Form NRC313A(AUD) NRC Form 313A (AUD)

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

n313aud

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

OMB: 3150-0120

Document [pdf]
Download: pdf | pdf
NRC FORM 313A (AUD)

U.S. NUCLEAR REGULATORY COMMISSION

(MM-YYYY)

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]

APPROVED BY OMB: NO. 3150-0120
EXPIRES: MM/DD/YYYY

State or Territory Where Licensed

Name of Proposed Authorized User

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 related continuing education and experience since the
required training and experience was completed. Provide dates, duration, and description of continuing
education and experience related to the uses checked above.
1. Board Certification
a. Provide a copy of the board certification.
b. If using only 35.500 materials, stop here. If using 35.100 and 35.200 materials, skip to and complete Part II
Preceptor Attestation.
2. Current 35.390 Authorized User Seeking Additional 35.290 Authorization
a. Authorized user on Materials License
State requirements seeking authorization for 35.290.

meeting 10 CFR 35.390 or equivalent Agreement

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

Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply).
35.290
NRC FORM 313A (AUD) (MM-YYYY)

35.390 + generator experience
PRINTED ON RECYCLED PAPER

PAGE 1

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

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (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.)
Description of Experience

Location of Experience/License or
Permit Number of Facility

Clock
Hours

Dates of
Experience*

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

PAGE 2

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

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

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

Location of Experience/License or
Permit Number of Facility

Clock
Hours

Dates of
Experience*

Using administrative controls to
prevent a medical event involving the
use of unsealed byproduct material
Using procedures to contain spilled
byproduct material safely and using
proper decontamination procedures
Administering dosages of radioactive
drugs to patients or human research
subjects
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 (required for 35.290 only)
Total Hours of Experience:
Supervising Individual

License/Permit Number listing supervising individual as an
authorized user

Supervisor meets the requirements below, or equivalent Agreement State requirements (check one).
35.190

35.290

35.390

35.390 + generator experience

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.
PAGE 3

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

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (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 directs or verifies the 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)

First Section
Check one of the following for each use requested:
For 35.190
Board Certification
has satisfactorily completed the requirements in

I attest that
Name of Proposed Authorized User

10 CFR 35.190(a)(1) and has achieved a level of competency sufficient to function independently as an
authorized user for the medical uses authorized under 10 CFR 35.100.
OR
Training and Experience
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 has achieved a level of competency sufficient to function independently as an
authorized user for the medical uses authorized under 10 CFR 35.100.
For 35.290
Board Certification
has satisfactorily completed the requirements in

I attest that
Name of Proposed Authorized User

10 CFR 35.290(a)(1) and has achieved a level of competency sufficient to function independently as an
authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200.
OR
Training and Experience
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 has achieved a level of competency sufficient to function independently as an
authorized user for the medical uses authorized under 10 CFR 35.100 and 35.200.
Second Section
Complete the following for preceptor attestation and signature:
I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:
35.190

35.290

Name of Preceptor

35.390
Signature

35.390 + generator experience
Telephone Number

Date

License/Permit Number/Facility Name

PAGE 4


File Typeapplication/pdf
File TitleInForms - n313aud.wpf
Authorcxc7
File Modified2006-10-05
File Created2006-10-05

© 2024 OMB.report | Privacy Policy