NRC Form 313A (AUD AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTES

NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation

NRC Form 313A (AUD)

NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation

OMB: 3150-0120

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U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0120
EXPIRES: (MM/DD/YYYY)

NRC FORM 313A (AUD)
(MM-YYYY)

AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
(for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590]
Name of Proposed Authorized User

State or Territory Where Licensed

Requested Authorization(s) (check all that apply)
35.100 Uptake, dilution, and excretion studies

35.200 Imaging and localization studies

35.500 Sealed sources for diagnosis (specify device)
PART I -- TRAINING AND EXPERIENCE
(Select one of the three methods below)
* Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of
application or the individual must have obtained related continuing education and experience since the required training
and experience was completed. Provide dates, duration, and description of continuing education and experience
related to the uses checked above.
1. Board Certification
a. Provide a copy of the board certification.
b. For a board certification issued on or before October 24, 2005 that is listed in 10 CFR 35.57(b)(2)(i), provide
the following:
(i)
(ii)
c.

Documentation that the individual performed each use checked above on or before October 24, 2005.
Dates, duration, and description of continuing education and experience within the past seven years for
each use checked above.
Stop here.

2. Current 35.390 Authorized User Seeking Additional 35.290 Authorization
a. Authorized user on Materials License

meeting 10 CFR 35.390, 10 CFR 35.57 for 35.300

uses, or equivalent Agreement State requirements seeking authorization for 35.290.
b. Supervised Work Experience.
(If more than one supervising individual is necessary to document supervised work experience, provide multiple
copies of this section.)
Description of Experience

Location of Experience/License or
Permit Number of Facility

Clock
Hours

Dates of
Experience*

Eluting generator systems
appropriate for the preparation of
radioactive drugs for imaging and
localization studies, measuring and
testing the eluate for radionuclidic
purity, and processing the eluate
with reagent kits to prepare labeled
radioactive drugs
Total Hours of Experience:
Supervising Individual

License/Permit Number listing supervising individual as an
authorized user or authorized nuclear pharmacist

Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply).
35.290

35.390 + generator experience in 32.290(c)(1)(ii)(G)

35.55

35.57 for 35.200 uses

c. If board certified, provide a copy of the certificate and stop here. If not board certified, skip to and complete
Part II Preceptor Attestation.
NRC FORM 313A (AUD) (MM-YYYY)

PAGE 1

NRC FORM 313A (AUD)
(MM-YYYY)

U. S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
(for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590](continued)

3. Training and Experience for Proposed Authorized User
a. Classroom and Laboratory Training.
Description of Training

Location of Training

Clock
Hours

Dates of
Training*

Radiation physics and
instrumentation

Radiation protection

Mathematics pertaining to the use
and measurement of radioactivity

Chemistry of byproduct material
for medical use (not required for
35.590)

Radiation biology

Total Hours of Training:
b. Supervised Work Experience (completion of this table is not required for 35.590).
(If more than one supervising individual is necessary to document supervised work experience,
provide multiple copies of this section.)
Supervised Work Experience
Description of Experience
Must Include:
Ordering, receiving, and unpacking
radioactive materials safely and
performing the related radiation
surveys
Performing quality control
procedures on instruments used to
determine the activity of dosages
and performing checks for proper
operation of survey meters
NRC FORM 313A (AUD) (MM-YYYY)

Total Hours of
Experience:

Location of Experience/License or
Permit Number of Facility

Confirm

Dates of
Experience*

Yes
No
Yes
No

PAGE 2

U. S. NUCLEAR REGULATORY COMMISSION

NRC FORM 313A (AUD)
(MM-YYYY)

AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
(for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590](continued)

3. Training and Experience for Proposed Authorized User (continued)
b. Supervised Work Experience. (continued)
Description of Experience
Must Include:

Location of Experience/License or
Permit Number of Facility

Dates of
Experience*

Yes

Calculating, measuring, and safely
preparing patient or human research
subject dosages

No

Using administrative controls to
prevent a medical event involving the
use of unsealed byproduct material

Yes
No
Yes

Using procedures to contain spilled
byproduct material safely and using
proper decontamination procedures

No
Yes

Administering dosages of radioactive
drugs to patients or human research
subjects

No

Eluting generator systems appropriate
for the preparation of radioactive
drugs for imaging and localization
studies, measuring and testing the
eluate for radionuclidic purity, and
processing the eluate with reagent
kits to prepare labeled radioactive
drugs
Supervising Individual

Confirm

Yes
No*

License/Permit Number listing supervising individual as an
authorized user or an authorized nuclear pharmacist for generator
training

Supervisor meets the requirements below, or equivalent Agreement State requirements (check one).
35.190
35.290
35.390
35.390 + generator experience in 35.290(c)(1)(ii)(G)
35.55

35.57 for 35.200 uses

*Not required for 10 CFR 35.100 use.
c. For 35.590 only, provide documentation of training on use of the device.
Device

Type of Training

Location and Dates

d. For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part II Preceptor Attestation.
NRC FORM 313A (AUD) (MM-YYYY)

PAGE 3

U. S. NUCLEAR REGULATORY COMMISSION

NRC FORM 313A (AUD)
(MM-YYYY)

AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
(for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.57, 35.190, 35.290, and 35.590](continued)
PART II – PRECEPTOR ATTESTATION

Note:

This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising
individual as long as the preceptor provides, directs, or verifies training and experience required. If more than
one preceptor is necessary to document experience, obtain a separate preceptor statement from each. (Not
required to meet training requirements in 35.590)
By checking the boxes below, the preceptor is not attesting to the individual's "general clinical competency."

First Section
Check one of the following for each use requested:
For 35.190
has satisfactorily completed the 60 hours of training and

I attest that
Name of Proposed Authorized User

experience, including a minimum of 8 hours of classroom and laboratory training, required by 10 CFR 35.190(c)(1),
and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses
authorized under 10 CFR 35.100.
For 35.290
has satisfactorily completed the 700 hours of training

I attest that
Name of Proposed Authorized User

and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 CFR 35.290
(c)(1), and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical
uses under 10 CFR 35.100 and 35.200.
Second Section
Complete one of the following for attestation and signature:
Authorized User:
I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:
35.190
35.290
35.390
35.390 + generator experience
35.57 for 35.200 uses
Residency Program Director:

OR

I affirm that the attestation represents the consensus of the residency program faculty where at least one
faculty member is an authorized user who meets the requirements below or equivalent Agreement State
requirements for:
35.190

35.290

35.390

35.390 + generator experience

35.57 for 35.200 uses

I affirm that this facility member concurs with the attestation I am providing as program director.
I affirm that the residency training program is approved by the:
Residency Review Committee of the Accreditation Council for Graduate Medical Education
Royal College of Physicians and Surgeons of Canada
Council on Post-Graduate Training of the American Osteopathic Association
I affirm that the residency training program includes training and experience specified in:
35.190

35.290

Name of Facility:

Name of Preceptor or Residency Program Director (Typed or Printed)

License/Permit Number:

Telephone Number

Date

Signature
NRC FORM 313A (AUD) (MM-YYYY)

PAGE 4


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