ML063110176

Availability of NRC 313A Series of Forms and Guidance for Their Completion

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];

ML063110176

RIS 2006-27

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.

RIS 2006-27

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.

RIS 2006-27

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

ML063110176

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

Enforcement Discretion When

(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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