ML063110176
| ML063110176 | |
| Person / Time | |
|---|---|
| Issue date: | 12/13/2006 |
| From: | Schlueter J NRC/FSME/DMSSA |
| To: | |
| References | |
| RIS-07-027 | |
| Download: ML063110176 (59) | |
See also: RIS 2007-27
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, DC 20555
December 13, 2006
NRC REGULATORY ISSUE SUMMARY 2006-27
AVAILABILITY OF NRC 313A SERIES OF FORMS
AND GUIDANCE FOR THEIR COMPLETION
ADDRESSEES
All NRC medical-use licensees, commercial nuclear pharmacies, and U.S. Nuclear Regulatory
Commission (NRC) Master Materials Licensees. All Agreement State Radiation Control Program
Directors and State Liaison Officers.
INTENT
NRC is issuing this Regulatory Issue Summary (RIS) to inform addressees of the availability of
the NRC 313A series of forms and the guidance for the completion of these forms. No specific
action or written response is required. NRC is providing this RIS to the Agreement States for
their information and for distribution to their medical licensees as appropriate.
BACKGROUND
A person wishing to be licensed to possess, use, or distribute licensed material must submit an
application that will permit NRC to determine whether the applicant has training, experience,
equipment, facilities, and procedures, for the use of radioactive material, that are adequate to
protect the public health and safety. NRC Form 313, "Application for Material License," which
may also include the NRC Form 313A series of forms, for medical use and commercial nuclear-
pharmacy applicants, is used to provide the information required. The information provided in
the NRC Form 313A series of forms permits NRC to determine whether the applicant has
training and experience, for the medical or commercial nuclear-pharmacy uses of radioactive
material, that are adequate to protect the public health and safety.
SUMMARY OF ISSUE
This RIS addresses the revision of the single NRC Form 313A used by medical Radiation
Safety Officers, medical physicists, nuclear pharmacists, and nine different types of physicians,
into six distinct new NRC Form 313As, with the following titles:
NRC FORM 313A(RSO), RADIATION SAFETY OFFICER TRAINING AND
EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.50];
NRC FORM 313A(AMP), AUTHORIZED MEDICAL PHYSICIST TRAINING AND
EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.51];
Page 2 of 4
NRC FORM 313A(ANP), AUTHORIZED NUCLEAR PHARMACIST TRAINING
AND EXPERIENCE AND PRECEPTOR ATTESTATION [10 CFR 35.55];
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 35.190, 35.290, and 35.590];
NRC FORM 313A(AUT), AUTHORIZED USER TRAINING AND EXPERIENCE
AND PRECEPTOR ATTESTATION (for uses defined under 35.300) [10 CFR
35.390, 35.392, 35.394, and 35.396]; and
NRC FORM 313A(AUS), AUTHORIZED USER TRAINING AND EXPERIENCE
AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600)
[10 CFR 35.490, 35.491, and 35.690].
NRC Form 313 must be submitted by all applicants seeking a license for the use of byproduct
material. The new NRC Form 313A series of forms may be used by medical use applicants to
document training and experience and preceptor attestations for individuals seeking recognition
as a Radiation Safety Officer (RSO); Authorized Medical Physicist (AMP); Authorized Nuclear
Pharmacist (ANP); or Authorized User (AU). The information required to complete the forms is
unchanged from the information required for the old NRC Form 313A and is aligned with the
requirements in the 2005 revision of 10 CFR Part 35.
Medical use applicants may elect to use the appropriate form from the NRC Form 313A series,
for each new individual, the first time that individual is seeking to be identified as an RSO, AMP,
ANP, or AU, or when one of these individuals is seeking to be identified for a new authorization
on a limited specific medical license. Broad-scope medical use applicants may use the NRC
Form 313A(RSO), when requesting an individual be identified as a new RSO or when adding an
additional RSO authorization for the individual. Commercial nuclear-pharmacy applicants may
also use NRC Form 313A(ANP) when requesting an individual be identified for the first time as
an ANP.
Revised guidance is also attached to aid applicants in completing the six forms in the NRC
Form 313A series. The new guidance should facilitate the use of the new forms during new
license applications, license amendments, and renewals.
FEDERAL REGISTER NOTIFICATION
A notice of opportunity for public comment on this RIS was not published in the Federal
Register because this RIS is informational, and does not represent a departure from current
regulatory requirements.
CONGRESSIONAL REVIEW ACT
Congressional Review Act, 5 U.S.C.§§ 801-80B.
Page 3 of 4
PAPERWORK REDUCTION ACT STATEMENT
This Regulatory Issue Summary contains information collection requirements that are subject to
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections
were approved by the Office of Management and Budget, approval number 3150-0120, which
expires October 31, 2008.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to respond to, a request for
information or an information collection requirement unless the requesting document displays a
currently valid OMB control number.
Page 4 of 4
CONTACT
This RIS requires no specific action nor written response. If you have any questions about this
summary, please contact the individual listed below or the appropriate regional office.
/RA/
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical contact: Donna-Beth Howe, Ph.D.
(301) 415-7848
E-mail: dbh@nrc.gov
Enclosures:
1. List of Recently Issued FSME/NMSS Generic
Communications
2. Licensing Guidance for Using the NRC
FORM 313A Series of Forms
3. NRC Form 313A(RSO), RADIATION
SAFETY OFFICER TRAINING
AND EXPERIENCE AND PRECEPTOR
ATTESTATION [10 CFR 35.50]
4. NRC FORM 313A(AMP), AUTHORIZED
MEDICAL PHYSICIST TRAINING AND
EXPERIENCE AND PRECEPTOR
ATTESTATION [10 CFR 35.51]
5. NRC FORM 313A(ANP), AUTHORIZED
NUCLEAR PHARMACIST TRAINING
AND EXPERIENCE AND PRECEPTOR
ATTESTATION [10 CFR 35.55]
6. 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 35.190, 35.290,
and 35.590]
7. NRC FORM 313A(AUT), AUTHORIZED
USER TRAINING AND EXPERIENCE
AND PRECEPTOR ATTESTATION
(for uses defined under 35.300)
[10 CFR 35.390, 35.392 35.394, and
35.396]
8. NRC FORM 313A(AUS), AUTHORIZED
USER TRAINING AND EXPERIENCE
AND PRECEPTOR ATTESTATION
(for uses defined under 35.400 and 35.600)
[10 CFR 35.490, 35.491, and 35.690]
RIS 2006-XX
Page 4 of 4
CONTACT
This RIS requires no specific action nor written response. If you have any questions about this summary, please
contact the individual listed below or the appropriate regional office.
/RA/
Janet R. Schleuter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical contact: Donna-Beth Howe, Ph.D.
(301) 415-7848
E-mail: dbh@nrc.gov
Enclosures:
1. List of Recently Issued FSME/NMSS Generic
Communications
2. Licensing Guidance for Using the NRC
FORM 313A Series of Forms
3. NRC FORM 313A(RSO), RADIATION
SAFETY OFFICER TRAINING
AND EXPERIENCE AND PRECEPTOR
ATTESTATION [10 CFR 35.50]
4. NRC FORM 313A(AMP), AUTHORIZED
MEDICAL PHYSICIST TRAINING AND
EXPERIENCE AND PRECEPTOR
ATTESTATION [10 CFR 35.51]
5. NRC FORM 313A(ANP), AUTHORIZED
NUCLEAR PHARMACIST TRAINING
AND EXPERIENCE AND PRECEPTOR
ATTESTATION [10 CFR 35.55]
6. 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 35.190, 35.290,
and 35.590]
7 NRC FORM 313A(AUT), AUTHORIZED
USER TRAINING AND EXPERIENCE
AND PRECEPTOR ATTESTATION
(for uses defined under 35.300)
[10 CFR 35.390, 35.392 35.394, and
35.396]
8. NRC FORM 313A(AUS), AUTHORIZED
USER TRAINING AND EXPERIENCE
AND PRECEPTOR ATTESTATION
(for uses defined under 35.400 and 35.600)
[10 CFR 35.490, 35.491, and 35.690]
DISTRIBUTION:
MSSA r/f
OFC MSEA MSEA MSEA Tech Editor
NAME DBHowe CFlannery SWastler EKraus
DATE 10 / 20 /06 10 / 20 /06 10 / 1 /06 11 / 1 /06
OFC OGC OGC-LCLSP OIS MSSA
NAME FCameron TRothschild E St.Mary JSchleuter
DATE 11 / 22 /06 11 / 21 /06 11/ 15 /06 12 /13 /06
OFFICIAL RECORD COPY
Enclosure 1
RIS 2006-XX
Page 1 of 2
Recently Issued FSME/NMSS Generic Communications
Date GC No. Subject Addressees
09/14/06 RIS-06-20 All community water systems (CWSs), in
Guidance for Receiving
U.S. Nuclear Regulatory Commission
(NRC) non-Agreement States, that during
Concentrating Uranium at
the treatment of drinking water, may
Community Water Systems
accumulate and concentrate naturally-
occurring uranium in media, effluents,
and other residuals, above 0.05 percent
by weight.
08/15/06 RIS-06-16 Transfer of the Management All NRC materials licensees.
Oversight Of Certain NRC Region I
Licensees in Mississippi
To the NRC Region IV Office
09/14/06 RIS-06-19 Availability of Guidance on All NRC medical licensees.
Radioactive Seed Localization
08/31/06 RIS-06-18 Requesting Exemption from the All NRC medical licensees.
Public Dose Limits for Certain
Caregivers of Hospital Patients
09/22/06 RIS-06-14 Enforcement Discretion for Facility All fuel cycle licensees regulated under
Changes Under 10 CFR Title 10 of the Code of Federal
70.72(c)(2) Regulations (10 CFR) Part 70, Subpart H.
07/20/06 RIS-06-11 Requesting Quality Assurance All 10 CFR Part 71 quality assurance
Program Approval Renewals program and certificate holders.
Online by Electronic Information
Exchange
04/23/06 RIS-06-10 Use of Concentration Control for All licensees authorized to possess a
Criticality Safety critical mass of special nuclear material.
01/26/06 RIS-02-15, NRC Approval of Commercial Data All authorized recipients and holders of
Rev. 1 Encryption Products For the sensitive unclassified safeguards
Electronic Transmission Of information (SGI).
Safeguards Information
01/24/06 RIS-06-01 Expiration Date for NRC-Approved The U.S. Nuclear Regulatory Commission
Spent Fuel Transportation Routes (NRC) licensees who transport, or deliver
to a carrier for transport, irradiated
reactor fuel (spent nuclear fuel (SNF)).
01/13/06 RIS-05-27, NRC Timeliness Goals, All 10 CFR Parts 71 and 72 licensees
Rev. 1 Prioritization of Incoming License and certificate holders.
Applications and Voluntary
Submittal of Schedule for Future
Actions for NRC Review
Enclosure 1
RIS 2006-XX
Page 2 of 2
Date GC No. Subject Addressees
07/10/06 IN-06-13 Ground-Water Contamination All holders of operating licenses for
Due to Undetected Leakage of nuclear power and research and test
Radioactive Water reactors including those who have
permanently ceased operations and
have certified that fuel has been
permanently removed from the
reactor and those authorized by Title
10 of the Code of Federal Regulations
(10 CFR) Part 72 licenses to store
spent fuel in water-filled structures.
07/06/06 IN-06-12 All materials licensees.
Exercising Due Diligence When
Transferring Radioactive
Materials
06/12/06 IN-06-11 Applicability of Patient Intervention All medical licensees.
in Determining Medical Events for
Gamma Stereotactic Radiosurgery
and Other Therapy Procedures
03/31/06 IN-06-07 Inappropriate Use of a Single- All licensees authorized to possess a
parameter Limit as a Nuclear critical mass of special nuclear material.
Criticality Safety Limit
03/21/06 IN-02-23, Unauthorized Administration of All medical licensees.
Supl. 1 Byproduct Material for Medical Use
01/19/06 IN-06-02 Use of Galvanized Supports and All holders of operating licenses for
Cable Trays with Meggitt Si 2400 nuclear reactors except those who have
Stainless- Steel-jacketed Electrical permanently ceased operations and have
Cables certified that fuel has been permanently
removed from the reactor vessel; and fuel
cycle licensees and certificate holders.
Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under Electronic
Reading Room/Document Collections.
Enclosure 2
RIS 2006-XX
Page 1 of 16
Licensing 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 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; 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.
Enclosure 2
RIS 2006-XX
Page 2 of 16
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).
Enclosure 2
RIS 2006-XX
Page 3 of 16
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 individuals 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 of dentistry, practice of podiatry, or practice
of 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.
Enclosure 2
RIS 2006-XX
Page 4 of 16
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.
Enclosure 2
RIS 2006-XX
Page 5 of 16
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.
Enclosure 2
RIS 2006-XX
Page 6 of 16
The NRC Form 313A series Part II - Preceptor Attestation pages have multiple sections. The
preceptor must complete an attestation of the proposed users 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 individuals 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. The applicant only has to identify the
supervising individual in the table in 3.c and his/her qualifications if the source of this training
was a Radiation Safety Officer, an authorized medical physicist, authorized nuclear pharmacist,
or authorized user. 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.
Enclosure 2
RIS 2006-XX
Page 7 of 16
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. The applicant only has to identify the
supervising individual in the table in 3.c and his/her qualifications if the source of this training
was a Radiation Safety Officer, an authorized medical physicist, authorized nuclear pharmacist,
or authorized user. 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 section 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. The applicant only has to identify the supervising individual in the table in 3.c and
his/her qualifications if the source of this training was a Radiation Safety Officer, an authorized
medical physicist, authorized nuclear pharmacist, or authorized user. 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 Licensees License
Enclosure 2
RIS 2006-XX
Page 8 of 16
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 Officers 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 individuals 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 preceptors
authorization as a Radiation Safety Officer on a medical use license in addition
to the preceptors 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.
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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 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
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 identifythe
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.
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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 physicists training is in the
first section.
- The attestation for the device specific training is in the second section.
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- The attestation of the individuals 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 preceptors
authorizations to use licensed material in addition to the preceptors 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 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 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.
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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 preceptors
authorization to use licensed material in addition to the preceptors 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 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
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 users 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.
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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 preceptors
authorization(s) to use licensed material in addition to the preceptors signature
The preceptor must fill out both sections.
Note: The attestation to the proposed users training and competency to function
independently under 35.190 covers the use of material permitted by 35.100 only. The
attestation to the proposed users 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.
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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 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 you are a nuclear medicine physician, radiologist, or radiation oncologist with a board
certification listed under 35.300 on NRCs 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 NRCs
website, provide the requested information (i.e., a copy of the board certification listed under
either 35.400 or 35.600 on NRCs 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 users 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
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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.
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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 preceptors authorization(s) to
use licensed material in addition to the preceptors 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 NRCs 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 NRCs 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 NRCs 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.
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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 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
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.
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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.
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- The attestation for the 35.600 device specific training is in the third section.
- The attestation of the individuals 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 preceptors
authorization(s) to use licensed material in addition to the preceptors 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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