35.100 and 35.200 medical uses, the chemical/physical form may be Any unsealed byproduct material permitted by 10 CFR 35.100 or 35.200, as appropriate. For 10 CFR 35.100 and 35.200 medical uses, the total amount requested may be As Needed.
The following format may be used:
11
 
Byproduct Material              Chemical/Physical Form                Maximum Amount Any byproduct material                            Any                          As needed permitted by 10 CFR 35.100 Any byproduct material                            Any                          As needed 1 permitted by 10 CFR 35.200 35.300 Use: For 10 CFR 35.300 use, the chemical/physical form may be Any unsealed byproduct material permitted by 10 CFR 35.300. The total amount requested must be specified.
The following format may be used:
Byproduct Material              Chemical/Physical Form                Maximum Amount Any byproduct material                            Any                          300 millicuries permitted by 10 CFR 35.300 35.400, 35.500, 35.600, and 35.1000 Use: For 10 CFR 35.400, 35.500, 35.600, and 35.1000 use, the radionuclide, the chemical/physical form (e.g., sealed source or device identified by manufacturer and model number), the total amount in becquerels (Bq), microcuries (µCi),
millicuries (mCi), or curies (Ci), and the maximum number of sources or activity possessed at any one time must be specified. For 10 CFR 35.500 use, the sealed source information described above does not need to be provided for calibration, transmission, or reference sources used for this medical use if the individual activity or a bundled activity is not greater than the maximum activity of any single source authorized in 10 CFR 35.65. The sealed source and device information described above must be provided for all other sources and devices used under 35.500. Sealed sources of Ra-226 may be used for 10 CFR 35.400, 35.500, and 35.1000 uses. Unsealed Ra-226 can only be used for medical use under 35.1000.
Applicants should include all possible new sources they might use, in order to minimize the need for license amendments if they change model or vendor. The following format may be used:
Byproduct Material              Chemical/Physical Form                Maximum Amount I-125 (specific radiation therapy Liquid source (Manufacturer        2 curies total system liquid brachytherapy        Name, Model #DEF) source, 35.1000 use) 1        Applicants that have their own cyclotrons and produce PET radionuclides that they use to produce PET radioactive drugs for their own use under the appropriate provisions of 10 CFR Part 35 may have different shielding or special equipment requirements than most medical use applicants who receive unit doses, multi-dosage vials, or generators from drug manufacturers or commercial nuclear pharmacies that are packaged in self-shielding radiation transport shields. Information needed for the different shielding or special equipment requirements can be found in Section 9.
12
 
Ra-226                                Sealed source or device    Not to exceed 50 millicuries per (Manufacturer Name, Model  source and 250 millicuries total
                                      #HIJ)
Cesium 137 (i.e., specific            Sealed source or device    2 curies total brachytherapy radionuclide,          (Manufacturer Name, Model 35.400 use)                          #MNO)
Pd-103 (i.e., specific manual Sealed source or device            Not to exceed 0.5 millicuries brachytherapy source, 35.400 (Manufacturer Name, Model            per source and 3 curies total use)                                  #QRS)
Gadolinium 153 (i.e., specific        Sealed source or device    Not to exceed 500 millicuries diagnostic sealed-source              (Manufacturer Name, Model  per source and 1 curie total radionuclide, 35.500 use)            #TUV)
Germanium 68 (transmission Sealed source or device                Not to exceed 30 millicuries per sources bundled to exceed 30 (Manufacturer Name, Model            source and 1 curie total millicuries, in PET scanners,        #CTR) 35.500 use)
Cobalt 60 (i.e., specific            Sealed source or device    Not to exceed 9,000 curies per teletherapy sealed-source            (Manufacturer Name, Model  source and 18,000 curies total radionuclide, 35.600 use)            #XYZ)
Iridium 192 (i.e., specific          Sealed source or device    Not to exceed 10 curies per afterloader sealed-source            (Manufacturer Name, Model  source and 20 curies total radionuclide, 35.600 use)            #XYZ)
Cobalt 60 (i.e., specific gamma Sealed source or device          Not to exceed 36 curies per stereotactic radiosurgery            (Manufacturer Name, Model  source and 6,600 curies total sealed- source radionuclide,          #XYZ) 35.600 use)
For sealed sources used in devices, an applicant may wish to request a possession limit adequate to allow for the possession of a spare source, to accommodate the total quantity of material in the licensees possession during replacement of the source in the device. The maximum activity for a single source or source loading may not exceed the activity specified by the manufacturer for the specific device and source combination as stated in the Sealed Source and Device Registry (SSDR) certificate. However, an applicant may request a maximum activity for the source in the shipping container that exceeds the maximum activity allowed in the device. To request this authorization, applicants should provide certification that the source transport container is approved for the requested activity. A source that is received with a higher activity than permitted in the device must be allowed to decay to or below the licensed activity limit prior to installation in the device.
Calibration, Transmission, and Reference Sources: For all calibration, transmission, and reference sources, including those with Ra-226, covered under 10 CFR 35.65, the specific sources do not need to be listed on the license as long as the licensee is authorized pursuant to 13
 
10 CFR 35.11 for the medical use of byproduct material. 10 CFR 35.65 only permits use of the calibration, transmission, and reference sources for intentional internal or external administration of byproduct material, or the radiation from byproduct material, to patients or human research subjects (i.e. medical use) in accordance with the requirements in 10 CFR 35.500, in which case they may be used without listing them on the license for medical use.
Calibration, transmission, and reference sealed sources with an individual activity or a bundled activity greater than the maximum activity of any single source authorized in 10 CFR 35.65 must be listed on the license.
Shielding Material/Depleted Uranium: Some high-activity radionuclide generators used to produce byproduct materials for 10 CFR 35.200 and 35.300 uses (e.g., Tc-99m generators) may include depleted uranium (i.e., uranium depleted in uranium-235 (U-235)) as shielding material. If a generator has depleted uranium shielding, an applicant should request authorization to possess depleted uranium as shielding material. Applicants receiving large therapy sources and devices also should determine if depleted uranium is used to shield the therapy sources and devices. This includes identifying depleted uranium used as shielding in linear accelerators because, even though NRC does not regulate the accelerator, it does regulate the depleted uranium in the accelerator. If applicable, the applicant should request authorization to possess depleted uranium (i.e., uranium depleted in U-235) in quantities sufficient to include shielding material in both the device(s) and source containers used for source exchange and shielding for other devices. The applicant should review the manufacturers specifications for each device specified in the license request to determine: (1) if depleted uranium is used to shield the source(s) within the device; and (2) the total quantity of depleted uranium present in the device (in kilograms). The applicant should also consult the manufacturers specifications or the source supplier to determine if depleted uranium is contained in shielding source containers used during source exchange, as well as the total quantity of depleted uranium in such containers (in kilograms). The following format may be used:
Byproduct Material            Chemical/Physical Form            Maximum Amount Depleted Uranium                                  Metal                    999 kilograms Other Material: The applicant should make a separate entry for other required items (e.g., Ra-226 not previously described, more byproduct material for in vitro testing than is allowed under 10 CFR 31.11, survey meter calibration source, dosimetry system constancy check source, material for in vitro, animal, or human research studies). The following format may be used:
Byproduct Material            Chemical/Physical Form            Maximum Amount Any byproduct material permitted          Prepackaged kits                50 millicuries by 10 CFR 31.11 Ra-226                                        unsealed                      1 millicurie Sources that are authorized by 10 CFR 35.65, Authorization for calibration, transmission, and reference sources, should not be listed.
Applicants should number each line entry consecutively, following the 10 CFR Part 35 material.
14
 
Blood Irradiators: If the use of a device to irradiate blood is anticipated, the applicant should review NUREG-1556, Volume 5, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator Licenses.
Production of Radionuclides by Accelerators: If the applicant will use an accelerator to produce radionuclides, a separate license application will be needed for the production of the radionuclides. The applicant should review NUREG-1556, Volume 21, Consolidated Guidance About Materials Licenses: Program-Specific Guidance about Possession Licenses for Production of Radioactive Materials Using an Accelerator.
Production of PET Radioactive Drugs for Noncommercial Distribution to Medical Use Licensees Within a Consortium: If the applicant will use PET radionuclides to produce PET radioactive drugs for its own medical use and noncommercial distribution to other members of its consortium, the applicant, to satisfy 10 CFR 30.33(a)(1), should identify the PET radionuclides, the proposed use of the material, and the maximum activity. The applicant should also review Appendix AA.
The following format may be used for unsealed PET radionuclides used to produce PET radioactive drugs for noncommercial transfer to other members within the consortium.
Byproduct Material            Chemical/Physical Form            Maximum Amount PET Radionuclides for Any                          ____ curies noncommercial distribution When applying for this authorization, the applicant should also consider applying for authorization to take back potentially contaminated transport shields from other consortium members. Each consortium member should dispose of unused dosages and used syringes and vials at its own facility.
When determining both individual radionuclide and total quantities, all materials to be possessed at any one time under the license should be included (i.e., materials received awaiting use (new teletherapy or brachytherapy sources for exchange), materials in use or possessed, material used for shielding, and materials classified as waste awaiting disposal or held for decay-in-storage).
Response from Applicant: The applicant should submit the information as described above.
Certain information about quantities of radioactive materials is no longer released to the public and needs to be marked security-related information - withhold under 10 CFR 2.390.
Therefore, when responding to this section, follow the guidance in Section 5.2 to determine if the response includes security-related sensitive information and needs to be marked accordingly. Applicants requesting authorization for the medical use of a discrete source of Ra-226 (which includes a sealed source of Ra-226) or other NARM sources or devices containing NARM sources that do not have the information described above (e.g., manufacturer and model number from an SSDR certificate), or the information required in 10 CFR 30.32(g)(3), should consult the appropriate NRC Regional Office to discuss the contents of their application.
15
 
[The following redline additions to Section 8.6 reflect changes to 10 CFR 35.65 to prohibit bundling of single sources or use of calibration, transmission, or reference sources for medical use under the provisions of 10 CFR 35.65, and to clarify that when used in accordance with the requirements in 35.500 the sources need not be listed on the license.]
8.6    ITEM 5: SEALED SOURCES AND Part 35  Applicability DEVICES (including Ra-226 sealed                                      100 sources and devices)                                                  200 300 400 Regulations: 10 CFR 30.32(g), 10 CFR 30.33(a)(2),
10 CFR 32.210, 10 CFR 35.65.                                                  500 600 Criteria: In accordance with 10 CFR 30.32(g), applicants must                1000 provide the manufacturers name and model number for each requested sealed source and device (except for calibration, transmission, and reference sources authorized by 10 CFR 35.65, and certain NARM sources for which this information is not available). 10 CFR 35.65(c) provides the exception for calibration, transmission, or reference sources and, as indicated in the regulation, applies to either medical uses under 10 CFR 35.500 or non-medical uses under 10 CFR 35.65. (Note: If the single or bundled activity of calibration, transmission, and reference sources exceeds the single source activity limit in 10 CFR 35.65, then the exception in 10 CFR 35.65(c) does not apply and under the requirements of 10 CFR 30.32(g) the manufacturers name and model number for each requested sealed source and device must be provided.) Licensees will be authorized to possess and use only those sealed sources and devices specifically approved or registered by NRC, an Agreement State or a non-Agreement State, or certain sources when information required in 10 CFR 30.32(g)(3) is provided.
Under the EPAct, the NRC was given regulatory authority over additional byproduct material including accelerator-produced radionuclides and discrete sources of Ra-226. See 10 CFR 30.4 for a complete definition of byproduct material.
Applicants and licensees should determine whether they possess, or will possess, sealed sources or devices containing this new byproduct material for uses under 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600, or 10 CFR 35.1000, as well as check, calibration, transmission, and references sources that are not included in 10 CFR 35.65.
Applicants will need to request authorization for possession of these sealed source(s) or device(s). It should also be noted that NRCs regulatory authority includes the new byproduct material produced prior to August 8, 2005. As a result, neither the NRC, an Agreement State, nor a non-Agreement State, may have performed a safety evaluation of the sealed source or device and it may not have an Sealed Source and Device Registry (SSDR) certificate.
Information that must be submitted for all sources is described in 10 CFR 30.32(g).
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Discussion: The NRC or an Agreement State performs a safety evaluation of sealed sources and devices before authorizing a manufacturer to distribute the sources or devices to specific licensees. The safety evaluation is documented in an SSDR certificate. Some non-Agreement States may also have performed similar safety evaluations for sealed sources and devices containing NARM, and these safety evaluations may be documented in SSDR certificates.
Applicants must provide the manufacturers name and model number for each requested sealed source and device so that NRC can verify whether they have been evaluated in an SSDR certificate or specifically approved on a license. Applicants should include all possible new sources they might use, in order to minimize the need for license amendments if they change model or vendor.
If such a review has not been conducted for the specific source/device model(s), licensees should request a copy of the latest version of NUREG-1556, Volume 3, Revision 1, Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration, from an NRC Regional Office and submit the information requested therein to NRC for review.
If the sealed source or device that has not been reviewed contains NARM material and was produced before the effective date of the rule, November 30, 2007, the information required by 10 CFR 32.210 may not be available. If this is the case, the applicant must provide the information required in 10 CFR 30.32(g)(3).
An applicant may consult with the proposed supplier or manufacturer to ensure that requested sources and devices are compatible with each other and that they conform to the SSDR designations registered with NRC or an Agreement State. Licensees may not make any changes to the sealed source, device, or source-device combination that would alter the description or specifications from those indicated in the respective SSDR certificates without obtaining NRCs prior permission in a license amendment. Licensees providing information in accordance with the provisions of 10 CFR 30.32(g) may not make changes to the sealed sources, device, or source-device combination that would alter the description provided to NRC without obtaining NRCs prior permission in a license amendment. To ensure that sealed sources and devices are used in ways that comply with the SSDR certificates, applicants may want to review or discuss them with the manufacturer.
Response from Applicant: If the possession of a sealed source(s) or device(s) is requested, the applicant shall submit the information described above.
 
==Reference:==
See the Notice of Availability on the inside front cover of this report to obtain a copy of NUREG-1556, Volume 3, Revision 1, Consolidated Guidance About Materials Licenses:
Applications for Sealed Source and Device Evaluation and Registration, and NUREG-1556, Volume 11, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope.
Note: To obtain copies of the SSDR certificate, applicants should contact the manufacturer/distributor of the device or the appropriate NRC Regional Office (see Figure 2.1 for addresses and telephone numbers).
17
 
[The following redline/strikeout revisions to Section 8.9 reflect changes to:
10 CFR 35.65 to clarify when used under 35.500 calibration, transmission, or references sources may not have to be listed on the license; changes to 10 CFR 35.400, 35.500, and 35.600 requiring sources be used in accordance with the radiation safety conditions and limitations described in the Sealed Source Device Registration not as approved in the Sealed Source Device Registration; and changes in 10 CFR 35.12 describing information needed for 10 CFR 35.1000 medical uses.]
8.9      ITEM 6: PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED Regulations: 10 CFR 30.32(j), 10 CFR 30.33(a)(1),                  Part 35 Applicability 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300,                          100 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600,                          200 10 CFR 35.1000.                                                      300 400 Criteria: In 10 CFR Part 35, byproduct material                      500 for medical use is divided into seven types of use as follows:
600 1000 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 10 CFR 35.300      Use of unsealed byproduct material for which a written directive is required 10 CFR 35.400      Use of sources for manual brachytherapy 10 CFR 35.500      Use of sealed sources for diagnosis 10 CFR 35.600      Use of a sealed source(s) in a device for therapy-teletherapy unit Use of a sealed source(s) in a device for therapy-remote afterloader unit Use of a sealed source(s) in a device for therapy-gamma stereotactic radiosurgery unit 10 CFR 35.1000 Other medical uses of byproduct material or radiation from byproduct material Under 10 CFR 30.32(j), medical use licensees within a consortium are authorized to produce PET radioactive drugs for noncommercial distribution to medical use licensees within the consortium. Appendix AA provides additional information on this 10 CFR Part 30 use.
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Discussion:
10 CFR 35.100, 35.200, and 35.300 Use: For 10 CFR 35.100, 35.200, and 35.300 use, the applicant should define the purpose of use by stating the applicable section of 10 CFR Part 35 (e.g., 10 CFR 35.100) and the description of the applicable modality (e.g., any uptake, dilution, and excretion procedure for which a written directive is not required).
The use of unsealed byproduct material in therapy (10 CFR 35.300) involves administering a byproduct material, either orally or by injection, to treat or palliate a particular disease. The most common form of use of unsealed byproduct material for therapy is the treatment of hyperthyroidism with iodine-131 (I-131) sodium iodide. Other therapeutic procedures include, for example, ablation of thyroid cancer metastasis, treatment of malignant effusions, treatment of polycythemia vera and leukemia, palliation of bone pain in cancer patients, and radiation synovectomy for rheumatoid arthritis patients. References to particular diagnostic or treatment modalities in this section are intended to be examples and are not intended to imply that licensees are limited to these uses.
If an applicants request is limited to I-131 under 10 CFR 35.300, the license will be limited to that radionuclide.
35.400 Use: The applicant should define the purpose of use by stating that the applicable section of 10 CFR Part 35 is 10 CFR 35.400. If a source is to be used in a device, applicants may need to define the purpose of use by including the manufacturers name and model number of the device. The licensee should relate the sealed sources, including sealed sources of Ra-226, listed in Item 5 to the devices described in this item.
In manual brachytherapy, several types of treatments are available. These may include, for example:
Interstitial Treatment of Cancer.
Eye Plaque Implants. This is considered interstitial, not topical, treatment.
Intracavitary Treatment of Cancer. For purposes of NRCs sealed source and device evaluation on radiation safety issues, intraluminal use is considered analogous to intracavitary use.
Topical (Surface) Applications.
35.500 Use: For 10 CFR 35.500 use, the applicant should define the purpose of use by stating that the applicable section of 10 CFR 35 is 10 CFR 35.500 and including the manufacturers name(s) and model number(s) of devices containing sealed sources (where applicable). In accordance with 35.65(c), calibration, reference and transmission sources used under the provisions of 35.500 do not have to be listed on a specific medical use license; therefore in this case the manufacturer and model numbers do not have to be provided. The licensee should correlate the sealed sources, including sealed sources of Ra-226, listed in Item 5 with the devices described in this item. Typically, a A licensee should use the sealed sources according to the manufacturers radiation safety and handling instructions and must use the sources in accordance with the radiation safety conditions and limitations described as approved in the SSDR.
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35.600 Use: For 10 CFR 35.600 use, the applicant should define the purpose of use by stating the applicable section of 10 CFR Part 35.600 (e.g., teletherapy, remote afterloading, GSR) and including the manufacturers name(s) and model number(s) of the device(s) containing a sealed source(s) (e.g., for use in a [Manufacturers Name and Unit Type, Model xxxx] radiation therapy unit for the treatment of humans). The applicant should correlate the sealed source(s) listed in Item 5 with the device described in this item. If applicable, the applicant should state that depleted uranium is used as shielding for the device and specify that authorization is being requested for an additional source to be stored in its shipping container, incident to source replacement.
35.1000 Use: Applicants must apply for authorization to use byproduct material, or radiation therefrom, in medical applications under 10 CFR 35.1000 when the type of use is not covered under 10 CFR 35.100-35.600. This includes the medical use of unsealed Ra-226 or of Ra-226 sealed sources for uses other than those described by 10 CFR 35.400 or 35.500.
When applying for use under the provisions of 10 CFR 35.1000, applicants should:
* Describe the purpose of use and submit the information required under Section 35.12(b) through (d).,
* Rreview regulatory requirements in other Subparts of 10 CFR Part 35, and use them as a guide on how to determine what should be included in an application that is required in Section 35.12.
* Address any aspects of the medical use of the material applicable to radiation safety but not addressed in, or different from those in, subparts A through C, L and M of 10 CFR Part 35.
* Identify and commit to follow the applicable radiation safety program requirements in subparts D through H of 10 CFR Part 35.
* Provide information, if needed, for additional radiation safety precautions and instructions, to describe methodologies for measurement of dosages or doses to be administered to patients or human research subjects, and describe any calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.
If applying to use a 10 CFR 35.1000 medical use for which NRC has already developed guidance, review the applicable licensing guidance posted on NRCs Medical Uses Licensee Toolkit website (http://www.nrc.gov/materials/miau/med-use-toolkit.html).
It is anticipated that many of the uses of byproduct material under the provisions of Section 35.1000 may involve research or product development; thus, applicants should ensure review and compliance with 10 CFR 35.6, Provisions for the protection of human research subjects, and 10 CFR 35.7, FDA, other Federal, and State requirements. Use of byproduct material in a source or device after approval by the U.S. Food and Drug Administration (FDA) (e.g., under an IDE (investigational device exemption) or an IND (investigational new drug exemption)), does not relieve individuals of the responsibility to obtain a license to use the byproduct material in medicine under the provisions of 10 CFR Part 35.
If the source for the type of use sought under 10 CFR 35.1000 is a sealed source, including sealed sources of Ra-226, Section 8.6 of this guide describes the information that must be provided at the time of application. Broad-scope licensees are exempted under 35.15(a) from requirements of 35.12(d) (which relates to the need to put into an application certain information about the radiation safety aspects of medical use under Section 35.1000). However, broad-20
 
scope licensees should ensure that the quantity needed for the proposed use is authorized on their license or apply for an increase if not. Applicants should refer to IN 99-024, Broad-Scope Licensees Responsibilities for Reviewing and Approving Unregistered Sealed Sources and Devices for more information on sealed sources.
Applicants for uses under Section 35.1000 should consult with the appropriate NRC Regional Office to discuss the contents of their application.
Nonmedical Uses: Applicants may also describe nonmedical uses (e.g., survey meter calibrations with NIST-traceable brachytherapy sources) and reference the applicable radioactive material provided in response to Item 5. This would include the nonmedical use of discrete sources of Ra-226.
Authorization under 10 CFR 30.32(j) to produce PET radioactive drugs for noncommercial transfer to licensees in its consortium for medical use is another nonmedical use. Applicants intending to produce PET radioactive drugs under this provision should include this use under this section, list the applicable radioactive materials under Item 5, and review Appendix AA for additional information.
Radionuclide Production by an Accelerator: Production of radionuclides for both medical and nonmedical uses is beyond the scope of this guidance and a medical use license. See NUREG-1556, Volume 21, Consolidated Guidance About Materials Licenses: Program-Specific Guidance about Possession Licenses for Production of Radioactive Materials Using an Accelerator.
Response from Applicant: The applicant must submit information regarding the purpose for which the licensed material will be used. The applicant should consider including the information described above, as applicable to the type of use(s) proposed.
When responding to this section, follow the guidance in Section 5.2 to determine if the response includes security-related sensitive information and needs to be marked accordingly.
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[The following redline/strikeout revisions to Section 8.10 reflect changes to 10 CFR 35.57 grandfathering individuals that were board certified by boards listed in NRC regulations on or prior to October 24, 2005, and changes to 10 CFR 35.24 permitting licensees to name one or more Associate Radiation Safety Officers.]
8.10      ITEM 7: INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAMS AND THEIR TRAINING AND EXPERIENCE Part 35  Applicability Regulations: 10 CFR 30.33(a)(3), 10 CFR 30.34(j),                    100 10 CFR 33.13, 10 CFR 35.24, 10 CFR 35.50, 10 CFR 35.51,              200 10 CFR 35.55, 10 CFR 35.57, 10 CFR 35.59,                            300 10 CFR 35.190, 10 CFR 35.290, 10 CFR 35.390,                        400 10 CFR 35.392, 10 CFR 35.394, 10 CFR 35.396, 10 CFR                  500 35.433(a)(2),10 CFR 35.490, 10 CFR 35.491, 600 10 CFR 35.590, 10 CFR 35.690.
1000 Criteria: The RSO, ARSOs, AUs, AMPs, ophthalmic physicists, and ANPs must have adequate training and experience.
Discussion: Authorized user (AU) is not defined for nonmedical use, but for purposes of this discussion, the term AU will be used to also mean individuals who are authorized for such nonmedical uses. The requirements in 10 CFR 35.24 describe the authority and responsibilities for the Radiation Protection Program, including those of the licensees management and the RSO appointed by licensee management. Other personnel who have a role in the Radiation Protection Program are ARSOs, AUs, AMPs, ophthalmic physicists, ANPs, and members of the Radiation Safety Committee (RSC) (if the licensee is required to establish an RSC). The January 2019 rule added two new individuals, the ARSO and the ophthalmic physicist, described in sections 8.11 and 8.14b, respectively.
In 10 CFR 30.33(a)(3), the NRC requires that an applicant be qualified by training and experience to use licensed materials for the purposes requested in such a manner as to protect health and minimize danger to life or property. Subparts B, D, E, F, G, and H of 10 CFR Part 35 give specific criteria for acceptable training and experience for AUs for medical use, ANPs, the RSO, ARSOs, and AMPs, and ophthalmic physicists; AUs for nonmedical uses must meet the criteria in 10 CFR 30.33(a)(3).
A résumé or a curriculum vitae is likely to be insufficient because such documents usually do not supply all the information needed to evaluate an individuals training and experience for NRC purposes. Applicants should ensure that they submit the specific training information required by NRC regulations in 10 CFR Part 35. The NRC Form 313A series of forms provides a convenient format for submitting the information required in 10 CFR Part 35, Subparts B, D, E, F, G, and H. For nonmedical use AUs, the information provided should focus on educational training and radiation safety training and experience specific to the radionuclides and uses requested.
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Licensees are responsible for their Radiation Protection Programs; it is essential that strong management control and oversight exist to ensure that licensed activities are conducted properly. The licensees management must appoint an RSO, who agrees in writing to be responsible for implementing the Radiation Protection Program, and 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: identifying radiation safety problems; initiating, recommending, or providing corrective actions; stopping unsafe operations; and verifying the implementation of corrective actions. Nevertheless, the licensee retains the ultimate responsibility for the conduct of licensed activities.
The licensees management can name only one RSO, who is the individual who remains responsible for implementing the entire radiation protection program. Although not required, the licensees management may appoint one or more ARSOs to support the RSO. The ARSO is delegated radiation safety duties and tasks for the types of uses for which he or she is listed on the license. These duties and task are also commensurate with his or her training and experience.
Licensees that are authorized for two or more different types of uses of byproduct material under Subparts E, F, and H, 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. Membership in the committee must include an AU for each type of use permitted by the license, 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 the licensee considers appropriate.
Licensees may contract for medical use services, including those involving patient services.
However, the licensee should not assume that, by hiring a contractor 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 adequate mechanisms for oversight are in place to determine that the Radiation Protection Program, including the training of contractor staff, is effectively implemented by the appropriate individuals.
Training for an experienced RSO, teletherapy or medical physicist, AU or nuclear pharmacist; recentness of training. Under 10 CFR 35.57(a)(1) and a(2), experienced individuals, who may be candidates to serve as a RSO, AMP, or ANP, before January 2019 are not required to meet the requirements of Sections 35.50, 35.51, or 35.55, respectively (are grandfathered) for the same materials and authorizations. Experienced RSOs and AMPs after January 2019 must meet the requirements in Sections 35.51(d) and 35.51(c) for new uses and authorizations.
Under 10 CFR 35.57 (a)(2) and (a)(3), experienced individuals, who may be candidates to serve as RSO, AMP, or ANP, are not required to meet the requirements of Sections 35.50, 35.51, or 35.55, respectively (are grandfathered), for those materials and uses that these individuals performed on or before October 24, 2005. (e.g. the individual is named on an NRC or Agreement State license). Under 10 CFR 35.57(b)(1) and (b)(2)AUs are also not required to meet the requirements in Subparts D-H of 10 CFR Part 35 for the same materials and uses performed before January 2019. Under 10 CFR 35.57(b)(2), individuals not listed as an AU on medical licenses or permits are not required to meet the requirements in Subparts D-H of 10 CFR Part 35 for the same materials and uses performed on or before October 24, 2005.
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Subsequent to the EPAct, RSOs, medical physicists, nuclear pharmacists, physicians, podiatrists, and dentists that only used accelerator-produced radioactive material, discrete sources of Ra-226, or both, are also grandfathered, under NRC regulations in 10 CFR 35.57(a)(43) and (b)(3), for medical uses or the practice of nuclear pharmacy when using materials for the same uses performed before or under NRCs waiver issued August 31, 2005. The requirements in 10 CFR 35.59 (that the training and experience specified in 10 CFR 35, Subparts B, D, E, F, G, and H, must have been obtained within 7 years preceding the date of application or the individual must have related continuing education and experience) do not apply to those individuals grandfathered under the regulations implementing the EPAct.
Also, 10 CFR 35.57 provides that nuclear pharmacists, medical physicists, physicians, dentists, and podiatrists that meet the criteria in 10 CFR 35.57(a)(43) and (b)(3) qualify as ANPs, AMPs, and AUs for those materials and uses performed before or under NRCs waiver of August 31, 2005.
Resolution to a petition for rulemaking by American Association of Physicists in Medicine allows recognition of certifications issued by boards previously listed in 10 CFR Part 35, Subpart J, which under September 16, 2004, rulemaking expired on October 24, 2005. This recognition permits experienced board certified individuals who were not recognized as authorized individuals on licensees or permits to be grandfathered for modalities they practiced on or before October 24, 2005. The recognized certification boards are named in 10 CFR 35.57.
Response from Applicant: Refer to the subsequent sections specific to the individuals described above.
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[The following redline/strikeout revisions to Section 8.11 reflect changes to 10 CFR 35.57 grandfathering individuals that were board certified by boards listed in NRC regulations on or before October 24, 2005; changes to 10 CFR 35.24 permitting licensees to name one or more Associate Radiation Safety Officers; and changes to 10 CFR 35.50 training and experience pathways.]
8.11        ITEM 7: RADIATION SAFETY OFFICER (RSO) AND ASSOCIATE RADIATION                                Part 35  Applicability 100 SAFETY OFFICERS (ARSOs) 200 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14,                300 10 CFR 35.24, 10 CFR 35.50, 10 CFR 35.57, 10 CFR 35.59,                    400 10 CFR 35.2024.                                                            500 600 1000 Criteria: The RSOs and ARSOs must have adequate training and experience. The training and experience requirements for the RSO and ARSOs are described in 10 CFR 35.50 and allow for the following training pathways:
Certification as provided in 10 CFR 35.50(a) by a specialty board whose certification process has been recognized by the NRC or an Agreement State, plus a written attestation signed by a preceptor RSO as provided in 35.50(d) and completion of training as specified in 35.50(de); or Completion of classroom and laboratory training (200 hours) and 1 year of full-time radiation safety experience as described in 10 CFR 35.50(b)(1) plus a written attestation signed by a preceptor RSO or ARSO as provided in 10 CFR 35.50 (bd)(2) and training as specified in 35.50(de); or Certification as provided in 10 CFR 35.50(c)(1) as a medical physicist under 35.51(a), plus a written attestation signed by a preceptor RSO as provided in 35.50(d), demonstration that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO, and has completed training as specified in 35.50(de); or Identification as provided in 10 CFR 35.50(c)(2)on the licenseesa Commission or Agreement State license, a permit issued by a Commission master material license, a permit issued by a Commission or Agreement State licensee of broad scope, or a permit issued by a Commission master material license broad scope permittee as an AU, AMP, or ANP with experience in the radiation safety aspects of similar types of use of byproduct material use for which the licensee seeks the approval of the individual as the has RSO responsibilities or ARSO, with a written attestation signed by a preceptor RSO as provided in 10 CFR35.50(d)and completion of training as specified in 35.50(ed).
Completion of training and experience required to be named as an AU and meet the requirements in 35.50(d) when simultaneously applying to be the AU and RSO on a new medical license as permitted by 10 CFR 35.50(c)(3).
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The licensee must also establish, in writing, the authority, duties, and responsibilities of the RSO as required by 10 CFR 35.24(eb).
Discussion:
Radiation Safety Officer The RSO is responsible for day-to-day oversight of the Radiation Protection Program. In accordance with 10 CFR 35.24, the licensee must provide the RSO sufficient authority, organizational freedom, time, and resources to perform his or her duties. 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 in a safe manner. The NRC requires the name of the RSO on the license, and an agreement in writing from the RSO, to ensure that licensee management has identified a responsible, qualified person and that the named individual knows of his or her designation and assumes the responsibilities of an RSO.
Usually, the RSO is a full-time employee of the licensed facility. The NRC has authorized individuals who are not employed by the licensee, such as a consultant, to fill the role of RSO or to provide support to the facility RSO. In order 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. Appendix I contains a model RSO Delegation of Authority. Appendix B contains NRC Form NRC 313A (RSO), Radiation Safety Officer or Associate Radiation Safety Officer Training, Experience and Preceptor Attestation [10 CFR 35.57, 35.50]Medical Use Training and Experience and Preceptor Attestation [35.50], which can be used to document the RSOs training and experience.
RSO Responsibilities: Some of the typical duties and responsibilities of RSOs include ensuring the following:
Unsafe activities involving licensed materials are stopped; Radiation exposures are ALARA; Material accountability and disposal; Interaction with NRC; Timely and accurate reporting and maintenance of appropriate records; Annual program audits; Proper use and routine maintenance; Personnel training; and Investigation of incidents involving byproduct material (e.g., medical events).; and Assigning specific duties and tasks to an ARSO, restricted to the types of use for which the ARSO is listed on the license.
Appendix I contains a detailed list of typical duties and responsibilities of the RSO.
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In implementing the EPAct, the NRC grandfathered RSOs that performed as RSOs for medical uses of only accelerator-produced radioactive material, discrete sources of Ra-226, or both.
These individuals do not have to meet the requirements in either 10 CFR 35.59 or 10 CFR 35.50 when performing the same uses; however, the applicant must document that the individual meets the criteria in 10 CFR 35.57 (a)(34).
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(a)                                                (b)
Figure 8.a1. Licensing Examples of Potential Radiation Safety Officer (RSO) and Associate Radiation Safety Officer (ARSO) arrangements:
(a) a moderate sized program - the RSO is responsible for the entire program and has direct oversight over the 35.300 and 35.400 medical uses - a single ARSO has oversight duties and tasks for 35.100, 35.200, and 35.500 medical uses and reports to the RSO.
(b) a larger single campus program - the RSO is responsible for the entire program -
there are two ARSOs with oversight duties and tasks over different sections of the program and both report to the RSO.
(c) A large multi-campus program - the RSO is responsible for the entire program - there are two ARSOs with oversight duties and          (c) tasks over the two smaller campuses. Both ARSOs report to the RSO.
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Associate Radiation Safety Officer A licensee may choose to identify one or more individuals as ARSOs to support the RSO. The ARSOs could be assigned duties and tasks in the oversight of the radiation safety operations of designated sections of the licensed program, but the RSO retains responsibility for all sections of the program.
The ARSOs are required to complete the same training and experience requirements as the named RSO for their assigned sections of the radiation safety program. The RSO, with written agreement from licensee management, may assign duties and tasks to each ARSO that are limited to the types of use for which the ARSO is listed on the license. The ARSOs would perform duties and tasks in the oversight of the radiation safety operations of their assigned sections of the program, while reporting to the named RSO. The regulations continue to allow a licensee to name only one RSO on a license. Licensees with multiple operating locations or multiple types of uses can appoint a qualified ARSO at each location or for each type of byproduct material use. These individuals will be listed on the license as ARSOs. Their assigned sections of the program will also be listed.
Before the ARSO can be assigned duties and task in the oversight of the radiation safety operations of a different section of the program, the licensee must amend the license and provide documentation that the individual meets the training and experience requirements for the new duties and tasks.
Because the ARSOs have the same training and experience requirements as an RSO, the ARSOs will qualify to be named as the RSO on other licenses for the types of uses for which they are listed.
Requirements applicable to both RSO and ARSO An AU, AMP, or ANP listed on any license or permit may be identified as an RSO or ARSO, consistent with the individuals training and experience, allowing an increase in the number of qualified individuals available to serve as RSOs and ARSOs on NRC medical licenses.
Additionally, both RSOs and ARSOs could serve as preceptors for individuals seeking to be named as the RSO or ARSO on a license.
If the individual was board certified by any of the boards listed in 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-by-case basis to see if the time period of use, the materials used, and the types of use meet the criteria in the regulation. This provision of the rule lets these board certified individuals that were not named as an RSO but performing radiation safety duties and tasks prior to October 24, 2005, to be grandfathered.
Applicants are reminded of recentness of training requirements described in 10 CFR 35.59.
Specifically, RSO and ARSO applicants must have successfully completed the applicable training and experience described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, RSO and ARSO applicants must have had related continuing 29
 
education and experience since completing the required training and experience. This time provision applies to board certification as well as to other pathways to meeting requirements for training and experience.
Response from Applicant: Provide the following:
Name of the individualproposed RSO.
AND Identify if applying for RSO or ARSO.
AND For a proposed ARSO, identify the section(s) of the licensees program for which the individual will be given duties and task in the oversight of radiation safety operations (e.g.,
35.200 uses or 35.200 uses at one of the licensees alternate location)
AND For an individual previously identified as an RSO or ARSO on an NRC or Agreement State license or permit:
Previous license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee on which the individual was named as the RSO or ARSO if requesting the same materials and medical uses; AND After January 2019, documentation of completion of the training requirements in
      § 35.50(d) for any new materials or new medical uses requested.
For an individual qualifying under 10 CFR 35.57 (a)(43):
(Note: This is only for a new medical use license requesting use of only accelerator-produced radioactive material, discrete sources of Ra-226, or both, for the same uses authorized under NRCs waiver of August 31, 2005.)
Documentation that this individual functioned as an RSO for only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, 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 before or during the effective period of NRCs waiver of August 7, 2005; AND Documentation that the individual performed as the RSO for the same medical uses requested.
For an individual qualifying under 10 CFR 35.50(a):
30
 
Copy of certification by a specialty board whose certification process has been recognized 1 by the NRC or an Agreement State under 10 CFR 35.50(a);
AND Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO or ARSO is qualified by training in the radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND Written attestation, signed by a preceptor RSO, that the individual has successfully completed the training and experience specified for certification, as well as Completed the required training and experience in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.50(c)(1):
Copy of the certification(s) as a medical physicist by a board whose certification process has been recognized 2 by the NRC or an Agreement State under 10 CFR 35.51(a) and description of the experience specified in 35.50(c)(1) demonstrating that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar types of use of byproduct materialapplicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO ;
AND Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND Written attestation, signed by a preceptor RSO, that the individual has successfully completed the training and experience specified for certification, as well as Completed the required training and experience in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO.
1 The names of board certifications that have been recognized by the NRC or an Agreement State are posted on NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
2 The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
31
 
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.57(a)(2):
Copy of certification by a specialty board whose certification is listed in 10 CFR 35.57(a)
(2);
AND Documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.50(c)(2):
Copy of the Commission or Agreement State licensees license, permit issued by a Commission master material license, permit issued by a Commission or Agreement State licensee of broad scope, or permit issued by a Commission master material license broad scope permittee indicating that the individual is an AU, AMP or ANP identified on the licensees license and has experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO ;
AND Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO AND Written attestation, signed by a preceptor RSO, that the individual has successfully completed the training and experience specified for certification, as well as Completed the required training and experience in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.50(c)(3):
Documentation of training and experience required to be named as an AU when simultaneously applying to be the AU and RSO on a new medical license; 32
 
AND Description of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO; For an individual qualifying under 10 CFR 35.50(b):
Description of the training and experience specified in 10 CFR 35.50(b)(1) demonstrating that the proposed RSO or ARSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an individual to serve as RSO or ARSO; AND Written attestation, signed by a preceptor RSO or ARSO, that the individual has successfully completed the training and experience in 10 CFR 35.50(b)(1), as well as the required training and experience in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval and is ablehas achieved a level of radiation safety knowledge sufficient to function independently fulfill the radiation safety-related duties as an RSO or as an ARSO for a medical use licensee; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Notes:
NRC Form 313A (RSO), Radiation Safety Officer or Associate Radiation Safety Officer Training, and Experience, and Preceptor Attestation [10 CFR 35.57, 35.50], may be used to document training and experience for those individuals qualifying under 10 CFR 35.50.
The licensee must notify the NRC within 30 days if, under 10 CFR 35.14, an RSO or ARSO permanently discontinues his or her performance of duties under the license or has a name change; licensees must also request an amendment to change an RSO or ARSO under 10 CFR 35.13.
An AU for medical uses, AMP, or ANP may be designated 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 he or she will have has RSO responsibilities or ARSO duties and tasks (see 10 CFR 35.50(c)(2)) and the RSO, as required by 10 CFR 35.24(g),
has sufficient time, authority, organizational freedom, resources, and management prerogative to perform the duties.
33
 
Descriptions of training and experience will be reviewed using the criteria listed above.
The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35, Subpart B, are met. If the training and experience do not appear to meet the criteria in Subpart B, the NRC may request additional information from the applicant or may request the assistance of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) in evaluating such training and experience.
The training and experience for the RSO of a medical use broad-scope license will be reviewed using the above criteria as well as criteria in 10 CFR Part 33.
34
 
[The following redline/strikeout revisions to Section 8.12 reflect changes to 10 CFR 35.57 grandfathering individuals that were board certified by boards listed in NRC regulations prior to October 25, 2005, and changes to 10 CFR 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, and 35.690 revising the preceptor attestation requirements. The revisions to preceptor attestation requirements include rewording the attestation statement, removing the attestation requirement for most board certified individuals, and allowing residency program directors to provide attestation statements.]
8.12      ITEM 7: AUTHORIZED USERS (AUs)
Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.11,                Part 35  Applicability 10 CFR 35.14, 10 CFR 35.27, 10 CFR 35.57, 10 CFR 35.59, 10 CFR              100 35.190, 10 CFR 35.290, 10 CFR 35.390, 10 CFR 35.392,                        200 10 CFR 35.394, 10 CFR 35.396, 10 CFR 35.490, 10 CFR 35.491, 300 10 CFR 35.590, 10 CFR 35.690.
400 Criteria: Training and experience requirements for AUs for medical          500 uses are described in 10 CFR 35.190, 10 CFR 35.290,                          600 10 CFR 35.390, 10 CFR 35.392, 10 CFR 35.394, 10 CFR 35.396,                1000 10 CFR 35.490, 10 CFR 35.491, 10 CFR 35.590, or 10 CFR 35.690.
Discussion: Although NRC does not define AU for nonmedical uses, for purposes of this discussion the term AU will be used to also mean individuals authorized for such nonmedical uses.
AU for Medical Uses: The responsibilities of AUs involved in medical use include the following:
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; Preparation of written directives (WD), if required.
Applicants must meet recentness of training requirements described in 10 CFR 35.59. The AU applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, applicants must have had related continuing education and experience since completing the 35
 
required training and experience. This time provision applies to board certification as well as to other training pathways.
Section 35.57 of 10 CFR Part 35 provides that experienced AUs who are named on a license or permit are not required to comply with the training requirements in Subparts D through H to continue performing those medical uses for which they were authorized before the effective date of changes to the regulations in Section 35.57 (check the regulations to determine this date).
For example, a physician who was authorized to use sodium iodine-131 for imaging and localization, involving greater than 30 microcuries (a quantity for which a written directive is required under 10 CFR 35.40), a use that was authorized under Section 35.200 prior to 2002, would continue to be authorized for this use even though it is currently authorized under Section 35.300 after 2002.
If the physician, dentist, or podiatrist has never been identified as an AU and was board certified by any of the boards listed in 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 on or 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-by-case basis to see if the time period of use, the materials used, and the types of medical use meet the criteria in the regulation. This provision of the rule grandfathers these board certified individuals that were never named as an AU but perform medical uses with the same materials on or before October 24, 2005.
In implementing the EPAct, the NRC grandfathered physicians, podiatrists, and dentists using only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, for medical use, for the same uses performed before or under the NRC waiver of August 31, 2005.
These individuals do not have to meet the requirements in 10 CFR 35.59, 35.190, 35.290, 35.390, 35.396, or 35.490. However, the applicant must document that the individual meets the criteria in 10 CFR 35.57(b)(3). This Section also states that physicians, dentists, and podiatrists who met certain criteria will qualify as AUs for those materials and uses performed before NRCs waiver was terminated for them.
Technologists, therapists, or other personnel may use byproduct material for medical use under an AUs supervision in accordance with 10 CFR 35.27, Supervision, and in compliance with applicable FDA, other Federal, and State requirements (10 CFR 35.7). Examples include FDA requirements for the conduct of certain types of clinical research after the submission of applications for Investigational New Drugs (IND) and under the auspices of a Radioactive Drug Research Committee (21 CFR 361.1).
There is no NRC requirement that an AU must render an interpretation of 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.
An individual, who is qualified to be an AU but has not been named as an AU on a medical use license or permit may apply for and be authorized simultaneously as the RSO and the AU on the same new medical use license. The individual must have experience with radiation safety 36
 
aspects of the types of use of byproduct material for which the individual is seeking simultaneous authorization and training specified in 35.50(d).
A licensee may request an AU on any medical use license or permit to be named as the RSO or ARSO for the same byproduct material and uses for which the AU is authorized.
AU for Nonmedical Uses: For in vitro studies, animal research, calibration of survey instruments, and other uses that do not involve the intentional exposure of humans, the list of proposed AUs should include the individuals who will actually be responsible for the safe use of the byproduct material for the requested use. This includes the individuals responsible for the production of PET radioactive drugs for noncommercial transfer to other medical users within a consortium (see Appendix AA).
An applicant should note which user will be involved with a particular use by referring to Items 5 and 6 of the application and providing information about the users training and experience.
Authorized nonmedical use or uses that do not involve the intentional exposure of humans (e.g., in vitro and animal research, calibration, dosimetry research) will be reviewed on a case-by-case basis.
Response from Applicant:
AU for Medical Uses: Provide the following:
Name of the proposed AU and uses requested; AND Medical, podiatry, or dental license number and issuing entity; AND For an individual previously identified as an AU on an NRC or Agreement State license or permit:
Previous license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC Master Materials License broad-scope permittee on which the physician, dentist, or podiatrist was specifically named as an AU for the uses requested; AND For an AU requesting a medical use not currently authorized on a license or permit, a description of the additional training and experience is needed to demonstrate the AU is also qualified for the new medical uses requested (e.g., training and experience needed to meet the requirements in 10 CFR 35.290(b), 35.396, 35.390(b)(1)(ii)(G) or 35.690(c)). A preceptor attestation may also be required. (For example, a preceptor attestation is needed for all individuals to meet the requirements of 10 CFR 35.396 and for individuals seeking authorization through the alternate training and experience pathway for 35.390 and 35.690.)
AND 37
 
If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.57(b)(3):
Documentation that the physician, dentist, or podiatrist used only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, for medical uses performed 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 before or during the effective period of NRCs waiver of August 31, 2005; AND Documentation that the physician, dentist, or podiatrist used these materials for the same medical uses requested; AND For an AU requesting a medical use for which he or she is not currently authorized on a license or permit, a description of the additional training and experience to demonstrate the AU is also qualified for the new medical uses requested (e.g., training and experience needed to meet the requirements in 10 CFR 35.290(b), 35.396, 35.390(b)(1)(ii)(G) or 35.690(c)). A preceptor attestation may also be required. (For example, a preceptor attestation is needed for all individuals to meet the requirements of 10 CFR 35.396 and for individuals seeking authorization through the alternate training and experience pathway for 35.390 and 35.690training, experience, and attestations are needed to meet the requirements in 10 CFR 35.290(b), 35.396, 35.390(b)(1)(ii)(G) or 35.690(c).)
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual who was certified on or before October 24, 2005, by a board listed in 10 CFR 35.57(b)(2):
Copy of certification issued on or before October 24, 2005, by a specialty board whose certification is listed in 10 CFR 35.57(b)(2);
AND Documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
38
 
For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H, who is board-certified:
A copy of the certification(s) by a specialty board(s) whose certification process has been recognized 3 by the NRC under 10 CFR Part 35, Subpart D, E, F, G, or H, as applicable to the use requested; AND For a physician with a board certification recognized under 10 CFR 35.390, a description of the supervised work experience administering dosages of radioactive drugs required in 10 CFR 35.390(b)(1)(ii)(G) demonstrating that the proposed AU is qualified for the types of administrations for which authorization is sought; AND For a physician with a board certification recognized under 10 CFR 35.390 for medical uses described in 10 CFR 35.200, a description of the supervised work experience eluting generator systems required in 10 CFR 35.290(c)(1)(ii)(G) demonstrating that the proposed AU is also qualified for imaging and localization medical uses; AND For a physician with a board certification recognized under 10 CFR 35.490 or 10 CFR 35.690 for medical uses described in 10 CFR 35.396, a description of the training and supervised work experience required in10 CFR 35.396(b)(1)and (2) and a copy of the attestation required in 10 CFR 35.396(b)(3)d) to demonstrate qualifications for administering parenteral administrations of unsealed byproduct material requiring a written directive; AND For an individual seeking authorization under 10 CFR Part 35, Subpart H, a description of the training specified in 10 CFR 35.690 (c) demonstrating that the proposed AU is qualified for the type(s) of use for which authorization is sought; AND A written attestation, signed by a preceptor physician AU, that the training and experience specified for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has been achieved. For individuals seeking authorization under 10 CFR 35.390, 10 CFR 35.396, and 10 CFR 35.690, the attestation must also include successful completion of the clinical case work in 10 CFR 35.390(b)(1)(ii)(G), or training and experience required by 10 CFR 35.396(d), or training for 10 CFR 35.600 types of use, as appropriate; 3
The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
39
 
AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H, who is not board-certified:
A description of the training and experience identified in 10 CFR Part 35, Subparts D, E, F, G, and H, demonstrating that the proposed AU is qualified by training and experience for the use(s) requested; AND For an individual seeking authorization under 10 CFR Part 35, Subpart H, a description of the training specified in 10 CFR 35.690(c), demonstrating that the proposed AU is qualified for the type(s) of use for which authorization is sought; AND A written attestation, signed by a preceptor physician AU or if applicable the residency program director, that the above training and experience have been satisfactorily completed and the individual is able to that a level of competency sufficient to function independently fulfill the radiation safety-related duties as an AU for the requested medical uses authorized has been achieved; AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
Notes:
NRC Form 313A (AUD), Authorized User Training, and Experience and Preceptor Attestation (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.57, 35.190, 35.290, and 35.590]; or NRC Form 313A (AUT), Authorized User Training, and Experience and Preceptor Attestation (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396]; or NRC Form 313A (AUS), Authorized User Training, and Experience and Preceptor Attestation (for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690] may be used as appropriate to document training and experience for those individuals qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H.
Under 10 CFR 35.14, Llicensees must notify the NRC within 30 days if an AU permanently discontinues his or her duties under the license or has a name change under 10 CFR 35.14.
Descriptions of training and experience will be reviewed using the criteria listed above.
The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35 are met. If the training and experience do not appear to meet the 10 CFR Part 35 criteria, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
40
 
Note to reviewers: Licenses will reflect any limitations on use for listed AUs (e.g., whether administrations in excess of 33 mCi of iodine-131 are allowed and specific uses under 10 CFR 35.600).
AU for Nonmedical Uses: Provide the following:
Name of the proposed nonmedical use AU, Description of types, quantities, and proposed nonmedical uses for which the individual is responsible, and Description of individuals educational and radiation safety training and experience with the types of materials and uses requested. This may include:
      - A copy of the NRC or Agreement State License listing the individual as an AU for the same types, quantities, and uses requested.
      - A permit issued by a Master Materials License licensee or broad-scope licensee or broad-scope permittee identifying the individual as an AU for the types, quantities, and uses requested.
Note: Authorized nonmedical use or uses that do not involve the intentional exposure of humans (e.g., in vitro and animal research, calibration, dosimetry research) will be reviewed on a case-by-case basis.
41
 
[The following redline/strikeout revisions to Section 8.13 reflect changes to 10 CFR 35.55 revising the wording of the attestation statement and removing the attestation requirement for board certified individuals.]
8.13 ITEM 7: AUTHORIZED NUCLEAR                                              Part 35  Applicability PHARMACIST (ANP)                                                                100 200 Regulations: 10 CFR 30.33(a)(3), 10 CFR 32.72(b)(2),                            300 10 CFR 35.2, 10 CFR 35.11, 10 CFR 35.14, 10 CFR 35.27,                          400 10 CFR 35.55, 10 CFR 35.57, 10 CFR 35.59.                                      500 600 Criteria: Training and experience requirements for                            1000 ANPs are described in 10 CFR 35.55.
Discussion: At many licensed medical facilities, an ANP is directly involved with the preparation of radiopharmaceuticals under the provisions of 10 CFR 35.100(b), 35.200(b), or 35.300(b). This may include the production of PET radioactive drugs under the provisions of 10 CFR 30.32(j).
Technologists, or other personnel, may prepare byproduct material for medical use under an ANPs supervision in accordance with 10 CFR 35.27, Supervision, and in compliance with applicable FDA, other Federal, and State requirements (10 CFR 35.7). (Preparation of byproduct material for medical use may also be performed under the supervision of a physician who is an AU.)
Applicants are reminded that the recentness of training requirements described in 10 CFR 35.59 also apply to training and experience requirements in 10 CFR Part 35, Subpart B. Specifically, nuclear pharmacist applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, nuclear pharmacist applicants must have had related continuing education and experience since initially completing the required training and experience. This time provision applies to board certification as well as to other training pathways for meeting requirements for training and experience.
In implementing the EPAct, the NRC grandfathered nuclear pharmacists using only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, in the practice of nuclear pharmacy for the uses performed before or under the NRC waiver of August 31, 2005. These individuals do not have to meet the requirements of 10 CFR 35.59 or 10 CFR 35.55. The applicant must, however, document that the individual meets the criteria in 10 CFR 35.57(a)(43). Section 35.57 also provides that nuclear pharmacists who met certain criteria will qualify as ANPs for those materials and uses performed before or under NRCs waiver of August 31, 2005.
Response from Applicant: Provide the following:
Name of the proposed ANP; 42
 
AND Pharmacists license number and issuing entity; AND For an individual previously identified as an ANP on an NRC or Agreement State license or permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs:
Previous license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC Master Materials License broad-scope permittee on which the individual was named an ANP or a copy of an authorization as an ANP from a commercial nuclear pharmacy that has been authorized to identify ANPs.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 35.57(a)(43):
Documentation that the nuclear pharmacist used only accelerator-produced radioactive material, discrete sources of Ra-226, or both, in the practice of pharmacy 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 at an earlier date as noticed by the NRC before or during the effective period of NRCs waiver of August 31, 2005; AND Documentation that the nuclear pharmacist used these materials for the same uses as requested.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
43
 
OR For an individual qualifying under 10 CFR 35.55(a):
Copy of the certification of the specialty board whose certification process has been recognized 1 under 10 CFR 35.55(a);
AND Written attestation, signed by a preceptor ANP, that training and experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 35.55(b):
Description of the training and experience specified in 10 CFR 35.55(b) demonstrating that the proposed ANP is qualified by training and experience; AND Written attestation, signed by a preceptor ANP, that the above training and experience have been satisfactorily completed and that the individual is able competency sufficient to function independently fulfill the radiation safety-related duties as an ANP has been achieved; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Notes:
NRC Form 313A (ANP), Authorized Nuclear Pharmacist Training, and Experience, and Preceptor Attestation [10 CFR 35.55] may be used to document training and experience for those individuals qualifying under 10 CFR 35.55.
Under 10 CFR 35.14, licensees must notify the NRC within 30 days if an ANP permanently discontinues his or her duties under the license or has a name change.
Descriptions of training and experience will be reviewed using the criteria listed above.
The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35, Subpart B, are met. If the training and experience do not appear to meet 1
The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
44
 
the criteria in Subpart B, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
45
 
[The following redline/strikeout revisions to Section 8.14 reflect changes to 10 CFR 35.51 revising the attestation statement and removing the attestation requirement for board certified individuals.]
8.14a ITEM 7: AUTHORIZED MEDICAL PHYSICIST (AMP)                                                  Part 35  Applicability 100 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14,                  200 10 CFR 35.51, 10 CFR 35.57, 10 CFR 35.59, 10 CFR 35.433.                      300 400 Criteria: Training and experience requirements for                            500 AMPs are described in 10 CFR 35.51.                                          600         
.                                                                            1000 Discussion: While the AMP may not administer the dose, at licensed medical facilities conducting radiation therapy treatments, an AMP is directly involved with the calculation and other tasks associated with the administration of the radiation dose. A licensee performing ophthalmic radiation therapy treatments under 10 CFR 35.400 must ensure that certain tasks described in 10 CFR 35.433(b) are performed by either an AMP or an ophthalmic physicist. The American Association of Physicists in Medicine (AAPM) suggests that a medical physicist limit his or her involvement in radiation therapy to areas for which he or she has established competency.
Applicants are reminded of recentness of training requirements described in 10 CFR 35.59.
Specifically, medical physicist and applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, medical physicist applicants must have had related continuing education and experience since completing the required training and experience. This time provision applies to board certification as well as to other training pathways for meeting requirements for training and experience.
10 CFR 35.57 provides that experienced AMPs who were named on a license or permit are not required to comply with the training requirements in 10 CFR 35.51 to continue performing those uses for which they were authorized on or before January 2019. Section 35.57 also provides that physicists holding certain board certifications on or before October 24, 2005, are not required to comply with the training requirements in 10 CFR 35.51 for those materials and uses that they performed on or before October 24, 2005. All AMPs are required to meet the requirements of 10 CFR 35.51(c) after January 2019 if they are seeking authorizations for new materials and medical uses.
If the medical physicist has never been identified as an AMP and was board certified by any of the boards listed in 35.57(a)(3) on or before October 24, 2005, the applicant must provide 46
 
documentation that the individual used the materials and performed the medical uses on or 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 see if the time period of use, the materials used, and the types of medical use meet the criteria in the regulation. This provision of the rule grandfathers these board certified individuals that were never named as an AMP but perform medical uses with the same materials on or before to October 24, 2005.
In implementing the EPAct, the NRC grandfathered medical physicists using only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, for medical uses performed before or under the NRC waiver of August 31, 2005. These individuals do not have to meet the requirements of 10 CFR 35.59 or 10 CFR 35.51. The applicant must, however, document that the individual meets the criteria in 10 CFR 35.57(a)(43). Section 35.57 also provides that medical physicists who met certain criteria will qualify as AMPs for those materials and uses performed before or under NRCs waiver of August 31, 2005. Note: Although there may be a number of medical physicists working with manual brachytherapy sources during the waiver, the NRC only requires AMPs for the medical use of strontium-90 eye applicators, teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units. Because none of these devices are known to contain only NARM material, the NRC expects few, if any, medical physicists to meet the criteria in 10 CFR 35.57 of an AMP.
Response from Applicant: Provide the following:
Name of the proposed AMP.
AND For an individual previously identified as an AMP on an NRC or Agreement State license or permit:
Previous license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC Master Materials License broad-scope permittee on which the individual was specifically named an AMP for the uses requested.
AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 35.57(a)(43):
Documentation that the medical physicist used only accelerator-produced radioactive material, discrete sources of Ra-226, or both, for medical 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 before or during the effective period of NRCs waiver of August 31, 2005; 47
 
AND Documentation that the medical physicist used these materials for the same medical uses as requested.
AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 35.51(a):
Copy of the certification(s) of the specialty board(s) whose certification process has been recognized 2 under 10 CFR 35.51(a);
AND Description of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which he or she is requesting AMP status, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system; AND Written attestation, signed by a preceptor AMP, that the required training and experience required for certification, as well as the required training in 10 CFR 35.51(c) for the types of uses specified, have been satisfactorily completed and that a level of competency sufficient to function independently as an AMP has been achieved; AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 35.57(a)(3):
Copy of the certification issued by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005; AND Documentation that the medical physicist performed the same medical uses as requested on or before October 24, 2005.
AND 2 The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
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If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 35.51(b):
Description of the training and experience demonstrating that the proposed AMP is qualified by training and experience identified in 10 CFR 35.51(b)(1) for the uses requested; AND Description of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the licensee seeks approval of an individual as AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system; AND Written attestation, signed by a preceptor AMP, that the proposed AMP has satisfactorily completed the training and experience required in 10 CFR 35.51(b)(1), as well as the training in 10 CFR 35.51(c) for the types of use specified, have been satisfactorially completed and is able that a level of competency sufficient to function independently fulfill the radiation safety-related duties as an AMP for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status has been achieved; AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
Notes:
NRC Form 313A (AMP), Authorized Medical Physicist or Ophthalmic Physicist Training, and Experience and Preceptor Attestation [10 CFR 35.51, 35.57 (a)(3), and 35.433], may be used to document training and experience for those individuals qualifying under 10 CFR 35.51.
Under 10 CFR 35.14, licensees must notify NRC within 30 days if an AMP permanently discontinues his or her duties under the license or has a name change.
Descriptions of training and experience will be reviewed using the criteria listed above.
The NRC will review the documentation to determine if the applicable criteria in 10 CFR Part 35, Subpart B or F, are met. If the training and experience do not appear to meet the criteria in Subpart B or F, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
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[The following redline addition in Section 8.14b reflects the addition of the ophthalmic physicist and the corresponding training requirements in 35.433.]
8.14b ITEM 7: OPHTHALMIC PHYSICIST                                                Part 35    Applicability 100 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14,                          200 10 CFR 35.59, 10 CFR 35.433.
300 400 Criteria: Training and experience requirements for ophthalmic physicists are described in 10 CFR 35.433(a)(2).                                                500 600 Discussion: A licensee performing ophthalmic radiation therapy treatments          1000 under 35.400 must ensure that either an AMP or an ophthalmic physicist performs certain tasks described in 10 CFR 35.433(b). These individuals perform the same tasks but have different training and experience requirements.
While the ophthalmic physicist may not administer the dose at licensed medical facilities conducting ophthalmic radiation therapy treatments, this individual is responsible for calculating the activity of each strontium-90 source that is used to determine treatment times. This individual will further assist the licensee in developing and implementing written procedures to provide high confidence that the administration is in accordance with the written directive.
Applicants are reminded of recentness of training requirements described in 10 CFR 35.59.
Specifically, ophthalmic physicist applicants must have successfully completed the applicable training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, ophthalmic physicist applicants must have had related continuing education and experience since completing the required training and experience.
Response from Applicant: Provide the following:
Name of the proposed Ophthalmic Physicist; AND Documentation of a masters or doctors degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; AND Documentation of successful completion of 1 year of full time training in medical physics and an additional year of full time work experience under the supervision of a medical physicist; AND Documentation of training in:
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The creating, modifying, and completing of written directives; Procedures for administrations requiring a written directive; and Performing the calibration measurements of brachytherapy sources as detailed in
            § 35.432.
Notes:
NRC Form 313A (AMP), Authorized Medical Physicist or Ophthalmic Physicist, Training, Experience, and Preceptor Attestation [10 CFR 35.51, 35.57 (a)(3), and 35.433], may be used to document training and experience ophthalmic physicist identified in 10 CFR 35.433.
Under 10 CFR 35.14, licensees must notify NRC within 30 days if an ophthalmic physicist permanently discontinues his or her duties under the license or has a name change.
Descriptions of training and experience will be reviewed using the criteria listed above.
The NRC will review the documentation to determine if the applicable criteria in 10 CFR 35.433(a)(2), are met. If the training and experience do not appear to meet the criteria in 10 CFR 35.433(a)(2), the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
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[The following redline additions to Section 8.19 address the addition of the ophthalmic physicist, changes made to 10 CFR 35.12 to clarify information needed for 10 CFR 35.1000 medical uses, and reminds applicant that there are calibration and use provisions similar to those for therapy units in 10 CFR 35.400 and 35.600 for certain 10 CFR 35.1000 medical uses.]
8.19      ITEM 9: THERAPY UNIT CALIBRATION AND USE Regulations: 10 CFR 30.33(a)(2), 10 CFR 35.12, 10 CFR 35.27,              Part 35      Applicability 10 CFR 35.432, 10 CFR 35.630, 10 CFR 35.632, 10 CFR 35.633,                  100 10 CFR 35.635, 10 CFR 35. 642, 10 CFR 35.643,                                200 10 CFR 35.645, 10 CFR 35.2432, 10 CFR 35.2630,                                300
* 10 CFR 35.2632, 10 CFR 35.2642, 10 CFR 35.2643,                              400 10 CFR 35.2645.        ,                                                      500 600
* Criteria: The above regulations contain NRC requirements,                    1000
                                                                            *Special requirements re:
including recordkeeping requirements, for verification and                  brachytherapy and LDR afterloader sources and Sr-90 periodic spot-checks of source activity or output. To perform sources.
these measurements, the applicant must possess appropriately calibrated dosimetry equipment. For manual brachytherapy sources and low dose-rate (LDR) remote afterloader sources, licensees may use source activity or output determined by the manufacturer, provided that the manufacturers measurements meet applicable requirements.
Similar provisions are included in licensing guidance for certain therapy 35.1000 medical uses.
See NRCs web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html) for specific information.
Discussion: Except for manual brachytherapy sources and LDR remote afterloader sources, where the source output or activity is determined by the manufacturer in accordance with 10 CFR Part 35, the applicant must possess a calibrated dosimetry system (e.g., Farmer chamber, electrometer, well-type ionization chamber) that will be used to perform calibration measurements of sealed sources to be used for patient therapy. Dosimetry systems and/or sealed sources used to calibrate the licensees dosimetry systems must be traceable to NIST or to a laboratory accredited by AAPM, pursuant to 10 CFR 35.630. The licensee must maintain records of calibrations of dosimetry equipment for the duration of the license.
The licensees AMP must perform full calibrations of sealed sources and devices used for therapy in accordance with published protocols currently accepted by nationally recognized bodies (e.g., AAPM, ACR, ANSI). (Note: Calibration by an AMP is not required for manual brachytherapy sources, except for calculating the activity of strontium-90 sources.) The licensees AMP or ophthalmic physicist must calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. In addition, the licensee must perform spot-check measurements of sealed sources and devices used for therapy in accordance with written procedures established by the AMP (10 CFR 35.642, 52
 
10 CFR 35.643, and 10 CFR 35.645). If the licensee seeks authorization for a medical use under 35.1000, the licensing guidance on NRCs website (http://www.nrc.gov/materials/miau/med-use-toolkit.html) should be reviewed to determine if calibration and use procedures need to be submitted for that 35.1000 medical use. Calibration procedures described by the AAPM or any published protocol approved by a nationally recognized body, as applicable, may be used.
The calibration procedures should address, in part, the method used to determine the exposure rate (or activity) under specific criteria (i.e., distances used for the measurement, whether the measurement is an in air measurement or done using a phantom configuration of the chamber with respect to the source(s) and device, scatter factors used to compute the exposure rate, etc.).
Full calibrations must be performed before first medical use 1, whenever spot-check measurements (if required) indicate that the output differs by more than 5% from the output obtained at the last full calibration corrected mathematically for decay, following replacement of the sources or reinstallation of the unit in a new location not previously described in the license, following any repairs of the unit that include removal of sealed sources or major repair of the components associated with the source exposure assembly, and at intervals as defined in 10 CFR 35.632, 10 CFR 35.633, and 10 CFR 35.635. Manual brachytherapy sources must be calibrated only initially, prior to use.
For sealed sources used in therapy, and in particular, for new types of use, licensees should select dosimetry equipment that will accurately measure the output or the activity of the source.
Contact a licensing specialist at an NRC Regional Office for additional assistance.
Response from Applicant: Provide the following:
The applicant must provide the procedures required by 10 CFR 35.642, 10 CFR 35.643, and 10 CFR 35.645, if applicable to the license application.
The applicant for a medical use under 35.1000 must provide the procedures for 10 CFR35.642, 10 CFR 35.643, and 10 CFR 35.645 required by 10 CFR 35.12(b)(2) that are described in the licensing guidance posted for that 35.1000 medical use on NRCs website (http://www.nrc.gov/materials/miau/med-use-toolkit.html), or explain why the procedure is not provided.
 
==References:==
 
AAPM Task Group No. 21, A Protocol for the Determination of Absorbed Dose from High Energy Photon and Electron Beams; AAPM Task Group No. 40, Comprehensive QA for Radiation Oncology, AAPM Report No. 54, Stereotactic Radiosurgery; AAPM Task Group No. 56, Code of Practice for Brachytherapy Physics.
1 For brachytherapy sources, first medical use is defined as the first use following the effective date of the revised 10 CFR Part 35, October 24, 2002.
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Copies of these documents and many other documents from AAPM referenced in this guide may be obtained from Medical Physics Publishing (MPP), 4513 Vernon Boulevard, Madison, WI 53705-4964 or ordered electronically from http://www.medicalphysics.org.
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[The following redline additions to Section 8.20 reflect clarifications made to 10 CFR 35.12 for information needed for 10 CFR 35.1000 medical uses, and remind applicants that there are equipment and facility descriptions similar to those for medical uses in 10 CFR 35.300, 35.400, and 35.600 for certain 10 CFR 35.1000 medical uses.]
8.20 ITEM 9: OTHER EQUIPMENT AND                                            Part 35  Applicability 100 FACILITIES 200 Regulations: 10 CFR 20.1101, 10 CFR 20.1801,                                    300 10 CFR 30.33(a)(2), 10 CFR 30.34, 10 CFR 35.12,                                400 10 CFR 35.315, 10 CFR 35.415, 10 CFR 35.457,                                    500 10 CFR 35.615, 10 CFR 35.647, 10 CFR 35.657.                                    600 1000 Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property.
Discussion: The applicant should describe, in Item 9 of the application, other equipment and facilities available for safe use and storage of byproduct material listed in Item 5 of this application. This description should be identified as Attachment 9.4.
The applicant must describe additional facilities and equipment for PET radionuclide and radiopharmaceutical therapy programs to safely receive, use, store, and dispose of radioactive material. The applicant should focus on facilities to be used for radioactive drug therapy administration and patient accommodations (e.g., private room with private bath). The most widely used source of radiopharmaceutical therapy is I-131 sodium iodide. If the radionuclide is administered in volatile liquid form, it is important to place the patient dosage in a closed environment (e.g., a fume hood). Also note there are hazards associated with volatile iodine in pill form; applicants should consider this in establishing their radiological controls. When patients are treated with I-131 sodium iodide, sources of contamination include airborne I-131, urine, perspiration, saliva, and other secretions.
For PET radionuclide use and PET radioactive drug production areas, the applicant should focus on the need for (1) additional shielding, (2) hot cells containing remote handling devices, (3) other remote handling devices that may be needed when handling and storing the higher energy emissions of these materials, and (4) special delivery systems if the applicant prepares its own PET radionuclides or has them delivered by a direct transfer tube or system from a PET radionuclide producer. Applicants synthesizing PET radioactive drugs should also focus on volatility issues and releases.
For teletherapy, GSR, and high dose-rate (HDR) facilities, the licensee shall require any individual entering the treatment room to ensure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels. One method of meeting the requirements of 10 CFR 35.615(c) is a beam-on radiation monitor permanently mounted in each therapy treatment room that is equipped with an emergency power supply separate from the power supply for the therapy unit. Such beam-on monitors can provide a visible indication 55
 
(e.g., flashing light) of an exposed or partially exposed source. Applicants may propose an alternative to a permanently mounted monitor.
Section 10 CFR 35.615(d) requires that, except for LDR units, each licensee shall construct or equip each treatment room so as to permit continuous observation of the patient while the patient is in the treatment room. If a shielded viewing window will be used, the thickness, density, and type of material used should be specified. If a closed-circuit television system (or some other electronic system) will be used to view the patient, the backup system or procedure to be used in case the electronic system malfunctions should be specified, or the applicant must commit to suspending all treatments until the electronic system is repaired and functioning again. The communications system should allow the patient to communicate with the unit operator in the event of medical difficulties. An open microphone system can be used to allow communication without requiring a patient to move to activate controls.
The regulations require adequate equipment and controls to maintain exposures of radiation to workers ALARA and within regulatory limits. Section 10 CFR 35.615(b), in part, requires that each door leading into the treatment room be provided with an electrical interlock system to control the on-off mechanism of the therapy unit. The interlock system must cause the source(s) to be shielded if the door to the treatment room is opened when the source is exposed. The interlock system must also prevent the operator from initiating a treatment cycle unless the treatment room entrance door is closed. Further, the interlock must be wired so that the source(s) cannot be exposed after interlock interruption until the treatment room door is closed and the on-off control for the source(s) is reset at the console.
Due to the unique characteristics of pulsed dose-rate (PDR) remote afterloaders and the lack of constant surveillance of their operation, a more sophisticated alarm system is essential to ensure the patient is protected during treatment. In addition to the above, consider the following:
The PDR device control console is not accessible to unauthorized personnel during treatment.
A primary care provider checks the patient to ensure that the patients device has not been moved, kinked, dislodged, or disconnected.
A more sophisticated interlock/warning system is normally installed for PDR devices. This system should perform the following functions or possess the following characteristics:
    -    The signal from the PDR device and the signal from the room radiation monitor should be connected in such a manner that an audible alarm sounds if the room monitor indicates the presence of radiation and the device indicates a safe or retracted position.
    -    The alarm circuit should also be wired in such a manner that an audible alarm is generated for any device internal error condition that could indicate the unintended extension of the source. This would constitute a circuit that generates the audible alarm when either the source retracted and radiation present or the appropriate internal error condition(s) exists.
    -    The source safe and radiation present signal should also be self-testing. If a source not safe input is received without a corresponding radiation present signal, the circuit 56
 
should generate an interlock/warning circuit failure signal that will cause the source to retract. Reset this circuit manually before attempting to continue treatment.
    -    The audible alarm should be sufficiently loud to be clearly heard by the facilitys responsible device/patient monitoring staff at all times.
    -    No provisions for bypassing this alarm circuit or for permanently silencing the alarm should be made to the circuit as long as the room radiation monitor is indicating the presence of radiation. If any circuitry is provided to mute the audible alarm, such circuitry should not mute the alarm for a period of more than 1 minute. Controls that disable this alarm circuit or provide for silencing the alarm for periods in excess of 1 minute should be prohibited.
If the alarm circuit is inoperative for any reason, licensees should prohibit further treatment of patients with the device until the circuit has been repaired and tested. If the alarm circuit fails during the course of a patient treatment, the treatment in progress may continue as long as continuous surveillance of the device is provided during each treatment cycle or fraction.
Applicants may submit information on alternatives to fixed shielding as part of their facility description. This information must demonstrate that the shielding will remain in place during the course of patient treatment.
For patient rooms where LDR remote afterloader use is planned, neither a viewing nor an intercom system is required. However, the applicant should describe how the patient and device will be monitored during treatment to ensure that the sources and catheter guide tube are not disturbed during treatment and to provide for prompt detection of any operational problems with the LDR device during treatment.
Similar provisions regarding equipment and facilities are included in licensing guidance for certain 35.1000 medical uses. See NRCs web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html) for specific information.
Response from Applicant: Follow the guidance in Section 5.2 to determine if the response to this section includes security-related sensitive information and needs to be marked accordingly.
For PET radionuclide use, PET radioactive drug production, and radiopharmaceutical therapy programs, describe the additional facilities and equipment for these uses.
For manual brachytherapy facilities, provide a description of the emergency response equipment.
For teletherapy, GSR, and remote afterloader facilities, provide a description of the following:
Warning systems and restricted area controls (e.g., locks, signs, warning lights and alarms, interlock systems) for each therapy treatment room; Area radiation monitoring equipment; Viewing and intercom systems (except for LDR units);
57
 
Steps that will be taken to ensure that no two units can be operated simultaneously, if other radiation-producing equipment (e.g., linear accelerator, X-ray machine) is in the treatment room; Methods to ensure that whenever the device is not in use or is unattended, the console keys will be inaccessible to unauthorized persons; and Emergency response equipment.
For 35.1000 medical uses, review the licensing guidance posted for that 35.1000 medical use on NRCs website (http://www.nrc.gov/materials/miau/med-use-toolkit.html), and provide the appropriate descriptions of other equipment and facilities, or explain why the descriptions are not provided.
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[The following redline additions to Section 8.21 remind applicants that there are minor radiation safety program change provisions similar to those in 10 CFR 35.26 for certain 10 CFR 35.1000 medical uses.]
8.21 ITEM 10: RADIATION PROTECTION PROGRAM                                                                          Part 35    Applicability 100 Regulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 30.33,                          200 10 CFR 30.34(e), 10 CF R 35.24, 10 CFR 35.26, 10 CFR 35.610,                        300 10 CFR 35.2024, 10 CFR 35.2026.                                                    400 500 Criteria: The regulations in 10 CFR 20.1101 state that each 600 licensee must develop, document, and implement a Radiation Protection Program commensurate with the scope of the                                        1000 licensed activity. The program must be sufficient to ensure compliance with the provisions of 10 CFR Part 20 regulations. The licensee is responsible for the conduct of all licensed activities and the acts and omissions of individuals handling licensed material. Under 10 CFR 30.34(e), the NRC may incorporate into byproduct materials licenses, at the time of issuance or thereafter, additional requirements and conditions that it deems appropriate or necessary to protect health or to minimize danger to life and property. Licensee managements authorities and responsibilities for the Radiation Protection Program are described in 10 CFR 35.24, while 10 CFR 35.26 sets forth four circumstances in which the licensee may revise its Radiation Protection Program without NRC approval. For example, no NRC approval is required when the revision does not require a license amendment. Applicants for 35.1000 medical uses may apply for license conditions that will permit the licensee to revise its radiation safety program for that 35.1000 medical use to conform to revised licensing guidance posted on NRCs web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html) without additional NRC approvals. The circumstances for this approval are similar to those in 10 CFR 35.26.
Discussion: Applicants/licensees must abide by all applicable regulations, develop, implement, and maintain procedures when required, and/or provide requested information about the proposed Radiation Protection Program during the licensing process. Tables C.1 and C.2 in Appendix C may be helpful in determining what information should be provided when requesting a license. If the licensee has authority for the production of PET radioactive drugs under 10 CFR 30.32(j), the radiation production program must include radiation safety issues associated with this nonmedical use.
Response from Applicant: Respond to subsequent sections of this document regarding Item 10 of the application.
Applicants for 35.1000 medical uses may apply for approval to revise, without further NRC approval, the radiation safety program for that 35.1000 medical use to conform to revised licensing guidance posted on NRCs web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html).
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[The following redline additions to Section 8.22 remind applicants that safety and emergency procedures required in 10 CFR 35.12 may be required for 10 CFR 35.1000 medical uses.]
8.22        ITEM 10: SAFETY PROCEDURES AND                                Part 35    Applicability INSTRUCTIONS                                                      100 200 Regulations: 10 CFR 30.34(j), 10 CFR 35.12(c)(2),                              300 10 CFR 35.610, 10 CFR 35.642, 10 CFR 35.643,                                  400 10 CFR 35.645.                                                                500 600 Criteria: When applying for authorization under                              1000 10 CFR 30.32(j) to produce PET radioactive drugs for noncommercial distribution to other medical use licensees in the consortium, the applicant must develop, document, and implement certain procedures. See Appendix AA for discussion and response from applicant.
Before using materials under 10 CFR 35.600, the applicant must develop, document, submit, and implement written safety procedures for emergency response. Section 10 CFR 35.610 requires, in part, that written procedures be developed, implemented, and maintained for responding to an abnormal situation involving a remote afterloader unit, a teletherapy unit, or a gamma stereotactic radiosurgery unit. The procedures needed to meet 10 CFR 35.610 must include:
Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions, The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure, and The names and telephone numbers of AUs, AMPs, and the RSO to be contacted if the unit or console operates abnormally.
A copy of these procedures must be physically located at the therapy unit console. The instructions must inform the operator of procedures to be followed if the operator is unable to place the source(s) in the shielded position, or remove the patient from the radiation field with controls from outside the treatment room.
Before using materials under certain 35.1000 medical uses, the applicant must develop, document, submit, and implement written safety procedures for emergency responses. The licensing guidance on NRCs web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html) for 35.1000 medical uses provides specific information for each 35.1000 medical use.
Discussion: The applicant must establish and follow written procedures for emergencies that may occur (e.g., a therapy source fails to retract or return to the shielded position, or a GSR couch fails to retract). A copy of the manufacturers recommendations and instructions should be given to each individual performing therapy treatments or operating the therapy device.
60
 
Practice drills, using nonradioactive (dummy) sources (when possible), must be practiced annually or more frequently, as needed. The drills should include dry runs of emergency procedures that cover stuck or dislodged sources and applicators (if applicable), and emergency procedures for removing the patient from the radiation field. Team practice may also be important for adequate emergency coordination for such maneuvers as removing a patient from a malfunctioning GSR unit and manual movement of the patient treatment table. These procedures, designed to minimize radiation exposure to patients, workers, and the general public, should address the following points, as applicable to the type of medical use:
When the procedures are to be implemented, such as any circumstance in which the source becomes dislodged, cannot be retracted to a fully shielded position, or the patient cannot be removed from the beam of radiation.
The actions specified for emergency source recovery or shielding that primarily consider minimizing exposure to the patient and health care personnel while maximizing the safety of the patient.
The step-by-step actions for single or multiple failures that specify the individual(s) responsible for implementing the actions. The procedures should clearly specify which steps are to be taken under different scenarios. The procedure should specify situations in which surgical intervention may be necessary and the steps that should be taken in that event.
Location of emergency source recovery equipment, specifying what equipment may be necessary for various scenarios. Emergency equipment should include shielded storage containers, remote handling tools, and if appropriate, supplies necessary to surgically remove applicators or sources from the patient and tools necessary for removal of the patient from the device.
Radiation safety priorities, such as giving first consideration to minimizing exposure to the patient, usually by removing the patient from the room (rather than using tools to attempt to return the source to the off position). Note: If the first step of the emergency procedures for teletherapy units specifies pressing the emergency bar on the teletherapy unit console, the applicant is advised that this action may cause the source to return to the off position but may also cut power to the entire teletherapy unit or to the gantry or the couch.
Instructing the staff to act quickly and calmly, and to avoid the primary beam of radiation.
Specifying who is to be notified.
Requirements to restrict (lock, as necessary) and post the treatment area with appropriate warning signs as soon as the patient and staff are out of the treatment room.
Response from Applicant:
Provide procedures required by 10 CFR 35.610.
See Appendix AA for responses required by 10 CFR 30.32(j).
If appropriate, review 35.1000 medical use licensing guidance on NRCs website (http://www.nrc.gov/materials/miau/med-use-toolkit.html), and provide safety and emergency procedures requested for the particular 35.1000 medical use, or describe why the procedures are not needed.
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[The following redline/strikeout revisions to Section 8.27 reflect changes to 35.655 that extend the time for full-inspection servicing for gamma stereotactic radiosurgery units to 7 years and reminds applicants that similar inspection and servicing requirements may apply to certain 10 CFR 35.1000 medical uses.]
8.27      ITEM 10: INSTALLATION, MAINTENANCE, ADJUSTMENT, REPAIR, AND INSPECTION OF THERAPY DEVICES CONTAINING SEALED SOURCES                                                          Part 35    Applicability Regulations: 10 CFR 20.1101, 10 CFR 30.32, 10 CFR 30.34,                    100 10 CFR 35.605, 10 CFR 35.655, 10 CFR 35.2605,                                200 10 CFR 35.2655.                                                              300 400 Criteria: In accordance with 10 CFR 35.605 and 10 CFR 35.655,                500 licensees must ensure that therapy devices containing sealed                600 sources are installed, maintained, adjusted, repaired, and inspected        1000 by persons specifically licensed to conduct these activities. The above activities should be conducted according to the manufacturers written recommendations and instructions and according to the SSDR. In addition, 10 CFR 35.655 requires that teletherapy and GSR units be fully inspected and serviced during source replacement. The interval between each full-inspection servicing shall not exceedor at intervals not to exceed 5 years for teletherapy units and 7 years for gamma stereotactic radiosurgery units, whichever comes first, to ensure that the source exposure mechanism and other safety components functions properly. Maintenance is necessary to ensure that the device functions as designed, and source integrity and safety components are is not compromised and that the device functions as designed. Similar provisions are included in licensing guidance for certain therapy 35.1000 medical uses. See NRCs web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html) for specific information.
Discussion: Maintenance and repair includes installation, replacement, and relocation or removal of the sealed source(s) or therapy unit that contains a sealed source(s). Maintenance and repair also includes any adjustment involving any mechanism on the therapy device, treatment console, or interlocks that could expose the source(s), reduce the shielding around the source(s), affect the source drive controls, or compromise the radiation safety of the unit or the source(s).
The NRC requires that maintenance and repair (as defined above) be performed only by persons specifically licensed by NRC or an Agreement State to perform such services. Most licensee employees do not perform maintenance and repair because they do not have the specialized equipment and technical expertise to perform these activities. Applicants requesting authorization to possess and use LDR remote afterloaders should review 10 CFR 35.605 before 62
 
responding to this item. Section 10 CFR 35.605 allows for an AMP to perform certain service activities with regard to LDR remote afterloader units.
Response from Applicant: No response is necessary if the licensee contracts with personnel who are licensed by NRC or an Agreement State to install, maintain, adjust, repair, and inspect the specific therapy device possessed by the licensee. However, if the applicant requests that an employee who is trained by the manufacturer be authorized to perform the aforementioned activities, the applicant must provide sufficient information to allow the NRC to evaluate and approve such authorization (see CFR 35.605 and 10 CFR 35.655). This should include the following:
Name of the proposed employee and types of activities requested, AND Description of the training and experience demonstrating that the proposed employee is qualified by training and experience for the use requested, AND Copy of the manufacturers training certification and an outline of the training in procedures to be followed.
Note: The applicant should specify only those installation, maintenance, inspection, adjustment, and repair functions, as described in a certificate or letter from the manufacturer of the device, that document the employees training in the requested function(s).
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[The following redline addition to Section 9 reflects changes to 10 CFR 35.13 requiring a licensee to amend the license before permitting an individual to work as an ARSO or before assigning a current ARSO to oversee a new section of the radiation protection program.]
9      AMENDMENTS AND RENEWALS TO                                          Part 35  Applicability 100 A LICENSE                                                              200 300 Regulations: 10 CFR 30.37, 10 CFR 30.38, 400 10 CFR 35.13.
500 The NRC now has regulatory authority over sealed sources                      600 and devices containing accelerator-produced radioactive                      1000 material and discrete sources of Ra-226, under the new definition of byproduct material resulting from the EPAct.
Licensees may need license amendments for such purposes as to authorize use of these materials, to revise their Radiation Safety Programs to meet new requirements, or to provide new facility diagrams. The NRC issued a waiver on August 31, 2005, that permitted licensees to continue to use the newly defined byproduct material until the waiver was terminated on August 8, 2009. Licensees in Government agencies, Federally recognized Indian tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana who possess and use accelerator-produced radioactive material or discrete sources of Ra-226, or both, may continue to use these materials for medical use or prepare PET radioactive drugs for noncommercial distribution to other consortium members until the date of NRCs final licensing determination, provided the licensee submits an amendment application within 6 months after November 30, 2007. Other licensees should check with the appropriate NRC Regional Office to determine when they have to submit their license amendments.
Licensees are responsible for applying for amendments to licenses and for keeping them up-to-date. Furthermore, to continue a license after its expiration date, the licensee must submit an application for a license renewal at least 30 days before the expiration date (10 CFR 2.109, 10 CFR 30.36(a)).
Under 10 CFR 35.13, a licensee is required to apply for and receive a license amendment before several activities can occur, including:
Receipt or use of byproduct material for a type of use permitted by 10 CFR Part 35, but not authorized on the licensees current Part 35 license; Permitting anyone to work as an AU for medical uses, AMP, ophthalmic physicist, or ANP, unless the individual meets one of the exceptions listed in 10 CFR 35.13(b). (information required to document training and experience may be provided on the appropriate NRC Form 313A series of forms for change or addition of AU for medical uses, AMP, ophthalmic physicist, ANP, or RSO, or ARSOs);
Changing the RSO; 64
 
Permitting an individual to work as an ARSO, or before the RSO assigns a current ARSO duties and tasks in the oversight for a new section of the radiation protection program.
Receiving byproduct material in excess of the amount, or receiving radionuclides or forms different than, currently authorized on the NRC license; Changing an area or address of use identified in the application or on the license. This includes additions and relocations of areas where PET radionuclides are produced or additions or relocations of a radionuclide delivery line from the PET radionuclide production area to a 10 CFR 35.100 or 10 CFR 35.200 medical use area. However, other changes and additions to the 10 CFR 35.100 and 10 CFR 35.200 medical use area do not require a license amendment and can be made, provided NRC is notified as required by 10 CFR 35.14 within 30 days following the changes, and Revising procedures required by 10 CFR 35.610, 35.642, 35.643, and 35.645, when the revision reduces the level of radiation safety.
Receiving a sealed source from a different manufacturer or of a different model number than authorized by the license unless the sealed source is used in manual brachytherapy, is listed in the SSDR, for the quantity and for an isotope authorized by the license.
In case of a medical emergency requiring an expedited license amendment, contact the materials licensing staff at the appropriate NRC Regional Office.
For both renewal and amendment requests, applicants should do the following:
Use the most recent guidance in preparing an amendment or renewal request, Submit in duplicate either an NRC Form 313 or a letter requesting an amendment or renewal, and Provide the license number.
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APPENDIX B NRC Form 313A Series Medical Use Training and Experience and Preceptor Attestation
[The most current revisions to the NRC Form 313A series may be found at:
http://www.nrc.gov/reading-rm/doc-collections/forms/#NRC. Copies of the versions of the forms that conform to the final rule amending 10 CFR Part 35 in 2016 are provided below.]
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NRC FORM 313A (AMP)                                  U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0120 (MM-YYYY)                                                                                      EXPIRES: (MM/DD/YYYY)
AUTHORIZED MEDICAL PHYSICIST OR OPHTHALMIC PHYSICIST, TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
[10 CFR 35.51, 35.57(a)(3), and 35.433]
Name of Individual                                                    Authorized Medical Physicist Ophthalmic Physicist (go to Page 4)
Requested                35.400 Ophthalmic use of strontium-90        35.600 Teletherapy unit(s)
Authorization(s)
(check all that apply)          35.600 Remote afterloader unit(s)            35.600 Gamma stereotactic radiosurgery unit(s)
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
*Training and Experience, including Board Certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.
AUTHORIZED MEDICAL PHYSICIST
: 1. Board Certification
: a. Provide a copy of the board certification.
: b. If the board certification process has been recognized by the Commission or an Agreement State under 10 CFR 35.51:
(i) Go to the table in 3.c. and describe training provider and dates of training for each type of use for which authorization is sought.
(ii) Stop here.
: c. If the board certification was issued on or before October 24, 2005 and is listed in 10 CFR 35.57(a)(3), attach:
(i)  Documentation that the individual performed each use checked above on or before October 24, 2005.
(ii) Dates, duration, and description of continuing education and experience within the past seven years for each use checked above.
(iii) Stop here.
: 2. Current Authorized Medical Physicist Seeking Additional Authorization for use(s) checked above
: a. Go to the table in section 3.c. to document training for new device.
: b. If not board certified skip to and complete Part II Preceptor Attestation.
: c. If board certified, stop here.
: 3. Education, Training, and Experience for Proposed Authorized Medical Physicist
: a. Education: Document master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university.
Degree                                                      Major Field College or University
: b. Supervised Full-Time Medical Physics Training and Work Experience 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.
Yes. Completed 1 year of full-time training in medical physics (for areas identified below) under the supervision of                                          who meets the requirements for an Authorized Medical Physicist.
AND Yes. Completed 1 year of full-time work experience in medical physics (for areas identified below) under the supervision of                                              who meets the requirements for an Authorized Medical Physicist.
NRC FORM 313A (AMP) (MM-YYYY)                                                                                              67
 
NRC FORM 313A (AMP)                                                                                        U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED MEDICAL PHYSICIST OR OPHTHALMIC PHYSICIST, TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
[10 CFR 35.51, 35.57(a)(3), and 35.433] (continued)
: 3. Education, Training, and Experience for Proposed Authorized Medical Physicist (continued)
: b. Supervised Full-Time Medical Physics Training and Work Experience (continued)
If more than one supervising individual is necessary to document supervised training, provide multiple copies of this page.
Description of Training/                Location of Training/License or Permit Number                  Dates of      Dates of Work Experience                        of Training Facility/Medical Devices Used+                  Training*        Experience*
Medical Physics Performing sealed source leak tests and inventories Performing decay corrections Performing full calibration and periodic spot checks of external beam treatment unit(s)
Performing full calibration and periodic spot checks of stereotactic radiosurgery unit(s)
Performing full calibration and periodic spot checks of remote afterloading unit(s)
Conducting radiation surveys around external beam treatment unit(s), stereotactic radiosurgery unit(s), remote after loading unit(s)
Supervising Individual**                                                    License/Permit Number listing supervising individual as an authorized Medical Physicist for the following types of use:
Remote afterloader unit(s)                      Teletherapy unit(s)                      Gamma stereotactic radiosurgery unit(s)
      + Training and work experience must be conducted 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.
* 1 year of Full-time medical physics training and 1 year of full time work experience cannot be concurrent.
      ** If the supervising medical physicist is not an authorized medical physicist, the licensee must submit evidence that the supervising medical physicist meets the training and experience requirements in 10 CFR 35.51 and 35.59 for the types of use for which the individual is seeking authorization.
NRC FORM 313A (AMP) (MM-YYYY)                                                                                                                      68
 
NRC FORM 313A (AMP)                                                                                                        U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED MEDICAL PHYSICIST OR OPHTHALMIC PHYSICIST, TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
[10 CFR 35.51, 35.57(a)(3), and 35.433] (continued)
: 3. Education, Training, and Experience for Proposed Authorized Medical Physicist (continued)
: c. Describe training provider and dates of training for each type of use for which authorization is sought.
Description                                                                      Training Provider and Dates of Training Gamma Stereotactic Remote Afterloader                                  Teletherapy Radiosurgery Hands-on device operation Safety procedures for the device use Clinical use of the device Treatment planning system operation Supervising Individual If training is provided by Supervising Medical Physicist, (If more than one supervising License/Permit Number listing supervising individual as an authorized individual is necessary to document supervised training, provide multiple copies of Medical  Physicist this page.)
for the following types of use:
Remote afterloader unit(s)                                    Teletherapy unit(s)                  Gamma stereotactic radiosurgery unit(s)
Authorization Sought                                      Device                          Training Provided By              Dates of Training 35.400 Ophthalmic Use of strontium-90
: d. Skip to and complete Part II Preceptor Attestation.
NRC FORM 313A (AMP) (MM-YYYY)                                                                                                                                  69
 
NRC FORM 313A (AMP)                                                                    U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED MEDICAL PHYSICIST OR OPHTHALMIC PHYSICIST, TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
[10 CFR 35.51, 35.57(a)(3), and 35.433] (continued)
: 4. Education, Training, and Experience for Proposed Ophthalmic Physicist
: a. Complete the table below to document education; Degree                                                    Major Field College or University
: b. Supervised Full-Time practical training and experience in medical physics Yes. Completed 1 year of full-time training in medical physics under the supervision of medical physicist at AND Yes. Completed 1 year of full-time work experience in medical physics at under the supervision of                                                          medical physicist.
If more than one supervising individual is necessary to document supervised training, provide multiple copies of this page.
: c. Complete the table below to document training and supervised work experience.
Location of Training/License or Permit Number                Dates of Description of Training of Training Facility                          Training*
The creating, modifying, and completing of written directives.
Procedures for administrations requiring a written directive Performing the calibration measurements of brachytherapy sources as detailed in 10 CFR 35.432 Supervising Individual                                    License/Permit Number
: d. Stop here NRC FORM 313A (AMP) (MM-YYYY)                                                                                              70
 
NRC FORM 313A (AMP)                                                                                  U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED MEDICAL PHYSICIST OR OPHTHALMIC, TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
[10 CFR 35.51, 35.57(a)(3), and 35.433] (continued)
PART II - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.
First Section Complete the following:
I attest that                                                    has satisfactorily completed the 1-year of full-time Name of Proposed Authorized Medical Physicist training in medical physics and an additional year of full-time work experience as required by 10 CFR 35.51(b)(1).
AND Second Section Complete the following:
I attest that                                                    has training for the types of use for which authorization Name of Proposed Authorized Medical Physicist is sought that include hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system.
AND Third Section Complete the following:
I attest that                                                    is able to independently fulfill the radiation safety-related Name of Proposed Authorized Medical Physicist duties as an Authorized Medical Physicist for the following:
35.400 Ophthalmic use of strontium-90                    35.600 Teletherapy unit(s) 35.600 Remote afterloader unit(s)                        35.600    Gamma stereotactic radiosurgery unit(s)
AND Fourth Section Complete the following for preceptor attestation and signature:
I meet the requirements in 10 CFR 35.51, 35.57, or equivalent Agreement State requirements for Authorized medical physicist for the following:
35.400 Ophthalmic use of strontium-90                    35.600 Teletherapy unit(s) 35.600 Remote afterloader unit(s)                        35.600    Gamma stereotactic radiosurgery unit(s)
Name of Facility:                                                                        License/Permit Number:
Name of Preceptor (Typed or Printed)                                                                    Telephone Number        Date Signature NRC FORM 313A (AMP) (MM-YYYY)                                                                                                              71
 
NRC FORM 313A (ANP)                                    U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED NUCLEAR PHARMACIST TRAINING,                                  APPROVED BY OMB: NO. 3150-EXPERIENCE, AND PRECEPTOR ATTESTATION                                    0120 EXPIRES: (MM/DD/YYYY)
[10 CFR 35.55]
Name of Proposed Authorized Nuclear Pharmacist                    State or Territory Where Licensed PART I -- TRAINING AND EXPERIENCE (Select one of the two methods below)
* Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the nuclear pharmacy uses.
: 1. Board Certification
: a. Provide a copy of the board certification.
: 2. Structured Educational Program for Proposed Authorized Nuclear Pharmacist
: a. Classroom and Laboratory Training.
Description of Training                      Location of Training                  Clock        Dates of Hours        Training*
Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Chemistry of byproduct material for medical use Radiation biology Total Hours of Training:
NRC FORM 313A (ANP) (MM-YYYY)                                                                                              72
 
NRC FORM 313A (ANP)                                                                  U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED NUCLEAR PHARMACIST TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION [10 CFR 35.55] (continued)
: 2. Structured Educational Program for Proposed Authorized Nuclear Pharmacist (continued)
: b. Supervised Practical Experience in a Nuclear Pharmacy.
Description of Experience              Location of Experience/License or          Clock      Dates of Permit Number of Facility            Hours    Experience*
Shipping, receiving, and performing related radiation surveys Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha-or beta-emitting radionuclides Calculating, assaying, and safely preparing dosages for patients or human research subjects Using administrative controls to avoid medical events in administration of byproduct material Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures Total Hours of Experience:
Supervising Individual
: c. Go to and complete Part II Preceptor Attestation.
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NRC FORM 313A (ANP)                                                                                    U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED NUCLEAR PHARMACIST TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION [10 CFR 35.55] (continued)
PART II - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.
First Section Complete the following:
Structured Educational Program I attest that                                                      has satisfactorily completed a 700-hour structured Name of Proposed Authorized Nuclear Pharmacist educational program consisting of both 200 hours of classroom and laboratory training, and practical experience in nuclear pharmacy, as required by 10 CFR 35.55(b)(1) and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.
Second Section Complete the following for preceptor attestation and signature:
I am an Authorized Nuclear Pharmacist for                                                                            ,
Nuclear Pharmacy or Medical Facility
                                                .
License/Permit Number Name of Preceptor                                  Signature                                          Telephone Number      Date 74
 
NRC FORM 313A (AUD)                                    U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0120 (MM-YYYY)                                                                                          EXPIRES: (MM/DD/YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590]
Name of Proposed Authorized User                                  State or Territory Where Licensed Requested Authorization(s) (check all that apply) 35.100 Uptake, dilution, and excretion studies            35.200 Imaging and localization studies Generator elution for 35.300 AU 35.500 Sealed sources for diagnosis (specify device)
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
* Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.
: 1. Board Certification
: a. Provide a copy of the board certification.
: b. For a board certification issued on or before October 24, 2005 that is listed in 10 CFR 35.57(b)(2)(i), provide the following:
(i)    Documentation that the individual performed each use checked above on or before October 24, 2005.
(ii)  Dates, duration, and description of continuing education and experience within the past seven years for each use checked above.
(iii) Stop here.
: 2. Current 35.390 Authorized User Seeking Additional 35.290(c)(1)(ii)(6) Authorization
: a. Authorized user on Materials License                              meeting 10 CFR 35.390, 10 CFR 35.57 for 35.300 uses, or equivalent Agreement State requirements seeking authorization for 35.290.
: b. Supervised Work Experience.
(If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.)
Location of Experience/License or                Clock          Dates of Description of Experience Permit Number of Facility                  Hours        Experience*
Eluting generator systems appropriate for the preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs Total Hours of Experience:
License/Permit Number listing supervising individual as an Supervising Individual authorized user Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply).
35.290          35.390 + generator experience in 35.290(c)(1)(ii)(G)            35.57 for 35.200 uses 75
 
NRC FORM 313A (AUD)                                                                  U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590](continued)
: 3. Training and Experience for Proposed Authorized User
: a. Classroom and Laboratory Training.
Location of Training                  Clock      Dates of Description of Training Hours      Training*
Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Chemistry of byproduct material for medical use (not required for 35.590)
Radiation biology Total Hours of Training:
: b. Supervised Work Experience (completion of this table is not required for 35.590).
(If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.)
Total Hours of Supervised Work Experience Experience:
Description of Experience              Location of Experience/License or                      Dates of Confirm Must Include:                        Permit Number of Facility                        Experience*
Ordering, receiving, and unpacking                                                            Yes radioactive materials safely and performing the related radiation                                                              No surveys Performing quality control Yes procedures on instruments used to determine the activity of dosages                                                            No and performing checks for proper operation of survey meters 76
 
NRC FORM 313A (AUD)                                                                    U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590](continued)
: 3. Training and Experience for Proposed Authorized User (continued)
: b. Supervised Work Experience. (continued)
Description of Experience              Location of Experience/License or                                Dates of Confirm Must Include:                        Permit Number of Facility                                Experience*
Calculating, measuring, and safely                                                                Yes preparing patient or human research No subject dosages Using administrative controls to                                                                  Yes prevent a medical event involving the use of unsealed byproduct material                                                                No Using procedures to contain spilled                                                                Yes byproduct material safely and using proper decontamination procedures                                                                  No Administering dosages of radioactive                                                              Yes drugs to patients or human research subjects                                                                                          No Eluting generator systems appropriate                                                              Yes for the preparation of radioactive drugs for imaging and localization                                                                No studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs License/Permit Number listing supervising individual as an Supervising Individual authorized user or an authorized nuclear pharmacist Supervisor meets the requirements below, or equivalent Agreement State requirements (check one).
35.190        35.290        35.390      35.390 + generator experience in 35.290(c)(1)(ii)(G) 35.55        35.57 for 35.200 uses
: c. For 35.590 only, provide documentation of training on use of the device.
Device                        Type of Training                              Location and Dates d.
For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part II Preceptor Attestation.
77
 
NRC FORM 313A (AUD)                                                                                    U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590](continued)
PART II - PRECEPTOR ATTESTATION Note:    This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each. (Not required to meet training requirements in 35.590)
By checking the boxes below, the preceptor is not attesting to the individual's "general clinical competency."
First Section Check one of the following for each use requested:
For 35.190 I attest that                                                has satisfactorily completed the 60 hours of training and Name of Proposed Authorized User experience, including a minimum of 8 hours of classroom and laboratory training, required by 10 CFR 35.190(c)(1),
and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 10 CFR 35.100.
For 35.290 I attest that                                                has satisfactorily completed the 700 hours of training Name of Proposed Authorized User and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 CFR 35.290 (c)(1), and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses under 10 CFR 35.100 and 35.200.
Second Section Complete one of the following for attestation and signature:
Authorized User:
I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:
35.190          35.290            35.390          35.390 + generator experience              35.57 for 35.200 uses OR Residency Program Director:
I affirm that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements below or equivalent Agreement State requirements for:
35.190          35.290            35.390          35.390 + generator experience              35.57 for 35.200 uses I affirm that this facility member concurs with the attestation I am providing as program director.
I affirm that the residency training program is approved by the:
Residency Review Committee of the Accreditation Council for Graduate Medical Education Royal College of Physicians and Surgeons of Canada Committee on Post-Graduate Training of the American Osteopathic Association I affirm that the residency training program includes training and experience specified in:
35.190(c)(1)              35.290(c)(1)
Name of Facility:                                                                      License/Permit Number:
Name of Preceptor or Residency Program Director (Typed or Printed)                                      Telephone Number        Date Signature 78
 
NRC FORM 313A (AUS)                                  U. S. NUCLEAR REGULATORY COMMISSION          APPROVED BY OMB: NO. 3150-0120 (MM-YYYY)                                                                                          EXPIRES: (MM/DD/YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690]
Name of Proposed Authorized User                                  State or Territory Where Licensed 35.400 Manual brachytherapy sources            35.600 Teletherapy unit(s)
Requested Authorization(s)                  35.400 Ophthalmic use of strontium-90          35.600 Gamma stereotactic radiosurgery unit(s)
(check all that apply) 35.600 Remote afterloader unit(s)
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
*Training and Experience, including Board Certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.
: 1. Board Certification
: a. Provide a copy of the board certification.
: b. For 35.690, go to the table in 3.e. and describe training provider and dates of training for each type of use for which authorization is sought.
: c. For a board certification issued on or before October 24, 2005, that is listed in 10 CFR 35.57(b)(2)(iii),
provide the following:
(i)    Documentation that the individual performed each use checked above on or before October 24, 2005.
(ii)  Dates, duration, and description of continuing education and experience within the past seven years for each use checked above.
(iii) Stop here.
: 2. Current 35.600 Authorized User Requesting Additional Authorization for 35.600 Use(s) Checked Above
: a. Go to the table in section 3.e. to document training for new device.
: b. If board certified stop here. If not board certified, provide completed Part II Preceptor Attestation.
: 3. Training and Experience for Proposed Authorized User
: a. Classroom and Laboratory Training            35.490              35.491              35.690 Description of Training                                                                Clock        Dates of Location of Training Hours        Training*
Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Radiation biology Total Hours of Training:
NRC FORM 313A (AUS) (MM-YYYY)                                                                                                  79
 
NRC FORM 313A (AUS)                                                                U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
: 3. Training and Experience for Proposed Authorized User (continued)
: b. Supervised Work and Clinical Experience for 10 CFR 35.490 (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this page.)
Supervised Work Experience                          Total Hours of Experience:
Description of Experience          Location of Experience/License or              Confirm          Dates of Must Include:                    Permit Number of Facility                                  Experience*
Ordering, receiving, and                                                                    Yes unpacking radioactive materials safely and performing the related                                                            No radiation surveys Yes Checking survey meters for proper operation                                                                            No Yes Preparing, implanting, and safely removing brachytherapy sources                                                              No Maintaining running inventories                                                              Yes of material on hand                                                                          No Using administrative controls to                                                            Yes prevent a medical event involving the use of byproduct                                                              No material Yes Using emergency procedures to control byproduct material                                                                  No Clinical experience in radiation Location of Experience/License or                        Dates of oncology as part of an approved Permit Number of Facility                          Experience*
formal training program Approved by:
Residency Review Committee for Radiation Oncology of the ACGME Royal College of Physicians and Surgeons of Canada Committee on Postdoctoral Training of the American Osteopathic Association Supervising Individual                                  License/Permit Number listing supervising individual as an Authorized User NRC FORM 313A (AUS) (MM-YYYY)                                                                                            80
 
NRC FORM 313A (AUS)                                                                  U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
: 3. Training and Experience for Proposed Authorized User (continued)
: c. Supervised Clinical Experience for 10 CFR 35.491 Location of Experience/License or                Clock            Dates of Description of Experience Permit Number of Facility                    Hours          Experience*
Use of strontium-90 for ophthalmic treatment, including:
examination of each individual to be treated; calculation of the dose to be administered; administration of the dose; and follow up and review of each individual's case history Supervising Individual                                    License/Permit Number listing supervising individual as an Authorized User
: d. Supervised Work and Clinical Experience for 10 CFR 35.690 Remote afterloader unit(s)            Teletherapy unit(s)        Gamma stereotactic radiosurgery unit(s)
Supervised Work Experience                                        Total Hours of Experience:
Description of Experience            Location of Experience/License or                                Dates of Confirm Must Include:                    Permit Number of Facility                                  Experience*
Reviewing full calibration                                                                    Yes measurements and periodic                                                                    No spot-checks Preparing treatment plans and                                                                Yes calculating treatment doses and No times Using administrative controls to                                                              Yes prevent a medical event involving the use of byproduct                                                                No material Implementing emergency                                                                        Yes procedures to be followed in the event of the abnormal operation                                                              No of the medical unit or console Yes Checking and using survey meters                                                                                        No Yes Selecting the proper dose and how it is to be administered                                                                  No NRC FORM 313A (AUS) (MM-YYYY)                                                                                            81
 
NRC FORM 313A (AUS)                                                                              U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
: 3. Training and Experience for Proposed Authorized User                        (continued)
: d. Supervised Work and Clinical Experience for 10 CFR 35.690 (continued)
Clinical experience in radiation Location of Experience/License or                            Dates of oncology as part of an approved Permit Number of Facility                              Experience*
formal training program Approved by:
Residency Review Committee for Radiation Oncology of the ACGME Royal College of Physicians and Surgeons of Canada Committee on Postdoctoral Training of the American Osteopathic Association Supervising Individual                                                License/Permit Number listing supervising individual as an Authorized User
: e. For 35.600, describe training provider and dates of training for each type of use for which authorization is sought.
Description Training Provider and Dates of Training Gamma Stereotactic Remote Afterloader                          Teletherapy                        Radiosurgery Device operation Safety procedures for the device use Clinical use of the device Supervising Individual. (If training provided by Supervising      License/Permit Number listing supervising individual as an Individual (If more than one supervising individual is necessary  Authorized User to document supervised work experience, provide multiple copies of this page.)
Authorized for the following types of use:
Remote afterloader unit(s)                        Teletherapy unit(s)            Gamma stereotactic radiosurgery unit(s)
: f. Provide completed Part II Preceptor Attestation.
NRC FORM 313A (AUS) (MM-YYYY)                                                                                                        82
 
NRC FORM 313A (AUS)                                                                            U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.57, 35.490, 35.491, and 35.690] (continued)
PART II - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.
By checking the boxes below, the preceptor is attesting that the individual has knowledge to fulfill the duties of the position sought and not attesting to the individual's "general clinical competency."
First Section Check one of the following for each requested authorization:
For 35.490:
I attest that                                              has satisfactorily completed the 200 hours of Name of Proposed Authorized User classroom and laboratory training, 500 hours of supervised work experience, and 3 years of supervised clinical experience in radiation oncology, as required by 10 CFR 35.490(b)(1) and (b)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under 10 CFR 35.400.
For 35.491:
I attest that                                                has satisfactorily completed the 24 hours of Name of Proposed Authorized User classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy, has used strontium-90 for ophthalmic treatment of 5 individuals, as required by 10 CFR 35.491(b), and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.
Second Section For 35.690:
I attest that                                                has satisfactorily completed 200 hours of classroom Name of Proposed Authorized User and laboratory training, 500 hours of supervised work experience, and 3 years of supervised clinical experience in radiation therapy, as required by 10 CFR 35.690(b)(1) and (b)(2).
AND Third Section For 35.690: (continued)
I attest that                                              has received training required in 35.690(c) for device Name of Proposed Authorized User operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought, as checked below.
Remote afterloader unit(s)          Teletherapy unit(s)        Gamma stereotactic radiosurgery unit(s)
AND NRC FORM 313A (AUS) (MM-YYYY)                                                                                                  83
 
NRC FORM 313A (AUT)                                      U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE, AND                                  APPROVED BY OMB: NO. 3150-0120 PRECEPTOR ATTESTATION                                      EXPIRES: (MM/DD/YYYY)
(for uses defined under 35.300)
[10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396]
Name of Proposed Authorized User                                    State or Territory Where Licensed Requested Authorization(s) (check all that apply):
35.300    Use of unsealed byproduct material for which a written directive is required OR 35.300    Oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) 35.300    Oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries) 35.300    Parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or for its photon energy of less than 150 keV, for which a written directive is required PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
* Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.
: 1. Board Certification
: a. Provide a copy of the board certification.
: b. For 35.390, provide documentation on supervised case experience. The table in section 3.c. may be used to document this experience.
: c. For 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Skip to and complete Part II Preceptor Attestation.
: d. For a board certification issued on or before October 24, 2005 that is listed in 10 CFR 35.57(b)(2)(ii), provide the following:
(i)    Documentation that the individual performed each use checked above on or before October 24, 2005.
(ii)  Dates, duration, and description of continuing education and experience within the past seven years for each use checked above.
: e. Stop here.
: 2. Current 35.300, 35.400, or 35.600 Authorized User Seeking Additional Authorization
: a. Authorized User on Materials License                                                  under the requirements below or equivalent Agreement State requirements (check all that apply):
35.390              35.392            35.394              35.490              35.690
: b. If currently authorized for a subset of clinical uses under 35.300, provide documentation on additional required supervised case experience. The table in section 3.c. may be used to document this experience. If board certified stop here. If not board certified, provide completed Part II Preceptor Attestation.
: c. If currently authorized under 35.490 or 35.690 and requesting authorization for 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation.
84
 
NRC FORM 313A (AUT)                                                                          U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)
: 3. Training and Experience for Proposed Authorized User
: a. Classroom and Laboratory Training              35.390              35.392              35.394              35.396 Description of Training                                                                            Clock            Dates of Location of Training Hours            Training*
Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Chemistry of byproduct material for medical use Radiation biology Total Hours of Training:
: b. Supervised Work Experience                    35.390              35.392              35.394              35.396 (If more than one supervising individual is necessary to document supervised training, provide multiple copies of this page.)
Supervised Work Experience                            Total Hours of Experience:
Description of Experience                Location of Experience/License or                                    Dates of Confirm Must Include:                            Permit Number of Facility                                      Experience*
Ordering, receiving, and Yes unpacking radioactive materials safely and performing the                                                                            No related radiation surveys Performing quality control procedures on instruments                                                                            Yes used to determine the activity of dosages and performing                                                                            No checks for proper operation of survey meters Calculating, measuring, and                                                                          Yes safely preparing patient or human research subject                                                                              No dosages Using administrative controls to                                                                      Yes prevent a medical event involving the use of unsealed                                                                        No byproduct material Using procedures to contain                                                                          Yes spilled byproduct material safely and using proper                                                                              No decontamination procedures 85
 
NRC FORM 313A (AUT)                                                                              U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)
: 3. Training and Experience for Proposed Authorized User (continued)
: b. Supervised Work Experience (continued)
License/Permit Number listing supervising individual as an Supervising Individual authorized user Supervising individual meets the requirements below, or equivalent Agreement State requirements (check all that apply)**:
35.390        With experience administering dosages of:
35.392            Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) 35.394            Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries) 35.396 Parenteral administration of any radionuclide that is primarily used for its beta radiation 35.57              characteristics, alpha radiation characteristics, or for its photon energy of less than 150keV, for which a written directive is required
  ** Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.
: c. Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this page.
Number of Cases Location of Experience/License or Permit                Dates of Description of Experience              Involving Personal Number of Facility                      Experience*
Participation Oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)
Oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)
Parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required 86
 
NRC FORM 313A (AUT)                                                                          U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)
: 3. Training and Experience for Proposed Authorized User (continued)
: c. Supervised Clinical Case Experience (continued)
License/Permit Number listing supervising individual as an Supervising Individual authorized user Supervising individual meets the requirements below, or equivalent Agreement State requirements (check all that apply)**:
35.390        With experience administering dosages of:
Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 35.392 gigabecquerels (33 millicuries) 35.394            Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries) 35.396            Parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or for its photon energy of less than 150 35.57              keV, for which a written directive is required
    ** Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.
: d. Provide completed Part II Preceptor Attestation.
PART II - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.
By checking the boxes below, the preceptor is not attesting to the individual's "general clinical competency."
First Section Check one of the following for the requested authorization:
For 35.390:
I attest that                                            has satisfactorily completed the 700 hours of training Name of Proposed Authorized User and experience, including a minimum of 200 hours of classroom and laboratory training, as required by 10 CFR 35.390 (b)(1).
For 35.392:
I attest that                                            has satisfactorily completed the 80 hours of classroom Name of Proposed Authorized User and laboratory training, as required by 10 CFR 35.392(c)(1), and the supervised work and clinical case experience required in 35.392(c)(2).
For 35.394:
I attest that                                              has satisfactorily completed the 80 hours of classroom Name of Proposed Authorized User and laboratory training, as required by 10 CFR 35.394 (c)(1), and the supervised work and clinical case experience required in 35.394(c)(2).
NRC FORM 313A (AUT) (MM-YYYY)                                                                                                  87
 
NRC FORM 313A (AUT)                                                                              U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)
Second Section I attest that                                                  has satisfactorily completed the required clinical case Name of Proposed Authorized User experience required in 35.390(b)(1)(ii)G listed below:
Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)
Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)
Parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or for its photon energy less than 150 keV, for which a written directive is required Third Section I attest that                                                  is able to independently fulfill the radiation safety-related Name of Proposed Authorized User duties as an authorized user for the medical uses authorized under 10 CFR 35.300 for:
Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)
Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)
Parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or for its photon energy of less than 150 keV, for which a written directive is required Fourth Section For 35.396:
Current 35.490 or 35.690 authorized user:
I attest that Name of Proposed Authorized User is an authorized user under 10 CFR 35.490 or 35.690 or equivalent Agreement State requirements, has satisfactorily completed the 80 hours of classroom and laboratory training, as required by 10 CFR 35.396 (e)(1), and the supervised work and clinical case experience required by 35.396(e)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user under 10 CFR 35.300 for parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or for its photon energy of less than 150 keV, for which a written directive is required OR Board Certification:
I attest that Name of Proposed Authorized User has satisfactorily completed the board certification requirements of 35.396(d),
has satisfactorily completed the 80 hours of classroom and laboratory training required by 10 CFR 35.396 (e)(1) and the supervised work and clinical case experience required by 35.396(e)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user under 10 CFR 35.300 for Parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or for its photon energy of less than 150 keV, for which a written directive is required NRC FORM 313A (AUT) (MM-YYYY)                                                                                                          88
 
NRC FORM 313A (AUT)                                                                        U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
AUTHORIZED USER TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396] (continued)
Fifth Section Complete one of the following for the attestation and signature:
Authorized User I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:
35.390                35.392          35.394            35.396          35.57 for 35.300 uses I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization:
Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)
Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)
Parenteral administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or for its photon energy of less than 150 keV, for which a written directive is required OR Residency Program Director:
I affirm that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements below or equivalent Agreement State requirements:
35.390              35.392            35.394            35.396          35.57 for 35.300 uses I affirm that this facility member has experience in administering dosages in the same dosage category or categories for which the individual is requesting authorized user status and concurs with the attestation I am providing as program director.
I affirm that the residency training program is approved by the:
Residency Review Committee of the Accreditation Council for Graduate Medical Education Royal College of Physicians and Surgeons of Canada Committee on Post-Graduate Training of the American Osteopathic Association I affirm that the residency training program includes training and experience specified in:
35.390(b)(1)            35.392(c)(1) and (2)        35.394(b)(1) and (2)          35.396(b)(1) and (2)
Name of Facility:                                                              License/Permit Number:
Name of Preceptor or Residency Program Director (Typed or Printed)                          Telephone Number        Date Signature NRC FORM 313A (AUT) (MM-YYYY)                                                                                                  89
 
NRC FORM 313A (RSO)                                  U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
RADIATION SAFETY OFFICER OR                                  APPROVED BY OMB: NO. 3150-0120 ASSOCIATE RADIATION SAFETY OFFICER                                EXPIRES: (MM/DD/YYYY)
TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
[10 CFR 35.57, 35.50]
Name of Individual                                          RSO                    ARSO Requested Authorization(s) The license authorizes the following medical uses (check all that apply):
35.100            35.200        35.300            35.400          35.500            35.600 (remote afterloader) 35.600 (teletherapy)              35.600 (gamma stereotactic radiosurgery)            35.1000 (                  )
PART I -- TRAINING AND EXPERIENCE (Select one of the five methods below)
*Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.
1.Board Certification
: a. Provide a copy of the board certification.
: b. If the board certification process has been recognized by the Commission or an Agreement State under 10 CFR 35.50; (i) Go to the table in 5c and describe training provider and dates of training for each type of use for which authorization is sought.
(ii) Stop here
: c. If the board certification process has been recognized by the Commission or an Agreement State under 10 CFR 35.51(a);
(i) Provide documentation demonstrating that the individual has experience using the requested materials and uses in the boxes checked above; (ii) Go to the table in 5c and describe training provider and dates of training for each type of use for which authorization is sought.
(iii) Stop here
: d. If the board certification was issued on or before October 24, 2005 and is listed in 10 CFR 35.57 (a)(2);
(i) Provide documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005; (ii) Stop here                                            OR
: 2. Current Radiation Safety Officer (RSO) or Associate Radiation Safety Officer (ARSO) Seeking Authorization to Be Recognized as a RSO or ARSO for the Additional Medical Uses Checked Above
: a. Use the table in section 5.c. to describe training in radiation safety, regulatory issues, and emergency procedures for the additional types of medical use for which recognition as RSO or ARSO is sought.
: b. If board certified stop here. If not board certified, provide completed Part II Preceptor Attestation.
OR
: 3. Authorized User, Authorized Medical Physicist, or Authorized Nuclear Pharmacist identified on a license or permit identified in 10 CFR 35.50 (c)(2)
: a. Provide the NRC license number, or a copy of the license or permit identifying the individual as as authorized user.
: b. Use the table in section 5.c. to describe training in radiation safety, regulatory issues, and emergency procedures for all types of medical use on the license.
: c. If board certified stop here. If not board certified, provide completed Part II Preceptor Attestation.
OR 90
 
NRC FORM 313A (RSO)                                                                        U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.57, 35.50] (continued)
: 4. Individuals applying simultaneously to be the RSO and AU on a new license
: a. Documentation of training and experience to be a new AU is attached
: b. The new license application is attached.
: c. Go to the table in 5c and describe training provider and dates of training for each type of use for which authorization is sought.
: d. Stop here.
OR
: 5. Structured Educational Program for Proposed RSO or ARSO
: a. Classroom and Laboratory Training Clock          Dates of Description of Training                          Location of Training Hours        Training*
Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Radiation biology Radiation dosimetry Total Hours of Training:                                                  91
 
NRC FORM 313A (RSO)                                                                                      U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.57, 35.50] (continued)
: 5. Structured Educational Program for Proposed RSO or ARSO (continued)
: b. Supervised Radiation Safety Experience (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies copies of this section.)
Description of Experience                                    Location of Training/                              Dates of License or Permit Number of Facility                      Training*
Shipping, receiving, and performing related radiation surveys Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides Securing and controlling byproduct material Using administrative controls to avoid mistakes in administration of byproduct material Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures Using emergency procedures to control byproduct material Disposing of byproduct material Licensed Material Used (e.g., 35.100, 35.200, etc.)+
          + Choose all applicable sections of 10 CFR Part 35 to describe radioisotopes and quantities used: 35.100, 35.200, 35.300, 35.400, 35.500, 35.600 remote afterloader units, 35.600 teletherapy units, 35.600 gamma stereotactic radiosurgery units, emerging technologies (provide list of devices).
92
 
NRC FORM 313A (RSO)                                                                          U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.57, 35.50] (continued)
: 5. Structured Educational Program for Proposed RSO or ARSO (continued)
: b. Supervised Radiation Safety Experience (continued)
(If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.)
License/Permit Number listing supervising individual as a Supervising Individual Radiation Safety Officer or Associate Radiation Safety Officer The supervising individual is authorized as the                Radiation Safety Officer or the for the following medical uses:                              Associate Radiation Safety Officer 35.100          35.200              35.300                  35.400 35.500          35.600 (remote afterloader)                  35.600 (teletherapy) 35.600 (gamma stereotactic radiosurgery)                      35.1000 (                                                    )
: c. Describe training in radiation safety, regulatory issues, and emergency procedures for all types of medical use on the license.
Dates of Description of Training                                Training Provided By Training*
Radiation safety, regulatory issues, and emergency procedures for 35.100, 35.200, and 35.500 uses Radiation safety, regulatory issues, and emergency procedures for 35.300 uses Radiation safety, regulatory issues, and emergency procedures for 35.400 uses Radiation safety, regulatory issues, and emergency procedures for 35.600 -
teletherapy uses Radiation safety, regulatory issues, and emergency procedures for 35.600 - remote afterloader uses Radiation safety, regulatory issues, and emergency procedures for 35.600 - gamma stereotactic radiosurgery uses Radiation safety, regulatory issues, and emergency procedures for 35.1000, specify use(s):
93
 
NRC FORM 313A (RSO)                                                                                U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.57, 35.50] (continued)
: 5. Structured Educational Program for Proposed RSO or ARSO (continued)
: c. Training in radiation safety, regulatory issues, and emergency procedures for all types of medical use on the license (continued)
Supervising Individual If training was provided by supervising        License/Permit Number listing supervising individual RSO, ARSO, AU, AMP, or ANP. (If more than one supervising individual is necessary to document supervised training, provide multiple copies of this page.)
License/Permit lists supervising individual as:
Radiation Safety Officer                Associate Radiation Safety Officer Authorized User                        Authorized Nuclear Pharmacist            Authorized Medical Physicist Authorized as RSO, ARSO, AU, ANP, or AMP for the following medical uses:
35.100              35.200              35.300                35.400 35.500              35.600 (remote afterloader)                35.600 (teletherapy) 35.600 (gamma stereotactic radiosurgery)                        35.1000 (                                          )
: d. Skip to and complete Part II Preceptor Attestation.
PART II - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.
First Section Structured Educational Program for Proposed RSO or ARSO I attest that                                                                            has satisfactorily completed Name of Proposed RSO/ARSO a structural educational program consisting of both 200 hours of classroom and laboratory training and one year of full-time radiation safety experience as required by 10 CFR 35.50(b)(1).
AND Second Section I attest that                                                                              has training in Name of Proposed RSO/ARSO radiation safety, regulatory issues, and emergency procedures for the following types of use:
Complete for all (check all that apply):
35.100                35.200 35.300            oral administration of less than or equal to 33 millicuries of sodium iodide I-131, for which a written directive is required 35.300            oral administration of greater than 33 millicuries of sodium iodide I-131 35.300            parental administration of any radionuclide that is primarily used for its beta radiation characteristics, alpha radiation characteristics, or its photon energy, less than 150 keV for which a written directive is required NRC FORM 313A (RSO) (MM-YYYY)                                                                                                      94
 
NRC FORM 313A (RSO)                                                                                                U. S. NUCLEAR REGULATORY COMMISSION (MM-YYYY)
RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.57, 35.50] (continued)
PART II - PRECEPTOR ATTESTATION (continued)
Complete for all (check all that apply):
35.400 35.500 35.600            remote afterloader units 35.600            teletherapy units 35.600            gamma stereotactic radiosurgery units 35.1000          emerging technologies, including:
Third Section                                                            AND I attest that Name of Proposed Radiation Safety Officer or Associate Radiation Safety Officer is able to independently fulfill the radiation safety-related duties as:
A Radiation Safety Officer for a medical use licensee.
OR An Associate Radiation Safety Officer for a medical use licensee.
Fourth Section Complete the following for Preceptor Attestation and signature I am the Radiation Safety Officer for                          I am the Associate Radiation Safety Officer for Name of Facility:
License/Permit Number:
Name of Preceptor (Typed or printed)                                                                            Telephone Number        Date Signature NRC FORM 313A (RSO) (MM-YYYY)                                                                                                                    95
 
[The following redline/strikeout revisions to Appendix C reflect the changes to 10 CFR 35.2 and 35.433 adding an Associate Radiation Safety Officer and the ophthalmic physicist in 10 CFR 35.433; the change to 10 CFR 35.65 to prohibit bundling of single sources; changes to 10 CFR 35.57 grandfathering individuals that were board certified by boards prior to October 24, 2005 by the Boards listed in 10 CFR 35.57; changes to 10 CFR 35.50, 35.51, 35.55, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, and 35.690 revising the preceptor attestation requirements and the preceptor attestation statement; changes to 10 CFR 35.50 training and experience pathways; and the change to 10 CFR 35.12 describing information needed for 10 CFR 35.1000 medical uses.]
APPENDIX C License Application Checklists License Application Checklists This Appendix contains checklists that may be used to assist in organizing an application. It addresses information a medical use licensee needs to provide for authorization to produce PET radioactive drugs for noncommercial transfer to consortium members. See Appendix AA for additional information.
Table C.1, Applicability Table, may be used to determine if particular information must be provided or if N/A (not applicable) may be the response to each item that follows. To determine those items to which applicants must respond, highlight the columns under the categories of materials requested in Item 5 (e.g., 10 CFR 35.300, 35.400). If any Y beside an item is highlighted, applicants must provide detailed information in response to that item. If the letters N/A are highlighted, applicants may respond N/A on their applications. If any N beside an item is highlighted, no information in response is required, but NRC regulations that apply to the given category apply to that type of license. If any P beside an item is highlighted, applicants should provide a commitment as described in the section referenced in the body of this document. If any G beside an item is highlighted, see subsequent sections for required responses. APP indicates that this document contains an appendix that addresses the item.
96
 
Table C.1 Applicability Table Section #          Topic          35.100/200 35.300 35.400 35.500 35.600 35.1000 APP 8.5        Unsealed Byproduct            Y Material - Uptake, Dilution, Excretion, Imaging, and Localization Studies 8.5        Unsealed Byproduct                      Y Material - Written Directive Required 8.5        Manual Brachytherapy                          Y 8.5        Sealed Sources for                                    Y Diagnosis 8.5        Teletherapy Units                                            Y 8.5        Remote Afterloader                                          Y Units 8.5        Gamma Stereotactic                                          Y Radiosurgery Units 8.5        Other Medical Uses                                                  Y 8.6        Sealed Sources and            N      N      Y      Y      Y      Y Devices 8.7        Discrete Source of Ra-        Y        Y    N      N      N      Y 226 (Other than sealed sources) 8.8        Financial Assurance            Y        Y      Y      Y      Y      Y Determination 8.9        Purpose(s) for Which          Y        Y      Y      Y      Y      Y Licensed Material Will Be Used 8.10      Training and Experience        G        G    G      G      G      G 8.11      Radiation Safety Officer      Y        Y      Y      Y      Y      Y    I, D (RSO) and Associate Radiation Safety Officers (ARSOs) 8.12      Authorized User(s) (AUs)      Y        Y      Y      Y      Y      Y    D 97
 
Table C.1 Applicability Table Section #            Topic        35.100/200 35.300 35.400 35.500 35.600 35.1000 APP 8.13      Authorized Nuclear            Y        Y    N/A    N/A    N/A      Y    D Pharmacist (ANP) 8.14a      Authorized Medical          N/A      N/A    Y*    N/A      Y      Y    D Physicist (AMP) 8.14b      Ophthalmic Physicist        N/A      N/A    Y*    N/A    N/A    N/A    D 8.15      Facilities and Equipment      G        G    G      G      G      G 8.16      Facility Diagram              Y        Y      Y      Y      Y      Y 8.17      Radiation Monitoring        Y, P    Y, P  Y, P  Y, P  Y, P    Y, P  K Instruments 8.18      Dose Calibrator and          P        P    N/A    N/A    N/A      P Other Equipment 8.19      Therapy Unit -              N/A      N/A    N    N/A      Y      N Calibration and Use 8.20      Other Equipment and          N        N    N      N      Y      N Facilities 8.21      Radiation Protection          G        G    G      G      G      G Program 8.22      Safety Procedures and        N/A      N/A  N/A    N/A      Y    N/A Instructions 8.23      Occupational Dose            P        P    P      P      P      P    M 8.24      Area Surveys                  P        P    P      P      P      P    R 8.25      Safe Use of Unsealed          P        P    N/A    N/A    N/A      P    T Licensed Material 8.26      Spill/Contamination          P        P    P    N/A    N/A      P    N Procedures 8.27      Service of Therapy          N/A      N/A  N/A    N/A      Y      Y Devices Containing Sealed Sources 8.28      Minimization of              N        N    N      N      N      N Contamination 8.29      Waste Management              P        P    P      P      P      P    W 8.30      Fees                          Y        Y      Y      Y      Y      Y 98
 
Table C.1 Applicability Table Section #            Topic          35.100/200 35.300  35.400    35.500  35.600    35.1000 APP 8.31      Certification                  Y        Y        Y        Y        Y        Y 8.32      Safety Instruction for        N      N        N        N        N        N    J Individuals in Restricted Areas 8.33      Public Dose                    N      N        N        N        N        N 8.34      Opening Packages              N      N        N        N        N        N 8.35      Written Directive            N/A      N        N        N/A        N        N    S Procedures 8.36      Release of Patients or        N      N        N        N/A      N/A        N    U Human Research Subjects 8.37      Mobile Medical Service        N      N        N        N        N        N    V 8.38      Audit Program                  N      N        N        N        N        N    L 8.39      Operating and                  N      N        N        N        N        N    N Emergency Procedures 8.40      Material Receipt and          N      N        N        N        N        N Accountability 8.41      Ordering and Receiving        N      N        N        N        N        N    O 8.42      Sealed Source Inventory        N      N        N        N        N        N 8.43      Records of Dosages and        N      N        N        N        N        N Use of Brachytherapy Source 8.44      Recordkeeping                  N      N        N        N        N        N    X 8.45      Reporting                      N      N        N        N        N        N    Y 8.46      Leak Tests                    N      N        N        N        N        N    Q 8.47      Safety Procedures for        N/A      N        N        N/A      N**        N Treatments when Patients are Hospitalized 8.48      Transportation                N      N        N        N        N        N    Z
* Y beside item 8.134a and 8.14b for use under 35.400 applies to Sr-90 sources for ophthalmic treatment only.
** N/A for teletherapy and gamma stereotactic radiosurgery outpatient treatments.
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Table C.2 outlines the detailed responses that may be made to Items 5 and 6 on Form 313 for the type of radioactive material requested and the purposes for which it will be used. For example, if the applicant is seeking a license for unsealed byproduct material under 10 CFR 35.100 or 35.200, then the applicant should check the yes column next to 10 CFR 35.100 and 35.200 in Table C.2. The table then indicates appropriate responses for that type of use. An applicant may copy the checklist and include it in the license application.
The applicant should review the guidance in Section 5.2 and mark security-related information appropriately.
Note: The NRC now has regulatory authority for accelerator-produced radioactive material and discrete sources of Ra-226, as a result of the EPAct. Uses of these materials are added to Table C.2.
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Table C.2 Items 5 and 6 on NRC Form 313: Radioactive Material and Use (If using this checklist, check applicable rows and fill in details, and attach copy of checklist to the application.)
Yes This response includes security-related sensitive information (see Section 5.2) which is included in Attachment _____ and marked Security-related information - withhold under 10 No CFR 2.390 Form or Manufacturer/            Maximum Yes      Radionuclide                                                                  Purpose of Use Model No.                  Quantity Any byproduct          Any                      As needed                  Any uptake, dilution, material permitted                                                          and excretion study by 10 CFR 35.100                                                            permitted by 10 CFR 35.100.
Any byproduct          Any                      As needed                  Any imaging and material permitted                                                          localization study by 10 CFR 35.200                                                            permitted by 10 CFR 35.200.
F-18                  Any                      _____ curies                Production of PET radioactive drugs under 10 CFR 30.32(j).
O-15                  Any                                                  Production of PET radioactive drugs under
_____ curies                10 CFR 30.32(j).
C-11                  Any                      _____ curies                Production of PET radioactive drugs under 10 CFR 30.32(j).
Any byproduct          Any                      _____ millicuries          Any material permitted                                                          radiopharmaceutical by 10 CFR 35.300                                                            therapy procedure permitted by 10 CFR 35.300.
Iodine-131            Any                      ___millicuries              Administration of I-131 sodium iodide.
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Table C.2 Items 5 and 6 on NRC Form 313: Radioactive Material and Use (If using this checklist, check applicable rows and fill in details, and attach copy of checklist to the application.)
Byproduct material Sealed source or device ___millicuries                  Any brachytherapy permitted by          (Manufacturer                                        procedure permitted by 10 CFR 35.400                                                              10 CFR 35.400.
__________________,
(Radionuclide        Model No._________)
________)
Byproduct material Sealed source or device ___millicuries                  Any brachytherapy permitted by          (Manufacturer                                        procedure permitted by 10 CFR 35.400                                                              10 CFR 35.400.
__________________,
(Radionuclide        Model No._________)
________)
Byproduct material Sealed source or device ___millicuries                  Any brachytherapy permitted by          (Manufacturer                                        procedure permitted by 10 CFR 35.400                                                              10 CFR 35.400.
_________________,
(Radionuclide        Model No.________)
________)
Byproduct material Sealed source or device ___millicuries                  Any brachytherapy permitted by          (Manufacturer                                        procedure permitted by 10 CFR 35.400                                                              10 CFR 35.400.
_________________,
(Radionuclide        Model No.________)
________)
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Table C.2 Items 5 and 6 on NRC Form 313: Radioactive Material and Use (If using this checklist, check applicable rows and fill in details, and attach copy of checklist to the application.)
Form or Manufacturer/          Maximum Yes    Radionuclide                                                                  Purpose of Use Model No.                  Quantity Strontium-90            Sealed source or device ___millicuries                Treatment of superficial (Manufacturer                                        eye conditions using an applicator distributed
_________________,                                    pursuant to Model No.________)
10 CFR 32.74 and permitted by 10 CFR 35.400.
Byproduct material Sealed source or device ___curies per source              Diagnostic medical use permitted by            (Manufacturer            and                        of sealed sources 10 CFR 35.500                                                                permitted by
_________________, ___curies total                    10 CFR 35.500 in Check all that apply: Model No.________)                                      compatible devices Gd-153;                                                                    registered pursuant to 10 CFR 30.32(g).
I-125; Radionuclide (transmission sources bundled and exceeding single source limits in 35.65)
Other, describe 103
 
Iridium-192 Sealed source or device ___curies per source One source for medical (Manufacturer          and                  use permitted by 10 CFR 35.600, in a
_________________,      ___curies total      Manufacturer Model No.________)                          __________________,
Model No. _________
remote afterloading brachytherapy device.
One source in its shipping container as necessary for replacement of the source in the remote afterloader device.
Cobalt-60  Sealed source or device ___curies per source One source for medical (Manufacturer          and                  use permitted by 10 CFR 35.600, in a
_________________,      ___curies total      Manufacturer Model No.________)                          __________________,
Model No. _________
teletherapy unit. One source in its shipping container as necessary for replacement of the source in the teletherapy unit.
Cobalt-60  Sealed source or device ___curies per source For medical use (Manufacturer          and                  permitted by 10 CFR 35.600, in a
_________________,      ___curies total      Manufacturer Model No.________)                          __________________,
Model No. _________
stereotactic radiosurgery device.
Sources in the shipping container as necessary for replacement of the 104
 
sources in the stereotactic radiosurgery device.
Any byproduct          Prepackaged kits        ___millicuries    In vitro studies.
material under 10 CFR 31.11 Depleted uranium      Metal                  ___kilograms      Shielding in a teletherapy unit.
Depleted uranium      Metal                  ___kilograms      Shielding in a linear accelerator.
Any radionuclide in    Sealed source or device ___millicuries    For use in a excess of 30          (Manufacturer                              Manufacturer millicuries for use in                                            __________________,
calibration,          __________________,                        Model No. _________
transmission, and      Model No._________)                        for calibration and reference sources.                                                checking of licensees (List radionuclide:                                              survey instruments.
________)
Americium-241          Sealed source or device ___millicuries per Use as an anatomical (Manufacturer          source and        marker.
__________________, ___millicuries total Model No._________)
105
 
Plutonium (principal Sealed sources      ___millicuries per As a component of radionuclide Pu-238)                    source and        Manufacturer
__________________,
___grams total    Model No. ________
nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturers protocol dated ______.
This authorization includes: follow-up, explantation, recovery, disposal, and implantation.
Other                Form or            ___millicuries    Purpose of use Manufacturer/Model                    ___________________.
No.
___________________
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Table C.3 contains a checklist that may be used to identify the attached documents that the applicant is supplying for items for which a response is required. For example, an applicant may fill in the name of the Radiation Safety Officer in Table C.3 and then check the boxes indicating which documents pertaining to the RSO are being included in the license application. An applicant may copy the checklist and include it in the license application.
Table C.3        Items 7 through 11 on NRC Form 313: Training & Experience, Facilities
                  & Equipment, Radiation Protection Program, and Waste Disposal (Check all applicable rows and fill in details and attach a copy of the checklist to the application or provide information separately.)
Check box to indicate Item Number Suggested Response                                material and Title included in application Item 7:              For an individual previously identified as an RSO or ARSO on an NRC
[ ] Radiation Safety or Agreement State license or permit:
Officer or
[ ] Associate Radiation Safety Officer Name:                        Previous license number (if issued by the NRC), or a copy of a license (if issued by an Agreement State), or a copy of a permit (if issued by an NRC master materials licensee) on which the individual was specifically named as the RSO or ARSO.
After January 2019 documentation of the training requirements in § 35.50(d) for any new materials or new medical uses requested.
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Table C.3      Items 7 through 11 on NRC Form 313: Training & Experience, Facilities
                & Equipment, Radiation Protection Program, and Waste Disposal (Check all applicable rows and fill in details and attach a copy of the checklist to the application or provide information separately.)
Check box to indicate Item Number Suggested Response                                material and Title included in application For an individual qualifying under 10 CFR 35.57(a)(3):
Documentation that the individual was:                                         
                    - the RSO for only the medical uses of accelerator-produced radioactive material, or discrete sources of Ra-226, or both included in the definition of byproduct material as a result of the EPAct;
                    - the RSO for the medical uses of these materials 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 at an earlier date as noticed by the NRCduring the effective period of NRCs waiver of August 31, 2005.
For an individual qualifying under 10 CFR 35.50(a):
Copy of certification by a specialty board whose certification process has been recognized 1 by NRC or an Agreement State under 10 CFR 35.50(a).
AND 1The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
108
 
Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an the individual to serve as the RSO or ARSO.
AND Written attestation, signed by a preceptor RSO, that the individual has satisfactorily completed training in and experience required for certification, as well as training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval, and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
109
 
For an individual qualifying under 10 CFR 35.50(c)(1):
Copy of the certification(s) as a medical physicist by a board whose certification process has been  recognized 2  by the NRC or an Agreement State under 10 CFR 35.51(a) and description of the experience specified in 10 CFR 35.50(c)(1) demonstrating that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar as applicable to the types of use of byproduct material for which the applicant seeks approval of an the individual to serve as the RSO or ARSO.
AND Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of the individual to serve as the RSO or ARSO.
AND Written attestation, signed by a preceptor RSO, that the individual has satisfactorily completed the required training and experience specified for certification, as well as training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval, and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.57 (a)(2):
Copy of certification on or before October 24, 2005 by a specialty board whose certification is listed in 10 CFR 35.57 (a)(2) 110
 
2The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
111
 
Documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
AND For an individual qualifying under 10 CFR 35.50(c)(2):
Copy of the Commission or Agreement State license, permit issued by a Commission master material license, permit issued by a Commission or Agreement State licensee of broad scope, or permit issued by a Commission master material license broad scope permittee licensees license indicating that the individual is an AU, AMP, or ANP identified on the license or permit and has experience with radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an the individual to serve as the RSO or ARSO.
AND Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of an the individual to serve as RSO or ARSO.
AND Written attestation, signed by a preceptor RSO, that the individual has satisfactorily completed the requirements in 10 CFR 35.50(c)(2),
as well as training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval, and has achieved a level of radiation safety knowledge sufficient to function independently as an RSO.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
112
 
For an individual applying simultaneously to be the RSO and AU on a new license under 10 CFR 35.50 (c)(3).
Documentation of training and experience to be a new AU is attached.
AND The new license application is attached.
AND Description of the training and experience specified in 10 CFR 35.50(d) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of the individual as the RSO or ARSO.
113
 
For an individual qualifying under 10 CFR 35.50(b):
Description of the training and experience specified in 10 CFR 35.50(b) demonstrating that the proposed RSO or ARSO is qualified by training and experience as applicable to the types of use for which the applicant seeks approval of an the individual to serve as the RSO or ARSO.
AND Description of the training and experience specified in 10 CFR 35.50(de) demonstrating that the proposed RSO or ARSO is qualified by training in radiation safety, regulatory issues, and emergency procedures as applicable to the types of use for which the applicant seeks approval of anthe individual to serve as the RSO or ARSO.
AND Written attestation, signed by a preceptor RSO or ARSO, that the individual has satisfactorily completed the required training and experience specified in 10 CFR 35.50(b)(1), as well as the training in radiation safety, regulatory issues, and emergency procedures for the types of use for which the licensee seeks approval, and is able has achieved a level of radiation safety knowledge sufficient to function independently fulfill the radiation safety-related duties as an RSO or ARSO for a medical use license.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
114
 
Item 7: Authorized For an individual previously identified as an AU on an NRC or Users for medical Agreement State license or permit:
uses:
Name(s), (including Previous license number (if issued by the NRC), or a copy of the license number      license (if issued by an Agreement State), or a copy of a permit authorizing        issued by an NRC master materials licensee, or a copy of a permit practice of        issued by an NRC or Agreement State broad-scope licensee, or a medicine, podiatry, copy of a permit issued by an NRC Master Materials License broad-or dentistry if not scope permittee on which the physician, dentist, or podiatrist was provided            specifically named as an AU for the uses requested.
previously or in attachment);
Requested uses for each individual For an AU requesting authorization for an additional medical use:
Description of the additional training and experience to demonstrate the AU is also qualified for the new medical uses requested (e.g., training and experience needed to meet the requirements in 10 CFR 35.290 (bc)(1)(ii)(G), 35.396, 35.390(b)(1)(ii)(G), or 35.690(c)).
AND A preceptor attestation, if required (e.g., attestation is required for all individuals to meet the requirements in 10 CFR 35.396 and for individuals seeking authorization under the alternate training and experience pathway for, 35.390(b)(1)(ii)(G), or and 35.690(c)).
For an individual qualifying under 10 CFR 35.57(b)(3):
115
 
Documentation that the physician, podiatrist, or dentist:
* used only accelerator-produced radioactive materials, or discrete sources of Ra-226, or both, for medical uses performed 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 at an earlier date as noticed by the NRCbefore or during the effective period of NRCs waiver of August 31, 2005; and
* used these materials for the same medical uses requested.
 
For an individual who was certified on or before October 24, 2005, by a board listed in 10 CFR 35.57(b)(2):
Copy of the board certification.
 
AND Documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005; AND If applying for a new medical use, a description of the additional training and experience to demonstrate the individual is also qualified for the new medical uses requested (e.g., training and experience needed to meet the requirements in 10 CFR 35. 290 (c)(1)(ii)(G), 35.396, 35.390(b)(1)(ii)(G), or 35.690(c)).
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H, who is board-certified:
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Copy of the certification(s) by a specialty board(s) whose certification process has been  recognized 3 by the NRC under 10 CFR Part 35, Subpart D, E, F, G, or H, as applicable to the use requested.
AND For an individual with a board certification recognized under 10 CFR 35.390, a description of the supervised work experience administering dosages of radioactive drugs required in 10 CFR 35.390(b)(1)(ii)(G) demonstrating that the proposed AU is qualified for the types of administrations for which authorization is sought; AND For an individual with a board certification recognized under 10 CFR 35.390 for medical uses described in 10 CFR 35.200, a description of the supervised work experience eluting generator systems required in 10 CFR 35.290(c)(1)(ii)(G) demonstrating the proposed AU is also qualified for imaging and localization medical uses; AND For an individual with a board certification recognized under 10 CFR 35.490 or 35.690 seeking authorization under 10 CFR 35.396(bd), a description of the classroom and laboratory training and supervised work experience required to demonstrate qualifications for administering parenteral administrations of unsealed byproduct material requiring a written directive; AND 3The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
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For an individual seeking authorization under 10 CFR Part 35, Subpart H, description of the training specified in 10 CFR 35.690(c) demonstrating that the proposed AU is qualified for the type(s) of use for which authorization is sought; AND Written attestation, signed by a preceptor physician AU, that the training and experience specified for certification, as well as the clinical casework, or training and experience required by 10 CFR 35.396(d), or training for 10 CFR 35.600 types of use, if appropriate, have been satisfactorily completed and that a level of competency sufficient to function independently as an AU for the medical uses authorized has been achieved; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H, who is not board-certified:
A description of the training and experience identified in 10 CFR Part 35, Subparts D, E, F, G, and H, demonstrating that the proposed AU is qualified by training and experience for the use(s) requested.
AND For an individual seeking authorization under 10 CFR Part 35, Subpart H, description of the training specified in 10 CFR 35.690 (c) demonstrating that the proposed AU is qualified for the type(s) of use for which authorization is sought.
AND 118
 
Written attestation, signed by a preceptor physician AU, or if applicable the residency program director, that the above training and experience have been satisfactorily completed and the individual is able that a level of competency sufficient to function independently fulfill the radiation safety-related duties as an AU for the requested medical uses authorized has been achieved.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Item 7: Authorized For an individual previously identified as an ANP on an NRC or Nuclear            Agreement State license or permit:
Pharmacists Name(s) and        Previous license number (if issued by the NRC), or a copy of the license to practice license (if issued by an Agreement State), or a copy of a permit pharmacy:          issued by an NRC master materials licensee, or a copy of a permit issued by an NRC or Agreement State broad-scope licensee, or a copy of a permit issued by an NRC Master Materials License broad-scope permittee on which the individual was specifically named ANP.
For an individual qualifying under 10 CFR 35.57(a)(43):
Documentation that the nuclear pharmacist:
* used only accelerator-produced radioactive materials or discrete sources of Ra-226, or both, in the practice of nuclear pharmacy 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 at an earlier date as noticed by the NRCbefore or during the effective period of NRCs waiver of August 31, 2005; and
* used these materials for the same uses requested.
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For an individual qualifying under 10 CFR 35.55(a):
Copy of the certification(s) of the specialty board whose certification process has been  recognized 4 under 10 CFR 35.55(a).
AND Written attestation, signed by a preceptor ANP, that training and experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.55(b):
Description of the training and experience specified in 10 CFR 35.55(b) demonstrating that the proposed ANP is qualified by training and experience.
AND Written attestation, signed by a preceptor ANP, that the above training and experience have been satisfactorily completed and the individual is able that a level of competency sufficient to function independently fulfill the radiation safety-related duties as an ANP has been achieved.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Item 7: Authorized For an individual previously identified as an AMP on an NRC or Medical Physicists Agreement State license or permit:
4The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
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Name(s): Previous license number (if issued by the NRC), or a copy of the license (if issued by an Agreement State), or a copy of a permit issued by an NRC master materials licensee, or a copy of a permit issued by an NRC or Agreement State broad-scope licensee, or a copy of a permit issued by an NRC Master Materials License broad-scope permittee on which the individual was specifically named an AMP for the uses requested.
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For an individual qualifying under 10 CFR 35.57(a)(43):
Documentation that the medical physicist:
-    used only accelerator-produced radioactive material, discrete
 
sources of Ra-226, or both, for medical 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 NRCbefore or during the effective period of NRCs waiver of August 31, 2005; and
-    used these materials for the same medical uses requested.
For an individual qualifying under 10 CFR 35.51(a):
Copy of the certification(s) of the specialty board(s) whose certification process has been recognized5 under 10 CFR 35.51(a).
AND Description of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the applicant seeks approval of an individual as the AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system.
AND Written attestation, signed by a preceptor physician AMP, that the training and experience specified for certification, as well as the training and experience specified in 10 CFR 35.51(c) have been satisfactorily completed and that a level of competency sufficient to function independently as an AMP has been achieved; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
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For an individual qualifying under 10 CFR 35.57(a)(3):
Copy of the certification issued on or before October 24, 2005, by a specialty board listed in 10 CFR 35.57(a)(3).
AND Documentation that the medical physicist used these materials on or before October 24, 2005, for the same medical uses requested.
AND If applying for a new medical use, a description of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the applicant seeks approval of an individual as the AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system.
AND Description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.51(b):
Description of the training and experience demonstrating that the proposed AMP is qualified by training and experience identified in 10 CFR 35.51(b)(1) for the uses requested.
AND Description of the training and experience specified in 10 CFR 35.51(c) demonstrating that the proposed AMP is qualified by training in the types of use for which the applicant seeks approval of an individual as the AMP, including hands-on device operation, safety procedures, clinical use, and operation of a treatment planning system.
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Written attestation, signed by a preceptor AMP, that the required training and experience have been satisfactorily completed and that the individual is able a level of competency sufficient to functionindependently fulfill the radiation safety-related duties as an AMP has been achievedfor each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Item 7:            Documentation of a masters or doctors degree in physics, Ophthalmic        medical physics, other physical science, engineering, or applied
 
physicist          mathematics from an accredited college or university.
Name(s):                                              AND
 
Documentation of successful completion of 1 year of full-time training in medical physics and an additional year of full-time work experience under a medical physics.
AND
 
Documentation of training in:
                        - The creating, modifying, and completing of written directives;
                        - Procedures for administrations requiring a written directive; and
 
                        - Performing the calibration measurements of brachytherapy sources as detailed in 10 CFR 35.432.
Item 7: Authorized Note: For purposes of this section of the table, the term User for          authorized user is used to mean individuals authorized for the nonmedical uses nonmedical uses described. See Sections 8.11 and 8.12.
For an individual previously authorized for nonmedical use on an NRC or Agreement State license or permit:
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Name(s):            Previous license number (if issued by the NRC), or a copy of the Requested types, license (if issued by an Agreement State), or a copy of a permit quantities, and    issued by an NRC master materials licensee, or a copy of a permit nonmedical uses issued by an NRC or Agreement State broad-scope licensee, or a for each individual copy of a permit issued by an NRC Master Materials License broad-scope permittee on which the individual was specifically named an AU for the types, quantities, and uses requested.
For individuals qualifying under 10 CFR 30.33(a)(3):
Documentation of the individuals training and experience demonstrating that the individual is qualified to use the types and quantities of licensed materials for the requested uses.
Item 9: Facility    A diagram is enclosed that describes the facilities and identifies Diagram            activities conducted in all contiguous areas surrounding the area(s) of use. The following information is included:
Guidance in Section 5.2 was reviewed and security-related sensitive information provided is marked accordingly.
 
Drawings should be to scale, indicating the scale used.
Location, room numbers, and principal use of each room or area where byproduct material is prepared, used or stored, location of direct transfer delivery tubes from a PET radionuclide/radioactive drug production facility or production area of PET radioactive drugs under 10 CFR 30.32(j), and areas where higher energy gamma- emitting radionuclides (e.g., PET radionuclides) are used; Location, room numbers, and principal use of each adjacent room (e.g., office, file, toilet, closet, hallway), including areas above, beside, and below therapy treatment rooms, indicating whether the room is a restricted or unrestricted area as defined in 10 CFR 20.1003; and 125
 
Provide shielding calculations and include information about the type, thickness, and density of any necessary shielding to enable independent verification of shielding calculations, including a description of any portable shields used (e.g.,
shielding of proposed patient rooms used for implant therapy, including the dimensions of any portable shield, if one is used; source storage safe).
In addition to the above, for teletherapy and GSR facilities, applicants should provide the directions of primary beam usage for teletherapy units and, in the case of an isocentric unit, the plane of beam rotation.
Item 9: Radiation A statement that: Radiation monitoring instruments will be Monitoring        calibrated by a person qualified to perform survey meter Instruments      calibrations.
AND/OR A statement that: We have developed and will implement and maintain written survey meter calibration procedures in accordance with the requirements in 10 CFR 20.1501 and that meet the requirements of 10 CFR 35.61.
AND A description of the instrumentation (e.g., gamma counter, solid state detector, portable or stationary count rate meter, portable or stationary dose rate or exposure rate meter, single or multichannel analyzer, liquid scintillation counter, proportional counter) that will be used to perform required surveys.
AND A statement that: We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used.
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Item 9: Dose      A statement that: Equipment used to measure dosages will be Calibrator and    calibrated in accordance with nationally recognized standards or Other Dosage      the manufacturers instructions.
Measuring Equipment When administering dosages of alpha-emitting unsealed byproduct material in other than unit dosages made by a manufacturer or preparer licensed under 10 CFR 32.72 or 10 CFR 30.32(j),
A statement that: Dosages will be determined by relying on the providers dose label for measurement of the radioactivity and a combination of volumetric measurement and mathematical calculation.
OR We are providing a description of the dosage measurement equipment, the nationally recognized calibration standard (or manufacturers calibration instructions), and dosage measurement procedures.
Item 9: Therapy    We are providing the procedures required by 10 CFR 35.642, Unit - Calibration 10 CFR 35.643, and 10 CFR 35.645, if applicable to the license and Use            application.
We are providing the calibration and use procedures requested by NRC licensing guidance on NRCs web site for the following 10 CFR 35.1000 medical uses:
__________________________.
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Item 9: Other Guidance in Section 5.2 was reviewed and security-related Equipment and information provided is marked accordingly.
Facilities Attached is a description, identified as Attachment 9.4, of additional facilities and equipment.
For manual brachytherapy facilities, we are providing a description of the emergency response equipment.
For PET radionuclide use, PET radioactive drug production, and radiopharmaceutical therapy programs, we are providing a description of the additional facilities and equipment for these uses.
For teletherapy, GSR, and remote afterloader facilities, we are providing a description of the following:
Warning systems and restricted area controls (e.g., locks, signs, warning lights and alarms, interlock systems) for each therapy treatment room; Area radiation monitoring equipment; Viewing and intercom systems (except for LDR units);
Steps that will be taken to ensure that no two units can be operated simultaneously, if other radiation-producing equipment (e.g., linear accelerator, X-ray machine) is in the treatment room; Methods to ensure that whenever the device is not in use or is unattended, the console keys will be inaccessible to unauthorized persons; and Emergency response equipment.
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For the following 35.1000 medical uses, we reviewed NRCs licensing guidance on NRCs web site and are providing a description of the equipment and facilities appropriate for each 35.1000 medical use, or explaining why the description is not needed.
______________________________
Item 10: Safety  Attached are procedures required by 10 CFR 35.610.
Procedures and Instructions For the following 35.1000 medical uses, we reviewed the licensing guidance on NRCs web site and are applying for approval to revise, without further NRC approval, the radiation safety program for each 35.1000 medical use to conform to revised licensing guidance posted on NRCs web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html).
_________________________
For the following 35.1000 medical uses, we reviewed NRCs licensing guidance on NRCs web site and are providing safety and emergency procedures appropriate for each 35.1000 medical use, or explaining why the description is not needed.
______________________________________
Guidance in Section 5.2 was reviewed and security-related sensitive information provided is marked accordingly.
Item 10:          A statement that: Either we will perform a prospective evaluation Occupational Dose demonstrating that unmonitored individuals are not likely to receive, in 1 year, a radiation dose in excess of 10% of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the requirements listed under Criteria in NUREG-1556, Vol. 9, Rev. 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses.
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A description of an alternative method for demonstrating compliance with the referenced regulations.
Item 10: Area    A statement that: We have developed and will implement and Surveys          maintain written procedures for area surveys in accordance with 10 CFR 20.1101 that meet the requirements of 10 CFR 20.1501 and 10 CFR 35.70.
Item 10: Safe Use A statement that: We have developed and will implement and of Unsealed      maintain procedures for safe use of unsealed byproduct material Licensed Material that meet the requirements of 10 CFR 20.1101 and 10 CFR 20.1301.
Item 10:          A statement that: We have developed and will implement and Spill/Contamina-  maintain written procedures for safe response to spills of licensed tion Procedures  material in accordance with 10 CFR 20.1101.
Item 10:          Name of the proposed employee and types of activities requested:
Installation,
_____________________________________
Maintenance, Adjustment,                                        AND Repair, and Inspection of    Description of the training and experience demonstrating that the Therapy Devices  proposed employee is qualified by training and experience for the Containing Sealed use requested.
Sources                                            AND Copy of the manufacturers training certification and an outline of the training in procedures to be followed.
Item 10:          A response is not required under the following condition: the NRC    N/A Minimization of  will consider that the above criteria have been met if the Contamination    information provided in applicants responses satisfy the criteria in Sections 8.15, 8.16, 8.21, 8.25, 8.27, and 8.29, on the topics:
facilities and equipment, facility diagram, Radiation Protection Program, safety program, and waste management.
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Item 11: Waste A statement that: We have developed and will implement and Management    maintain written waste disposal procedures for licensed material in accordance with 10 CFR 20.1101, that also meet the requirements of the applicable section of 10 CFR Part 20, Subpart K, and of 10 CFR 35.92.
Attached is a description of the radioactive waste incinerator facility and related portions of the Radiation Safety Program (10 CFR 20.2004).
Attached is a request to receive potentially contaminated radiation transport shields from consortium members receiving PET radioactive drugs noncommercially transferred under 10 CFR 30.32(j) authorization.
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APPENDIX D Documentation of Training and Experience to Identify Individuals on a License as Authorized User, Radiation Safety Officer, Associate Radiation Safety Officer, Authorized Medical Physicist, Ophthalmic Physicist, or Authorized Nuclear Pharmacist Note: The most current guidance is found on NRCs public Web site at http://www.nrc.gov/materials/miau/med-use-toolkit.html (Medical Uses Toolkit).
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Documentation of Training and Experience to Identify Individuals on a License as Authorized User, Radiation Safety Officer, Associate Radiation Safety Officer, Authorized Medical Physicist, Ophthalmic Physicist, or Authorized Nuclear Pharmacist I. Experienced Authorized Users, Authorized Medical Physicists, Ophthalmic Physicists, Authorized Nuclear Pharmacists, Radiation Safety Officer, or Associate Radiation Safety Officers An applicant or licensee who is adding an experienced authorized user (AU) for medical uses, authorized medical physicist (AMP), ophthalmic physicist, authorized nuclear pharmacist (ANP),
Radiation Safety Officer (RSO) or Associate Radiation Safety Officer (ARSO) to its medical use license or application only needs to provide evidence that the individual is listed on a medical use license issued by the NRC or Agreement State, a permit issued by an NRC master materials licensee, 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 the individual meets the recentness of training criteria described in 10 CFR 35.59. When adding an experienced ANP to the license, the applicant also may provide evidence that the individual is listed on an NRC or Agreement State commercial nuclear pharmacy license or identified as an ANP by a commercial nuclear pharmacy authorized to identify ANPs. For individuals who have been previously authorized by, but not listed on, the commercial nuclear pharmacy license, medical broad-scope license, or Master Materials License medical broad-scope permit, the applicant should submit either verification of previous authorizations granted or evidence of acceptable training and experience.
II. Experienced Physicians, Podiatrists, Dentists, Nuclear Pharmacists, Medical Physicists, and Radiation Safety Officers Who Only Used Accelerator-Produced Nuclear Materials, or Discrete Sources of Radium-226, or Both, for Medical or Nuclear Pharmacy Uses.
In implementing the EPAct, the NRC grandfathered physicians, podiatrists, dentists, medical physicists, and nuclear pharmacists that used only accelerator-produced radioactive materials, discrete sources of radium-226 (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 NRCbefore or under the NRC waiver of August 31, 2005, when using these materials for the same uses.
These individuals, as well as individuals that performed RSO duties only for uses of accelerator-produced radionuclides or discrete sources of Ra-226 at medical or nuclear pharmacy facilities before or during the effective period of the waiver, do not have to meet the requirements of 10 CFR 35.59, or the training and experience requirements in 10 CFR Part 35, Subparts B, D, E, F, and G.
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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 effective period of the waiver 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 non-Agreement State license or permit authorizing these materials for the requested uses.
III. Applications that Include New Authorized User, Authorized Medical Physicist, Ophthalmic Physicist, Authorized Nuclear Pharmacist, or Radiation Safety Officer or Associate Radiation Safety Officer Recognition by NRC Applicants should submit the appropriate completed form in the NRC Form 313A series to show that the individuals meet the correct training and experience criteria in 10 CFR Part 35, Subparts B, D, E, F, G, and H. For the applicants convenience, the NRC Form 313A series has been separated into six separate forms. The forms are NRC FORM 313A (RSO) for the Radiation Safety Officer and Associate Radiation Safety Officer ; NRC FORM 313A (AMP) for the authorized medical physicist and ophthalmic physicist; NRC FORM 313A (ANP) for the authorized nuclear pharmacist; NRC FORM 313A (AUD) for the authorized user of the medical uses included in 10 CFR 35.100, 35.200, and/or 35.500; NRC FORM 313A (AUT) for the authorized user for the medical use included in 10 CFR 35.300; and NRC FORM 313A (AUS) for the authorized user for the medical uses included in 10 CFR 35.400 and/or 35.600.
When an applicant wants to identify one or more ARSOs, it must describe the portions of the licensed program for which the ARSO will be assigned duties and task in the oversight of the radiation safety operations, so that the NRC is assured that the individual has the requisite training and experience needed to meet the requirements in 10 CFR 35.50(d).
There are two primary training and experience routes to qualify an individual as a new AU, AMP, ANP, RSO or ARSO. The first is by means of certification by a board recognized by NRC and listed on the NRC Web site 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), 35.490(a), 35.590(a), or 35.690(a), or included in the regulations in 35.57(a)(2), 35.57(a)(3), 35.57(b)(2). Preceptor attestations must also be submitted for all individuals to qualify under 10 CFR Part 35, Subparts B and D through H.
Additional training may also need to be documented for RSOs, ARSOs, AMPs, and AUs under 10 CFR 35.50, 35.51, 35.300 and 35.600.
The second route is by meeting the structured educational program, supervised work experience, and preceptor attestation requirements in 10 CFR Part 35, Subparts B, D, E, F, G, and H. In some cases there may be additional training and experience routes and requirements for recognized AUs, ANPs, AMPs, RSOs or ARSOs to seek additional authorizations.
IV. Recentness of Training The required training and experience, including board certification, described in 10 CFR Part 35 must be obtained within the 7 years preceding the date of the application, or the individual must 134
 
document having had related continuing education, retraining, and experience since obtaining the required training and experience. Examples of acceptable continuing education and experience for physicians include the following:
Successful completion of classroom and laboratory review courses that include radiation safety practices relative to the proposed type of authorized medical use, 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, and For therapy devices, experience with the therapy unit and/or comparable linear accelerator experience and completion of an in-service review of operating and emergency procedures relative to the therapy unit to be used by the applicant.
V. General Instructions and Guidance for Filling Out NRC Form 313A Series If the applicant is proposing an individual for more than one type of authorization, the applicant may need to either submit multiple forms in the NRC Form 313A series or fill out some sections more than once. For example, an applicant that requests a physician be authorized for 10 CFR 35.200 and 10 CFR 35.300 medical uses and as the RSO, should provide three completed NRC Form 313A series forms (i.e., NRC Form 313A (RSO), NRC Form 313A (AUD) and NRC Form 313A (AUT)). Also, if the applicant requests that a physician be authorized for both high dose-rate remote afterloading and gamma stereotactic radiosurgery under 10 CFR 35.600, only one form, NRC Form 313A (AUS) needs to be completed, but one part (i.e.,
Supervised Work and Clinical Experience) must be filled out twice.
To identify an Agreement State license, provide a copy of the license. To identify a Master Materials License permit, provide a copy of the permit. To identify an individual (i.e., supervising individual or preceptor) who is authorized under a broad-scope license or broad-scope permit of a Master Materials License, provide a copy of the permit issued by the broad-scope licensee/permittee. Alternatively, provide a statement signed by the Radiation Safety Officer or chairperson of the Radiation Safety Committee similar to the following:
__________(name of supervising individual or preceptor) is authorized under
_______________(name of licensee/permittee) broad-scope license number__________ to use_________(materials) during ____________( time frame).
INTRODUCTORY INFORMATION Name of individual Provide the individuals complete name so that NRC can distinguish the training and experience received from that received by others with a similar name.
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Note: Do not include personal or private information (e.g., date of birth, Social Security Number, home address, personal telephone number) as part of your qualification documentation.
State or territory where licensed 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).
Requested Authorization(s).
Check all authorizations that apply and fill in the blanks as provided.
Part I. Training and Experience There are always multiple pathways provided for each training and experience section. Select the applicable one.
Item 1.      Board Certification The applicant or licensee may use this pathway if the proposed new authorized individual is certified by a board recognized by NRC (to confirm that NRC recognizes that boards certifications, see NRC's Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html or if certified on or before October 24, 2005, by a board listed in 10 CFR 35.57.
Note: An individual that is board-eligible will not be considered for this pathway until the individual is actually board-certified. Further, individuals holding other board certifications will also not be considered for this pathway.
The applicant or licensee will need to provide a copy of the board certification and other documentation of training, experience, or clinical casework as indicated on the specific form of the NRC Form 313A series.
With the exception of an applicant requesting a proposed individual under the provisions of 10 CFR 35.396, board certified applicants do not need to provide a preceptor attestation.
All applicants under this pathway (except for 10 CFR 35.500 uses) must submit a completed Part II Preceptor Attestation.
Item 2.      Current Authorized Individuals Seeking Additional Authorizations Provide the information requested for training, experience, or clinical casework as indicated on the specific form of the NRC Form 313A series. (Note: This section does not include individuals who are authorized only on foreign licenses.)
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With the exception of applicants seeking authorizations for individuals applying under 10 CFR 35.396, board certified applicants do not need to provide a preceptor attestation. All other non-board certified individuals seeking applicants for additional authorizations (except those applying for 35.500 medical uses) under this pathway, the applicant must submit a completed Part II Preceptor Attestation.
Item 3. Alternate Pathway for Training and Experience for Proposed New Authorized Individuals This pathway is used for those individuals not listed on the license as authorized individuals, who do not meet the requirements for the board certification pathway.
The regulatory requirements refer to two categories of training: (a) classroom and laboratory training, and (b) supervised work experience. 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 (a) classroom and laboratory training, or (b) supervised work experience. Note that a single hour of training may only be counted once and may not be credited to both of these categories.
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. The date should be provided in the month/day/year (mm/dd/yyyy) format.
The specific number of hours needed for each training and supervised work experience element will depend upon the type of approval sought. Under the classroom and laboratory training, provide the number of clock hours spent on each of the topics listed in the regulatory requirements.
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 particular 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, as long as 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.
Under the supervised work experience sections of the forms, provide only the total number of hours of supervised work experience and check the boxes for each of the topics listed in the regulatory requirements to confirm that the listed subject areas were included in the supervised work experience.
The supervised work experience for physicians must include, but is not limited to, the subject areas listed in the applicable training and experience requirements. The NRC recognizes that 137
 
physicians in training will not dedicate all of their supervised work experience time specifically to the subject areas listed in the regulatory requirements and will be attending to other clinical activities involving the medical use of byproduct material (e.g., reviewing case histories or interpreting scans). Hours spent on these other duties not directly related to radiation safety or hands-on use of byproduct material, even though not specifically required by the NRC, may be credited to the supervised work experience category but not to the classroom and laboratory training category.
For nuclear pharmacists, under the supervised practical experience section, provide the number of clock hours for each topic. The supervised practical experience topics for the nuclear pharmacists include all the basic elements in the practice of nuclear pharmacy. Therefore, all the hours of supervised experience are allocated to these topics.
The applicant must submit a completed Part II Preceptor Attestation for all non-board certified individuals (except for ophthalmic physicist and individuals meeting just the criteria for 35.500 medical uses)
Note: If the proposed new authorized individual had more than one supervisor, provide the information requested for each supervising individual.
Part II. Preceptor Attestation The NRC defines the term preceptor in 10 CFR 35.2, Definitions, to mean an individual who provides, directs, or verifies training and experience required for an individual to become an AU, an AMP, an ANP, an ARSO, or an RSO. While the supervising individual for the work experience may also be the preceptor, the preceptor does not have to be the supervising individual as long as the preceptor directs or verifies the training and experience required. The preceptor must attest in writing regarding the training and experience of any individual to serve as an authorized individual and attest that the individual has satisfactorily completed the appropriate training and experience requirements and is able has achieved a level of competency or a level of radiation safety knowledge sufficient to function independently fulfill the radiation safety-related duties of an authorized individual. The preceptor language in NRC Forms 313A (AUD), 313A (AUT), and 313A (AUS) does not require an attestation of general clinical competency but requires sufficient attestation to demonstrate that the individual is able has the knowledge to fulfill the duties of the position for which the attestation is sought. The preceptor also has to meet specific requirements.
The NRC may require supervised work experience conducted under the supervision of an authorized individual in a licensed material use program. In this case, a supervisor is an individual who provides frequent direction, instruction, and direct oversight of the student as the student completes the required work experience in the use of byproduct material.
Supervision may occur at various licensed facilities, from a large teaching university hospital to a small private practice.
The NRC Form 313A series Part II - Preceptor Attestation has multiple sections. The preceptor must complete an attestation of the proposed users training, experience, and that the proposed 138
 
user is able competency to function independently fulfill the radiation safety-related duties for the authorization sought, as well as provide information concerning his/her own qualifications and sign the attestation. Because there are a number of different pathways to obtain the required training and experience for different authorized individuals, specific instructions are provided below for each form in the NRC 313A series.
VI. RADIATION SAFETY OFFICER and ASSOCIATE RADIATION SAFETY OFFICER - Specific Instructions and Guidance for Filling Out NRC Form 313A (RSO)
See Section V, General Instructions and Guidance for Filling out NRC Form 313A Series, for additional clarification on providing information about an individuals status on an Agreement State license, medical broad-scope license, or Master Materials License permit.
When requesting approval for an RSO or ARSO, to ensure that the requirements of section 30.33 are met, the applicant must designate whether the individual will be an RSO or ARSO.
The applicant must also specify the medical uses for which the RSO will have responsibilities and the portion of the program for which the ARSO will have duties and task in the oversight of the radiation safety operations. The RSO has responsibility for the entire radiation safety program. The RSO responsibilities are identified by all the specific medical uses (e.g., 35.100, 35.200) that will be listed on the license. The oversight duties and task for the ARSO also include other. Other may be used to designate program divisions such as different geographic locations or health physics functions.
Documentation needed to meet the Requirements to be an RSO or ARSO Regulation                  35.50(a)      35.50(b)    35.50(c)(1)  35.50(c)(2)    35.50(c)(3)  35.57(a)(2)
Board Certification                X                          X                                          X Used requested Materials on or before October 24,                                                                                  X 2005 License or Permit                                                            X Experience with the Radiation Safety Aspects of the Types of Use                                              X            X Classroom and Laboratory Training                                          X 139
 
Supervised Work Experience                                        X Training in Radiation Safety, Regulatory Issues and Emergency Procedures          X                X            X              X            X NRC Form 313A(AUD) 313A(AUT) or                                                                                X 313A(AUS 35.50                                              X            *              *
* Preceptor Statement
* Only needed if individual is not board certified by a Board recognized by NRC or listed in 10 CFR 35.57 Part I. Training and Experience - select one of four methods below:
Item 1.      Board Certification Provide the requested information (i.e., a copy of the board certification, and documentation of specific radiation safety training for all types of use on the license, and a completed preceptor attestation). As indicated on the form, additional information is needed if the board certification or radiation safety training was completed more than 7 years ago.
Specific radiation safety training for each type of use on the license may be supervised by an RSO, ARSO, AMP, ANP, or AU who is authorized for that type of use. Specific information regarding the supervising individual only needs to be provided in the table in 53.c if the training was provided by an RSO, ARSO, AMP, ANP, or AU. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
Item 2.      Current Radiation Safety Officer Seeking Authorization to Be Recognized as a Radiation Safety Officer for the Additional Medical Use(s) Checked Above.
Provide the requested information (i.e., documentation of specific radiation safety training (complete the table in 53.c) and a completed preceptor attestation in Part II if the individual is not board certified). As indicated on the form, additional information is needed if the specific radiation safety training was completed more than 7 years ago.
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Specific radiation safety training for each type of use on the license may be supervised by an RSO, ARSO, AMP, ANP, or AU who is authorized for that type of use. Specific information regarding the supervising individual only needs to be provided in the table in 5.c if the training was provided by an RSO, ARSO, AMP, ANP, or AU. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
Item 3.      Authorized User, Authorized Medical Physicist, or Authorized Nuclear Pharmacist Identified on a License or Permit as Specified in 10 CFR 35.
50(c)(2) the licensees license Provide the requested information (i.e., the license number and documentation of specific radiation safety training for each use on the license (complete the table in 53.c)). As indicated on the form, additional information is needed if the specific radiation safety training was completed more than 7 years ago.
Specific radiation safety training for each type of use on the license may be supervised by an RSO, ARSO, AMP, ANP, or AU who is authorized for that type of use. Specific information regarding the supervising individual only needs to be provided in the table in table 3.c if the training was provided by an RSO, AMP, ANP, or AU. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
Item 4. Individuals Applying to be Simultaneously the RSO and AU on a New License When the application is for a new medical use license and the proposed AU has never been recognized as an AU, the individual will be qualified to be the RSO on the new license based upon his or her experience with the radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as RSO and AU.
Therefore, the applicant must submit documentation of training and experience for the individual to be an AU (NRC Form 313A (AUD), 313A (AUT), or 313A (AUS)) with the NRC Form 313A (RSO) as well as complete table 5.c. This documents the individual has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. If there was more than one supervising individual, identify each supervising individual by name and provide his/her qualifications.
Item 5. Structured Educational Program for Proposed New Radiation Safety Officer or Associate Radiation Safety Officer As indicated on the form, additional information is needed if the training, supervised radiation safety experience and specific radiation safety training was completed more than 7 years ago.
Submit a completed Section 53.a.
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Submit a completed Section 53.b. The individual must have completed 1 year of full-time radiation safety experience under the supervision of an RSO or ARSO. This is documented in Section 5.b by providing the ranges of dates for supervised radiation safety experience. If there was more than one supervising individual, identify each supervising individual by name and provide his/her qualifications.
Provide the requested information (i.e., documentation of specific radiation safety training for each use on the license (complete the table in 53.c)). Specific radiation safety training for each type of use on the license may be supervised by an RSO, ARSO, AMP, ANP, or AU who is authorized for that type of use. Specific information regarding the supervising individual only needs to be provided in the table in table 3.c if the training was provided by an RSO, AMP, ANP, or AU. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
Submit a completed Preceptor Attestation in Part II.
Part II. Preceptor Attestation The Preceptor Attestation page has four sections.
The attestation for the new proposed RSOs or ARSOs training or identification on the license as an AU, AMP, or ANP is in the first section.
The attestation for the specific radiation safety training is in the second section.
The attestation for that the individuals is able competency to function independently fulfill the radiation safety-related duties as an RSO (or as an ARSO), and for a medical use license is in the third section.
The fourth and final section requests specific information about the preceptors authorization as an RSO or ARSO on a medical use license in addition to the preceptors signature.
The preceptor for a new proposed RSO or ARSO must fill out all four sections.
The preceptor for an RSO or ARSO, who did not become authorized via the board certification pathway, who is seeking authorization to be recognized as an RSO or ARSO for the additional medical use(s) must fill out the second, third, and fourth sections.
VII. AUTHORIZED MEDICAL PHYSICIST AND OPHTHALMIC PHYSICIST-Specific Instructions and Guidance for Filling Out NRC Form 313A (AMP) 142
 
See Section V, General Instructions and Guidance for Filling Out NRC Form 313A Series, for additional clarification on providing information about an individuals status on an Agreement State license, medical broad-scope license, or Master Materials License permit.
When requesting approval for an AMP or ophthalmic physicist, the applicant must designate whether the individual will be an AMP or an ophthalmic physicist.
Part I. Training and Experience - select one of the three methods below:
Authorized Medical Physicist Item 1.      Board Certification Provide the requested information (i.e., a copy of the board certification and documentation of device-specific training in the table in 3.c, and a completed Preceptor Attestation). As indicated on the form, additional information is needed if the board certification or device-specific training was completed more than 7 years ago.
Device-specific training may be provided by the vendor or a supervising medical physicist authorized for the requested type of use. Specific information regarding the supervising individual only needs to be provided in the table in 3.c if the training was provided by an AMP. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
If the individuals board certification was issued on or before October 24, 2005, and is listed in 10 CFR 35.57(a)(3), attach documentation that the individual performed the requested type of use on or before October 24, 2005. Also provide the dates, duration, and description of continuing education and experience for each requested type of use within the past 7 years.
Item 2.      Current Authorized Medical Physicist Seeking Additional Uses(s)
Checked above Provide the requested information (i.e., documentation of device-specific training (complete the table in 3.c) and, for an individual who did not become authorized via the board certification pathway who is seeking a new authorization, complete the Preceptor Attestation in Part II). As indicated on the form, additional information is needed if the device-specific training was completed more than 7 years ago.
Device-specific training may be provided by the vendor or a supervising medical physicist authorized for the requested type of use. Specific information regarding the supervising individual only needs to be provided in the table in 3.c if the training was provided by an AMP. If more than one supervising medical physicist provided the training, identify each supervising individual by name and provide his/her qualifications.
Item 3.      Training and Experience for Proposed Authorized Medical Physicist As indicated on the form, additional information is needed if the degree, training, and/or work experience was completed more than 7 years ago.
Submit a completed Section 3.a. Submit documentation of a graduate degree (for example, a copy of a diploma or transcript from an accredited college or university).
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Submit a completed Section 3.b. The individual must have completed 1 year of full-time training in medical physics and an additional year of full-time work experience, which cannot be concurrent. This is documented in Section 3.b by providing the ranges of dates for training and work experience.
If the proposed AMP had more than one supervisor, provide the information requested in Section 3.b for each supervising individual. If the supervising individual is not an AMP, the applicant must provide documentation that the supervising individual meets the requirements in 10 CFR 35.51 and 10 CFR 35.59.
Submit a completed Section 3.c for each specific device for which the applicant is requesting authorization.
Device-specific training may be provided by the vendor or a supervising medical physicist authorized for the requested type of use. Specific information regarding the supervising individual only needs to be provided in the table in 3.c if the training was provided by an AMP. If more than one supervising medical physicist provided the training, identify each supervising individual by name and provide his/her qualifications.
Submit a completed Preceptor Attestation in Part II.
Item 4. Training and Experience for Proposed Ophthalmic Physicist Submit a completed Section a. Submit documentation of a graduate degree (for example, a copy of a diploma or transcript from an accredited college or university).
Submit a completed Section b. The proposed ophthalmic physicist must have completed 1 year of full time training in medical physics and an additional year of full time work experience in medical physics. Provide the name of the facility where the training and the facility where the work experience took place and the name of the supervising medical physicist.
Submit a completed Section c. Document completion of specific training in each area specified in the table. If more than one supervising individual provided the training, identify each supervising individual by name and identify license or permit number where they used byproduct material.
Note: A preceptor attestation is not required for this individual.
Part II. Preceptor Attestation The Preceptor Attestation page has four sections.
The attestation to the proposed AMPs training is in the first section.
The attestation for the device-specific training is in the second section.
The attestation of the individuals ability competency to function independently fulfill the radiation safety-related duties as an AMP for the specific devices requested by the applicant is in the third section.
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The fourth and final section requests specific information about the preceptors authorizations to use licensed material, in addition to the preceptors signature.
The preceptor for a proposed new AMP must fill out all four sections of this page. The preceptor for an AMP, who did not become authorized via the board certification pathway and is seeking additional authorizations, must complete the last three sections.
VIII. AUTHORIZED NUCLEAR PHARMACIST - Specific Instructions and Guidance for Filling Out NRC Form 313A (ANP)
See Section V, General Instructions and Guidance for Filling out NRC Form 313A Series, for additional clarification on providing information about an individuals status on an Agreement State license, medical broad-scope license, or Master Materials License permit.
Part I. Training and Experience - select one of the two methods below:
Item 1.          Board Certification Provide the requested information (i.e., a copy of the board certification and a completed Preceptor Attestation). As indicated on the form, additional information is needed if the board certification occurred more than 7 years ago.
Item 2.      Structured Educational Program for a Proposed Authorized Nuclear Pharmacist As indicated on the form, additional information is needed if the training and/or supervised practical experience was completed more than 7 years ago.
Submit completed Sections 2.a and 2.b. If the proposed new nuclear pharmacist had more than one supervisor, provide the name of each supervising individual in Section 2.b.
Submit a completed Preceptor Attestation.
Part II. Preceptor Attestation The Preceptor Attestation page has two sections. The preceptor must select either the board certification or the structured educational program when filling out the provide his or her attestation in the first section on this page.
The second and final section of the page requests specific information about the preceptors authorization to use licensed material, in addition to the preceptors signature.
IX. 10 CFR 35.100, 35.200, AND 35.500 AUTHORIZED USERS - Specific Instructions and Guidance for Filling Out NRC Form 313A (AUD)
See Section V, General Instructions and Guidance for Filling out NRC Form 313A Series, for additional clarification on providing information about an individuals status on an Agreement State license, medical broad-scope license, or Master Materials License permit.
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Part I. Training and Experience - select one of the three methods below:
Item 1.      Board Certification Provide the requested information (i.e., a copy of the board certification and a completed Preceptor Attestation). As indicated on the form, additional information is needed if the board certification occurred more than 7 years ago.
Item 2. Current 35.390 Authorized User Seeking Additional 10 CFR 35.290(c)(1)(ii)(G) Authorization (a)      Fill in the blank in Section 2.a with the current license number on which the proposed user is listed.
(b)      Provide a description of the proposed users experience that meets the requirements of 10 CFR 35.290 (c)(1)(ii)(G) as shown in the table in 2.b. As indicated on the form, additional information is needed if this experience was obtained more than 7 years ago.
List each supervising individual by name and include the license showing the supervising individual as an AU or an ANP if the supervising individual for the 35.290(c)(1)(ii)(G) supervised work experience is an ANP.
Item 3.      Training and Experience for Proposed Authorized Users As indicated on the form, additional information is needed if the training and/or work experience was completed more than 7 years ago.
Note: Providing the training and experience information required under 10 CFR 35.290 will allow the individual to be authorized to use materials permitted by both 10 CFR 35.100 and 10 CFR 35.200.
Submit a completed Section 3.a for each proposed authorized use.
Submit a completed Section 3.b, except for 10 CFR 35.500 uses. If the proposed user had more than one supervisor, provide the information requested in Section 3.b for each supervising individual.
Submit a completed Section 3.c for 10 CFR 35.500 uses.
Submit a completed Preceptor Attestation, except for 10 CFR 35.500 uses.
Part II. Preceptor Attestation The Preceptor Attestation page has two sections.
The preceptor attestation is provided by either a preceptor AU or residency program director.
The attestations for training and experience requirements in 10 CFR 35.190 and 10 CFR 35.290 are found in the first section.
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The second and final section requests specific information about the preceptors authorization(s) to use licensed material, or the residency program directors attestation, and in addition to the preceptor AUs or residency program directors signature.
The preceptor AU or the residency program director must fill out both sections.
Note: The attestation of the proposed users training and ability competency to function independently fulfill the radiation safety-related duties of an AU under 10 CFR 35.1900 covers the use of material permitted by 10 CFR 35.100 only. The attestation for the proposed users training and ability competency to function independently fulfill the radiation safety related duties of an AU under 10 CFR 35.2900 will allow the individual to be authorized to use material permitted by both 10 CFR 35.100 and 10 CFR 35.200.
X.      35.300 AUTHORIZED USER - Specific Instructions and Guidance for Filling Out NRC Form 313A (AUT)
See Section V, General Instructions and Guidance for Filling out NRC Form 313A Series, for additional clarification on providing information about an individuals status on an Agreement State license, medical broad-scope license, or Master Materials License permit.
Part I. Training and Experience - select one of the three methods below:
Item 1.      Board Certification If the applicant is requesting AU identification for a nuclear medicine physician, radiologist, or radiation oncologist with a board certification listed under 10 CFR 35.300 on NRCs Web site, provide the requested information (i.e., a copy of the board certification, and documentation of supervised clinical experience (complete the table in section 3.c), and a completed Preceptor Attestation). As indicated on the form, additional information is needed if the board certification or supervised clinical experience occurred more than 7 years ago. List each supervising individual by name and include the license showing the supervising individual as an AU.
If the applicant is requesting AU identification for a radiation oncologist whose board certification is not listed under 10 CFR 35.300 on NRCs Web site, provide the requested information (i.e., a copy of the board certification listed under either 10 CFR 35.400 or 10 CFR 35.600 on NRCs Web site, documentation of training and supervised work experience with unsealed materials requiring a written directive (complete the tables in Sections 3.a and 3.b), documentation of supervised clinical experience (complete the table in Section 3.c), and a completed Preceptor Attestation). As indicated on the form, additional information is needed if the board certification, training, and supervised work experience or clinical experience occurred more than 7 years ago.
List each supervising individual by name and include the license showing the supervising individual as an AU.
If the applicant is requesting AU identification for a physician with a board certification issued on or before October 24, 2005, and that is listed in 10 CFR 35.57(b)(2)(ii), provide a copy of the board certification and documentation that the individual performed each use on or before October 24, 2005. As indicated on the form, additional information is needed if the board certification, training, and supervised work experience or clinical experience occurred more than 7 years ago.
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Item 2. Current 10 CFR 35.300, 10 CFR 35.400, or 10 CFR 35.600 Authorized User Seeking Additional Authorization Submit a completed Section 2.a, listing the license number and the users current authorizations.
If the AU applicant is currently authorized for a subset of clinical uses under 10 CFR 35.300, submit the requested information (i.e., complete the table in Section 3.c to document the new supervised clinical case experience and, if not board certified, the completed Preceptor Attestation). As indicated on the form, additional information is needed if the clinical case experience occurred more than 7 years ago. List each supervising individual by name and include the license showing the supervising individual as an AU.
If the AU applicant is currently authorized under 10 CFR 35.490 or 10 CFR 35.690 and meets the requirements in 10 CFR 35.396, submit the requested information (i.e., documentation of training and supervised work experience with unsealed materials requiring a written directive (complete the tables in Sections 3.a and 3.b), documentation of supervised clinical experience (complete the table in Section 3.c), and a completed Preceptor Attestation)). As indicated on the form, additional information is needed if the training and supervised work experience or clinical experience occurred more than 7 years ago. List each supervising individual by name and include the license showing the supervising individual as an AU.
Item 3. Training and Experience for Proposed Authorized Users This section is for proposed AUs that are neither certified by a board recognized by NRC on its web site nor a board listed in 10 CFR 35.57(b)(2)(ii).
As indicated on the form, additional information is needed if the degree, training, and/or work experience was completed more than 7 years ago.
Submit a completed Section 3.a.
Submit a completed Section 3.b. List each supervising individual by name and include the license number showing the supervising individual as an AU.
Submit a completed Section 3.c for each requested authorization. List each supervising individual by name and include the license number showing the supervising individual as an AU.
Submit a completed Preceptor Attestation in Part II.
Part II. Preceptor Attestation The Preceptor Attestation page has five sections.
The preceptor attestation is provided by either a preceptor AU or residency program director.
The attestations for training and experience requirements in 10 CFR 35.390, 10 CFR 35.392, and 10 CFR 35.394 are in the first section.
The attestation for supervised clinical experience is in the second section.
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The attestations for ability competency to function independently fulfill the radiation safety-related duties as an AU for specific uses is in the third section.
The attestation for training and experience requirements and abilitycompetency to function independently fulfill the radiation safety duties as an AU for a radiation oncologist meeting the requirements in 10 CFR 35.396 is in the fourth section.
The fifth and final section requests specific information about the preceptor AUs authorization(s) to use licensed material, or the residency program directors attestation, and in addition to the preceptor AUs or residency program directors signature.
There are seven possible categories of individuals seeking AU status under this form. Follow the instructions for the applicable category.
The preceptor for a proposed AU who is a nuclear medicine physician, radiologist, or radiation oncologist with a board certification listed under 10 CFR 35.390 on NRCs Web site must complete the first, second, third, and fifth sections.
The preceptor AU or residency program director for a proposed AU for all the uses listed in 10 CFR 35.390(b)(1)(ii)(G) who is a radiation oncologist with a board certification that is not listed under 10 CFR 35.390 on NRCs Web site or in 10 CFR 35.57(b)(2)(iii) must complete the first, second, third, and fifth sections.
The preceptor AU or residency program director for a proposed AU for 10 CFR 35.390(b)(1)(ii)(G)(iii) and (iv) uses who is a radiation oncologist with a board certification listed under 10 CFR 35.490 or 10 CFR 35.690 on NRCs Web site or in 10 CFR 35.57(b)(2)(iii) must complete the fourth and fifth sections.
The preceptor AU or residency program director for an AU who is not board certified and is currently authorized for a subset of clinical uses under 10 CFR 35.300 must complete the second, third, and fifth sections of this part, except for an AU meeting the criteria in 10 CFR 35.392 seeking to meet the training and experience requirements under 10 CFR 35.394.
The preceptor AU or residency program director for an AU who is not board certified and meetings the criteria in 10 CFR 35.392 but is seeking to meet the training and experience requirements under 10 CFR 35.394 must complete the first, second, third, and fifth sections.
The preceptor AU or residency program director for an AU currently authorized under 10 CFR 35.490 or 10 CFR 35.690 and meeting the requirements in 10 CFR 35.396 must complete the fourth, and fifth sections.
The preceptor AU or the residency program director for a proposed new AU who is not board certified must complete the first, second, third and fifth sections.
XI.      35.400 AND 35.600 AUTHORIZED USERS - Specific Instructions and Guidance for Filling Out NRC Form 313A (AUS)
See Section V, General Instructions and Guidance for Filling out NRC Form 313A Series, for additional clarification on providing information about an individuals status on an Agreement State license, medical broad-scope license, or Master Materials License permit.
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Part I. Training and Experience - select one of the three methods below:
Item 1.        Board Certification Provide the requested information (i.e., a copy of the board certification if listed on NRCs board recognition web site) for 10 CFR 35.600 uses, and documentation of device-specific training in the table in 3.e , and for all uses, a completed Preceptor Attestation. As indicated on the form, additional information is needed if the board certification or device-specific training was completed more than 7 years ago.
Device-specific training may be provided by the vendor for new users, or either a supervising AU or an AMP authorized for the requested type of use. Specific information regarding the supervising individual only needs to be provided in the table in 3.e if the training was provided by an AU or AMP. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
If the individuals board certification was issued on or before October 24, 2005, and is listed in 10 CFR 35.57(b)(2)(iii), provide a copy of the board certification and documentation that the individual performed each use on or before October 24, 2005. As indicated on the form, additional information is needed if the board certification, training, and supervised work experience or clinical experience occurred more than 7 years ago.
Item 2.      Current 10 CFR 35.600 Authorized User Requesting Additional Authorization for 10 CFR 35.600 Use(s) Checked Above Provide the requested information (i.e., documentation of device-specific training (complete the table in 3.e)) and, if not board certified, a completed Preceptor Attestation in Part II. As indicated on the form, additional information is needed if the device-specific training was completed more than 7 years ago.
Device-specific training may be provided by the vendor, a supervising AU, or an AMP authorized for the requested type of use. Specific information regarding the supervising individual only needs to be provided in the table in 3.e if the training was provided by an AU or AMP. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
Item 3.        Training and Experience for Proposed Authorized Users This section is for proposed AUs that are neither certified by a board recognized by NRC on its web site nor a board listed in 10 CFR 35.57(b)(2)(ii).
As indicated on the form, additional information is needed if the training, residency program, supervised work, and clinical experience were completed more than 7 years ago.
Submit a completed Section 3.a for each requested use.
Submit a completed Section 3.b if applying for 10 CFR 35.400 uses. However, Section 3.b does not have to be completed when only applying for use of strontium-90 for ophthalmic use.
If more than one supervising AU provided the supervised work and clinical experience, identify each supervising individual by name and provide his/her qualifications.
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Submit a completed Section 3.c if only applying for use of strontium-90 for ophthalmic use. If more than one supervising AU provided the supervised clinical experience, identify each supervising individual by name and provide his/her qualifications.
Submit a completed Section 3.d for each requested 10 CFR 35.600 use. If more than one supervising AU provided the supervised work and clinical experience, identify each supervising individual by name and provide his/her qualifications.
Submit a completed Section 3.e for each specific 10 CFR 35.600 device for which the applicant is requesting authorization.
Device-specific training may be provided by the vendor, a supervising AU, or an AMP authorized for the requested type of use. Specific information regarding the supervising individual only needs to be provided in the table in 3.e if the training was provided by an AU or AMP. If more than one supervising individual provided the training, identify each supervising individual by name and provide his/her qualifications.
Submit a completed Preceptor Attestation in Part II.
Part II. Preceptor Attestation The Preceptor Attestation part has five sections.
The preceptor attestation is provided by either a preceptor AU or the residency program director.
The attestation to the training and individuals ability to independently fulfill the radiation safety related duties as an authorized user competency for 10 CFR 35.400 uses or strontium-90 ophthalmic eye applicator use is in the first section.
The attestation to the training for the proposed AU for 10 CFR 35.600 uses is in the second section.
The attestation for the 10 CFR 35.600 device-specific training is in the third section.
The attestation of the individuals abilitycompetency to function independently fulfill the radiation safety-related duties as an AU for the specific 10 CFR 35.600 devices requested by the applicant is in the fourth section.
The fifth and final section requests specific information about the preceptors authorization(s) to use licensed material, or the residency program directors attestation, and, in addition to the preceptor AUs or residency program directors signature.
The preceptor AU or residency program director for a 10 CFR 35.400 proposed AU must fill out the first and fifth sections.
The preceptor AU or residency program director for a 10 CFR 35.600 proposed AU must fill out the second, third, fourth and fifth sections.
The preceptor AU or residency program director for an AU seeking additional 10 CFR 35.600 authorizations must complete the third, fourth, and fifth sections.
151
 
[The following redline additions to Appendix I reflect the change to 10 CFR 35.204, requiring the licensee to report breakthrough of molybdenum-99, strontium-82, and strontium-85 exceeding the limits in 10 CFR 35.204(a).
The revision also reflects the changes to 10 CFR 35.24, adding an Associate Radiation Safety Officer.]
Appendix I Typical Duties and Responsibilities of the Radiation Safety Officer and Sample Delegation of Authority Model Radiation Safety Officer Duties and Responsibilities The duties and responsibilities of the Radiation Safety Officer (RSO) include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license. Model procedures for describing the RSOs duties and responsibilities appear below.
Applicants may either adopt these model procedures or develop alternative procedures to meet the requirements of 10 CFR 35.24. As a result of implementation of the EPAct, licensed material now includes accelerator-produced radioactive materials and discrete sources of Ra-226. Licensees authorized under 10 CFR 30.32(j) to produce and noncommercially transfer PET radioactive drugs to consortium members should review the model duties and responsibilities below, expanding on them as necessary to ensure radiation safety oversight of the production and transfer only to medical use consortium members.
Typically, these duties and responsibilities include ensuring the following:
Unsafe activities involving licensed material are stopped; Radiation exposures are ALARA; Up-to-date radiation protection procedures in the daily operation of the licensees byproduct material program are developed, distributed, and implemented; Possession, use, and storage of licensed material are consistent with the limitations in the license, the regulations, the SSDR certificate(s), and the manufacturers recommendations and instructions; Individuals installing, relocating, maintaining, adjusting, or repairing devices containing sealed sources are trained and authorized by an NRC or Agreement State license; Personnel training is conducted and is commensurate with the individuals duties regarding licensed material; Documentation is maintained to demonstrate that individuals are not likely to receive, in 1 year, a radiation dose in excess of 10% of the allowable limits or that personnel monitoring devices are provided; 152
 
When necessary, personnel monitoring devices are used and exchanged at the proper intervals, and records of the results of such monitoring are maintained; Licensed material is properly secured; Documentation is maintained to demonstrate, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for members of the public; Proper authorities are notified of incidents such as loss or theft of licensed material, excess breakthrough values for Mo-99/Tc-99m or Sr-82/ Rb-82 generators, damage to or malfunction of sealed sources, and fire; Medical events and precursor events are investigated and reported to NRC, cause(s) and appropriate corrective action(s) are identified, and timely corrective action(s) are taken; Audits of the Radiation Protection Program are performed at least annually and documented; If violations of regulations, license conditions, or program weaknesses are identified, effective corrective actions are developed, implemented, and documented; Licensed material is transported, or offered for transport, in accordance with all applicable DOT requirements; Licensed material is disposed of properly; Appropriate records are maintained; and An up-to-date license is maintained, and amendment and renewal requests are submitted in a timely manner.; and Assigning tasks and duties to an ARSO, if applicable.
153
 
Model Delegation of Authority Memo To: Radiation Safety Officer From:      Chief Executive Officer
 
==Subject:==
Delegation of Authority You, _______________________________, have been appointed Radiation Safety Officer and are responsible for ensuring the safe use of radiation. You are responsible for managing the Radiation Protection Program; identifying radiation protection problems; initiating, recommending, or providing corrective actions; verifying implementation of corrective actions; stopping unsafe activities; and ensuring compliance with regulations. You are hereby delegated the authority necessary to meet those responsibilities, including prohibiting the use of byproduct material by employees who do not meet the necessary requirements and shutting down operations where justified to maintain radiation safety. You are required to notify management if staff does not cooperate and does not address radiation safety issues. In addition, you are free to raise issues with the Nuclear Regulatory Commission at any time. It is estimated that you will spend _____ hours per week conducting radiation protection activities.
____________________________________                        ____________________
Signature of Management Representative Date I accept the above responsibilities,
_____________________________________                              ____________________
Signature of Radiation Safety Officer                              Date cc: Affected department heads 154
 
Model Appointment of ARSO Memo To: Associate Radiation Safety Officer From:      Chief Executive Officer Radiation Safety Officer
 
==Subject:==
Appointment of ARSO You, _______________________________, have been appointed an Associate Radiation Safety Officer and the Radiation Safety Officer with written agreement from management will assign specific oversight duties and tasks. These duties and tasks are restricted to the types of use for which you are listed on our license.
You are free to raise issues with the Nuclear Regulatory Commission at any time. It is estimated that you will spend _____ hours per week conducting Associate Radiation Safety Officer duties and tasks.
You will report to the Radiation Safety Officer, who retains responsibility for oversight of the entire radiation safety program.
____________________________________                          ____________________
Signature of Management Representative                            Date
____________________________________                          _____________________
Signature of Radiation Safety Officer                            Date cc: Affected department heads 155
 
[The following redline additions to Appendix J reflect changes to 10 CFR 35.2, 35.24, and 35.433 adding an Associate Radiation Safety Officer and ophthalmic physicist. The revision also reflects changes to 10 CFR 35.610 requiring vendor operational and safety training for remote afterloader, teletherapy, and gamma stereotactic radiosurgery units.]
Appendix J Model Training Program Model procedures for describing training programs appear below. These models provide examples of topics to be chosen for training, based on the experience, duties, and previous training of trainees. The topics chosen will depend on the purpose of the training, the audience, and the state of learning (background knowledge) of the audience. These models also may be useful to identify topics for annual refresher training. Refresher training should include topics with which the individual is not involved frequently and topics that require reaffirmation. Topics for refresher training need not include review of procedures or basic knowledge that the trainee routinely uses. Applicants may either adopt these model procedures or develop an alternative program to meet NRC requirements. Guidance on requirements for training and experience for AMPs and AUs for medical use who engage in certain specialized practices is also included.
Note: With the implementation of the EPAct, the NRC now has regulatory authority for accelerator-produced radioactive material and discrete sources of Ra-226. Personnel should be provided new training on the application of the NRC requirements and license conditions to these materials when NRCs waiver of August 31, 2005, is terminated for the medical use facility. The waiver was terminated on November 30, 2007, for Government agencies, Federally recognized Indian tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana. The appropriate NRC Regional Office should be contacted to confirm the waiver termination date for other medical use facilities.
Model Training Program for Medical and Nonmedical Uses of Radionuclides, Sealed Sources, and Medical Devices Containing Sealed Sources Personnel will receive instruction before assuming duties with, or in the vicinity of, radioactive materials during annual refresher training, and whenever there is a significant change in duties, regulations, terms of the license, or type of radioactive material or therapy device used.
Records of worker training will be maintained for at least 3 years. The training records will include the date of the instruction or training and the name(s) of the attendee(s) and instructor(s).
Training for Individuals Involved in the Medical Usage of Byproduct Material Training for professional staff (e.g., AU, AMP, ophthalmic physicist, ANP, RSO, ARSO, nurse, dosimetrist, technologist, therapist) may contain the following elements for those who provide or are involved in the care of patients during diagnostic or therapeutic procedures, commensurate with their duties:
Basic radiation biology (e.g., interaction of ionizing radiation with cells and tissues);
156
 
Basic radiation protection to include concepts of time, distance, and shielding; Concept of maintaining exposure ALARA (10 CFR 20.1101);
Risk estimates, including comparison with other health risks; Posting requirements (10 CFR 20.1902);
Proper use of personnel dosimetry (when applicable);
Access control procedures (10 CFR 20.1601, 10 CFR 20.1802);
Proper use of radiation shielding, if used; Patient release procedures (10 CFR 35.75);
Instruction in procedures for notification of the RSO and AU, when responding to patient emergencies or death, to ensure that radiation protection issues are identified and addressed in a timely manner. The intent of these procedures should in no way interfere with or be in lieu of appropriate patient care (10 CFR 19.12, 10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610);
Occupational dose limits and their significance (10 CFR 20.1201);
Dose limits to the embryo/fetus, including instruction on declaration of pregnancy (10 CFR 20.1208);
Workers right to be informed of occupational radiation exposure (10 CFR 19.13);
Each individuals obligation to report unsafe conditions to the RSO (10 CFR 19.12);
Applicable regulations, license conditions, information notices, bulletins, etc.
(10 CFR 19.12);
Where copies of the applicable regulations, the NRC license, and its application are posted or made available for examination (10 CFR 19.11);
Proper recordkeeping required by NRC regulations (10 CFR 19.12);
Appropriate surveys to be conducted (10 CFR 20.1501);
Proper calibration of required survey instruments (10 CFR 20.1501);
Emergency procedures; Decontamination and release of facilities and equipment (10 CFR 20.1406, 10 CFR 30.36);
Dose to individual members of the public (10 CFR 20.1301); and Licensees operating procedures (e.g., survey requirements, instrument calibration, waste management, sealed-source leak testing) (10 CFR 35.27, 10 CFR 30.32(a)(3)).
Training for Individuals Involved in Nonmedical Usage of Byproduct Material Training for staff working with byproduct material for nonmedical uses or animals containing byproduct material may include, as appropriate, the elements that are listed above for medical uses. Licensees authorized under 10 CFR 30.32(j) to produce PET radioactive drugs for noncommercial transfer to other medical use licensees in the consortium should also provide training on the production of PET radioactive drugs and special requirements in 10 CFR 30.32(j) 157
 
and 10 CFR 30.34(j) for this activity. All training should be commensurate with the individuals duties.
Training for the Staff Directly Involved in Administration to or Care of Patients Administered Byproduct Material for which a Written Directive Is Required (Including Greater-than-30 microcuries of I-131), or Therapeutic Treatment Planning Note: Byproduct material now includes accelerator-produced radionuclides and discrete sources of Ra-226.
In addition to the topics identified above, the following topics may be included in instruction for staff involved in the therapy treatment of patients (e.g., nursing, RSO, AMP, AU, and dosimetrist), commensurate with their duties:
Leak testing of sealed sources (10 CFR 35.67 and 10 CFR 35.1000, as applicable);
Emergency procedures (including emergency response drills) (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610, and 10 CFR 35.1000, as applicable);
Operating instructions (10 CFR 35.27, 10 CFR 35.610, and 10 CFR 35.1000, as applicable);
Computerized treatment planning system (10 CFR 35.657 and 10 CFR 35.1000, as applicable);
Dosimetry protocol (10 CFR 35.630 and 10 CFR 35.1000, as applicable);
Detailed pretreatment quality assurance checks (10 CFR 35.27, 10 CFR 35.610, and 10 CFR 35.1000, as applicable);
Safe handling (when applicable) of the patients dishes, linens, excretions (saliva, urine, feces), and surgical dressings that are potentially contaminated or that may contain radioactive sources (10 CFR 35.310, 10 CFR 35.410);
Patient control procedures (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610, and 10 CFR 35.1000, as applicable);
Visitor control procedures, such as visitors stay times and safe lines in radiation control areas (patients room) (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610);
Licensees WD Procedures, to ensure that each administration is in accordance with the WD, patient identity is verified, and where applicable, attention is paid to correct positioning of sources and applicators to ensure that treatment is to the correct site (or, for GSR, correct positioning of the helmet) (10 CFR 35.41 and 10 CFR 35.1000, as applicable);
Proper use of safety devices and shielding to include safe handling and shielding of dislodged sources (or, in the case of remote afterloaders, disconnected sources)
(10 CFR 35.410, 10 CFR 35.610, and 10 CFR 35.1000, as applicable);
Size and appearance of different types of sources and applicators (10 CFR 35.410, 10 CFR 35.610, and 10 CFR 35.1000, as applicable);
Previous incidents, events, and/or accidents; and For remote afterloaders, teletherapy units, and GSR units, vendor training (prior to first use of a new unit or after manufacturer upgrades that affect operation and safety of the 158
 
unit) and licensee operational safety training (to new staff and annually to all individuals operating the unit) that is device model-specific and includes (10 CFR 35.610):
Design, use, and function of the device, including safety systems and interpretation of various error codes and conditions, displays, indicators, and alarms; Hands-on training in actual operation of the device under the direct supervision of an experienced user, including dry runs (using dummy sources) of routine patient set-up and treatment and implementation of the licensees emergency procedures; A method, such as practical examinations, to determine each trainees competency to use the device for each type of proposed use.
Additional Training for Authorized Medical Physicists and Ophthalmic Physicists Applicants for licenses to include AMPs and ophthalmic physicists who plan to engage in certain tasks requiring special training should ensure that the AMP is trained in the activities specific to the different types of uses listed in 10 CFR 35.51(b)(1) and 35.433 and that the ophthalmic physicist is trained in the activities specific to 10 CFR 35.433. Note, for example, that additional training is necessary for AMP planning tasks such as remote afterloader therapy, teletherapy, GSR therapy, the use of the treatment planning system that applicants contemplate using, as well as the calculation of activity of Sr-90 sources used for ophthalmic treatments and assisting the licensee in developing, implementing and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive (10 CFR 35.433).
Medical physicists must also have training for the type(s) of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system, as required in 10 CFR 35.51(c).
Additional Training for Authorized Users for Medical Uses of Byproduct Materials for Which a Written Directive Is Required Applicants for licenses should carefully consider the type of radiation therapy that is contemplated. In addition to the training and experience requirements of 10 CFR 35.390, 10 CFR 35.394, 10 CFR 35.396, 10 CFR 35.490, 10 CFR 35.491, and 10 CFR 35.690, and 10 CFR 35.1000, as applicable, attention should be focused on the additional training and experience necessary for treatment planning and quality control systems, and clinical procedures. Refer to the training and experience requirements associated with specialized uses discussed in Sections 35.390, 35.490, 35.491, and 35.690, and 35.1000, as applicable, of 10 CFR Part 35.
Training for Ancillary Staff For the purposes of this section, ancillary staff includes personnel engaged in janitorial and/housekeeping duties, dietary, laboratory, security, and life-safety services. The training program for ancillary staff performing duties that are likely to result in a dose in excess of 1 mSv (100 mrem) will include instruction commensurate with potential radiological health protection problems present in the work place. Alternatively, prohibitions on entry into controlled or restricted areas may be applied to ancillary personnel unless escorted by trained personnel.
Topics of instruction may include the following:
159
 
Storage, transfer, or use of radiation and/or radioactive material (10 CFR 19.12);
Potential biological effects associated with exposure to radiation and/or radioactive material, precautions or procedures to minimize exposure, and the purposes and functions of protective devices (e.g., basic radiation protection concepts of time, distance, and shielding) (10 CFR 19.12);
The applicable provisions of NRC regulations and licenses for the protection of personnel from exposure to radiation and/or radioactive material (e.g., posting and labeling of radioactive material) (10 CFR 19.12);
Responsibility to report promptly to the licensee any condition that may lead to or cause a violation of NRC regulations and licenses or unnecessary exposure to radiation and/or radioactive material (e.g., notification of the RSO regarding radiation protection issues)
(10 CFR 19.12);
Appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material (10 CFR 19.12);
Radiation exposure reports that workers may request, as per 10 CFR 19.13 (10 CFR 19.12).
160
 
[Redline/strikeout revisions are shown below for several sections of Appendix L. An explanation is provided in at the beginning of each section.]
Appendix L Model Medical Licensee Audit
[The following redline/strikeout revisions to the Organization and Scope of Program section of Appendix L reflect the change to 10 CFR 35.24 adding an Associate Radiation Safety Officer; the changes to 10 CFR 35.65 to prohibit bundling of single sources and clarify that calibration, transmission, or references sources may be used for medical use in accordance with the requirements of 35.500; and changes to 10 CFR 35.400, 35.500, and 35.600 requiring sources be used in accordance with the radiation safety conditions and limitations described in the Sealed Source Device Registration not as approved in the Sealed Source Device Registration. The Organization and Scope of Program section of Appendix L begins on page L-1 of the printed copy of NUREG-1556, Vol. 9, Rev. 2.]
Organization and Scope of Program A. Radiation Safety Officer:
: 1. If the RSO was changed, was the license amended [35.13]?
: 2. Does the new RSO meet NRC training requirements [35.50, 35.57, 35.59]?
: 3. If the scope of the program expands, does the RSO have training in radiation safety, regulatory issues, and emergency procedures for the new uses [35.50(e)]?
: 4. Is the RSO fulfilling all responsibilities duties [35.24]?
: 5. Is the written agreement in place for a new RSO [35.24(b)]?
B. Associate Radiation Safety Officer:
: 1. If the ARSO was changed, was the license amended [35.13]?
: 2. Does the new ARSO meet NRC training requirements [35.50, 35.57, 35.59]?
: 3. If the scope of the program expands and the RSO intends to assign duties for the expanded program, does the ARSO have training in radiation safety, regulatory issues, and emergency procedures for the new uses [35.50(d)]?
: 4. Is the ARSO fulfilling all duties and tasks [35.24]?
: 5. Is the written appointment in place for a new ARSO [35.24(b)]?
161
 
CB. Multiple places of use? If yes, list locations.
DC. Are all locations listed on license? Includes locations of accelerator-produced radioactive materials and discrete sources of radium-226?
ED. Were annual audits performed at each location? If no, explain.
FE. Describe the scope of the program (staff size, number of procedures performed, etc.).
GF. Licensed Material:
: 1. Isotope, chemical form, quantity, and use as authorized? Includes accelerator-produced radioactive materials and discrete sources of radium-226?
: 2. Does the total amount of radioactive material possessed require financial assurance
[30.35(a)]? If so, is the financial assurance adequate?
: 3. Calibration, transmission, and reference sources [35.65]?
: a. Sealed sources manufactured and distributed by a person licensed pursuant to 10 CFR 32.74, equivalent Agreement State regulations, or redistributed by a licensee authorized to redistribute sealed sources, and sources do not exceed 30 millicuries each [35.65(a)(1) and (2b)]?
: b. Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 15 millicuries [35.65(a)(3c)]?
: c. Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 200 microcuries or 1000 times the quantities in Appendix B of Part 30 [35.65(a)(4d)]?
: d. Technetium-99m in individual amounts as needed [35.65(a)(5e)]?
: e. The sealed sources are not combined (bundled or aggregated) to create an activity greater than the maximum activity listed above?
: f. The sources are not used for medical use except in accordance with the requirements in 35.500 [35.65(b)(1)]?
: 4. Unsealed materials used under 10 CFR 35.100, 35.200, and 35.300 are:
: a. Obtained from a manufacturer or preparer licensed under 10 CFR 32.72?
OR
: b. Obtained from a producer of PET radioactive drugs under 10 CFR 30.32(j)?
OR
: c. Prepared by a physician AU, an ANP, or an individual under the supervision of an ANP or physician AU?
OR 162
: d. Obtained and prepared for research in accordance with 10 CFR 35.100, 10 CFR 35.200, and 10 CFR 35.300, as applicable?
: 5. Production of PET radioactive drugs Authorized under 10 CFR 30.32(j)?
For internal use from licensees PET radionuclide production facility as authorized in 10 CFR 35.100(b), 35.200(b), or 35.300(b)?
HG. Are the sealed sources possessed and used under 35.400, 35.500, and 35.600 approved as described in the Sealed Source and Device Registry (SSDR) certificate in 10 CFR 32.210, 35.400, 35.500, 35.600? Are the sealed sources used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry? Are copies of (or access to) SSDR certificates possessed? Are manufacturers manuals for operation and maintenance of medical devices possessed?
IH. Are there sealed sources containing accelerator-produced radioactive materials or discrete sources of radium-226 that do not have an SSDR certificate? If the sealed source is not generally licensed or exempt from licensing, seek a license amendment providing information under 10 CFR 32(g)(2) or (3).
JI. Are the actual uses of medical devices consistent with the authorized uses listed on the license?
KJ. If places of use changed, was the license amended [35.13(e)]?
LK. If control of the license was transferred or bankruptcy filed, was NRCs prior consent obtained or notification made [30.34(b) and 30.34(h) respectively]?
[The following redline additions to the Radiation Safety Program section of Appendix L reflect a change to 10 CFR 35.12 describing information needed for 10 CFR 35.1000 medical uses. The Radiation Safety Program section of Appendix L appears on page L-3 of the printed copy of NUREG-1556, Vol. 9, Rev. 2.]
Radiation Safety A. Minor changes to program [10 CFR 35.26 or, if license condition permits, changes conforming to revised licensing guidance for 10 CFR 35.1000 medical uses]?
B. Records of changes maintained for 5 years [35.2026]?
C. Content and implementation reviewed annually by the licensee [20.1101(c)]?
D. Records of reviews maintained [20.2102]?
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E. Changes include addition of accelerator-produced radioactive materials or discrete sources of radium-226 to NRC-regulated Radiation Safety Program?
F. Changes include authorization to produce PET radioactive drugs for noncommercial distribution to other medical use licensees in the consortium [10 CFR 30.32(j)]?
[The following redline additions to the Use by Authorized Individuals section of Appendix L reflect changes to 10 CFR 35.57 including a numbering change and provision to grandfather individuals that were certified by boards listed in NRC regulations prior to March 30, 2005, and the change to 10 CFR 35.433 adding ophthalmic physicist. The Use by Authorized Individuals section of Appendix L begins on page L-3 of the printed copy of NUREG-1556, Vol. 9, Rev. 2]
Use by Authorized Individuals Compliance is established by meeting at least one criterion under each category.
A. Authorized Nuclear Pharmacist [35.55, 35.57, 35.59] (Note: Does not apply to facilities that are registered with FDA as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a) or registered with the State as a drug manufacturer or PET drug production facility with distribution regulated under 10 CFR 32.72):
_____ 1.        Certified by specialty board?
_____ 2.        Identified on NRC or Agreement State license?
_____ 3.        Identified on permit issued by broad-scope or master materials licensee?
_____ 4.        Identified on permit issued by master materials permittee of broad scope?
_____ 5.        Identified as an ANP by a commercial nuclear pharmacy that has been authorized to identify ANPs?
_____ 6.        Designated as an ANP in accordance with 10 CFR 32.72(b)(4)?
_____ 7.        Meets requirements in 35.57(a)(43)?
_____ 8.        Listed on facility license?
B. Authorized User [35.57, 35.59, and 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, 35.590, 35.690]:
_____ 1.        Certified by specialty board whose certification process has been recognized under 10 CFR 35.190(a), 35.290(a), 35.390(a), 35.392(a),
35.394(a), 35.490(a), 35.590(a), or 35.690(a)?
164
 
_____ 2.      Identified on NRC or Agreement State license?
_____ 3.      Identified on permit issued by broad-scope or master materials licensee?
_____ 4.      Identified on permit issued by master materials permittee of broad scope?
_____ 5.      Meets requirements in 35.57(b)(2) or (b)(3)?
_____ 6.      Listed on facility license?
C. Authorized Medical Physicist [35.51, 35.57, 35.59]:
_____ 1.      Certified by specialty board whose certification process has been recognized under 10 CFR 35.51(a)?
_____ 2.      Identified on NRC or Agreement State license?
_____ 3.      Identified on permit issued by broad-scope or master materials licensee?
_____ 4.      Identified on permit issued by master materials permittee of broad scope?
_____ 5.      Meets requirements in 35.57(a)(3) or (a)(4)?
_____ 6.      Listed on facility license?
_____ 7.      If applicable, performs tasks described in 10 CFR 35.433(b)?
D. Ophthalmic Physicist
_____ 1.      Meets requirements in 10 CFR 35.433(a)(2)?
_____ 2.      Listed on facility license?
_____ 3.      Performs tasks described in 10 CFR 35.433(b)?
E. Nonmedical use authorized users [30.33(a)(3)]:
_____ Listed on facility license for same materials and uses?
[The following redline additions to the Notifications Since Last Audit section of Appendix L reflect the changes to 10 CFR 35.24 and 35.433 adding an Associate Radiation Safety Officer and Ophthalmic Physicist.
The Notifications Since Last Audit section of Appendix L appears on page L-5 of the printed copy of NUREG-1556, Vol. 9, Rev. 2.]
Notifications Since Last Audit [35.14]
A. Any Notifications since last audit [35.14]?
B. Appropriate documentation provided to NRC, for ANP, AMP, ophthalmic physicist, or AU, no later than 30 days after the individual starts work [35.14(a), 30.34(j)(4)]?
165
 
C. NRC notified within 30 days after: AU, ANP, AMP, ophthalmic physicist, or RSO/ARSO stops work or changes name; licensees mailing address changes; licensees name changes without a transfer of control of the license; or licensee has added to or changed an area of use for 10 CFR 35.100 or 35.200 use, if the change does not include addition or relocation of either an area where PET radionuclides are produced or a radionuclide delivery line from a PET radionuclide production area; the licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number [35.14(b)]?
[The following redline/strikeout revisions to the Training, Retraining and Instructions to Workers section of Appendix L reflect the change to 10 CFR 35.610 requiring vendor operational and safety training to be provided prior to the first use of a new or upgraded remote afterloader, teletherapy, or gamma stereotactic radiosurgery unit. The Training, Retraining, and Instructions to Workers section of Appendix L begins on page L-5 of the printed copy of NUREG-1556, Vol. 9, Rev. 2.]
Training, Retraining, and Instructions to Workers A. Have workers been provided with required instructions [19.12, 35.27, 35.310, 35.410, 35.610]?
B. Have workers been informed of NRCs regulatory authority for accelerator-produced radioactive materials and discrete sources of radium-226?
C. Is the individuals understanding of current procedures and regulations adequate?
D. Is the training program implemented?
: 1. Operating procedures [35.27, 35.310, 35.410, 35.610]?
: 2. Emergency procedures [35.27, 35.310, 35.410, 35.610]?
: 3. Periodic training required and implemented [35.310, 35.410, 35.610]?
: 4. Vendor operational and safety training provided prior to first patient treatment of a new or upgraded remote afterloader, teletherapy, or gamma stereotactic radiosurgery unit [35.610]?
: 54. Were all workers who are likely to exceed 1 mSv (100 mrem) in a year instructed and was refresher training provided, as needed [19.12]?
: 65. Was each supervised user instructed in the licensees written radiation protection procedures and administration of written directives, as appropriate [35.27]?
: 76. Are initial and periodic training records maintained for each individual [35.2310]?
166
: 87. Briefly describe training program.
E. Do additional therapy device instructions/training include:
: 1. Unit operation, inspection, associated equipment, survey instruments?
: 2. License conditions applicable to the use of the unit?
: 3. Emergency drills [35.610]?
F. 10 CFR Part 20 - Are workers cognizant of requirements for:
: 1. Radiation Safety Program [35.24, 35.26, 20.1101]?
: 2. Annual dose limits [20.1201, 20.1301, 20.1302]?
: 3. NRC Forms 4 and 5?
: 4. 10% monitoring threshold [20.1502]?
: 5. Dose limits to embryo/fetus and declared pregnant worker [20.1208]?
: 6. Grave Danger Posting [20.1902(c)]?
: 7. Procedures for opening packages [20.1906]?
G. Is supervision of individuals by AU and/or ANP in accordance with 10 CFR 35.27?
[The following redline/strikeout revisions to the Dose or Dosage Measuring Equipment section of Appendix L reflect the change to 10 CFR 35.204 requiring the licensee to report breakthrough of molybdenum-99, strontium-82, and strontium-85 exceeding the limits in 10 CFR 35.204(a).
The Dosage or Dosage Measuring Equipment section of Appendix L begins on page L-7 of the printed copy of NUREG-1556, Vol. 9, Rev. 2.]
Dose or Dosage Measuring Equipment A. Possession, use, and calibration of instruments to measure activities of unsealed radionuclides [35.60] or PET radioactive drugs produced by licensee [30.34(j)]:
: 1. Types of equipment listed?
: 2. Approved procedures for use of instrumentation followed?
: 3. Constancy, accuracy, linearity, and geometry dependence tests performed in accordance with nationally recognized standards or the manufacturers instructions?
: 4. Instrument repaired or replaced or dosages mathematically corrected, as required, when tests do not meet the performance objectives provided in the nationally recognized standard or manufacturers instructions (e.g., +/-10%)?
: 5. Records maintained and include required information [35.2060]?
167
 
B. Determination of dosages of unsealed byproduct material [35.63, 30.34(j)]?
: 1. Each dosage determined and recorded prior to medical use [35.63(a)]? Or transfer
[30.34(j)]?
: 2. Measurement of unit dosages of photon- or beta-emitting radionuclides made either by direct measurement or by decay correction [35.63(b), 30.34(j)(2)(ii)]?
: 3. Measurement of unit dosage of alpha-emitting radionuclide by decay correction of the activity provided by the producer licensed in accordance with 10 CFR 32.72 or 30.32(j)?
: 4. For other than unit dosages of photon- or beta-emitting radionuclides, measurement made by direct measurement of radioactivity or by combination of radioactivity or volumetric measurement and calculation [35.63(c), 30.34(j)(2)(ii)]?
: 5. For other than unit dosages of alpha-emitting radionuclide, measurement made by combination using the activity provided by the producer licensed in accordance with 10 CFR 32.72, or 30.32(j) volumetric measurement, and calculation [35.63(c)]?
C. Licensee uses generators?
: 1. EachFirst eluate after receipt tested for Mo-99 breakthrough [35.204(b)]?
: 2. No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 µCi per mCi of Tc-99m [35.204(a)(1)]?
: 3. Before first patient use of the dayFirst eluate after receipt tested for strontium-82 and strontium-85 when eluting rubidium-82 [35.204(c)]?
: 4. No radiopharmaceuticals administered with strontium-82 concentrations over 0.02 µCi per mCi of rubidium-82 or strontium-85 concentrations over 0.2 µCi per mCi of rubidium-82 [35.204(a)(2)]?
: 5. Each measurement that exceeds the limits in paragraph 2 or 4 above reported to NRC and distributor of the generator in accordance with § 35.3204?
: 65. Records maintained [35.2204]?
D. Dosimetry Equipment [35.630]:
: 1. Calibrated system available for use [35.630(a)]?
: 2. Calibrated by NIST or an AAPM-accredited lab within previous 2 years and after servicing [35.630(a)(1)] OR calibrated by intercomparison per 10 CFR 35.630(a)(2)?
: 3. Calibrated within the previous 4 years [35.630(a)(2)]?
: 4. Licensee has available for use a dosimetry system for spot-check measurements
[35.630(b)]?
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: 5. Record of each calibration, intercomparison, and comparison maintained [35.2630]?
[The following redline/strikeout revisions to the Teletherapy and Gamma Stereotactic Radiosurgery section of Appendix L reflect the change to 10 CFR 35.655 updating the intervals at which full-inspection servicing is required for teletherapy and gamma stereotactic radiosurgery units. The Teletherapy and Gamma Stereotactic Radiosurgery Servicing section of Appendix L appears on page L-13 of the printed copy of NUREG-1556, Vol.
9, Rev. 2.]
Teletherapy and Gamma Stereotactic Radiosurgery Full-inspection Servicing A. Full iInspection and servicing performed during source replacement at intervals not to exceed 5 years for each teletherapy unit and not to exceed 7 years for each gamma stereotactic radiosurgery unit [35.655(a)]?
B. Needed service arranged for as identified during the inspection?
C. Service performed by persons specifically authorized to do so [35.655(b)]?
[The following redline/strikeout revisions to the Notification and Reports section of Appendix L reflect the change to 10 CFR 35.204, requiring the licensee to report breakthrough of molybdenum-99, strontium-82, and strontium-85 exceeding the limits in 10 CFR 35.204(a). The Notifications and Reports section of Appendix L appears on page L-19 of the printed copy of NUREG-1556, Vol. 9, Rev. 2.]
Notification and Reports (this now includes notifications and reports for accelerator-produced radioactive materials and discrete sources of radium-226)
A. In compliance with 10 CFR 19.13, and 10 CFR 30.50 (reports to individuals, public and occupational, monitored to show compliance with Part 20)?
B. In compliance with 10 CFR 20.2201, and 10 CFR 30.50 (theft or loss)?
C. In compliance with 10 CFR 20.2202, and 10 CFR 30.50 (incidents)?
D. In compliance with 10 CFR 20.2203, and 10 CFR 30.50 (overexposure and high radiation levels)?
E. In compliance with 10 CFR 35.204(e) (generator eluate that exceeds breakthrough levels)?
FE. Aware of NRC Operations Center telephone number?
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FG. In compliance with 10 CFR 20.2203 (constraint on air emissions)
[The following redline/strikeout revisions to Appendix S reflect the change to 10 CFR 35.40 adding separate written directive requirements for permanent implant brachytherapy.]
Appendix S Model Procedures for Developing, Maintaining, and Implementing Written Directives With the implementation of the EPAct, the NRC now has regulatory authority over accelerator-produced radioactive materials and discrete sources of radium-226. Therefore, the requirements for written directives and procedures to assure that administrations are in accordance with these written directives also apply to the medical use of accelerator-produced radioactive materials and discrete sources of radium-226 after NRCs waiver of August 31, 2005, is terminated for medical use facilities. The NRC waiver that applied to Government agencies, Federally recognized Indian tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana was terminated on November 30, 2007. The NRC Regional Offices should be contacted to confirm the waiver termination date for other medical use facilities.
This model provides acceptable procedures for administrations that require written directives (WDs). Applicants may either adopt this model procedure or develop their own procedure to meet the requirements of 10 CFR 35.40 and 10 CFR 35.41.
Written Directive Procedures This model provides guidance to licensees and applicants for developing, maintaining, and implementing procedures for administrations that require WDs. This model does not restrict the use of other guidance in developing, implementing, and maintaining written procedures for administrations requiring a WD. Such procedures are to provide high confidence that the objectives specified in 10 CFR 35.41 will be met.
The WD must be prepared for any administration of I-131 sodium iodide greater than 1.11 MBq (30 µCi), any therapeutic dosage of a radiopharmaceutical, and any therapeutic dose of radiation from byproduct material. The WD must contain the information described in 10 CFR 35.40 and be retained in accordance with 10 CFR 35.2040.
Discussion The administration of radioactive materials can be a complex process for many types of diagnostic and therapeutic procedures in nuclear medicine or radiation oncology departments.
A number of individuals may be involved in the delivery process. For example, in an oncology 170
 
department, when the authorized user (AU) prescribes a teletherapy treatment, the delivery process may involve a team of medical professionals such as an authorized medical physicist (AMP), a dosimetrist, and a radiation therapist. Treatment planning may involve a number of measurements, calculations, computer-generated treatment plans, patient simulations, portal film verifications, and beam-modifying devices to deliver the prescribed dose. Therefore, instructions must be clearly communicated to the professional team members with constant attention devoted to detail during the treatment process. Complicated processes of this nature require good planning and clear, understandable procedures. To help ensure that all personnel involved in the treatment fully understand instructions in the WD or treatment plan, the licensee should instruct all workers to seek guidance if they do not understand how to carry out the WD.
Specifically, workers should ask if they have any questions about what to do or how it should be done before administration, rather than continuing a procedure when there is any doubt.
Licensees should also consider verification of WDs or treatment plans by at least one qualified person (e.g., an oncology physician, AMP, nuclear medicine technologist, or radiation therapist),
preferably other than the individual who prepared the dose, the dosage, or the treatment plan.
The administration of radioactive materials, including the administration of accelerator-produced radioactive materials and discrete sources of radium-226, can involve a number of treatment modalities (e.g., radiopharmaceutical therapy, teletherapy, brachytherapy, gamma stereotactic radiosurgery (GSR), and future emerging technologies). For each such modality for which 10 CFR 35.40 requires, or would require, a WD (as defined in 10 CFR 35.2), the licensee should develop, implement, and maintain written procedures to meet the requirements and/or objectives of 10 CFR 35.40, 35.41, and 35.63, outlined below:
Have an AU date and sign a WD, prior to the administration, that includes the information in 10 CFR 35.40(b), including the name of the patient or human research subject; Verify the identity of the patient or human research subject prior to each administration; Verify that the administration is in accordance with the treatment plan, if applicable, and the WD; Check both manual and computer-generated dose calculations; Verify that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical devices authorized by 10 CFR 35.60 or 35.1000; Determine if a medical event, as defined in 35.3045 has occurred; Determine for permanent implant brachytherapy, within 60 calendar days from the date of implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implant portion of the written directive; and Determine and record the activity of the radiopharmaceutical dosage or radiation dose before medical use.
The following procedures are provided as assistance in meeting the above objectives.
Procedures for Any Therapeutic Dose or Dosage of a Radionuclide, Including Doses or Dosages of Accelerator-Produced Radioactive Materials and Discrete 171
 
Sources of Radium-226, or Any Dosage of Quantities Greater than 30 Microcuries of I-131 Sodium Iodide Develop, implement, and maintain the following procedures to meet the objectives of 10 CFR 35.40 and 10 CFR 35.41:
An AU must date and sign a WD prior to the administration of any dose or dosage.
Written directives may be maintained in patients charts.
Prior to administering a dose or dosage, the identity of a patient or human research subject will be positively verified as the individual named in the WD. Examples of positive patient identity verification include examining the patients ID bracelet, hospital ID card, drivers license, or Social Security card. Asking or calling the patients name does not constitute positive patient identity verification.
The specific details of the administration will be verified, including the dose or dosage, in accordance with the WD or treatment plan. All components of the WD (radionuclide, total dose or dosage, etc.) will be confirmed by the person administering the dose or dosage to verify agreement with the WD. Appropriate verification methods include: measuring the activity in the dose calibrator, checking the serial number of the sealed sources behind an appropriate shield, using color-coded sealed sources, or using clearly marked storage locations.
Additional Procedures for Sealed Therapeutic Sources and Devices Containing Sealed Therapeutic Sources (this now includes sources containing accelerator-produced radioactive materials or discrete sources of radium-226)
Licensees are required under 10 CFR 35.40 and 10 CFR 35.41 to have WDs for certain administrations of doses and to have procedures for administrations for which a WD is required.
Model procedures for meeting these requirements appear below.
A. To ensure that the dose is delivered in accordance with the WD, the AU (and the neurosurgeon for GSR therapy) must date and sign (indicating approval of) the treatment plan that provides sufficient information and direction to meet the objectives of the WD.
B. For sealed sources inserted into the patients body, radiographs or other comparable images (e.g., computerized tomography) will be used as the basis for verifying the position of the nonradioactive dummy sources and calculating the administered dose before administration. However, for some brachytherapy procedures, the use of various fixed geometry applicators (e.g., appliances or templates) may be required to establish the location of the temporary sources and to calculate the exposure time (or, equivalently, the total dose) required to administer the prescribed brachytherapy treatment. In these cases, radiographs or other comparable images may not be necessary, provided the position of the sources is known prior to insertion of the radioactive sources and calculation of the exposure time (or, equivalently, the total dose).
C. Dose calculations will be checked before administering the prescribed therapy dose. An AU or a qualified person under the supervision of an AU (e.g., an AMP, oncology physician, dosimetrist, or radiation therapist), preferably one who did not make the original 172
 
calculations, will check the dose calculations. Methods for checking the calculations include the following:
: 1. For computer-generated dose calculations, examining the computer printout to verify that correct input data for the patient was used in the calculations (e.g., source strength and positions).
: 2. For computer-generated dose calculations entered into the therapy console, verifying correct transfer of data from the computer (e.g., channel numbers, source positions, and treatment times).
: 3. For manually-generated dose calculations, verifying:
: a.      No arithmetical errors;
: b.      Appropriate transfer of data from the WD, treatment plan, tables, and graphs;
: c.      Appropriate use of nomograms (when applicable); and
: d.      Appropriate use of all pertinent data in the calculations.
The therapy dose will be manually calculated to a single key point and the results compared to the computer-generated dose calculations. If the manual dose calculations are performed using computer-generated outputs (or vice versa), verify the correct output from one type of calculation (e.g., computer) to be used as an input in another type of calculation (e.g., manual). Parameters such as the transmission factors for wedges and applicators and the source strength of the sealed source used in the dose calculations will be checked.
D. After implantation but before completion of the procedure or the patient leaves the post-treatment recovery area, record in the WD: For temporary implants, as required by 10 CFR 35.40(b)(7)(ii),record in the WDthe radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose).; the signature of an AU authorized for 10 CFR 35.400 uses for manual brachytherapy involving 35.400 materials or the signature of an authorized user for low, medium, and pulsed dose rate remote after loaders under 35.600 for low, medium, and pulsed dose rate remote after loaders; and the date. proceedures involving; For permanent implants, as required by 10 CFR 35.40 (b)(6)(ii), the treatment site, the number of sources implanted, the total source strength implanted, the signature of an AU for §35.400 uses for manual brachytherapy, and the date. For example, after insertion of permanent implant brachytherapy sources, an AU should promptly record the actual number of radioactive sources implanted and the total source strength. The WD may be maintained in the patients chart.
E. Acceptance testing will be performed by a qualified person (e.g., an AMP) on each treatment planning or dose calculating computer program that could be used for dose calculations. Acceptance testing will be performed before the first use of a treatment planning or dose calculating computer program for therapy dose calculations. Each treatment planning or dose calculating computer program will be assessed based on specific needs and applications. A check of the acceptance testing will also be performed 173
 
after each source replacement or when spot check measurements indicate that the source output differs by more than 5% from the output obtained at the last full calibration corrected mathematically for radioactive decay.
F. Independent checks on full calibration measurements will be performed. The independent check will include an output measurement for a single specified set of exposure conditions and will be performed within 30 days following the full calibration measurements. The independent check will be performed by either:
: 1. An individual who did not perform the full calibration (the individual will meet the requirements specified in 10 CFR 35.51) using a dosimetry system other than the one that was used during the full calibration (the dosimetry system will meet the requirements specified in 10 CFR 35.630); or
: 2. An AMP (or an oncology physician, dosimetrist, or radiation therapist who has been properly instructed) using a thermoluminescence dosimetry service available by mail that is designed for confirming therapy doses and that is accurate within 5%.
G. For GSR, particular emphasis will be directed on verifying that the stereoscopic frame coordinates on the patients skull match those of the treatment plan.
H. A physical measurement of the teletherapy output will be made under applicable conditions prior to administration of the first teletherapy fractional dose, if the patients treatment plan includes: (1) field sizes or treatment distances that fall outside the range of those measured in the most recent full calibration; or (2) transmission factors for beam-modifying devices (except nonrecastable and recastable blocks, bolus and compensator materials, and split-beam blocking devices) not measured in the most recent full calibration measurement.
I. A weekly chart check will be performed by a qualified person under the supervision of an AU (e.g., an AMP, dosimetrist, oncology physician, or radiation therapist) to detect mistakes (e.g., arithmetical errors, miscalculations, or incorrect transfer of data) that may have occurred in the daily and cumulative dose administrations from all treatment fields or in connection with any changes in the WD or treatment plan.
J. Treatment planning computer systems using removable media to store each patients treatment parameters for direct transfer to the treatment system will have each card labeled with the corresponding patients name and identification number. Such media may be reused (and must be relabeled) in accordance with the manufacturers instructions.
Review of Administrations Requiring a Written Directive (this now includes administrations of accelerator-produced radioactive materials or discrete sources of radium-226)
Conduct periodic reviews of each applicable program area (e.g., radiopharmaceutical therapy, high-dose-rate brachytherapy, implant brachytherapy, teletherapy, gamma stereotactic radiosurgery, and emerging technologies). The number of patient cases to be sampled should 174
 
be based on the principles of statistical acceptance sampling and be representative of each treatment modality performed in the institution (e.g., radiopharmaceutical, teletherapy, brachytherapy and gamma stereotactic radiosurgery).
If feasible, the persons conducting the review should not review their own work. If this is not possible, two people should work together as a team to conduct the review of that work.
Regularly review the findings of the periodic reviews to ensure that the procedures for administrations requiring a WD are effective.
As required by 10 CFR 35.41, a determination will be made as to whether the administered radiopharmaceutical dosage or radiation dose was in accordance with the WD or treatment plan, as applicable. When deviations from the WD are found, the cause of each deviation and the action required to prevent recurrence should be identified.
Reports of Medical Events (this now includes reports of events involving accelerator-produced radioactive materials or discrete sources of radium-226)
Notify by telephone the NRC Operations Center 1 no later than the next calendar day after discovery of a medical event and submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after the discovery of the medical event, as required by 10 CFR 35.3045. Also notify the referring physician and the patient as required by 10 CFR 35.3045.
1The  commercial telephone number of the NRC Operations Center is (301) 816-5100. The Center will accept collect calls.
175
 
[The following redline/strikeout revision to Appendix X reflects the change to 10 CFR 35.655 updating the intervals at which full-inspection servicing is required for teletherapy and gamma stereotactic radiosurgery units.]
Appendix X Recordkeeping Requirements With the implementation of the EPAct, the NRC now has regulatory authority over accelerator-produced radioactive materials and discrete sources of radium-226. Therefore, the recordkeeping requirements below also apply to the medical uses of accelerator-produced radioactive materials and discrete sources of radium-226 after NRCs waiver of August 31, 2005, is terminated for medical use facilities. The NRC waiver that applied to Government agencies, Federally recognized Indian tribes, Delaware, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana was terminated on November 30, 2007. The NRC Regional Offices should be contacted to confirm the waiver termination date for other medical use facilities.
Table X.1 Typical Records and Retention Times Survey      Recordkeeping Record                                                    Retention Period Requirement Requirement 20.1501; Results of surveys and calibrations                          20.2103(a)      3 years 20.1906(b)
Results of surveys to determine dose from 20.2103(b)(1)    duration of license external sources Results of measurements and calculations 20.2103(b)(2)    duration of license used to determine individual intakes Results of air samplings, surveys, and        20.1703(c)(1);
20.2103(b)(3)    duration of license bioassays                                    20.1703(c)(2)
Results of measurements and calculations used to evaluate the release of radioactive                  20.2103(b)(4)    duration of license effluents to the environment Determination of prior occupational dose                    20.2104          duration of license Planned special exposure                      20.1206        20.2105          duration of license Individual monitoring results                20.1502        20.2106          duration of license Dose to individual members of the public      20.1301        20.2107          duration of license 176
 
Table X.1 Typical Records and Retention Times Survey  Recordkeeping Record                                              Retention Period Requirement Requirement 20.2002; 20.2003; Waste disposal                                        20.2108        duration of license 20.2004; 20.2005 duration of possession and Records of receipt of byproduct material              30.51(a)(1) 3 years after transfer 3 years after Records of transfer of byproduct material              30.51(a)(2) transfer Records of disposal of byproduct material              30.51(a)(3)    duration of license Table X.1 Typical Records and Retention Times (continued)
Survey  Recordkeeping Record                                              Retention Period Requirement Requirement Authority and responsibilities of Radiation 35.24(a)  35.2024        5 years Protection Program Radiation Protection Program changes        35.26(a)  35.2026        5 years Written directives                          35.40      35.2040        3 years Procedures for administrations requiring a 35.41(a)  35.2041        duration of license written directive Calibrations of instruments used to measure activity of unsealed byproduct      35.60      35.2060        3 years material Radiation survey instrument calibrations    35.61      35.2061        3 years Dosages of unsealed byproduct material 35.63      35.2063        3 years for medical use Leak tests and inventory of sealed sources 35.67(b)  35.2067        3 years and brachytherapy sources Surveys for ambient radiation exposure 35.70      35.2070        3 years rate Release of individuals containing unsealed byproduct material or implants containing 35.75        35.2075        3 years byproduct material 177
 
Table X.1 Typical Records and Retention Times Survey      Recordkeeping Record                                                Retention Period Requirement Requirement Mobile medical services                    35.80(a)(1)  35.2080        3 years Decay-in-storage                          35.92        35.2092        3 years Molybdenum-99 or strontium-82 or 35.204(b)    35.2204        3 years strontium-85 concentrations 35.310; Safety instruction                        35.410;      35.2310        3 years 35.610 35.404; Surveys after source implant and removal                35.2404        3 years 35.604 Brachytherapy source accountability        35.406        35.2406        3 years Calibration measurements of 35.432        35.2432        3 years brachytherapy sources Decay of strontium-90 sources for 35.433        35.2433        life of source ophthalmic treatments Installation, maintenance, adjustment, and repair of remote afterloader units, 35.604        35.2605        3 years teletherapy units, and gamma stereotactic radiosurgery units duration of 35.610(a)(4);                possession of Safety procedures                                        35.2610 35.610(d)(2)                specified equipment Dosimetry equipment used with remote afterloader units, teletherapy units, and  35.630        35.2630        duration of license gamma stereotactic radiosurgery units Teletherapy, remote afterloader, and      35.632; gamma stereotactic radiosurgery full      35.633;      35.2632        3 years calibrations                              35.635 Periodic spot-checks of teletherapy units  35.642        35.2642        3 years Periodic spot-checks of remote afterloader 35.643        35.6243        3 years units Periodic spot-checks of gamma 35.645        35.6245        3 years stereotactic radiosurgery units 178
 
Table X.1 Typical Records and Retention Times Survey  Recordkeeping Record                                              Retention Period Requirement Requirement Additional technical requirements for 35.647    35.6247        3 years mobile remote afterloader units duration of use of Surveys of therapeutic treatment units      35.652    35.2652 unit Full-inspection servicing 5-year inspection duration of use of for teletherapy and gamma stereotactic      35.655    35.2655 unit radiosurgery units 179
 
[The following redline addition to Appendix Y reflects the change to 10 CFR 35.204, requiring the licensee to report breakthrough of molybdenum-99, strontium-82, and strontium-85 exceeding the limits in 10 CFR 35.204(a).]
Appendix Y Reporting Requirements With the implementation of the EPAct, the NRC now has regulatory authority over accelerator-produced radioactive materials and discrete sources of radium-226. Therefore, the reporting requirements below also apply to the medical uses of accelerator-produced radioactive materials and discrete sources of radium-226 after NRCs waiver of August 31, 2005, is terminated for medical use facilities. The NRC waiver that applied to Government agencies, Federally recognized Indian tribes, Delaware, the District of Columbia, Puerto Rico, the U.S.
Virgin Islands, Indiana, Wyoming, and Montana was terminated on November 30, 2007. The NRC Regional Offices should be contacted to confirm the waiver termination date for other medical use facilities.
Table Y.1 Typical NRC Notifications and/or Reports Telephone        Written              Regulatory Event Notification      Report            Requirement Reports to individual workers    None            annually      10 CFR 19.13(b)
Reports to former individual None            upon request  10 CFR 19.13(c) workers Notification of special None            30 days        10 CFR 19.13(d) circumstances to individuals Reports to worker terminating None            upon request  10 CFR 19.13(e) employment Theft or loss of material        immediate        30 days        10 CFR 20.2201(a)(1)(i)
Whole body dose greater than                                      10 CFR 20.2202(a)(1)(i),
immediate        30 days 0.25 Sv (25 rems)                                                10 CFR 20.2203 (a)
Extremity dose greater than                                      10 CFR 20.2202(a)(1)(iii),
immediate        30 days 2.5 Sv (250 rems)                                                10 CFR 20.2203 (a)
Whole body dose greater than                                      10 CFR 20.2202(b)(1)(i),
24 hours        30 days 0.05 Sv (5 rems) in 24 hours                                      10 CFR 20.2203 (a) 180
 
Table Y.1 Typical NRC Notifications and/or Reports Telephone        Written        Regulatory Event Notification      Report        Requirement Extremity dose greater than                                  10 CFR 20.2202(b)(1)(iii),
24 hours        30 days 0.5 Sv (50 rems) in 24 hours                                  10 CFR 20.2203(a)
Doses in excess of specified None            30 days    10 CFR 20.2203(a)(2) criteria Levels of radiation or concentrations of radioactive None            30 days    10 CFR 20.2203(a)(3) material in excess of specified criteria Planned special exposures        None            30 days    10 CFR 20.2204 Report to individuals of None            30 days    10 CFR 20.2205 exceeding dose limits Report of individual monitoring None              annually  10 CFR 20.2206 Defect in equipment that could create a substantial safety      2 days          30 days    10 CFR 21.21(d)(3)(i) hazard Event that prevents immediate protective actions necessary to avoid exposure to radioactive immediate            30 days    10 CFR 30.50(a) materials that could exceed regulatory limits Equipment is disabled or fails to function as designed when required to prevent radiation    24 hours        30 days    10 CFR 30.50(b)(2) exposure in excess of regulatory limits Unplanned fire or explosion that affects the integrity of any licensed material or device,      24 hours        30 days    10 CFR 30.50(b)(4) container, or equipment with licensed material Licensee permits individual to work as AU, ANP, Ophthalmic None                  30 days    10 CFR 35.14(a) physicist, or AMP 181
 
Table Y.1 Typical NRC Notifications and/or Reports Telephone        Written        Regulatory Event Notification      Report        Requirement AU, ANP, RSO, ARSO, Ophthalmic physicist, or AMP discontinues performance of      None            30 days    10 CFR 35.14(b)(1) duties under license or has a name change Qualified individual under 35.50 and 35.59 function as      None            30 days    10 CFR 35.14(b)(2) temporary RSO under 35.24 Licensees mailing address None            30 days    10 CFR 35.14(b)(32) changes Licensees name changes without constituting a transfer  None            30 days    10 CFR 35.14(b)(43) of control Licensee adds or changes areas of 10 CFR 35.100 or 35.200 use of byproduct material identified in application or license if the None            30 days    10 CFR 35.14(b)(54) change or addition did not involve movement of a PET radionuclide production facility or transfer line from a PET radionuclide production facility Obtains sealed source for manual brachytherapy from different manufacturer or with  None            30 days    10 CFR 35.14(b)(6) different model number than authorized on the license Medical event                    1 day            15 days    10 CFR 35.3045 Dose to embryo or nursing 1 day            15 days    10 CFR 35.3047 child Leaking source                  none            5 days    10 CFR 35.3067 Eluate exceeding permissible molybdenum-99, strontium-82, 7 days              30 days    10 CFR 35.3204 or strontium-85 concentrations 182
 
Table Y.1 Typical NRC Notifications and/or Reports Telephone        Written          Regulatory Event Notification      Report          Requirement Note: Telephone notifications shall be made to the NRC Operations Center at 301-951-0550, except as noted.
183
 
PART 2 Supplemental Guidance Effective January 2019 for NUREG-1556, Volume 13, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses 184
 
[The following redline/strikeout changes for Section 8.7.2 reflect the changes to 10 CFR 35.55 removing the preceptor attestation requirement from the nuclear pharmacist board certification pathway and changes to the attestation statement for the alternate training and experience pathway.]
: 8. AUTHORIZED NUCLEAR PHARMACIST (ANP)
Regulations:10 CFR 32.72 (b)(2), (4), and (5); 10 CFR 35.2; 10 CFR 35.55(a) and (b); and 10 CFR 35.59.
Criteria: The ANP must be a State-licensed or State-registered pharmacist with adequate training and experience.
Discussion: Each commercial nuclear pharmacy must have an ANP to prepare or supervise the preparation of radioactive drugs for medical use. An individual who is not qualified to be an ANP may work under the supervision of an ANP.
The criteria for a pharmacist to work as an ANP at a commercial radiopharmacy are described in 10 CFR 32.72(b)(2) and (4). This section of the regulation refers to the training for an ANP, which includes the definition of an ANP in 10 CFR 35.2 (which in turn includes the board certification requirements in 10 CFR 35.55(a)); the training and experience criteria for the alternate pathway described in 10 CFR 35.55(b); and the recentness of training criteria in 10 CFR 35.59 that requires the successful completion of training within 7 years preceding the date of the application. Additional training and experience may be necessary if the time interval is greater than 7 years. Applicants may find it convenient to present this documentation using NRC Form 313A (ANP) in Appendix G. Each hour of training may be listed only once, (i.e., under the most applicable category). The recentness of training requirements apply to board certification as well as to other recognized training pathways.
In implementing the EPAct, NRC grandfathered nuclear pharmacists by permitting the licensee to designate a pharmacist as an ANP, if the pharmacist used only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, in the practice of nuclear pharmacy for the uses performed before November 30, 2007, or under the NRC waiver of August 31, 2005. These individuals do not have to meet the requirements of 10 CFR 32.72(b)(2)(i) or (ii). However, the applicant must document that the individual meets the criteria in 10 CFR 32.72(b)(4).
On-the-job training may not be counted toward the hours listed above unless it was obtained as part of a formal training course. A "formal" training course is one that incorporates the following elements:
* A detailed description of the content of the course is maintained on file at the sponsoring institution and can be made available to NRC upon request;
* Evidence that the sponsoring institution has examined the students knowledge of the course content is maintained on file at the institution and can be made available to NRC upon request. This evidence of the students overall competency in the course material should include a final grade or percentile; and 185
* A permanent record that the student successfully completed the course is kept at the institution.
Response from Applicant: For each proposed ANP, provide the following:
* Name of the proposed ANP.
AND
* Pharmacists license number and issuing entity.
For an individual previously identified as an ANP on an NRC or Agreement State license or permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs (10 CFR 32.72(b)(2)(i)):
* Previous license number (if issued by NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC Master Material License broad-scope permittee on which the individual was named an ANP or a copy of an authorization as an ANP from a commercial nuclear pharmacy that has been authorized to identify ANPs, OR For an individual qualifying under 10 CFR 32.72(b)(4):
* Documentation that the individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, AND
* Documentation that the individual practiced at a pharmacy, a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC, OR For an individual qualifying under 10 CFR 35.55(a):
* Copy of the certification(s) of the specialty board whose certification process has been recognized2 under 10 CFR 35.55(a),
AND
* Written attestation, signed by a preceptor ANP, that training and experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved, 186
 
AND
* If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 32.72(b)(2)(ii):
* Description of the training and experience specified in 10 CFR 35.55(b) demonstrating that the proposed ANP is qualified by training and experience, AND
* Written attestation, signed by a preceptor ANP, that the individual has satisfactorily completed the training and experience requiredments in 10 CFR 35.55(b)(1)certification have has been satisfactorily completed and is able that a level of competency sufficient to function independently fulfill the radiation safety-related duties as an ANP has been achieved, AND
* If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Notes:
* NRC Form 313A (ANP), "Authorized Nuclear Pharmacist Training and Experience and Preceptor Attestation [10 CFR 35.55]," may be used to document training and experience for those individuals qualifying under 10 CFR 35.55(a) or (b).
* Descriptions of training and experience will be reviewed using the criteria listed above.
The NRC will review the documentation to determine if the applicable criteria in 10 CFR 32.72(b)(2) are met. If the training and experience do not appear to meet the criteria in Subpart B, the NRC may request additional information from the applicant or may request the assistance of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) in evaluating such training and experience.
187
 
[The following redline/strikeout changes to Section 8.10.6 reflect revisions to 10 CFR 30.34(g) and 35.204 adding new molybdenum-99/technetium-99m generator elution test frequencies and new reporting requirements when the Molybdenum99/technetium-99m and strontium-82/rubidium-82 generator eluates exceed breakthrough values.]
8.10.6 SAFE USE OF RADIONUCLIDES AND EMERGENCY PROCEDURES Regulations: 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2201, 10 CFR 20.2202, 10 CFR 20.2203, 10 CFR 30.34(g), 10 CFR 30.50, 10 CFR 19.11(a)(3).
Criteria: Licensees are required to do the following:
* Keep radiation doses to workers and members of the public ALARA;
* Ensure security of licensed material; and
* Make the required notifications of events to NRC.
Discussion: Licensees are responsible for the security and safe use of all licensed material from the time it arrives or is produced at their facility until its use, transfer, and/or disposal.
Licensees should develop written procedures to ensure safe use of licensed material., and tThe procedures should also include operational and administrative guidelines, as well as procedures to assure reports of events are complete and made in a timely manner in accordance with reporting requirements. See Appendix P of this NUREG. The written procedures should provide reasonable assurance that only appropriately trained personnel will handle and use licensed material without undue hazard to workers or members of the public.
General Safety Procedures The written procedures should include the following elements:
* Contamination controls;
* Waste disposal practices;
* Personnel and area monitoring (including limits);
* Use of protective clothing and equipment;
* Safe handling of radioactive materials;
* Recording requirements;
* Reporting requirements; and
* Responsibilities.
These procedures should include policies for:
* Frequency of personnel monitoring;
* Performing molybdenum-99 breakthrough measurements on each the first eluate after receipt of a molybdenum-99/technetium-99m generator; 188
* Reporting to NRC and the distributor when there is more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m) in the eluate;
* Use of appropriate shielding (see Figure 8.8);
* Frequent glove changes to minimize exposure to the individual and to avoid spread of contamination in the facility; and
* Special procedures for higher risk activities, such as use of radioiodine and repair of chemistry synthesis equipment for PET radiopharmaceuticals.
Figure 8.8 Use of Appropriate Shielding.
Applicants should also develop radionuclide-specific procedures based on the respective hazards associated with the radionuclides. General safety guidelines are described in Appendix Q. Applicants should use these guidelines to aid in the development of their own procedures for the safe use of radionuclides.
Furthermore, applicants that produce radioactive materials using an accelerator should also refer to the safety procedures found in NUREG-1556, Vol. 21, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of Radioactive Materials Using an Accelerator.
Licensees should determine if they have areas that require posting in accordance with 10 CFR 20.1902, unless they meet the exemptions listed in 10 CFR 20.1903. Also, containers of licensed material (including radioactive waste) must be labeled in accordance with 10 CFR 20.1904, unless they meet the exemptions in 10 CFR 20.1905.
189
 
Emergency Procedures Accidents and emergencies can happen during any operation with radionuclides, including their receipt, transportation, use, transfer, and disposal. Such incidents can result in contamination or release of material to the environment and unintended radiation exposure to workers and members of the public. In addition, loss or theft of licensed material, and fires involving radioactive material, can adversely affect the safety of personnel and members of the public. Applicants should therefore develop and implement procedures to minimize, to the extent practical, the potential impact of these incidents on personnel, members of the public, and the environment.
Applicants should establish written procedures to handle events ranging from a minor spill to a major accident that may require intervention by outside emergency response personnel.
These procedures should include provisions for immediate response, after-hours notification, handling of each type of emergency, equipment, and the appropriate roles of staff and the RSO. In addition, the licensee should develop procedures for routine contacts with its local fire department officials to inform them of its operations and identify locations of radioactive materials and elevated radiation levels in the event of their response to a fire. Except for minor spills or releases of radioactivity that can be controlled and cleaned up by the user, licensee staff should have a clear understanding of their limitations in an emergency with step-by-step instructions and clear direction of whom to contact. The licensee should establish clear delineations between minor contamination events, minor spills, and major spills and events.
Emergency spill response materials should be strategically placed in well-marked locations for use by all trained staff. All equipment should be periodically inspected for proper operation and replenished as necessary. Appendix Q includes model emergency procedures.
Applicants may adopt these procedures or develop their own, incorporating the safety features included in these model procedures.
Certain incidents and emergencies require notification of NRC. Appendix T provides a list of major NRC reporting and notification requirements relevant to commercial radiopharmacies.
Response from Applicant: Submit the following statement:
"We have developed and will implement and maintain written procedures for the safe use of radioactive materials that address:
* Facility and personnel radioactive contamination minimization, detection, and control;
* Performing molybdenum-99 breakthrough measurements on each the first eluate from a after receipt of the molybdenum-99/technetium-99m generator;
* Reporting under the requirements in 10 CFR 30.34(g) if there is more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m) in an eluate; and
* Use of protective clothing and equipment by personnel 190
 
that meet the requirements in 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.34(g), and 10 CFR 19.11(a)(3), as applicable;" AND "We have developed and will implement and maintain written procedures for identifying and responding to emergencies involving radioactive material, including:
* Lost, stolen, or missing licensed material;
* Exposures to personnel and the public in excess of NRC regulatory limits;
* Releases of licensed materials in effluents and the sanitary sewer in excess of NRC regulatory limits;
* Excessive radiation levels or radioactive material concentrations in restricted or unrestricted areas;
* Radioactive spills and contamination;
* Fires, explosions, and other disasters with the potential for the loss of containment of licensed material; and
* Routine contacts with local fire departments and local law enforcement agencies (LLEA),
that meet the requirements in 10 CFR 20.1101, 10 CFR 20.2201-2203, and 30.50, and other requirements, as applicable;"
191
 
[The following redline/strikeout revisions to Section 8.10.8 reflect the conforming changes needed for commercial nuclear pharmacies that prepare radiopharmaceuticals used primarily for their alpha-emitting radiation characteristics in response to the revision of 10 CFR 35.390(b)(1)(G)(3) to specifically include these radionuclides.]
8.10.8 DOSAGE MEASUREMENT SYSTEMS Regulation: 10 CFR 32.72(c).
Criteria: Commercial radiopharmacy licensees must possess and use instrumentation capable of accurately measuring the radioactivity in radioactive drugs.
Discussion: Due to the potential for radiopharmacy errors to adversely affect their customers (medical facilities) and their customers patients, each dosage of a radioactive drug must be measured prior to transfer to provide high confidence that the correct amount of the radioactive drug is transferred in accordance with the customers request.
The applicant must have procedures for the use of the instrumentation, including the measurement, by direct measurement or by a combination of measurement and calculation, of the amount of radioactivity in dosages of alpha-, beta-, gamma-, or photon-emitting radioactive drugs prior to their transfer for commercial distribution.
These procedures must ensure that the dose calibrator, or other dose measurement system, functions properly. This is accomplished by performing periodic checks and tests prior to first use, followed by checks at specified intervals, and following repairs that could affect system performance. Equipment used to measure dosages that emit gamma, alpha, or beta radiation must be calibrated for the applicable radionuclide being measured. For most photon-emitters, activity measurement is a fairly straightforward determination; however, for low-energy photon emitters, beta-emitters, and alpha-emitters, a correction factor is often necessary to accurately determine the activity. There are inherent technical difficulties to overcome in the determination and application of low-energy photon-, beta-, and alpha-correction factors.
These difficulties include dependence on geometry, lack of an industry standard for materials used in the manufacture of both vials and syringes, and lack of a National Institute of Standards and Technology (NIST)- traceable standard for all radionuclides currently in use. If radiopharmacies intend to initially distribute (i.e., measure, prepare, and label) low-energy photon-, beta-, and alpha-emitting radionuclides, the applicant must provide the calculation to demonstrate its ability to accurately dispense such materials. If the applicant intends to use low-energy photon-, beta-, and alpha- correction factors supplied by the instrument manufacturer, or other entity, it should include a means for ensuring the accuracy of the supplied factor. If radiopharmacy applicants intend to only redistribute low-energy photon-,
beta-, and alpha-emitting radionuclides that have been previously prepared and distributed by other persons licensed pursuant to 10 CFR 32.72, then the correction factor calculation is not required.
192
 
Licensees must assay patient dosages in the same type of vial and geometry as used to determine the correct dose calibrator settings. The use of different vials or syringes may result in measurement errors, for example, due to the variation of bremsstrahlung created by interaction between beta particles and the differing dosage containers. Licensees are reminded that beta emitters should be shielded using a low-atomic-numbered material to minimize the production of bremsstrahlung, followed by a high-atomic-numbered material thick enough to attenuate the bremsstrahlung intensity.
For each dose measurement system, specific periodic tests must be performed, as appropriate to the system, to ensure correct operation. Typically, all systems must be checked each day of use for constancy to ensure continued proper operation of the system. In addition, other appropriate tests may include accuracy (for the range of energies to be measured), linearity (for the range of activities to be measured), and geometry dependence (for the range of volumes and product containers).
The applicant should ensure that it possesses a sufficient number of such instruments to allow for periods when instruments are out of service for repair and calibration.
Appendix O contains a model procedure for dose calibrator testing.
Response from Applicant: The applicant shall describe the types of systems (measurement or combination of measurement and calculation) it intends to use for the measurement of alpha-, beta-, gamma-, and photon-emitting radioactive drugs; AND For each dose measurement system used to measure the amount of radioactivity in alpha-,
beta-, gamma-, or photon-emitting radioactive drugs, state: "We have developed, and will implement and maintain a written procedure for the performance of dose measurement system checks and tests that meets the requirements in 10 CFR 32.72(c)";
AND If applicable, e.g., when dose calibrators are used to measure photon emissions associated with beta or alpha emissions, the applicant must include a sample calculation for determining low-energy photon-, beta-, and alpha-correction factors for dose calibrators with ionization chambers; Radiopharmacies that intend to initially distribute (i.e., measure, prepare, and label) low-energy photon-, beta-, and alpha-emitting radionuclides must provide the calculations to demonstrate its ability to accurately dispense such materials; however, a correction factor calculations isare not required if radiopharmacy applicants intend to only redistribute low-energy photon-, beta- or alpha-emitting radionuclides that were previously prepared and distributed by others who are licensed pursuant to 10 CFR 32.72.
193
 
OR If applicable, the applicant must include a means for ensuring the accuracy of low-energy photon-, beta-, and alpha-correction factors supplied by the instrument manufacturer, or other entity.
194
 
Redline/strikeout revisions are shown below for several sections of Appendix C. An explanation is provided in at the beginning of each section.
APPENDIX C Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313
[The following redline/strikeout revisions to the Item 7, Individual(s) responsible for radiation safety program and their training and experience, section of Appendix C reflect the change to 10 CFR 35.55 removing the preceptor attestation requirement from the nuclear pharmacist board certification pathway and changes to the attestation statement for the alternate training and experience pathway. The Item 7, Individual(s) responsible for radiation safety program and their training and experience, section of Appendix C starts on page C-5 of the printed copy of NUREG-1556, Vol. 13, Rev.
1.]
Item                          Title and Criteria                          Yes  Description No.                                                                            Attached Description Item Number and Title                    Suggested Response          Yes  Attached
: 7. Individual(s) Responsible for        An organizational chart describing Radiation Safety Program and        the management structure, Their Training and Experience        reporting paths, and the flow of authority between executive management and the RSO.
7.1 RSO                                  A copy of the license (NRC or Agreement State) that authorized Name of Proposed RSO:
the uses requested and on which
_______________                the individual was specifically named as the RSO, ANP, or AU; OR 195
 
Description Item Number and Title            Suggested Response        Yes  Attached Description of the training and experience demonstrating that the proposed RSO is qualified by training and experience as applicable to commercial nuclear pharmacies.
7.2 Authorized Nuclear          For each proposed ANP:
Pharmacist(s)
Name of the proposed ANP.
Name(s) of Proposed ANP(s):
_____________                              AND Pharmacists license number and issuing entity; AND For an individual previously identified as an ANP on an NRC or Agreement State license or permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs (10 CFR 32.72(b)(2)(i)):
Previous license number (if issued by NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC Master Materials License broad scope permittee on which the individual was named an ANP or a copy of an authorization as an ANP from a commercial nuclear pharmacy that has been authorized to identify ANPs.
OR For an individual qualifying under 10 CFR 32.72(b)(4):
196
* Documentation that the individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material.
AND
* Documentation that the individual practiced at a pharmacy at a Government agency or federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC.
OR For an individual qualifying under 10 CFR 35.55(a):
* Copy of the certification(s) of the specialty board whose certification process has been recognized under 10 CFR 35.55(a).
Written attestation, signed by a preceptor ANP, that training and experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved.
AND
* If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 32.72(b)(2)(ii):
* Description of the training and experience specified in 10 CFR 35.55(b) demonstrating that the proposed ANP is qualified by training and experience.
197
 
AND
* Written attestation, signed by a preceptor ANP, that the individual has satisfactorily completed the training and experience requirements in 10 CFR 35.55(b)(1)d for certification have been satisfactorily completed and is ablethat a level of competency sufficient to function independently fulfill the radiation safety-related duties as an ANP has been achieved.
AND
* If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Notes:
NRC Form 313A (ANP),
Authorized Nuclear Pharmacist Training and Experience and Preceptor Attestation [10 CFR 35.55] may be used to document training and experience for those individuals qualifying under 10 CFR 35.55(a) or (b).
Descriptions of training and experience will be reviewed using the criteria listed above.
The NRC will review the documentation to determine if the applicable criteria in 10 CFR 32.72(b)(2) are met. If the training and experience do not appear to meet the criteria in Subpart B of 10 CFR Part 35, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
7.3    Authorized User(s)  For each proposed AU:
Name(s) of Proposed Name of the proposed AU.
AU(s):
AND 198
 
__________________
* Types, quantities, and proposed uses of licensed material.
AND
* A copy of license (NRC or Agreement State) on which the individual was specifically named as an AU for the types, quantities, and proposed uses of licensed materials.
OR
* A copy of the permit maintained by a licensee of broad scope that identifies the individual as an AU for the types, quantities, and proposed uses of licensed materials.
OR
* A description of the training and experience demonstrating that the proposed AU is qualified by training and experience to use the requested licensed materials.
[The following redline/strikeout revisions to the Item 10, Radiation Safety Program, Safe Use of Radionuclides and Emergency Procedures, section of Appendix C reflect the changes to 10 CFR
: 10. 35.204 increasing the frequency for performing the Mo-99 breakthrough test and 10 CFR 35.3204 Mo-99 breakthrough reporting requirements.
The Item 10, Radiation Safety Program, Safe Use of Radionuclides and Emergency Procedures, section of Appendix C starts on page C-12 of the printed copy of NUREG-1556, Vol. 13, Rev. 1.]
199
 
Safe Use of Radionuclides and Emergency Procedures We have developed and will implement and maintain written procedures for the safe use of radioactive materials that address:
* facility and personnel radioactive contamination minimization, detection, and control;
* performing molybdenum-99 breakthrough measurements on all the first eluates after receipt of athe molybdenum-99/technetium-99m generator; and
* reporting to NRC and the distributor when there is more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m) in the eluate; and
* use of protective clothing and equipment by personnel that meet the requirements in 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.34(g), and 10 CFR 19.11(a)(3), as applicable; AND We have developed and will implement and maintain written procedures for identifying and responding to emergencies involving radioactive material, including:
* lost, stolen, or missing licensed material;
* exposures to personnel and the public in excess of NRC regulatory limits;
* releases of licensed materials in effluents and the sanitary sewer in excess of NRC regulatory limits;
* excessive radiation levels or radioactive material concentrations in restricted or unrestricted areas;
* radioactive spills and contamination;
* fires, explosions, and other disasters with the potential for the loss of containment of licensed material; and 200
* routine contacts with local fire departments and local law enforcement agencies.
that meet the requirements in 10 CFR 20.1101, 10 CFR 20.2201-2203, and 10 CFR 30.50 and other requirements, as applicable.
201
 
[The following redline revisions to the Item 10, Radiation Safety Program, Dosage Measurements Systems, section of Appendix C reflect conforming changes for the radiopharmacy from the revision of 10 CFR 35.390 with the addition of alpha emitters. The Item 10, Radiation Safety Program, Dosage Measurements Systems, section of Appendix C starts on page C-13 of the printed copy of NUREG-1556, Vol. 13, Rev. 1.]
Dosage Measurement Systems Describe the types of systems (measurement or combination of measurement and calculation) to be used for the measurement of alpha-,
beta-, gamma-, and photon-emitting radioactive drugs; AND For each dose measurement system used to measure the amount of radioactivity in alpha-, beta-, gamma-, or photon-emitting radioactive drugs, state: "We have developed, and will implement and maintain a written procedure for the performance of dosage measurement system checks and tests that meets the requirements in 10 CFR 32.72(c)";
AND If applicable, include a sample calculation for determining low-energy photon-
,beta-, and alpha-correction factors for dose calibrators with ionization chambers; OR If applicable, include a means for ensuring the accuracy of low-energy photon-, beta-, and alpha-correction factors supplied by the instrument manufacturer or other entity.
202
 
Redline/strikeout revisions are shown below for several sections of Appendix D. An explanation is provided in at the beginning of each section.
APPENDIX D Checklist for License Application
[The following redline/strikeout revision to the D.5 Items 5 & 6 : Materials to be possessed and proposed uses, section of Appendix D corrects a citation in 10 CFR Part 35 for calibration and reference sources. The D.5 Items 5 & 6 :
Materials to be possessed and proposed uses, section of Appendix D starts on page D-1 of the printed copy of NUREG-1556, Vol. 13, Rev. 1.]
D.5 ITEMS 5 & 6 : MATERIALS TO BE POSSESSED AND PROPOSED USES Yes No    Radioisotope    Form or          Quantity            Purpose of    Specify Mfg/Model                                  Use Other Uses No.
Not Listed on SSD Certificate Byproduct      Any        __________millicuries 10 CFR 32.72 Materials with              per nuclide, 1 curie total and            Not Atomic No. 1-83            possession, except as      10 CFR 30.41 applicable noted:
                                                                              ------------
Uses are:
Molybdenum-99  Any        __________curies          10 CFR 32.72 and            Not 10 CFR 30.41 applicable
                                                                              ------------
Uses are:
203
 
Technetium- Any __________curies      10 CFR 32.72 and 99m                                  10 CFR 30.41        Not applicable
                                                      ------------
Uses are:
Iodine-131  Any __________millicuries 10 CFR 32.72 and 10 CFR 30.41        Not applicable
                                                      ------------
Uses are:
Fluorine-18 Any __________millicuries 10 CFR 32.72 and 10 CFR 30.41        Not applicable
                                                      ------------
Uses are:
Iodine-123  Any __________millicuries 10 CFR 32.72 and 10 CFR 30.41        Not applicable
                                                      ------------
Uses are:
Xenon-133  Any __________curies      10 CFR 32.72 and 10 CFR 30.41        Not applicable
                                                      ------------
Uses are:
204
 
Any              Sealed        ___________millicuries 10 CFR 32.74 and              Not Byproduct        Sources                              10 CFR 30.41              applicable Material in a Brachytherap y
Source,      as listed in 10 CFR 35.400                                                                          ------------
[ ] Uses are:
Any            Sealed        _____________curies    10 CFR 32.74 and Byproduct      Sources        per source and curies  10 CFR 30.41 Material in a                  total                                                Not sealed                                                                          applicable source for diagnosis, as                                                                    ------------
listed in 10 CFR                                                                              Uses 35.500                                                                          are:
Any            Prepackage _____________millicuri 10 CFR 31.11 byproduct      d units for in es                                                    Not material        vitro                                                            applicable listed in 10    diagnostic CFR            tests 31.11(a)                                                                        ------------
Uses are:
Any            Sealed        ______________millicu Calibration and checking of    Not byproduct      Sources        ries                  the licensees instruments applicable material                                              and authorized                                            10 CFR 32.74 and          ------------
under 10                                              10 CFR 30.41 CFR                                                                                  Uses 35.6557(                                                                        are:
a) 205
 
Depleted  Metal        _____________kilo-    Shielding for Uranium                grams                  molybdenum99/technetium-    Not 99m generators          applicable
                                                                        ------------
Uses are:
Cesium-137              Not to exceed maximum Instrument calibration      Not Sealed                                                      applicable sources in  activity per source as
                                                                        ------------
compatible  specified in Sealed device as    Source and Device specified in Registry Sheet Sealed                                                          Uses Source and                                                  are:
Device Registry Sheet Other (specify) 206
 
[The following redline/strikeout revisions to D.6 Item 7: Training and experience, section of Appendix D reflect the changes to 10 CFR 35.55 removing the preceptor attestation requirement from the nuclear pharmacist board certification pathway and changes to the attestation statement for the alternate training and experience pathway. The D.6 Item 7: Training and experience, section of Appendix D starts on page D-4 of the printed copy of NUREG-1556, Vol.
13, Rev. 1.]
D.6 ITEM 7:TRAINING AND EXPERIENCE, Item Number and Title            Suggested Response          Yes Alternative Procedures Attached
: 7. Individual(s) Responsible for  An organizational chart describing Radiation Safety Program and      the management structure, Their Training and Experience    reporting paths, and flow of authority between executive management and the RSO.
: 7. Individual(s) Responsible For  A copy of the license (NRC or Radiation Safety Program And      Agreement State) that authorized Their Training And Experience    the uses requested and on which the individual was specifically named as the RSO, an ANP, or an 7.1 Radiation Safety Officer AU; (RSO)
OR Name:_________________
Description of the training and experience demonstrating that the proposed RSO is qualified by training and experience as applicable to commercial nuclear pharmacies.
207
: 7. Individual(s) Responsible for
* Name of the proposed ANP; Radiation Safety Program and Their Training and Experience                    AND 7.2 Authorized Nuclear
* Pharmacist's license number and issuing entity; Pharmacist(s)
AND Name(s):_______________
For an individual previously identified as an ANP on an NRC or Agreement State license or permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs (10 CFR 32.72(b)(2)(i)):
* Previous license number (if issued by NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC Master Materials License broad-scope permittee on which the individual was named an ANP or a copy of an authorization as an ANP from a commercial nuclear pharmacy that has been authorized to identify ANPs.
208
 
OR For an individual qualifying under 10 CFR 32.72(b)(4):
* Documentation that the individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; AND
* Documentation that the individual practiced at a pharmacy, a Government agency, or Federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC.
OR For an individual qualifying under 10 CFR 35.55(a):
* Copy of the certification(s) of the specialty board whose certification process has been recognized under 10 CFR 35.55(a);
AND Written attestation, signed by a preceptor ANP, that training and experience required for certification have been satisfactorily completed and that a level of competency sufficient to function independently as an ANP has been achieved; 209
 
AND
* If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
OR For an individual qualifying under 10 CFR 32.72(b)(2)(ii):
* Description of the training and experience specified in 10 CFR 35.55(b) demonstrating that the proposed ANP is qualified by training and experience; AND Written attestation, signed by a preceptor ANP, that training and experience required for certification have been satisfactorily completed and is ablethat a level of competency sufficient to function independently fulfill the radiation safety-related duties as an ANP has been achieved; AND
* If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
Notes:
* NRC Form 313A (ANP),
      "Authorized Nuclear Pharmacist Training and Experience and Preceptor Attestation [10 CFR 35.55]"
210
 
may be used to document training and experience for those individuals qualifying under 10 CFR 35.55(a) or (b).
* Descriptions of training and experience will be reviewed using the criteria listed above. The NRC will review the documentation to determine if the applicable criteria in 10 CFR 32.72(b)(2) are met. If the training and experience do not appear to meet the criteria, the NRC may request additional information from the applicant or may request the assistance of the ACMUI in evaluating such training and experience.
211
: 7. Individual(s) Responsible for For each proposed AU:
Radiation Safety Program and Their Training and Experience                    AND 7.3 Authorized User(s)
* Name of each proposed AU; Name(s):_________________                        AND
* Types, quantities, and proposed uses of licensed material; AND
* A copy of license (NRC or Agreement State) on which the individual was specifically named as an AU for the types, quantities, and proposed uses of licensed materials; OR
* A copy of the permit maintained by a licensee of broad scope that identifies the individual as an AU for the types, quantities, and proposed uses of licensed materials; OR
* Description of the training and experience demonstrating that the proposed AU is qualified by training and experience to use the requested licensed materials.
212
 
[The following redline/strikeout revisions to D.10 Item 10.6: Safe Use of Radionuclides and Emergency Procedures, section of Appendix D reflect the changes to 10 CFR 35.204 increasing the frequency of the Mo-99 breakthrough test and 10 CFR 30.34(g) reporting requirements for Mo-99 breakthrough. The D.10 Item 10.6: Safe Use of Radionuclides and Emergency Procedures, section of Appendix D starts on page D-9 of the printed copy of NUREG-1556, Vol. 13, Rev. 1.]
: 10. Radiation    We have developed and will implement and maintain Safety Program  written procedures for the safe use of radioactive materials that address:
10.6 Safe Use of Radionuclides
* Facility and personnel radioactive contamination minimization, detection, and control; and Emergency
* Performing molybdenum-99 breakthrough Procedures              measurements on the first eluate after receipt of all molybdenum-99/technetium-99m generator eluates;
* Reporting to NRC and the distributor when there is more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m) in the eluate;and
* Use of protective clothing and equipment by personnel that meet the requirements in 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.34(g), and 10 CFR 19.11(a)(3), as applicable.
AND We have developed and will implement and maintain written procedures for identifying and responding to emergencies involving radioactive material, including:
* Lost, stolen, or missing licensed material,
* Exposures to personnel and the public in excess of NRC regulatory limits,
* Releases of licensed materials in effluents and the sanitary sewer in excess of NRC regulatory limits,
* Excessive radiation levels or radioactive material concentrations in restricted or unrestricted areas,
* Radioactive spills and contamination, 213
* Fires, explosions, and other disasters with the potential for the loss of containment of licensed material, and
* Routine contacts with local fire departments and local law enforcement agencies that meet the requirements in 10 CFR 20.1101, 10 CFR 20.2201, 20.2202, 20.2203, and 10 CFR 30.50 and other requirements, as applicable.
214
 
[The following redline revisions to D.10 Item 10.8, Dosage Measurement, section of Appendix D reflect the conforming radiopharmacy changes resulting from adding alpha emitters in 10 CFR 35.390. D.10 Item 10.8, Dosage Measurement, section of Appendix D starts on page D-10 of the printed copy of NUREG-1556, Vol. 13, Rev. 1.]
: 10. Radiation Describe the types of systems (measurement or Safety Program  combination of measurement and calculation) to be used for the measurement of alpha-, beta-, gamma-, and photonemitting radioactive drugs; 10.8 Dosage                                  AND Measurement Systems          For each dosage measurement system used to measure the amount of radioactivity in alpha-, beta-, gamma, or photon-emitting radioactive drugs, state: "We have developed, and will implement and maintain, a written procedure for the performance of dosage measurement system checks and tests that meets the requirements in 10 CFR 32.72(c)";
AND If applicable, include a sample calculation for determining low-energy photon-,beta-, and alpha-correction factors for dose calibrators with ionization chambers; OR If applicable, include a means for ensuring the accuracy of low-energy photon-,beta-, and alpha-correction factors supplied by the instrument manufacturer or other entity.
215
 
The following redline/strikeout revisions and the revised NRC Form 313A (ANP) in Appendix G reflect the changes to the training and experience requirements in 10 CFR 32.72, and 10 CFR 35.55 for the Authorized Nuclear Pharmacist.
APPENDIX G Formats for Documenting Training and Experience for Individuals Responsible for Radiation Protection Program Table G-1 Authorized User or Radiation Safety Officer Training in Basic Radioisotope Handling Techniques Name (Last, First, Initial)
Location of    Dates            Title          Total  Breakdown of Course in Training                                      Hours        Clock Hours RPP  BH  IR  INST REG TOTALS RPP - Radiation Protection Principles BH - Biological Hazards 216
 
IR - Ionizing Radiation Units & Characteristics INST - Radiation Detection Instrumentation REG - NRC Regulations and Standards Table G-2 Authorized User and Radiation Safety Officer Experience in Handling Radioisotopes (Actual use of radioisotopes under the supervision of an authorized user or Radiation Safety Officer, respectively)
Name (Last, First, Initial)
Isotope(s)    Maximum amount used Location of Purpose of          Total Hours of used            at any one time        use        use*        Experience
* Description of experience
: 1. Shipping, receiving, and performing related radiation surveys.
: 2. Using and performing checks for proper operation of dose calibrators, survey meters, and other instruments used to measure photon- and high-energy betaemitting radionuclides.
: 3. Using and performing checks for proper operation of instruments used to measure alpha- and low energy beta-emitting radionuclides.
: 4. Calculating, assaying, and safely preparing radioactive materials.
: 5. Use of procedures to prevent or minimize contamination and/or use of proper decontamination procedures.
217
 
Documentation of Training and Experience to Identify an Individual on a License as an Authorized Nuclear Pharmacist.
I. Experienced Authorized Nuclear Pharmacists An applicant or licensee that is adding an experienced Authorized Nuclear Pharmacist (ANP) to its commercial radiopharmacy license only needs to provide evidence that the individual is listed on a license issued by the NRC or Agreement State, a permit issued by an NRC Master Materials Licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC master materials broad-scope permittee, and that the individual meets the recentness of training criteria described in 10 CFR 35.59. The applicant also may provide evidence that the individual is listed on an NRC or Agreement State commercial nuclear pharmacy license or identified as an ANP by a commercial nuclear pharmacy authorized to identify ANPs. For individuals who have been previously authorized by, but not listed on, the commercial nuclear pharmacy license, medical broad-scope license, or master materials license medical broad-scope permit, the applicant should submit either verification of previous authorizations granted or evidence of acceptable training and experience.
II. Experienced Nuclear Pharmacists Who Only Used Accelerator-Produced Nuclear Materials, or Discrete Sources of Radium-226, or Both, for Medical or Nuclear Pharmacy Uses During the implementation of the EPAct, NRC "grandfathered" nuclear pharmacists that used only accelerator-produced radioactive materials, discrete sources of radium-226 (Ra-226), or both, for nuclear pharmacy uses under the NRC waiver of August 31, 2005, when using these materials for the same uses. Nuclear pharmacists that used accelerator-produced radionuclides or discrete sources of Ra-226 during the effective period of the waiver do not have to meet the requirements of 10 CFR 35.59, or the training and experience requirements in 10 CFR Part 35, Subpart B for those materials and uses.
The applicant or licensee that is adding one of these experienced individuals to its commercial nuclear pharmacy license should document that the individual used only accelerator-produced radionuclides, or discrete sources of Ra-226, for nuclear pharmacy uses during the effective period of the waiver 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 non-Agreement State license or permit authorizing these materials for the requested uses.
III. Applications that Include Individuals for Authorized Nuclear Pharmacist Recognition by NRC 218
 
Applicants should submit NRC Form 313A (ANP) to show that the individual meets the correct training and experience criteria in 10 CFR Part 35, Subpart B. There are two primary training and experience routes to qualify an individual as an ANP. The first is by means of certification by a board recognized by NRC and listed on the NRC website (http://www.nrc.gov/materials/miau/med-use-toolkit.html) as provided in 10 CFR 35.55(a).
The second route is by meeting the structured educational program, supervised work experience, and preceptor attestation requirements in 10 CFR Part 35.55(b), Subpart B.
IV. Recentness of Training The required training and experience, including board certification, described in 10 CFR Part 35 must be obtained within the 7 years preceding the date of the application, or the individual must document having had related continuing education, retraining, and experience since obtaining the required training and experience.
Examples of acceptable continuing education and experience include the following:
* Successful completion of classroom and laboratory review courses that include radiation safety practices relative to the practice of nuclear pharmacy, and
* Practical experience in nuclear pharmacy under the supervision of an ANP at the same or another licensed facility that is authorized as a nuclear pharmacy.
V. General Instructions and Guidance for Filling Out NRC Form 313A Series If the applicant wishes to identify a license and it is an Agreement State license, the applicant should provide a copy of the license. If the applicant wishes to identify a Master Materials License permit, the applicant should provide a copy of the permit. If the applicant wishes to identify an individual (i.e., supervising individual or preceptor) who is authorized under a broad-scope license or broad-scope permit of a Master Materials License, the applicant should provide a copy of the permit issued by the broad-scope licensee/permittee. Alternatively, the applicant may provide a statement signed by the Radiation Safety Officer or chairperson of the Radiation Safety Committee similar to the following: "__________(name of supervising individual or preceptor) is authorized under _______________(name of licensee/permittee) broad-scope license number__________ to use_________(materials) during
____________( time frame)".
219
 
INTRODUCTORY INFORMATION Name of Individual Provide the individual's complete name so that NRC can distinguish the training and experience received from that received by others with a similar name.
Note: Do not include personal or private information (e.g., date of birth, social security number, home address, personal phone number) as part of your qualification documentation.
State or Territory where Licensed Note that the NRC requires pharmacists to be licensed by a State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.
Requested Authorization(s)
Check all authorizations that apply and fill in the blanks as provided.
Part I. Training and Experience There are always multiple pathways provided for each training and experience section. Select the applicable one.
Item 1. Board Certification The applicant or licensee may use this pathway if the proposed nuclear pharmacist is certified by a board recognized by NRC (to confirm that NRC recognizes that board's certifications, see NRC's web page http://www.nrc.gov/materials/miau/med-usetoolkit.html.
Note:
* An individual that is board eligible will not be considered for this pathway until the individual is actually board-certified. Further, individuals holding other board certifications will also not be considered for this pathway.
* The applicant or licensee must provide a copy of the board certification and completed attestation as indicated on the attached NRC Form 313A (ANP).
* As indicated on the form, additional information is needed if the board certification was greater than 7 years ago.
220
 
Item 2. Structured Educational Program for a Proposed Authorized Nuclear Pharmacist This pathway is used for those individuals not listed on the license as an ANP, who do not meet the requirements for the board certification pathway.
The regulatory requirements refer to a structured educational program consisting of both (a) classroom and laboratory training, and (b) supervised practical experience in nuclear pharmacy. 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 10 CFR 35.55 (b)(1)(i).
The proposed ANP may receive the required classroom and laboratory training, and supervised practical experience at a single training facility or at multiple training facilities; therefore, space is provided to identify each location and date of training or experience. The date should be provided in the month/day/year (mm/dd/yyyy) format.
Under the "classroom and laboratory training," provide the number of clock hours spent on each of the topics listed in the regulatory requirements.
The proposed ANP 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 particular need and taught on 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, NRC will broadly interpret "classroom and laboratory training" to include various types of instruction, including online training, as long as 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.
Under the "supervised practical experience" section of the form, provide the number of clock hours for each topic. The supervised practical experience topics for the nuclear pharmacists include all the basic elements in the practice of nuclear pharmacy. Therefore, all the hours of supervised experience are allocated to these topics.
Note: As indicated on the form, additional information is needed if the training and/or supervised practical experience was completed more than 7 years ago.
Part II. Preceptor Attestation The NRC defines the term preceptor in 10 CFR 35.2, Definitions, to mean an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer. While the supervising 221
 
individual for the practical experience in nuclear pharmacy may also be the preceptor, the preceptor does not have to be the supervising individual as long as the preceptor directs or verifies the training and experience required. The preceptor must provide an attestation in writing regarding the training and experience of a pharmacist applying through the structured educational program for a proposed authorized nuclear pharmacist. The preceptor must attest that the individual has satisfactorily completed the appropriate training and experience criteria and is ablehas achieved a level of competency sufficient to function independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist. This preceptor also has to meet specific requirements.
The NRC Form 313A (ANP) Part II - Preceptor Attestation has two sections. The preceptor must complete both sections;, i.e., The preceptor must selects either the board certification or including the structured educational program, when filling out attestation, the first section on this page. The second and final sections of the page request specific information about the preceptors authorization to use licensed material, and in addition to the preceptors signature.
222
 
223 224 225 The following redline revisions in Appendix H reflect the new reporting Mo99 breakthrough requirements in 10 CFR 30.34(g).
APPENDIX H Typical Duties and Responsibilities of the Radiation Safety Officer The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations, and with the conditions of the license (see Figure H.1). Typically, these duties and responsibilities include ensuring that:
* General surveillance is provided over all activities involving radioactive material, including routine monitoring, special surveys, and responding to events;
* Incidents are responded to, investigated, their cause(s) and appropriate corrective action(s) are identified, and timely corrective action(s) are taken;
* Proper authorities are notified of incidents such as damage, fire, or theft;
* Proper NRC and manufacturer/distributor notification is made when required (e.g., over exposures; leaking sources).
* Proper NRC and distributor notification is made when there is more than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m) in an eluate))
* Corrective actions are developed, implemented, and documented when violations of regulations or license conditions or program weaknesses are identified;
* All activities are immediately terminated following any unsafe condition or activity that is found to be a threat to public health and safety;
* He or she is the primary source of radiation protection information for personnel at all levels of responsibility;
* All radiation workers are properly trained;
* Procedures for the safe use of radioactive materials are developed and implemented;
* The license's procedures and controls, based upon sound radiation protection principles, are periodically reviewed to ensure that occupational doses and doses to members of the public are as low as is reasonably achievable (ALARA). 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; 226
* General surveillance is provided over all activities involving radioactive material, including routine monitoring, special surveys, and responding to events.
* Incidents are responded to, investigated, their cause(s) and appropriate corrective action(s) are identified, and timely corrective action(s) are taken.
* Proper authorities are notified of incidents such as damage, fire, or theft.
* Corrective actions are developed, implemented, and documented when violations of regulations or license conditions or program weaknesses are identified.
* All activities are immediately terminated following any unsafe condition or activity that is found to be a threat to public health and safety.
* He or she is the primary source of radiation protection information for personnel at all levels of responsibility.
* All radiation workers are properly trained.
* Procedures for the safe use of radioactive materials are developed and implemented.
* The licensee's procedures and controls, based upon sound radiation protection principles, are periodically reviewed to ensure that occupational doses and doses to members of the public are as low as is reasonably achievable (ALARA). 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.
* Prospective evaluations are performed of occupational exposures, and those individuals likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits are provided personnel monitoring devices.
* When necessary, personnel monitoring devices are used and exchanged at the proper intervals, and records of the results of such monitoring are maintained.
* The performance of fume hoods and gloveboxes used for volatile radioactive material work are monitored for proper operation.
* The receipt, opening, and delivery of all packages of radioactive material arriving at the nuclear pharmacy are overseen and coordinated.
* An inventory of all radioactive materials is maintained and the types and quantities of radionuclides at the facility are limited to the forms and amounts authorized by the license.
* Sealed sources are leak-tested at required intervals.
* There is effective management of the radioactive waste program, including effluent monitoring.
* Packaging and transport of radioactive material is in accordance with all applicable DOT requirements.
* An up-to-date license is maintained and amendment and renewal requests and notifications of new ANPs are submitted in a timely manner.
* Radiation Safety Program audits are performed at least annually and documented.
227
* He or she acts as liaison to NRC.
* All required records are properly maintained.
Figure H.1 Typical Duties and Responsibilities of the RSO.
228
 
Redline/strikeout revisions are shown below for one section of Appendix I. An explanation is provided in at the beginning of this section.
APPENDIX I.
Suggested Commercial Radiopharmacy Audit Checklist
[The following redline revisions to the Notification and reports, section of Appendix I reflect the addition of new mo-99 breakthrough reporting requirements in 10 CFR 30.34(g). The Notification and reports, section of Appendix I starts on page I-7 of the printed copy of NUREG-1556, Vol. 13, Rev.
1.]
Notification and Reports A. Was any radioactive material lost or stolen? Were reports made? [10 CFR 20.2201, 10 CFR 30.50]
B. Did any reportable incidents occur? Were reports made? [10 CFR 20.2202, 10 CFR 30.34(g), 10 CFR 30.50]
C. Did any overexposures or high radiation levels occur? Reported? [10 CFR 20.2203, 10 CFR 30.50]
D. Were any contaminated packages or packages with surface radiation levels exceeding 200 mrem received? Reported to NRC?
E. If any events (as described in items A through D above) did occur, what was root cause? Were appropriate notifications made and corrective actions taken?
F.Is the management/RSO aware of telephone number for NRC Emergency Operations Center? [(301) 816-5100]
229
 
Redline/strikeout revisions are shown below for one section of Appendix Q. An explanation is provided in at the beginning of this section.
APPENDIX Q General Topics for Safe Use of Radioisotopes and Model Emergency Procedures
[The following redline revision to the General Topics for Safe Use of Radioisotopes, section of Appendix Q reflects the increased frequency of Mo-99 breakthrough measurements in 10 CFR 35.204 and new reporting requirements for Mo-99 breakthrough in 10 CFR 30.34. The General Topics for Safe Use of Radioisotopes, section of Appendix Q starts on page Q-1 of the printed copy of NUREG-1556, Vol. 13, Rev. 1.]
General Topics for Safe Use of Radioisotopes Each licensee using radioactive material should establish general rules for the safe use of the material so that workers know what is required. Typical instructions should include:
* Wear a laboratory coat or other protective clothing at all times when working with radioactive materials;
* Use syringe shields and vial shields when preparing and handling radioactive drugs;
* Measure all radiopharmaceuticals prior to transfer;
* Measure the molybdenum-99 content of each generator eluate. Do not transfer those radiopharmaceuticals for human medical use that will contain more than 0.15 microcuries of molybdenum-99 per millicurie of technetium-99m at the time of administration, and report each eluate that exceeds this limit at time of measurement to NRC and the distributor;
* Wear disposable gloves at all times when handling radioactive materials and change gloves frequently to minimize the spread of contamination;
* Before leaving the hot lab, monitor hands, shoes, and clothing for contamination in a low-background area, allowing sufficient time for instrument response;
* Do not eat, drink, smoke, or apply cosmetics in any area where licensed material is stored or used;
* Do not store food, drink, or personal effects in areas where licensed material is stored or used (see Figure Q.1). Personal items brought into the restricted area 230
 
(radios, compact discs, notepads, books, etc.) should be surveyed for contamination before removal from the area;
* Food and beverages used in the preparation of radiopharmaceuticals should be clearly labeled "Not for personal consumption" if stored with radioactive materials;
* Wear personnel monitoring devices, if required, at all times while in areas where licensed materials are used or stored;
* Dispose of radioactive waste only in designated, labeled, and properly shielded receptacles;
* Never pipette by mouth;
* Store radioactive solutions in clearly labeled containers; and
* Secure all licensed material when it is not under the constant surveillance and immediate control of the user(s).
Figure Q.1 Storage of Food and Drink. Food or drink for personal consumption should not be stored in refrigerators with radioisotopes.
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The following redline revisions in Appendix H reflect the new reporting Mo-99 breakthrough requirements in 10 CFR 30.34(g) and 10 CFR 30.50(b)(2).
APPENDIX T NRC Incident Notifications NRC Incident Notifications Table T.1 Typical Notifications Required for Radiopharmacy Licensees Event                  Telephone    Written  Regulatory Notification Report  Requirement Theft or loss of material                  immediate  30 days    10 CFR 20.2201(a)(1)(i)
Whole body dose greater than 0.25 Sv (25    immediate  30 days    10 CFR rems)                                                          20.2202(a)(1)(i)
Extremity dose greater than 2.5 Sv (250    immediate  30 days    10 CFR rems)                                                          20.2202(a)(1)(iii)
Intake of five times the annual limit on    immediate  30 days    10 CFR intake                                                          20.2202(a)(2)
Removable contamination exceeding the      immediate    none      10 CFR 20.1906(d)(1) limits of 10 CFR 71.87(i) -
(beta/gamma/low toxicity alpha - 22 dpm/cm2; all other alpha - 2.2 dpm/cm2)
External radiation levels exceeding the    immediate    none      10 CFR limits of 10 CFR 71.47 - (any point on the                      20.1906(d)(2) surface - 2 mSv/hr (200 mrem/hr))
Whole body dose greater than 0.05 Sv (5      24 hours  30 days    10 CFR rems) in 24 hours                                              20.2202(b)(1)(i)
Extremity dose greater than 0.5 Sv (50      24 hours  30 days    10 CFR rems) in 24 hours                                              20.2202(b)(1)(iii) 232
 
Intake of one annual limit on intake          24 hours      30 days        10 CFR 20.2202(b)(2)
Occupational dose greater than the              none        30 days        10 CFR applicable limit in 10 CFR 20.1201                                      20.2203(a)(2)(i)
Dose to individual member of public            none        30 days        10 CFR greater than 1 mSv (100 mrems)                                          20.2203(a)(2)(iv)
Defect in equipment that could create a        2 days      30 days        10 CFR substantial safety hazard                                                21.21(d)(3)(i)
Report molybdenum-99 content of a          Within 7 days  30 days    10 CFR 30.34(g) generator eluate that is more than 0.15                                      and microcuries of molybdenum-99 per                                            10 CFR millicurie of technetium-99m                                              35.3204(a)
Filing petition for bankruptcy under 11        none      immediately  10 CFR 30.34(h)
U.S.C.                                                    after filing petition Expiration of license                          none        60 days    10 CFR 30.36(d)
Decision to permanently cease licensed          none        60 days    10 CFR 30.36(d) activities at entire site Decision to permanently cease licensed          none        60 days    10 CFR 30.36(d) activities in any separate building or outdoor area that is unsuitable for release for unrestricted use No principal activities conducted for 24        none        60 days    10 CFR 30.36(d) months at the entire site No principal activities conducted for 24        none        60 days    10 CFR 30.36(d) months in any separate building or outdoor area that is unsuitable for release for unrestricted use immediate      30 days    10 CFR 30.50(a)
Event that prevents immediate protective actions necessary to avoid exposure to radioactive materials that could exceed regulatory limits 233
 
An unplanned contamination event              24 hours 30 days          10 CFR involving greater than 5 times the ALI, and                            30.50(b)(1) half-life greater than 24 hours requiring access to be restricted for more than 24 hours Equipment is disabled or fails to function    24 hours 30 days          10 CFR as designed when required to prevent                                  30.50(b)(2) radiation exposure in excess of regulatory limits 24 hours 30 days          10 CFR Unplanned fire or explosion that affects the 30.50(b)(4) integrity of any licensed material or device, container, or equipment with licensed material Note: Telephone notifications shall be made to NRC Operations Center, at 301-8165100 or 301-951-0550.
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Part 3 Medical Use Questions and Answers Effective January 2019, For the Final Rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments 235
 
Additional Questions and Answers may be incorporated into this guidance as NRC, the Agreement States, and licensees obtain operational experience with the rule.
Notifications - General Information
: 1. What change was made to 10 CFR 35.12, Application for license, amendment, or renewal?
This section was amended to require only the original NRC Form 313 or letter be submitted when applying for a license, amendment, or renewal; to clarify what information should be submitted; and to add a requirement to submit information on an individual seeking to be identified as an Associate Radiation Safety Officer or ophthalmic physicist.
: 2. NRC always asks for additional information on specialized facilities, equipment, and specialized training and experience for applicants requesting 10 CFR 35.1000 uses. Why isnt this information in 10 CFR 35.12(d)?
Information about what needs to be submitted for 10 CFR 35.1000 uses has been expanded in the rule to let applicants know the type of information expected by NRC. The expanded information in 10 CFR 35.12(d) does not include requirements to provide information on facilities, equipment, training, and experience because it is already required under 10 CFR 35.12(b)(1).
: 3. Does NRC require a medical use licensee who is already authorized for manual brachytherapy to receive a license amendment before obtaining and using a new type of manual brachytherapy source?
10 CFR 35.14(b)(6) allows a medical use licensee to obtain a sealed source for manual brachytherapy from a different manufacturer or with a different model number than authorized by its license, as long as the licensee notifies the NRC within 30 days. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.
: 4. What changes were made to 10 CFR 35.15, Exemptions regarding Type A specific licenses of broad scope?
This section was revised to update paragraph references in 10 CFR 35.13 and 35.14 and to add the ophthalmic physicist to the list of authorized individuals in paragraph 10 CFR 35.15(e).
These were conforming changes required because of changes to other parts of the regulation.
Training and Experience
: 5. What changes were made to the training and experience requirements for authorized individuals?
The significant changes are:
New individuals listed on the license 236
* Associate Radiation Safety Officer (ARSO). The ARSO is defined in 10 CFR 35.2 as an individual who meets training and experience requirements 10 CFR 35.50 and is identified on a license or a medical use permittee of a NRC Master Materials License licensee as an ARSO. The ARSOs role in the radiation safety program is described in 10 CFR 35.24(b).
* Ophthalmic physicist. Ophthalmic physicist is defined in 10 CFR 35.2 as an individual who meets the training requirements in 10 CFR 35.433(a)(2) and is identified on a license or permit as an ophthalmic physicist. The tasks of the ophthalmic physicist are described in 10 CFR 35.433(b).
Attestation changes
* The written attestation requirement was removed for nearly all individuals meeting the board certification training and experience pathway.
* The wording in the attestation statement for non board-certified individuals was revised to replace the attestation of competency with an attestation that the individual has demonstrated the ability to function independently to fulfill the required radiation safety-related duties.
* For most categories of authorized user physicians, the residency program director may now sign the attestation under certain conditions.
Specialty boards
* The specialty boards formerly listed in 10 CFR Part 35, Subpart J are now listed in 10 CFR 35.57.
* Individuals previously certified by specialty boards recognized under prior 10 CFR 35 Subpart J on or before October 24, 2005, are grandfathered so as to be authorized for those materials and uses that they performed on or before October 24, 2005.
: 6. Can a physician meeting the training and experience requirements for all three categories of radioactive drugs in paragraph 10 CFR 35.390(b)(1)(ii)(G) be authorized for the use of all unsealed byproduct material requiring a written directive?
No. 10 CFR 35.300 specifically limits the physician to the use of byproduct material identified in 10 CFR 35.390(b)(1)(ii)(G). In the future, there may be radioactive drugs that use radionuclides that are used for a primary emission that does not fall under the categories in 35.390(b)(1)(ii)(G). Therefore, the physician can be authorized for either the use of all byproduct material identified in 10 CFR 35.390(b)(1)(ii)(G) or for use of all byproduct material identified in 10 CFR 35.300.
: 7. What are the training and experience (T&E) requirements for 10 CFR 35.1000?
The training and experience requirements for 10 CFR 35.1000 medical uses are determined on a case-by-case basis. NRC has developed licensing guidance, including T&E guidance, for 237
 
certain 10 CFR 35.1000 medical uses. This information is available on the NRC public website at http://www.nrc.gov/materials/miau/med-use-toolkit.html#et in the section titled Emerging Technologies and 10 CFR 35.1000.
: 8. How can a licensee or regulator determine if a residency training program is approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education (ACGME) or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association?
Licensees and regulators will have to confirm that a residency program is approved. In addition to asking the individual or licensee to provide documentation that the residency program met the appropriate approval, the following web sites can be used to identify the accredited residency programs and program directors for these organizations:
(1) http://www.acgme.org/ under Data Collection Systems, Accredited Programs and Sponsoring Institutions for ACGME approvals from 2001-02 to present; (2) http://www.acgme.org/acgmeweb/tabid/126/About/AMAGreenBooks.aspx for approved ACGME residency programs from 1942-43 through 2000-01; (3) http://rcpsc.medical.org/ under Credentials, Examinations & Accreditation, Information by Discipline for the Royal College of Physicians and Surgeons of Canada; and (4) http://www.osteopathic.org/ for the American Osteopathic website. Although the Committee on Post-Graduate Training of the American Osteopathic Association had residency programs in the past, they do not have any at the time the rule was finalized.
: 9. Why does 10 CFR 35.590 include the authorized user (AU) for 10 CFR 35.200 uses?
NRC revised 10 CFR 35.65 to make it clear that the use of any sources authorized under 10 CFR 35.65 to administer radiation to patients and human research subjects is medical use, and to be conducted in accordance with the requirements in 10 CFR 35.500. Most of the transmission and reference sources in 10 CFR 35.65 used for medical use are used in imaging and localization procedures performed under 10 CFR 35.200. Therefore, an AU for 10 CFR 35.200 uses was included as an individual qualified for 10 CFR 35.500 medical uses in 10 CFR 35.590.
Board Certification Changes
: 10. What individuals are affected by the resolution of the Ritenour petition?
The affected individuals are those meeting all three of the following conditions: They are certified by boards that were formerly listed in 10 CFR Part 35, Subpart J and now listed in 10 CFR 35.57; they were certified on or before October 24, 2005; and they are requesting 238
 
authorization for only those materials and uses that they performed on or before October 24, 2005.
: 11. Over time, some certifying Boards may have changed their names, as well as the names of some of their specialties. How can I tell if my certification is recognized?
If the board was included in former 10 CFR Subpart J, it has been listed in 10 CFR 35.57 as it appeared in the prior regulation. NRC posts the names of the boards that meet NRCs current requirements and includes a sample of the boards certificates on the NRC website (http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html). If a board changes its name, specialty, or other wording on a certificate, a sample of its new certificate is submitted and also posted. The NRC will note by each certificate the time frame for recognition of that certificate (e.g. The American Board of Nuclear Medicine changed the wording of its certificates in 2007 so the web site provides sample certificates for 2005 to 2007 and for 2007 to present).
Preceptor Attestations
: 12. Why did NRC eliminate the requirement for preceptor attestations for most individuals certified by boards identified on the NRC website or in NRC regulations?
In order for the boards to be recognized, they are required to give an examination that assesses knowledge and competency in areas that include radiation safety. 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, provided that the provisions of 35.59 are met.
: 13. Were attestations eliminated for all board-certified individuals?
Attestations were eliminated for almost all individuals certified by boards recognized by NRC on its website and in its regulations. The attestation in 10 CFR 35.396(b)(3) is required for board-certified individuals requesting approval under 10 CFR 35.396(a)(3), as well as for the training in 10 CFR 35.396(b)(1) and (b)(2).
: 14. Who will continue to need a preceptor attestation?
Individuals applying under the alternate training and experience pathway and all physicians applying to be authorized users under the provisions of 10 CFR 35.396 will continue to need a preceptor attestation.
: 15. If a physician authorized user met the training and experience criteria under 10 CFR 35.390 or 35.690 and receives additional training and experience for a new medical use under the same section of the regulation, is another attestation statement needed?
Yes, under certain circumstances. Another attestation statement is not needed if the authorized user initially qualified under the board certification pathway. However, another attestation is needed if the authorized user initially qualified for 10 CFR 35.390 or 35.690 under the alternate training and experience pathway.
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: 16. If an authorized medical physicist met the training and experience criteria under 10 CFR 35.51 and receives additional training and experience for a new medical use under the same section of the regulation, is another attestation statement needed?
Yes, under certain circumstances. Another attestation statement is not needed if the authorized medical physicist initially qualified under the board certification pathway. However, another attestation is needed if the authorized medical physicist initially qualified under the alternate training and experience pathway.
: 17. If a licensee authorized for specific medical uses wants to expand those medical uses, and the RSO receives additional training specified in 10 CFR 35.50(d) for the new uses, does the RSO need a new attestation statement for this training?
Yes, under certain circumstances. An additional attestation statement is needed if the RSO initially qualified under the alternate training and experience pathway; i.e., 10 CFR 35.50(b)(1).
However, an attestation statement is not necessary for an individual who qualified via any other pathway.
: 18. Why did NRC amend the wording of attestation statements?
The NRC had intended level of competency in current attestations to refer to radiation safety competency. However, the medical community expressed concern that this could be interpreted to be as an attestation of medical competency. Therefore, NRCs new attestation statements no longer include the word competency.
: 19. May a non-authorized user residency program director sign an attestation form?
Yes, in most cases. The regulations specify the conditions necessary for a residency program director to sign an attestation. The attestation must represent the consensus of the residency program faculty where at least one faculty member is an authorized user for the same use and concurs with the attestation. The residency program must also be approved by one of the accreditation organizations listed in the regulation.
: 20. May an individual who qualifies as an AU or AMP under 10 CFR 35.57 serve as a preceptor or supervisor for an applicant seeking authorization on NRC licenses for the same uses?
Yes.
: 21. The wording of attestation statements changed in the rule and the number of individuals needing attestations has decreased. If a licensee submits an older version of the NRC Form 313A series for a proposed authorized individual and it includes an attestation that is now unnecessary or does not match the wording of the revised attestation, is it necessary for the proposed authorized individual to obtain a new NRC Form 313A?
No. Submission of information such as a preceptor statement that is not required is neither reviewed nor part of the license. While NRC expects future attestations to conform to the new rule, the former attestation language will be accepted as adequate to meet the current attestation requirements.
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Radiation Safety Officers and Associate Radiation Safety Officers
: 22. Can a medical use licensee have more than one Radiation Safety Officer (RSO)?
No, there can be only one RSO, but there may be more than one Associate Radiation Safety Officer, or more than one temporary RSO in accordance with 10 CFR 35.24(c).
: 23. Why would a licensee want to have an Associate Radiation Safety Officer (ARSO)?
The licensee may want to request a license amendment to identify one or more individuals to assist the Radiation Safety Officer (RSO). The approved ARSO(s) would be listed on the license. The ARSO(s) would be assigned duties and tasks in the oversight of the radiation safety operations of designated sections of the licensed program, while reporting to the named RSO.
The regulations continue to allow a licensee to name only one RSO on a license, who would be responsible for the day-to-day oversight of the entire radiation safety program. Similarly, licensees with multiple program components or operating locations could appoint one or more qualified ARSOs to perform duties and tasks in the oversight of designated program components or locations of byproduct material use.
: 24. How does an Associate Radiation Safety Officer differ from an Assistant Radiation Safety Officer?
NRC recognizes that licensees may use a variety of different terms to identify members of their radiation safety staff. Some Agreement States may already have similar programs in place using similar terminology. It was necessary for NRC to select a single term to describe the person other than the Radiation Safety Officer identified in 10 CFR 35.2, 35.24, 35.50 and on the license. Several different terms were considered, but Associate Radiation Safety Officer was chosen.
: 25. Why do ARSOs need to be listed on a license? Why cant the licensee just designate ARSOs in their program?
NRC requires that the ARSO be listed on the license to avoid confusion between individuals working in a radiation program and those that meet uniform training and experience criteria and are formally delegated duties and task for oversight of parts of the radiation safety program.
The regulators review of the potential ARSOs training and experience ensures all individuals meet the same standards. This allows the individual who is named as an ARSO to be recognized by Agreement States and the NRC as an RSO or ARSO for the same medical uses on another license without resubmitting their training and experience documents.
: 26. Will NRC recognize an individual named as an Associate Radiation Safety Officer on an Agreement State License that does not meet the requirements in 10 CFR 35.50 to be an Associate Radiation Safety Officer?
No, the individual must meet the requirements in 10 CFR 35.50 for the NRC to list the individual as an ARSO on a medical use license. Therefore, until all the Agreement States have adopted the rule and list only individuals that meet the requirements in 10 CFR 35.50 or equivalent Agreement state requirements as ARSOs, the licensee will have to verify that a proposed ARSO meets the NRC requirements.
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: 27. Will the Associate Radiation Safety Officer have any responsibility for the Radiation Protection Program?
No, only the Radiation Safety Officer has responsibility for the Radiation Protection Program.
: 28. The Radiation Safety Officer (RSO) has full responsibility for the program. During a documented absence of the RSO, does the Alternate Radiation Safety Officer (ARSO) assume any responsibilities of the RSO?
No, the ARSO cannot assume any RSO responsibilities unless the licensee designates the ARSO as a temporary RSO.
: 29. What training and experience requirements need to be satisfied for an Associate Radiation Safety Officer (ARSO) to be named in a medical license? And how do they differ from the Radiation Safety Officer (RSO) training and experience requirements?
An ARSO is required to complete the same training and experience requirements as a named RSO for the ARSOs assigned duties and tasks for the same types of use in a radiation safety program.
: 30. Can an Associate Radiation Safety Officer (ARSO) provide a preceptor statement for someone applying to be a Radiation Safety Officer?
Yes, provided the ARSO has experience with the radiation safety aspects of similar types of use of byproduct material for which the ARSO is providing the attestation.
: 31. How does the rule change the potential pool of Radiation Safety Officers (RSOs) and RSO supervisors/preceptors?
It increases the potential pool, because when an Associate Radiation Safety Officer (ARSO) meets the same training and experience requirements as an RSO, the ARSO may supervise and be a preceptor for other individuals training to become RSOs or ARSOs for the same types of use for which the ARSO is qualified.
In addition, because an authorized user, authorized medical physicist, or authorized nuclear pharmacist listed on any license or permit may serve as an RSO or ARSO, there are now an increased number of qualified individuals available to serve as RSOs and ARSOs on NRC and Agreement State medical licenses.
: 32. Can only an ARSO be assigned radiation safety duties and tasks?
No, a radiation safety duty or task can be assigned to any individual a licensee feels can perform the assignment with appropriate training and supervision.
: 33. Will a license amendment be required before a licensee allows an individual to work as an Associate Radiation Safety Officer (ARSO)?
Yes, a licensee must request and receive an amendment before allowing an individual to work as an ARSO. An amendment is also required before the Radiation Safety Officer assigns the ARSO the duties and tasks in the oversight of a new section of the radiation safety program for which the ARSO is not currently authorized.
: 34. Will a licensee need to notify the Commission when the Associate Radiation Safety Officer (ARSO) discontinues performance of duties?
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Yes, a licensee is required to notify the Commission no later than 30 days after the ARSO discontinues performance of duties under the license.
: 35. If a licensee is authorized for specific medical uses and wants to expand those medical uses, does the Radiation Safety Officer (RSO) need additional training specified in 10 CFR 35.50(d) for the new uses?
Yes. The RSO needs to obtain additional training, or document that he or she received related training and experience within the past 7 years. See question 17 to see if a preceptor attestation is needed for the additional training.
: 36. It appears that 10 CFR 35.50(c)(2) and (3) are the same for physicians. What is the difference?
Current regulations, under 10 CFR 35.50(c)(2), allow a physician who is named as an authorized user (AU) on a medical license or permit to be named as the Radiation Safety Officer (RSO) on the same license for the same byproduct material for which the AU is authorized. The revised 10 CFR 35.50(c)(2) will permit the AU to be named as an RSO on any license. NRC regulatory changes in 10 CFR 35.50(c)(3) will allow an individual who is not yet named as an AU on a medical license or permit, but is qualified to be an AU, to be named simultaneously as the RSO and the AU on the same new medical license.
: 37. What changed in 10 CFR 35.50(c)(2)?
Previously, 10 CFR 35.50(c)(2) permitted only an authorized user (AU), authorized medical physicist (AMP), or authorized nuclear pharmacist (ANP) who was listed on the licensees license to be named as the Radiation Safety Officer (RSO). The new 10 CFR 35.50(c)(2) will allow the licensee to request an AU, AMP, or ANP on any medical license or permit to be authorized as the RSO or Associate Radiation Safety Officer (ARSO) when the individual has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual will have RSO responsibilities or ARSO duties and tasks.
: 38. Who can be the RSO for a private practice?
Anyone can be the RSO for a private practice license as long as he or she meets the requirements in 10 CFR 35.50 and has experience with the radiation safety aspects of similar types of use for which the applicant or licensee is seeking approval of the individual as the RSO.
The applicant or licensee will need to provide documentation that the individual has training in radiation safety, regulatory issues, and emergency procedures for those types of use (i.e., meet the requirements in 10 CFR 35.50(d)). Therefore, a new AU, a new RSO, or an existing RSO, ARSO, AU, AMP, or ANP meeting these requirements can be the RSO for a private practice medical use license.
Ophthalmic Physicist
: 39. Why is an ophthalmic physicist added to the regulations?
At about the time of the 2002 major revision to 10 CFR Part 35, there were a large number of medical events that were caused by fundamental errors in calculating doses for strontium-90 eye applicators, and the licensees did not have individuals that could identify these problems.
Therefore, the requirement to have an authorized medical physicist (AMP) was added to the 2002 rule. After implementation of the 2002 rule, the NRC determined that there were a number of small ophthalmic therapy licensees in rural or isolated areas that had difficulty finding a local 243
 
AMP. Therefore, the ophthalmic physicist has been added to identify another individual that could perform the medical physics tasks associated with ensuring that ophthalmic therapies are administered in accordance with written directives.
: 40. Why is NRC requiring the ophthalmic physicist to have training in creating, modifying and completing written directives and procedures for administrations requiring a written directive? Isnt this usually part of AU training?
This training is required, in addition to the basic medical physics training and experience, to ensure the ophthalmic physicist can assist the AU in developing, implementing and maintaining written procedures that provide high confidence that the therapeutic administrations are in accordance with the physicians direction and to help the licensee identify issues that could lead to medical events.
Generator Breakthrough
: 41. Why is NRC requiring an increased frequency under section 10 CFR 35.204 for Mo-99 breakthrough tests?
Prior to 2002, licensees data showed few breakthroughs and those that did occur were identified on measurement of the Mo-99 concentration in the first eluate. For this reason, the 2002 revision of Part 35 removed the requirement to measure the Mo-99 concentration in each eluate. However, in 2006, medical use licensees reported that numerous generators had shown no Mo-99 breakthrough in the first eluate, but failed the Mo-99 breakthrough tests performed on subsequent eluates. NRC now believes that it is important to measure the Mo-99 concentration in each eluate to ensure patients are not administered amounts of Mo-99 in excess of regulatory limits.
: 42. Who needs to report breakthrough values in excess of regulatory limits for Mo-99/Tc-99m and Sr-82/Rb-82 generators? Who do they have to report to?
Under 10 CFR 35.3204, a licensee that elutes the generator has to report the results to the NRC and the distributor. This could be a commercial nuclear pharmacy or a medical use licensee who elutes their own generators.
: 43. How long do licensees that elute generators have to notify the NRC when an eluate from a generator exceeds the permissible concentration listed in 10 CFR 35.204(a)?
Under 10 CFR 35.3204, licensees eluting generators must make a telephone notification to the NRC Operations Center and the distributor within 7 calendar days after discovering that an eluate exceeded the permissible concentration listed in 10 CFR 35.204(a). The licensee must also submit a written report to the NRC within 30 days of this discovery.
: 44. What reports are made to NRC by the licensee who eluted the generator when an eluate exceeds the permissible concentrations listed in 10 CFR 35.204(a)?
The licensee eluting the generator must report generator and elution information, whether dosages were administered, and when the distributor was notified. If patient dosages were administered, a dose assessment must be performed and the methodology of the dose 244
 
assessment described. If an error occurred in the licensees breakthrough determination, the report must include action taken by the licensee, probable cause, evaluations and assessments of failure in the licensees equipment, procedures, or training that contributed to the excessive readings.
Calibration, transmission, and reference sources
: 45. Is bundling or aggregating of single calibration, transmission, or reference sealed sources authorized by 10 CFR 35.65 allowed under regulation?
Sometimes. Bundling or aggregating of single sealed sources is allowed when the combined source activity is not greater than the activities authorized by 10 CFR 35.65. Bundling or aggregating of single sealed sources is not allowed when the combined source activity is greater than the activities authorized by 10 CFR 35.65, and in this case, the source needs to be specifically listed on the license.
: 46. Does NRC define bundling?
Although bundling is not defined in 10 CFR 35.2, Definitions, in 10 CFR 35.65(b)(2) combined to create an activity is described as being the same as bundled or aggregated. Examples of bundled sources are those transmission sources used in PET scanners that are each less than the limits of individual sources in 10 CFR 35.65, but only used together as an aggregated group.
NRC does not consider individual sources placed together for storage to be bundled.
: 47. May a licensee use calibration, transmission, or reference sources to aid in performance of patient imaging and localization procedures if the sources otherwise meet the requirements of 10 CFR 35.65?
Yes. Some licensees may not recognize that use of calibration, transmission, or reference sources during imaging procedures meets the definition of medical use if this results in radiation exposure to the patient. 10 CFR 35.65(b)(1) recognizes that medical use of calibration, transmission, and reference sources must be performed in accordance with the requirements in 10 CFR 35.500, Use of Sealed Sources and Devices for Medical Diagnosis, and a physician authorized for 10 CFR 35.200 medical uses is authorized by 10 CFR 35.590(b) to use these sources under 35.500.
: 48. If a licensee uses calibration, transmission, or reference sources in patient imaging and localization procedures when the sources otherwise meet the requirements of 10 CFR 35.65, do these sources need to be specifically listed on the license?
No. Calibration, transmission, or reference sources that are used for medical use in accordance with the requirements of 10 CFR 35.500, and are not bundled to result in an activity greater than that specified in 10 CFR 35.65, do not have to be listed on the license.
Sealed and Device Registry
: 49. Why were 10 CFR 35.400, 35.500, and 35.600 revised to replace the requirement that the sealed sources be used as approved in the Sealed Source and Device Registry with the requirement that the sealed sources be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry?
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The requirement to use sources in accordance with the Sealed Source and Device Registry (SSDR) was revised because NRC recognized that the SSDR might not include all the medical uses for a sealed source (for example, the SSDR may list only interstitial use when intracavitary, intraluminal or superficial uses may also be acceptable). Requiring only those uses listed in the SSDR may interfere with the practice of medicine.
During the SSDR review, safety conditions and limitations are determined based on a review of the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing of sources and installation, service and maintenance, operating and safety instructions, and potential hazards for devices. This is done to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property for the proposed use. Use of the sources or devices within the safety conditions and limitations assures that the sources and devices are used in a manner that protects workers, users and patients.
In addition, NRC regulations still require sources and devices to be used for the type of medical use for which they are listed in the Sealed Source and Device Registry. For example, a source or device listed for diagnostic purposes (under 10 CFR 35.500 medical uses) cannot be used for therapy purposes (under 10 CFR 35.400 or 35.600 medical uses) and a source or device that is listed for a high dose remote afterloader use (under 10 CFR 35.600 medical uses) cannot be used for manual brachytherapy purposes (under 10 CFR 35.400 medical uses).
: 50. Why did NRC change the regulations to address sources and devices separately?
Many 10 CFR 35.500 and all 35.600 medical uses involve sources used with specific devices.
NRC revised 10 CFR 35.500 and 35.600 to separately address the sources and devices containing sealed sources. For devices containing sealed sources, both the sources and devices have to be approved in the SSDR. The changes require licensees to use only sources approved to be used in those devices. This assures that the sources and devices have been reviewed and determined to protect public health and safety when used together.
: 51. If device manufacturer training for units under 10 CFR 35.600 has been completed once at the facility, can the licensee train their own staff?
Sometimes. If there are no additional manufacturer upgrades that affect the operation and safety of the unit, the licensee can provide training to their staff under the provisions of 10 CFR 35.610(d)(2). 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.
: 52. 10 CFR 35.610(d) requires in part that prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. Is this just for actual operators or does this include AUs and AMPs?
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The requirement in 10 CFR 35.610(d) is for all individuals, including AUs, AMPs, operators, and others that need to know how the new unit operates and understand how the upgrades affect safety and operations.
Permanent Implant Brachytherapy
: 53. How were the revised written directive requirements and medical event reporting requirements for permanent implant brachytherapy developed?
The revised regulations are based on recommendations provided to the NRC in February 2012 by the Advisory Committee on the Medical Uses of Isotopes (ML12038A279) plus stakeholder input obtained during two stakeholder public workshops held in 2011 that focused on issues associated with medical event definitions for permanent implant brachytherapy (ML111930470 and ML112510385). The staffs recommendations (ML12072A299), based on this input and other stakeholder input, were approved by the Commission in SRM-SECY-12-0053, Recommendations on Regulatory Changes for Permanent Implant Brachytherapy Programs, issued August 2012 (ML122260211). The revised regulations are also based on comments received from the public on the proposed rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, (79 FR 42410) published in the Federal Register on July 21, 2014.
Note: The information in parentheses designate document accession numbers in the NRCs Agencywide Documents Access and Management System (ADAMS). To locate a referenced document on the NRC website, go to www.nrc.gov and enter the 11-character accession number into the search box in the top right-hand section of the screen.
Written Directives
: 54. What are the written directive and medical event reporting requirements for 10 CFR 35.1000?
The written directive requirements for 10 CFR 35.1000 medical uses are determined on a case-by-case basis. NRC has developed licensing guidance, including written directive and medical event guidance, for certain 10 CFR 35.1000 medical uses. If the 10 CFR 35.1000 medical use has unique properties that prevent the written directive requirements and medical event reporting requirements in the regulations from being met, specific written directive and medical event reporting commitments are developed for that use. This information is posted on the NRC public website at http://www.nrc.gov/materials/miau/med-use-toolkit.html#et in the section titled Emerging Technologies and 10 CFR 35.1000.
: 55. Why were the written directive requirements in 10 CFR 35.40, Written Directives, and the medical event reporting requirements in 10 CFR 35.3045, Reporting and Notification of a Medical Event, changed for permanent implant brachytherapy medical use?
The 2002 (67 FR 20250) requirements in 10 CFR 35.40 were for all brachytherapy procedures including permanent and temporary implant brachytherapy and reflect operational aspects of temporary and permanent implant brachytherapy medical use. Not all of the required information elements were appropriate for characterizing permanent implant brachytherapy use.
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The rule change makes it clear which information is needed for permanent implant brachytherapy. Moreover, for permanent implant brachytherapy, the current requirements were judged to interfere with physicians ability to take actions relating to delivered dose that they deem to be medically appropriate for patients being treated. Consequently, the NRC determined that the requirements for permanent implant brachytherapy are different and needed to be addressed separately.
: 56. What information is required for proper completion of the written directive for permanent implant brachytherapy?
The information required is:
: a. Before implantation: the treatment site, the radionuclide, and the total source strength; and
: b. After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date.
Note that the requirement is retained that the written directive must also be signed and dated by an authorized user before administration.
: 57. What does post-treatment recovery area mean in 10 CFR 35.40?
The term post-treatment recovery area as used in 10 CFR 35.40 means the area or place where a patient recovers immediately following the brachytherapy procedure before being released to a hospital intensive care unit or patient room or in the case of an outpatient treatment, released from the licensees facility.
: 58. For the two part written directive required for permanent implant brachytherapy medical use, when is the signature of an authorized user required?
An authorized user (AU) must sign the written directive after completion of the pre-implantation portion of the document (but before the administration begins). The current date must also be entered both before the administration begins and after implantation but before the patient leaves the post-treatment recovery area.
The requirement for the AU signature (pre-implantation portion) of the written directive is still addressed in 10 CFR 35.40(a), which refers to all administrations requiring a written directive.
The second part of the written directive (post-implantation portion) is now addressed in 10 CFR 35.40(b)(6)(ii), which is specific to permanent implant brachytherapy.
: 59. What are the main changes to the written directive requirements in 10 CFR 35.40, Written Directives, for permanent implant brachytherapy use?
The changes are:
: a. Requiring inclusion in the pre-implantation portion of the written directive of the total source strength;
: b. Deleting the total dose from the post-implantation portion of the written directive and deleting the requirement to include dose; and 248
: c. Requiring completion of the post-implantation portion of the written directive before the patient leaves the post-treatment recovery area.
Written Procedures in 10 CFR 35.41
: 60. What are the main changes to the procedural requirements in 10 CFR 35.41, Procedures for Administrations Requiring a Written Directive, for permanent implant brachytherapy use?
The main changes are requiring development, implementation, and maintenance of written procedures for:
: a. Determining if a medical event, as defined in Section 35.3045, has occurred (note that this applies to all administrations requiring a written directive); and
: b. Determining, for permanent implant brachytherapy, within 60 calendar days from the day the implant was performed (unless accompanied by a written justification related to patient unavailability): The total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive.
: 61. What is the basis for the 60 day limit on verifying that at least 80% of the total source strength was implanted within the treatment site?
The 60 day time limit was recommended by NRCs Advisory Committee on the Medical Uses of Isotopes and reflects the American Association of Physicists in Medicines (AAPM) suggested time for post implant assessment, which is 30 days for the longest half life radioactive source used in permanent implant brachytherapy, Iodine-125, which has a a half life of 60 days. Refer to AAPM Report 137, AAPM Recommendations on Dose Prescription and Reporting Methods for Permanent Interstitial Brachytherapy for Prostate Cancer, which is available on the AAPM website at www.aapm.org.
: 62. What if the patient is not available within the 60 day time limit for determining whether or not 80% or more of the sources were implanted within the treatment site?
If the patient is unavailable to the licensee within 60 days from the day that the implant was performed, then the licensee cannot perform this assessment. The licensee is required to provide a written justification that explains why the patient was unavailable.
: 63. Is it permissible for the licensee to verify source positioning on the same day as the implant procedure or is it necessary to have the patient come in on a different day?
Yes. Although licensees usually make the source positioning determination on a day after the implant procedure, nothing in the regulations precludes licensees from verifying source position on the same day. The requirement in 10 CFR 35.41(b)(6) is for the determination to be made within 60 calendar days from the date the implant was performed. This is a performance based requirement and does not specifically direct licensees as to how the objectives are to be achieved. One option could be to verify source positioning based on a CT scan performed immediately after a patient is discharged from the post-implant recovery area.
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: 64. Does the NRC require licensees conducting permanent implant brachytherapy to use a treatment planning software as well as perform post-implant imaging?
The requirements in 10 CFR 35.41, Procedures for Administrations Requiring a Written Directive, are performance based and do not explicitly direct licensees as to how the objectives are to be achieved. Accordingly, using treatment planning software or post-implant imaging are not explicitly required. However, NRC believes the use of both is likely necessary to outline the treatment site and make the determination of implanted source positioning to decide whether a medical event has occurred according to the criteria in 10 CFR 35.3045, Report and Notification of a Medical Event.
Medical Event Reporting
: 65. Do administrations that do not require a written directive but meet the medical event criteria still need to be reported to the NRC?
Yes, criteria for reporting and notification of a medical event in 10 CFR 35.3045 do not require that the administration be one that requires a written directive. Although it is unlikely that a medical event would be associated with a medical use that does not require a written directive, they do happen. For example, diagnostic procedures, which do not require WDs, may meet the ME reporting criteria and are reportable to the NRC. The ME reporting criteria requires that a licensee shall report any medical event, except for one that results from patient intervention.
: 66. What are the main changes to the medical event reporting requirements in 10 CFR 35.3045, Report and Notification of a Medical Event, for permanent implant brachytherapy use?
The main changes are:
: a. Addition of a separate section for permanent implant brachytherapy medical events.
: b. A criterion involving total source strength administered differeing by 20% or more from the total source strength documented in the post-implantation written directive. There is no longer a threshold dose criterion.
: c. A criterion for the difference between the total source strength implanted outside the treatment site exceeding 20 percent of the total source strength documented in the post-implant portion of the written directive.
: d. Including a dose threshold for the leaking sealed source criterion.
: e. Addition of a criterion for sealed source(s) implanted directly into a location discontinguous from the treatment site, as defined in the post-implatation portion of the written directive.
: f. Addition of a criterion for administration of the wrong radionuclide.
: 67. Are there any changes to the medical event reporting criteria for brachytherapy other than permanent implant brachytherapy?
Yes. Implantation of sealed sources containing the wrong radionuclide is now a medical event reporting criterion under 10 CFR 35.3045(a)(1)(ii)(A).
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: 68. 10 CFR 35.3045(a)(2)(iii)(C) lists the medical event criteria for permanent implant brachytherapy for administrations involving sealed sources implanted into a location discontiguous from the treatment site as documented in the post-implantation portion of the written directive. What does discontiguous mean?
Discontiguous in general terms is used to describe things that are not contiguous in space, things that are not adjacent or touching, and things that have a gap in between or are disconnected or separate. As it relates to the medical event criteria for permanent implant brachytherapy, discontiguous means a location that is not physically adjacent to or touching the treatment site.
: 69. Suppose that during a prostate implantation procedure several sealed sources are deposited into the adjacent urinary bladder, instead of into tissue comprising the intended treatment site. Also, suppose that the incorrect placement of those sources is promptly identified and the sources are removed before the implantation procedure is completed and all the other sources were implanted in the treatment site defined in the written directive. Does this occurrence require reporting as a medical event?
No, if the sources were removed before the post-implantation portion of the written directive was completed, and if the total activity in the treatment site in the post implant written directive include only those seeds implanted in the treatment site, this does not comprise a medical event.
: 70. Assume that during a permanent implant brachytherapy procedure one or more sources are directly deposited into tissue in a location near but discontiguous from the treatment site described in the post-implant written directive. Has a reportable medical event occurred?
Yes, this occurrence is a reportable medical event under the provisions of 10 CFR 35.3045(a)(2)(iii)(C), as a source was directly delivered to location discontiguous from the treatment site as documented in the post-implant written directive.
: 71. Assume that during a permanent implant brachytherapy procedure one or more sources are directly deposited into a far location discontiguous from the treatment site.
Also, assume that the total source strength administered outside of the treatment site did not exceed 20% of the total source strength documented in the post implantation portion of the written directive. Has a reportable medical event occurred?
Yes, this occurrence is a reportable medical event under the provisions of 10 CFR 35.3045(a)(2)(iii)(C), as a source was directly implanted into a location discontiguous from the the treatment site, as defined in the post implant written directive. Although the total strength administered outside of the treatment site was less than 20% of the total source strength, this is an example of a case of where a medical event would have occurred because one source met the discontiguous or wrong treatment site criterion for a medical event.
: 72. Assume that during a permanent implant brachytherapy procedure one or more sources are directly deposited into contiguous tissue outside of the treatment site described in the post-implant written directive. Also assume that the total source strength administered differs by less than 20 percent from the total source strength documented in the post-implantation written directive, and that the total source strength administered outside of the treatment site differs by less than 20 percent from the total 251
 
source strength documented in the post-implantation written directive. Has a reportable medical event occurred?
No, this occurrence is not a reportable medical event. Implantation of sources into tissue outside but contiguous with the treatment site described in the post implant written directive is not considered under the medical event provision of 10 CFR 35.3045(a)(2)(iii)(C) as directly delivered to the discontiguous from the treatment site, nor has any other criteria under 10 CFR 35.3045(a)(2) been met.
: 73. The medical event reporting criterion for the treatment site in permanent implant brachytherapy, 10 CFR 35.4035(a)(2)(i), does not include significant deviations of actual source placement within the treatment site volume relative to the intended source placement within the treatment site volume, which may impact the intended absorbed dose to the treatment site. For example, a physician authorized user prescribes a number of sources to be positioned in the treatment site volume at various intended positions to achieve the intended treatment site volume absorbed dose to treat cancer.
During placement of the sources, 100 percent of the prescribed number of sources are positioned in the treatment site volume; however, most of the sources are placed in a small area within the treatment site volume such that the positions of most of the sources differ significantly from the intended positions to achieve the intended absorbed dose. As a result, a portion of the treatment site that is a distance away from the area containing most of the implanted sources receives significantly less absorbed dose than intended. Do these deviations in source positioning constitute a medical event?
No. The NRC does not consider the details of source placement within the treatment site to be a medical event. In SECY-12-0053, Recommendations on Regulatory Changes for Permanent Implant Brachytherapy Programs (ML12072A299), NRC staff concluded that it is not necessary for an authorized user to affirm, in writing on the written directive after the implant is completed, that the distribution of the sources within the treatment site was as intended per the pre-implantation written directive. The Commission approved the staffs recommendations in SRM SECY-12-0053 (ML122260211).
10 CFR 35.40(b)(6)(i) does not require the authorized user to enter intended source placement within the treatment site into the pre-implantation portion of the written directive and 10 CFR 35.40(b)(6)(ii) does not require the authorized user to enter deviations from intended source placement into the post-implantation portion of the written directive.
If the actual positioning of implanted sources would not result in satisfactory absorbed doses to sections of the treatment site, it is expected that, as part of medical practice, the authorized user will take the actions that he or she deems are appropriate. This may include consideration of the need for additional treatment.
Note: The values in parentheses designate document accession numbers in the NRCs Agencywide Documents Access and Management System (ADAMS). To locate a referenced document on the NRC website, go to www.nrc.gov and enter the 11-character accession number into the search box in the top right-hand section of the screen.
: 74. During a manual brachytherapy implant treatment procedure, sources were implanted correctly into the treatment site, but later migrated to a location outside of the treatment site. Would this be considered a medical event?
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No, this would not be considered a medical event. The migration of sources that were implanted into the correct site is not considered a medical event. The reporting and notification requirement for permanent implant brachytherapy in 10 CFR 35.3045(a)(2) provides that treatments sources that were implanted in the correct site, but migrated outside the treatment site, do not constitute medical events.
: 75. As part of calculating the total source strength for a permanent implant brachytherapy procedure, is the licensee required to check their calculations and assay a portion of the seeds to ensure the total source strength is as ordered?
No, it is only a medical event if the total source strength administered differs from the total source strength documented in the post-implant written directive. While not required, it is encouraged that the licensee check its calculations and assay a portion of their seeds as these may identify an error in source strength or total source strength. A licensee may choose to adopt these practice as part their program to provide high confidence that the administration was in accordance with post implant written directive.
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PART 4 Comment Resolution for Proposed Guidance on the Proposed Rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments 254
 
The comments on the proposed guidance that the NRC published on July 21, 2014 (79 FR 42224) are addressed here.
10 CFR 35.390 and 35.396 Comment: In the proposed rule 10 CFR 35.390(b)(1)(ii)(G)(4) was changed from any other radionuclide to any other radionuclide that is primarily used for its alpha radiation characteristics. Based on prior guidance in Notice Of Licensing Decision On Radium-223 Dichloride (FSME-13-002), authorized users were permitted to administer Ra-223 Dichloride for its alpha characteristics under 10 CFR 35.390(b)(1)(ii)(G)(3). Presuming that these individuals are grandfathered when the new rules go into effect, how will licensees and regulators be able to identify those AUs that are authorized for Ra-223 Dichloride to use and sign as preceptors for 10 CFR 35.390(b)(1)(ii)(G)(4) uses going forward?
Response: The final rule was revised to include radionuclides that are primarily used for alpha radiation characteristics in 10 CFR 35.390(b)(1)(ii)(G)(3). 10 CFR 35.57 in the final rule was also revised to grandfather Authorized Users that were authorized for medical uses prior to the effective date of the rule to continue to use those materials and uses without needing to meet the new requirements. Therefore, AUs authorized to use unsealed byproduct materials for parenteral administrations continue to be authorized for that use. Radium-223 Dichloride will continue to be regulated under 10 CFR 35.390(b)(1)(ii)(G)(3) in the final rule. All AUs authorized for this medical use will be authorized to use Radium-223 Dichloride.
10 CFR 35.50 and 35.13 Comment: Some Agreement States permitted the listing of Assistant/Deputy/Associate RSOs on a license prior to this rule. If the current license does not list the specific functions for the individual, can it be presumed that the Assistant/Deputy/Associate RSO is approved for all the uses on the license, especially when they serve as a preceptor to another RSO or Associate RSO? Or, will it be incumbent upon each licensing agency to amend their licenses clarifying the specific functions of ARSOs prior to the effective date of the rule in order to be recognized by other licensees and licensing agencies?
Response: The final rule only recognizes Associate Radiation Safety Officers. If an individual is listed on an Agreement State as an Assistant Radiation Safety Officer or a Deputy Radiation Safety Officer and an NRC licensee wants to have the individual listed on an NRC license as an Associate Radiation Safety Officer, the NRC licensee will have to provide documentation that the individual meets the training and experience provisions in 10 CFR 35.50 for the intended functions. If an individual is listed on an Agreement State license as an Associate Radiation Safety Officer before the effective date of the rule for the Agreement State, and an NRC licensee wants to list the individual on an NRC license as an Associate Radiation Safety officer, the licensee will need to provide documentation that the individual meets the training and experience criteria in 10 CFR 35.50 to be an Associate RadiationSafety Officer. If an individual is listed on an Agreement State license after the effective date of the rule for the Agreement State as an Associate Radiation Safety Officer without designating the authorized types of use and an NRC licensee wants to list the individual on an NRC license as an Associate Radiation 255
 
Safety officer, the licensee will need to list the types of functions and provide documentation that the individual meets the training and experience criteria in 10 CFR 35.50 for those functions.
Comment: The commenter asked if the requirements in 10 CFR 35.13(d), which states in part that before a licensee permits anyone to work as an ARSO or before the RSO assigns duties and tasks to an Associate RSO that differ from those for which this individual is authorized on the license, means that the license will need to list the tasks and duties assigned to the Associate RSO in addition to the uses (and locations if applicable)?
Response: The NRC will list the types of medical uses for the Associate Radiation Safety Officer on the license in accordance with 10 CFR 35.2, based on the licensees submission of the appropriate training and experience criteria in 10 CFR 35.50. The licensee can assign any duties and tasks under that type of medical use. In their amendment request, the licensee does not have to list those duties and tasks that will be assigned to the individual. If the licensee intends to have the Associate Radiation Safety Officer perform duties and tasks at a specific location, the licensee can specify the location, but also must specify the types of medical uses for which the individual is qualified under 10 CFR 35.50.
Comment: In the proposed NRC Form 313A (RSO), it is unclear how to document training and experience for (c)(l) individuals (medical physicists) since section 1 Board Certification is now specified for certification processes only recognized under 10 CFR 35.50 and 35.50 (c)(l) includes specialty boards recognized under 35.51(a). Also, NRC Form 313A (RSO) has the preceptor verifying this experience for (c)(2) individuals only. There is no designated area on the proposed NRC Form 313A to document this experience that the regulations require; this could cause confusion.
Response: NRC Form 313A (RSO) was revised based on this comment. A new sub part was added specifically for the boards recognized under the provisions of 10 CFR 35.51(a) in section 1.Board Certification. The new subsection asks for documentation that the individual has experience with the types of uses checked and for Table 5.c. to be filled out providing the training in the radiation safety, regulatory issues, and emergency procedures. NRC no longer requires a preceptor statement for individuals that are certified by Boards recognized by NRC or listed in 10 CFR 35.57. This will clarify how to document the requirements under 10 CFR 35.51(c)(1) that the medical physicist be board certified under the criteria in 10 CFR 35.51(a),
has experience with similar types of use of byproduct material, and has training in the radiation safety, regulatory issues, and emergency procedures for which the licensee seeks the approval of the medical physicist as the Radiation Safety Officer or as an Associate Radiation Safety Officer. There is no requirement that this board certified medical physicist also be an authorized medical physicist.
The NRC Form 313A (RSO) was also revised to address the commenters concerns about documenting the requirements in 10 CFR 35.50(c)(2) for an individual identified as an authorized user, authorized medical physicist, or authorized nuclear pharmacist to be the Radiation Safety Officer or an Associate Radiation Safety Officer. Part 1, Section 3 of the form was revised to request the NRC license number or a copy of the license or permit identifying the individual as an authorized individual. This will provide documentation that the individual also 256
 
has experience with similar types of uses of byproduct material for which the licensee seeks the approval of the individual as the Radiation Safety Officer or as an Associate Radiation Safety Officer. Part 1, Section 3 of the form also describes the information needed to demonstrate that the individual meets the criteria in 10 CFR 35.50(c)(2). The applicant must use the table in section 5.c. to describe training in radiation safety, regulatory issues, and emergency procedures for all types of medical use on the license for which the licensee seeks the approval of the individual as the Radiation Safety Officer or as an Associate Radiation Safety Officer and a preceptor statement is needed if the individual is not board certified.
Also in response to this comment, the request to provide a license number was expanded to include a copy of the license (if the license was not issued by NRC) or permit identifying the individual as an authorized individual (i.e., an authorized user, authorized medical physicist, or authorized nuclear pharmacist). The applicant must use the table in section 5.c. to describe training in radiation safety, regulatory issues, and emergency procedures for the individual. This individual does not need a preceptor statement if he or she is board certified by a board recognized by NRC or listed in 10 CFR 35.57. The preceptor statement needed under the alternate pathway is for the training in radiation safety, regulatory issues, and emergency procedures for all types of medical use on the license for which the licensee seeks the approval of the individual as the Radiation Safety Officer or as an Associate Radiation Safety Officer.
Comment: In reading the proposed guidance, it seems that on page 25 the (c)(1) individuals must only provide his/her certificate and proof of (d), but on page 30 it appears that (c)(1 ) individuals must submit a copy of their certification as well as a description of the experience specified in (c)(1 ) and the training and experience detailed in (d). Page 25 somewhat implies that the submitting of a (c)(2) certification is separate from demonstrating experience in the radiation safety aspects. On page 31, (c)(2) individuals must submit a copy of the license/permit he/she is listed on that indicates the individual is an AU, AMP, or ANP and has experience with the pertinent radiation safety aspects (i.e., being on the license alone is evidence that the aforementioned experience has been achieved -no description of the experience is required).
Response: The guidance was revised based on this comment. The text on page 25 was revised to include the requirement demonstrating that the proposed RSO or ARSO is qualified by experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO in the discussion on requirements for 10 CFR 35.50(c)(1). The commenter is correct that for individuals meeting the requirements of 10 CFR 35.50(c)(2) being on the license alone is evidence that the individual has experience with the radiation safety aspects of similar types of use of byproduct material for which the applicant seeks approval of an individual to serve as RSO or ARSO. The individual is only eligible to be the RSO or ARSO for similar materials and uses for which he or she was authorized for on the license or permit listing them as an AU, AMP, or ANP. However, the applicant must still use the table in section 5.c. to describe training in radiation safety, regulatory issues, and emergency procedures for the individual and provide a preceptor statement if the individual is not board certified.
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Comment: The commenter stated that the guidance did not have a provision for the particular kind of experience needed for individuals under the requirements of 10 CFR 35.50(c)(3) and how to document it, even though the proposed regulations state it to be a requirement. The commenter wanted either the acceptable documentation/proof of experience for all the pathways to be clear and if the experience does not have to be documented, then it should not be required in regulation.
Response: No change was made to the guidance in response to this comment. Under the provisions of 10 CFR 35.50(c)(3), the experience the individual provides to be named as the AU is the same experience the individual needs to be simultaneously named as the RSO. The applicant is requesting a new license and the new license will only authorize the medical uses for which the proposed AU is qualified. Submission of the appropriate NRC Form 313A (AUD),
(AUT) or (AUS) will document the individuals experience with the radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as the Radiation Safety Officer and the authorized user. Submission of NRC Form 313A (RSO) is used to ensure the individual meets the requirements in 10 CFR 35.50(d) and if a preceptor statement is needed (the individual is not certified by a board recognized by NRC or listed in 10 CFR 35.57) for the training in radiation safety, regulatory issues, and emergency procedures.
Comment: A chart in guidance would be helpful that delineates exactly what should be submitted by each authorization route, whether 10 CFR 35.50(a), (b), (c)( l ), (c)(2), and (c)(3), designating what needs to be submitted (copy of board certificate, training documentation pursuant to paragraph (b), radiation safety aspects training, paragraph (d) training and experience, and/or preceptor attestation).
 
===Response===
The NRC staff agrees with this comment, and has modified its guidance to provide such a table found in Appendix D of NUREG-1556, Volume 9, which is reproduced below.
Documentation needed to meet the Requirements to be an RSO or ARSO Regulation                35.50(a)      35.50(b)        35.50(c)(1)  35.50(c)(2)    35.50(c)(3) 35.57(a)(2)
Board Certification            X                            X                                        X Used requested Materials on or before                                                                                X October 24, 2005 License or Permit                                                          X Experience with the Radiation Safety Aspects of the Types of                                      X            X Use 258
 
Classroom and Laboratory Training                        X Supervised Work Experience                                  X Training in Radiation Safety, Regulatory Issues and Emergency          X            X            X            X          X Procedures NRC Form 313A(AUD) 313A(AUT) or                                                                      X 313A(AUS 35.50                                      X              *          *
* Preceptor Statement
* Only needed if individual is not board certified by a Board recognized by NRC or listed in 10 CFR 35.57 259}}

Latest revision as of 18:09, 5 January 2025

Guidance for the Final Rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments and Comment Resolution for Proposed Guidance on the Proposed Rule
ML18176A377
Person / Time
Issue date: 07/03/2018
From:
Office of Nuclear Material Safety and Safeguards
To:
Howe D
References
Download: ML18176A377 (262)
v • d • e


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