Proposed guidance for using the NRC FORM 313A Series of Forms
Documentation of Training and Experience to Identify Individuals on a License as Authorized User, Radiation Safety Officer, Authorized Nuclear Pharmacist, or Authorized Medical Physicist
I. Experienced Authorized Users, Authorized Medical Physicists, Authorized Nuclear Pharmacists, or Radiation Safety Officer
An applicant or licensee that is adding an experienced authorized user, authorized medical physicist, authorized nuclear pharmacist, or Radiation Safety Officer to its medical use license only needs to provide evidence that the individual is listed on a medical use license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material broad scope permittee before October 25, 2005 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 authorized nuclear pharmacist 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 authorized nuclear pharmacist by a commercial nuclear pharmacy authorized to identify authorized nuclear pharmacists. 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. Applications that Include Individuals for New Authorized User, Authorized Medical Physicist, Authorized Nuclear Pharmacist or 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 applicant’s 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; NRC FORM 313A (AMP) for the authorized medical physicist; NRC FORM 313A (ANP) for the authorized nuclear pharmacist; NRC FORM 313A (AUD) for the authorized user of the medical uses included in 35.100, 35.200, and/or 35.500; NRC FORM 313A (AUT) for the authorized user for the medical use included in 35.300; and NRC FORM 313A (AUS) for the authorized user for the medical uses included in 35.400 and/or 35.600.
There are two primary training and experience routes to qualify an individual as an authorized user, authorized medical physicist, authorized nuclear pharmacist, or Radiation Safety Officer. 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). Preceptor attestations must also be submitted for all individuals to qualify under Subparts B and D through H. Additional training may need to also be documented for Radiation Safety Officers, authorized medical physicists, and 35.600 authorized users. 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 for recognized authorized users, authorized nuclear pharmacists, authorized medical physicists or Radiation Safety Officers to seek additional authorizations.
III. 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:
1. Successful completion of classroom and laboratory review courses that include radiation safety practices relative to the proposed type of authorized medical use;
2. Practical and laboratory experience with patient procedures using radioactive material for the same use(s) for which the applicant is requesting authorization;
3. 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
4. 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.
IV. 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 NRC Form 313A series forms or fill out some sections more than once. For example, an applicant that requests a physician be authorized for 35.200 and 35.300 medical uses and as the RSO, needs to 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 a physician be authorized for both high dose rate remote afterloading and gamma stereotactic radiosurgery under 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.
If you need to identify a license and it is an Agreement State license, provide a copy of the license. If you need to identify a Master Materials License permit, provide a copy of the permit. If you need 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, you 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)”.
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
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, practice dentistry, practice podiatry, or practice pharmacy, respectively (see definition of "Physician" 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 page <http://www.nrc.gov/materials/miau/med-use-toolkit.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 will need to provide a copy of the board certification and other training, experience, or clinical casework as indicated on the specific form of the NRC Form 313A series.
All applicants under this pathway (except for 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.)
All applicants under this pathway must submit a completed Part II Preceptor Attestation.
Item 3. Training and Experience for Proposed New Authorized Individuals
This pathway is used for those individuals not listed on the license as an authorized individual, who cannot meet requirements for the board certification pathway.
The proposed authorized individual is not required to receive the classroom and laboratory training, supervised work experience, or clinical casework at any one location or at one time, therefore space is provided to identify each location and date of training or experience. The date should be provided in the month/day/year format. The clock hours must be indicated for those individuals that must meet a minimum number of training and work experience hours. The specific number of hours needed for each training element will depend upon the type of approval sought.
Note: Classroom and Laboratory Training or Didactic Training may be provided at medical teaching/university institutions. In some cases, a course may be provided for that particular need and taught in consecutive days; in others, the period may be a semester or quarter as part of the formal curriculum. The required “structural educational programs” or “training” may be obtained in any number of settings, locations, and educational situations.
The NRC expects that clinical laboratory hours credited toward meeting the requirements for classroom and laboratory training will involve training in radiation safety aspects of the medical use of byproduct material. The NRC recognizes, for example, that physicians in training may not dedicate all of their clinical laboratory time specifically to the subject areas covered in these subparts and will be attending to other clinical matters involving the medical use of the material under the supervision of an AU (e.g., reviewing case histories or interpreting scans). However, those hours spent on other duties, not related to radiation safety, should not be counted toward the minimum number of hours of required classroom and laboratory training in radiation safety. This type of supervised work experience, even though not specifically required by the NRC, may be counted toward the supervised work experience to obtain the required total hours of training.
Similarly, the NRC recognizes that clinicians will not dedicate all of their time in training specifically to the subject areas described and will be attending to other clinical matters. The NRC will broadly interpret “classroom training” to include various types of instruction received by candidates for approval, including online training, as long as the subject matter relates to radiation safety and safe handling of byproduct material.
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 authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer.” 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 criteria and has achieved a level of competency or a level of radiation safety knowledge sufficient to function independently. This 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 pages have multiple sections. The preceptor must complete an attestation of the proposed user’s training, experience, and competency to function independently, 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 NRC 313A series form.
V. RADIATION SAFETY OFFICER - Specific Instructions and Guidance for Filling Out NRC Form 313A (RSO)
See Section “IV. General Instructions and Guidance for Filling out NRC Form 313A Series” for additional clarification on providing information about an individual’s status on an Agreement State license, medical broad scope license, or Master Materials License permit.
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, documentation of specific radiation safety training for all types of use on the license, and completed preceptor attestation. As indicated on the form, additional information is needed if the board certification or radiation safety training was greater than 7 years ago.
Specific radiation safety training for each type of use on the license may be supervised by a Radiation Safety Officer, an authorized medical physicist, authorized nuclear pharmacist, or authorized user who is authorized for that type of use. If more than one supervising individual provided the training, identify each supervising individual by name and provide their 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 3.c) and completed preceptor attestation in Part II. As indicated on the form, additional information is needed if the specific radiation safety training was greater than 7 years ago.
Specific radiation safety training for each type of use on the license may be supervised by a Radiation Safety Officer, an authorized medical physicist, authorized nuclear pharmacist, or authorized user who is authorized for that type of use. If more than one supervising individual provided the training, identify each supervising individual by name and provide their qualifications.
Item 3. Structured Educational Program for Proposed New 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 3.a.
Submit a completed section 3.b. The individual must have completed one year of full-time radiation safety experience under the supervision of a Radiation Safety Officer. This is documented in 3.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 their qualifications.
Provide the requested information, i.e., documentation of specific radiation safety training for each use on the license (complete the table in 3.c). Specific radiation safety training for each type of use on the license may be supervised by a Radiation Safety Officer, an authorized medical physicist, authorized nuclear pharmacist, or authorized user who is authorized for that type of use. If more than one supervising individual provided the training, identify each supervising individual by name and provide their qualifications.
Submit a completed preceptor attestation in Part II.
Item 4. Authorized User, Authorized Medical Physicist, or Authorized Nuclear Pharmacist Identified on the Licensee’s 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 3.c). As indicated on the form, additional information is needed if the specific radiation safety training was greater than 7 years ago.
Specific radiation safety training for each type of use on the license may be supervised by a Radiation Safety Officer, an authorized medical physicist, authorized nuclear pharmacist, or authorized user who is authorized for that type of use. If more than one supervising individual provided the training, identify each supervising individual by name and provide their qualifications.
Part II. Preceptor Attestation
The Preceptor Attestation page has four sections.
The attestation to the new proposed Radiation Safety Officer’s training or identification on the license as an authorized user, authorized medical physicist, or authorized nuclear pharmacist is in the first section.
The attestation for the specific radiation safety training is in the second section.
The attestation of the individual’s competency to function independently as a Radiation Safety Officer for a medical use license is in the third section.
The fourth and final section requests specific information about the preceptor’s authorization as a Radiation Safety Officer on a medical use license in addition to the preceptor’s signature.
The preceptor for a new proposed Radiation Safety Officer must fill out all four sections of this page.
The preceptor for a Radiation Safety Officer seeking authorization to be recognized as a Radiation Safety Officer for the additional medical use(s) must fill out the second, third, and fourth sections.
VI. AUTHORIZED MEDICAL PHYSICIST - Specific Instructions and Guidance for Filling Out NRC Form 313A (AMP)
See Section “IV. General Instructions and Guidance for Filling out NRC Form 313A Series” for additional clarification on providing information about an individual’s 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
Provide the requested information, i.e., a copy of the board certification, documentation of device specific training in the table in 3.c, and completed preceptor attestation. As indicated on the form, additional information is needed if the board certification or device specific training was greater 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. The applicant only has to identify the supervising medical physicist in the table in 3.c and his/her qualifications if this was the source of training. If more than one supervising individual provided the training identify each supervising individual by name and provide their qualifications.
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 completed preceptor attestation in Part II. As indicated on the form, additional information is needed if the device specific training was greater 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. The applicant only has to identify the supervising medical physicist in the table in 3.c and his/her qualifications if this was the source of training. If more than one supervising medical physicist provided the training identify each supervising individual by name and provide their 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 your graduate degree, for example, a copy of your diploma or transcript from an accredited college or university.
Submit a completed section 3.b. The individual must have completed one 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 3.b by providing the ranges of dates for training and work experience.
If the proposed authorized medical physicist had more than one supervisor, provide the information requested in section 3.b for each supervising individual. If the supervising individual is not an authorized medical physicist, the applicant must provide documentation that the supervising individual meets the requirements in 35.51 and 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. The applicant only has to identify the supervising medical physicist in the table in 3.c and his/her qualifications if this was the source of training. If more than one supervising medical physicist provided the training identify each supervising individual by name and provide their qualifications.
Submit a completed preceptor attestation in Part II.
Part II. Preceptor Attestation
The Preceptor Attestation page has four sections.
The attestation to the proposed authorized medical physicist’s training is in the first section.
The attestation for the device specific training is in the second section.
The attestation of the individual’s competency to function independently as an authorized medical physicist for the specific devices requested by the applicant is in the third section.
The fourth and final section requests specific information about the preceptor’s authorizations to use licensed material in addition to the preceptor’s signature.
The preceptor for a proposed new authorized medical physicist must fill out all four sections of this page. The preceptor for an authorized medical physicist seeking additional authorizations must complete the last three sections.
VII. AUTHORIZED NUCLEAR PHARMACIST - Specific Instructions and Guidance for Filling Out NRC Form 313A (ANP)
See Section “IV. General Instructions and Guidance for Filling out NRC Form 313A Series” for additional clarification on providing information about an individual’s 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 completed preceptor attestation. As indicated on the form, additional information is needed if the board certification was greater 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 first section on this page.
The second and final section of the page requests specific information about the preceptor’s authorization to use licensed material in addition to the preceptor’s signature.
VIII. 35.100, 35.200, AND 35.500 AUTHORIZED USERS - Specific Instructions and Guidance for Filling Out NRC Form 313A (AUD)
See Section “IV. General Instructions and Guidance for Filling out NRC Form 313A Series” for additional clarification on providing information about an individual’s 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
Provide the requested information, i.e., a copy of the board certification and completed preceptor attestation. As indicated on the form, additional information is needed if the board certification was greater than 7 years ago.
Item 2. Current 35.390 Authorized User Seeking Additional 35.290 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 user’s experience that meets the requirements of 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 authorized user.
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 35.290 will allow the individual to be authorized to use materials permitted by both 35.100 and 35.200.
Submit a completed section 3.a for each proposed authorized use.
Submit a completed section 3.b, except for 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 35.500 uses.
Submit a completed preceptor attestation, except for 35.500 uses.
Part II. Preceptor Attestation
The Preceptor Attestation page has two sections.
The attestations for training and experience requirements in 10 CFR 35.190 and 35.290 are found in the first section.
The second and final section requests specific information about the preceptor’s authorization(s) to use licensed material in addition to the preceptor’s signature
The preceptor must fill out both sections.
Note: The attestation to the proposed user’s training and competency to function independently under 35.190 covers the use of material permitted by 35.100 only. The attestation to the proposed user’s training and competency to function independently under 35.290 training will allow the individual to be authorized to use material permitted by both 35.100 and 35.200.
IX. 35.300 AUTHORIZED USER - Specific Instructions and Guidance for Filling Out NRC Form 313A (AUT)
See Section “IV. General Instructions and Guidance for Filling out NRC Form 313A Series” for additional clarification on providing information about an individual’s 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 you are a nuclear medicine physician, radiologist, or radiation oncologist with a board certification listed under 35.300 on NRC’s website, provide the requested information, i.e., a copy of the board certification, documentation of supervised clinical experience (complete the table in section 3.c), and completed preceptor attestation. As indicated on the form, additional information is needed if the board certification or supervised clinical experience was greater than 7 years ago. List each supervising individual by name and include the license showing the supervising individual as an authorized user.
If you are a radiation oncologist whose board certification is not listed under 35.300 on NRC’s website, provide the requested information (i.e., a copy of the board certification listed under either 35.400 or 35.600 on NRC’s website; 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 completed preceptor attestation). As indicated on the form, additional information is needed if the board certification, training and supervised work experience or clinical experience was greater than 7 years ago. List each supervising individual by name and include the license showing the supervising individual as an authorized user.
Item 2. Current 35.300, 35.400, or 35.600 Authorized User Seeking Additional Authorization
Submit a completed section 2.a, listing the license number and the user’s current authorizations.
If you are currently authorized for a subset of clinical uses under 35.300, submit the requested information, i.e., complete the table in section 3.c to document your new supervised clinical case experience and the completed preceptor attestation . As indicated on the form, additional information is needed if the clinical case experience was greater than 7 years ago. List each supervising individual by name and include the license showing the supervising individual as an authorized user.
If you are currently authorized under 35.490 or 35.690 and meet the requirements in 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 completed preceptor attestation). As indicated on the form, additional information is needed if the training and supervised work experience or clinical experience was greater than 7 years ago. List each supervising individual by name and include the license showing the supervising individual as an authorized user.
Item 3. Training and Experience for Proposed Authorized Users
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 authorized user.
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 authorized user.
Submit a completed preceptor attestation in Part II.
Part II. Preceptor Attestation
The Preceptor Attestation page has five sections.
The attestations for training and experience requirements in 35.390, 35.392, and 35.394 are in the first section.
The attestation for supervised clinical experience is in the second section.
The attestations for competency to function independently as an authorized user for specific uses is in the third section.
The attestation for training and experience requirements and competency to function independently for radiation oncologist meeting the requirements in 35.396 is in the fourth section.
The fifth and final section requests specific information about the preceptor’s authorization(s) to use licensed material in addition to the preceptor’s signature.
There are seven possible categories of individuals seeking authorized user status under this form. Follow the instructions for the applicable category.
The preceptor for a proposed authorized user who is a nuclear medicine physician, radiologist, or radiation oncologist with a board certification listed under 35.390 on NRC’s website must complete the first, second, third, and fifth sections of this part.
The preceptor for a proposed authorized user for all the uses listed in 35.390(b)(1)(ii)(G) who is a radiation oncologist with a board certification that is not listed under 35.390 on NRC’s website must complete the first, second, third, and fifth sections of this part.
The preceptor for a proposed authorized user for 35.390(b)(1)(ii)(G)(iii) and (iv) uses who is a radiation oncologist with a board certification listed under 35.490 or 35.690 on NRC’s website must complete the fourth and fifth sections of this part.
The preceptor for an authorized user who is currently authorized for a subset of clinical uses under 35.300 must complete the second, third, and fifth sections of this part, except for an authorized user meeting the criteria in 35.392 seeking to meet the training and experience requirements under 35.394.
The preceptor for an authorized user meeting the criteria in 35.392 seeking to meet the training and experience requirements under 35.394 must complete the first, second, third, and fifth sections of this part.
The preceptor for an authorized user currently authorized under 35.490 or 35.690 and meeting the requirements in 35.396 must complete the fourth, and fifth sections of this part.
The preceptor for a proposed new authorized user must complete the first, second, third and fifth sections of this part.
X. 35.400 AND 35.600 AUTHORIZED USERS - Specific Instructions and Guidance for Filling Out NRC Form 313A (AUS)
See Section “IV. General Instructions and Guidance for Filling out NRC Form 313A Series” for additional clarification on providing information about an individual’s 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
Provide the requested information, i.e., a copy of the board certification, for 35.600 uses 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 greater than 7 years ago.
Device specific training may be provided by the vendor for new users, or either a supervising authorized user or authorized medical physicist authorized for the requested type of use. The applicant only has to identify the supervising authorized user or authorized medical physicist in the table in 3.e and his/her qualifications if this was the source of training. If more than one supervising individual provided the training, identify each supervising individual by name and provide their qualifications.
Item 2. Current 35.600 Authorized User requesting Additional Authorization for 35.600 Use(s) Checked above
Provide the requested information, i.e., documentation of device specific training (complete the table in 3.e) and completed preceptor attestation in Part II. As indicated on the form, additional information is needed if the device specific training was greater than 7 years ago.
Device specific training may be provided by the vendor, or a supervising authorized user or authorized medical physicist authorized for the requested type of use. The applicant only has to identify the supervising authorized user or authorized medical physicist in the table in 3.e and his/her qualifications if this was the source of training. If more than one supervising individual provided the training, identify each supervising individual by name and provide their qualifications.
Item 3. Training and Experience for Proposed Authorized User
As indicated on the form, additional information is needed if the training, residency program, supervised work and clinical experience was 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 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 authorized user provided the supervised work and clinical experience identify each supervising individual by name and provide their qualifications.
Submit a completed section 3.c if only applying for use of strontium-90 for ophthalmic use. If more than one supervising authorized user provided the supervised clinical experience identify each supervising individual by name and provide their qualifications.
Submit a completed section 3.d for each requested 35.600 use. If more than one supervising authorized user provided the supervised work and clinical experience, identify each supervising individual by name and provide their qualifications.
Submit a completed section 3.e for each specific 35.600 device for which the applicant is requesting authorization.
Device specific training may be provided by the vendor, or a supervising authorized user or authorized medical physicist authorized for the requested type of use. The applicant only has to identify the supervising authorized user or authorized medical physicist in the table in 3.e and his/her qualifications if this was the source of training. If more than one supervising individual provided the training, identify each supervising individual by name and provide their qualifications.
Submit a completed preceptor attestation in Part II.
Part II. Preceptor Attestation
The Preceptor Attestation part has five sections.
The attestation to the training and individuals competency for 35.400 uses or strontium 90 eye applicator use is in the first section.
The attestation to the training for the proposed authorized user for 35.600 uses is in second section.
The attestation for the 35.600 device specific training is in the third section.
The attestation of the individual’s competency to function independently as an authorized user for the specific 35.600 devices requested by the applicant is in the fourth section.
The fifth and final section requests specific information about the preceptor’s authorization(s) to use licensed material in addition to the preceptor’s signature.
The preceptor for a 35.400 proposed authorized user must fill out the first and fifth sections of this Part.
The preceptor for a 35.600 proposed authorized user must fill out the second, third, fourth and fifth sections.
The preceptor for an authorized user seeking additional 35.600 authorizations must complete the third, fourth, and fifth sections.
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