Form 483- Final Supporting Statement (2)

FINAL OMB SUPPORTING STATEMENT
FOR
NRC FORM 483
REGISTRATION CERTIFICATE -IN VITRO TESTING WITH BYPRODUCT MATERIAL
UNDER GENERAL LICENSE
(3150-0038)
--EXTENSION
Description of the Information Collection
Section 31.11 of 10 CFR Part 31 establishes a general license authorizing any physician,
veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to receive,
acquire, possess, transfer, or use certain small quantities of byproduct material for in vitro
clinical or laboratory tests not involving the internal or external administration of the byproduct
material or the radiation therefrom to human beings or animals. Possession or use of byproduct
material under 10 CFR 31.11 is not authorized until the physician, veterinarian in the practice of
veterinary medicine, clinical laboratory, or hospital has filed NRC Form 483, "Registration
Certificate -- In Vitro Testing with Byproduct Material Under General License," and received
from the Commission a validated copy of NRC Form 483 with a registration number assigned.
A registration certificate is usually validated within 7 days of its receipt and is used by the
licensee to obtain byproduct material from a specifically licensed supplier.
NRC Form 483 contains the terms and conditions of the general license and provides a means
of assurance to the NRC that the general licensee is aware of those terms and conditions prior
to the receipt of byproduct material.
A. JUSTIFICATION
1.

Need for and Practical Utility of the Collection of Information
Section 31.11(a) provides for a general license for the possession and use of
iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, mock
iodine-125 reference or calibration sources, and cobalt-57 by any physician,
veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital for
the purpose of certain in vitro clinical or laboratory tests. The general license sets
forth the conditions pertaining to possession, use, and storage of the byproduct
material.
Section 31.11(b) specifies that in order for the physician, veterinarian in the practice
of veterinary medicine, clinical laboratory, or hospital to use the general license,
NRC Form 483, "Registration Certificate -- In Vitro Testing with Byproduct Material
Under General License" must be completed and submitted to the NRC. The
licensee must then receive a validated copy of the NRC Form 483 with a
registration number to complete the licensing process.
Suppliers of byproduct material are required to determine that the person receiving
the material is authorized to receive it. The validated certificate, maintained by the
licensee, serves as evidence for the supplier that a physician, veterinarian in the
practice of veterinary medicine, clinical laboratory or hospital is a general licensee
authorized to receive the byproduct material.

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Section 31.11(e) requires that a general licensee under this section report in writing
any change in a previously validated registration certificate. The licensee must
report the change to the NRC within 30 days after the effective date of such a
change.
Updating the information on the registration certificate is necessary so that NRC is
aware of any changes in either the name or the location of all persons authorized to
receive radioactive byproduct material under Section 31.11.
2.

Agency Use of the Information
The information derived from NRC Form 483 provides NRC with the name of each
physician, clinical laboratory, veterinarian, or hospital using byproduct material
under the general license. The registration certificate contains the terms and
conditions of the general license and provides a means of assurance to the NRC
that the general licensee is aware of those terms and conditions prior to the receipt
of byproduct material. The NRC incorporates the information from Form 483 into a
database. This database is used when manufacturers and suppliers call NRC to
verify that a physician, clinical laboratory, veterinarian, or hospital is authorized to
receive byproduct material.

3.

Reduction of Burden through Information Technology
There are no legal obstacles to reducing the burden associated with this
information collection. The NRC encourages respondents to use information
technology when it would be beneficial to them. The NRC estimates that none of
the responses will be filed electronically.

4.

Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no duplication of
requirements.

5.

Effort to Reduce Small Business Burden
The majority of the registrants who use byproduct material are small businesses.
The health and safety consequences of improper use or handling of radioactive
byproduct material are the same for large and small entities. The burden of
providing the small amount of information required on the NRC Form 483 is
minimal. In addition, NRC Form 483 is only submitted once, unless there is a
change of information from a previously registered license. Therefore, it is not
possible to reduce the burden on small businesses by less frequent or less
complete submittal.

6.

Consequences to Federal Program or Policy Activities if the Collection Is Not
Conducted or Is Conducted Less Frequently
If the NRC Form 483 is not submitted, the NRC will not have the necessary
information to certify general licensees authorized under Section 31.11 of 10 CFR
Part 31 to possess, use, and store byproduct material. If the information on NRC
Form 483 is collected less frequently, it could result in the NRC having outdated
contact information for its general licensees. Up-to-date information on the NRC
Form 483 is required for the NRC to fulfill its responsibility to ensure adequate

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protection of the public health and safety during the possession, use, or transfer of
radioactive byproduct material.
7.

Circumstances Which Justify Variation from OMB Guidelines
Contrary to OMB guidelines in 5 CFR 1320.5(d), Section 31.11(e) requires general
licensees to report in writing any change in a previously validated registration
certificate within 30 days after the effective date of such a change. The NRC needs
this information within 30 days to keep current on where the radioactive material is
being used in order to reach users immediately in the event of a problem, and to
provide registrants with immediate notification when there is a generic problem
involving the radioactive material.

8.

Consultations Outside the NRC
Opportunity for public comment on the information collection requirements for this
clearance package has been published in the Federal Register on August 28, 2017
(82 FR 40809). NRC contacted 4 licensees via email and these 4 licenses did not
reply to the information collection.

9.

Payment or Gift to Respondents
Not applicable.

10. Confidentiality of the Information
Confidential and proprietary information is protected in accordance with NRC
regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b). However, no information
normally considered confidential or proprietary is requested.
11. Justification for Sensitive Questions
This information collection does not involve sensitive questions.
12. Estimated Burden and Burden Hour Cost
Section 31.11(b) requires the submittal of NRC Form 483, "Registration Certificate - In Vitro Testing with Byproduct Material Under General License.” Below is the
breakdown of the burden. The estimates are based on submittals to the NRC in the
last 3 years. The cost to licensees and applicants is calculated at a rate of $263/hour.
The $263 hourly rate used in the burden estimate is based on the Nuclear Regulatory
Commission’s current fee for hourly rates as noted in 10 CFR 170.20 “Average cost
per professional staff-hour.” For more information on the basis of this rate, see the
Federal Register notice at: 82 FR 30681 (June 30, 2017). Actual licensee hourly rates
(and therefore overall financial burdens) for reporting and record keeping may differ
from estimated by the NRC. No public comments were received on the wage rate
estimate. NRC Form 483 does not require third-party disclosures.
NRC licensees:
The NRC receives approximately 6 registration certificates annually from persons
who wish to be general licensees. The time required for completion of NRC Form
483 is approximately 10 minutes. Completion of the form requires filling in the
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name and address, checking one of the categories of licensees, signing, and dating
the registration certificate and mailing. An additional field for email will be added to
the NRC Form 483. This is reflected in an increase to the completion time of the
form from 8 minutes to 10 minutes.
The total burden for all general licensees is 1.0 hours annually, as shown in the
table below (6 registrations/year using NRC Form 483 x 10 minutes per NRC Form
483 = 60 minutes). Therefore, the total annual cost for preparation of the 6
certificates is approximately $263 (1.0 hour x $263/hour).
Table 1: Annual Burden for NRC Licensees
No. Annual
Respondents
NRC

6

Responses
per
Respondent
1

No.
Responses
6

Burden
Hrs Per
Response
0.17

Total
Annual
Burden Hrs
1.02

Cost @
$263/hr
$263

Agreement State licensees:
The Agreement States are not required by the NRC to implement 10 CFR 31.11 for
compatibility purposes; therefore, any Agreement State usage of forms similar to
NRC Form 483 is not included in the burden calculations.
Recordkeeping
Licensees maintain an authorized copy of the license. Therefore, NRC estimates
that approximately ten percent of the annual reporting burden is equal to the
recordkeeping burden. Total estimated recordkeeping burden to the licensees is
estimated to be $26.3 (1.0 hours for NRC licensees x 0.10 = 0.1 recordkeeping
hours x $263/hour).
The total estimated responses are 6 responses (6 NRC licensees). The total
estimated burden is approximately 1.1 hours (1.0 hours for NRC licensees + 0.1
hour recordkeeping). The total burden hour cost is $263 (for NRC licensees,
Agreement State licensees are not included in this calculation).
13. Estimate of Other Additional Costs
The quantity of records to be maintained is roughly proportional to the
recordkeeping burden. Based on the number of pages maintained for a typical
clearance, the records storage cost has been determined to be equal to 0.0004
times the recordkeeping burden cost. Therefore, the storage cost for this clearance
is insignificant $0.01 (0.10 recordkeeping hours x 0.0004 x $263/hour).
14. Estimated Annualized Cost to the Federal Government

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Previous experience shows that the average time needed for processing an NRC
Form 483 is approximately 30 minutes, resulting in a burden of 3 hours per year.
This time includes researching the files to check for duplicate registration
certificates, maintaining and updating the database on registration certificates, and
preparing the letter and validated copy of the NRC Form 483 for each licensee. At
a rate of $263 per hour for professional staff, the annual cost to the Federal
government to process the 6 registration certificates is $789 (6 registrations/year
using Form 483 x 30 minutes per NRC Form 483 = 3 hours x $263/hour).
15. Reasons for Changes in Burden or Cost
The overall hourly burden has decreased by approximately 0.16 burden hours (from
1.18 burden hours to 1.02 burden hours), due to a decrease in the amount of
certificates being submitted, and to a correction to the method for calculation of the
recordkeeping burden.
The number of registration certificates submitted by NRC licensees has decreased
by 2, from 8 certificates to 6 certificates, a decrease of approximately 16 minutes (2
certificate x 10 minutes/certificate x 1 hour/60 minutes = 0.33 hours). The NRC has
received, on average, 6 less forms every year since the last extension of this
information collection. The number of NRC licensees has also decreased in the
last three years. Therefore, we expect less submissions in the near future.
The recordkeeping burden has decreased by 0.01 hours, from 0.11 hours to 0.10
hour. This is a result of a correction of the calculation for this burden. The cost per
hour was adjusted from $265 to $263 to reflect changes in the NRC’s fee billing
rate. As a result, the overall change in burden is decreased by approximately
0.278 hours (0.27 total annual burden to NRC licensees + 0.008 recordkeeping
burden).
The estimated hourly burden cost for this package is $263/hour.
16. Publication for Statistical Use
This information will not be published for statistical use.
17. Reason for Not Displaying the Expiration Date
The expiration date is displayed on NRC Form 483.
18. Exceptions to the Certification Statement
There are no exceptions.
B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Not applicable.

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