Form NRC Form 483 NRC Form 483 Registration Certificate - In Vitro Testing with Byprodu

NRC FORM 483

U.S. NUCLEAR REGULATORY COMMISSION

(MM-DD-YYYY)

REGISTRATION CERTIFICATE -IN VITRO TESTING
WITH BYPRODUCT MATERIAL UNDER
GENERAL LICENSE

APPROVED BY OMB: NO. 3150-0038

EXPIRES: (MM/DD/YYYY)

Estimated burden per response to comply with this mandatory collection request: 10 minutes. The validated
registration serves as evidence to suppliers of byproduct material that the registrant is entitled to receive the
byproduct material. Send comments regarding burden estimate to the FOIA, Library, and Information Collections
Branch (T-6 A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by email to Infocollects.
[email protected],and the OMB reviewer at: OMB Office of Information and Regulatory Affairs, (3150-0038), Attn:
Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503. The NRC may
not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document
requesting or requiring the collection displays a currently valid OMB control number.

Section 31.11 of 10 CFR 31 establishes a general license authorizing physicians, clinical laboratories, hospitals, and veterinarians in the practice of veterinary medicine to
possess 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 of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, hospital,
or veterinarian in the practice of veterinary medicine, has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with a registration
number.

1. Name and Business Address of Applicant (See Instruction 3.B. below)

2. Application (Check one box only)

I hereby apply for a registration number pursuant to 10
CFR 31, Section 31.11, for use of byproduct materials for:
Myself, a duly licensed physician authorized to
disperse drugs in the practice of medicine.

Business Telephone Number (Include area code)

The above-named clinical laboratory.
The above named hospital.

Business Email Address

Veterinarian in the practice
of veterinary medicine.
Instructions
A. Submit this form to:
Director, Office of Nuclear Materials Safety and Safeguards
ATTN: Materials Safety and Tribal Liaison Branch, MS: T-5 B60
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001

4. Registration
Registration Number:

Detailed guidance on making electronic submissions can be obtained by
visiting the NRC 's Web site at http://www.nrc.gov/site-help/e-submittals.
html; by email to [email protected]; or by writing the Office of
the Chief Information Officer, U.S. Nuclear Regulatory Commission,
Washington, DC 20555 -0001.
(At NRC, a registration number will be assigned and a validated copy of
NRC Form 483 will be returned.)

(If this an initial registration, leave this space blank -- number to

B. In the box above, print or type the name, address (including Zip Code), be assigned by NRC. If this is a change of information from a
telephone number, and email address of the registrant physician, clinical previously registered general license, include your registration
laboratory, hospital, or veterinarian in the practice of veterinary medicine number.)
for whom or for which this registration form is filed.
5. If place of use is different from the address listed in No. 1, give complete business address.

6. Certification
I hereby certify that:
A. All information in this registration certificate is true and complete.
B. The registrant has appropriate radiation measuring instruments to carry out the tests for which byproduct material will be used
under the general license of 10 CFR 31.11. The tests will be performed only by personnel competent in the use of the
instruments and in the handling of the byproduct materials.
C. I understand that Commission regulations require that any change in the information furnished by a registrant on this registration
certificate be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the effective date of
such change.
D. I have read and understand the provisions of Section 31.11 of NRC regulations 10 CFR 31 (on page 2 of this form); and I
understand that the registrant is required to comply with those provisions as to all byproduct material which he receives, acquires,
possesses, uses, or transfers under the general license for which this Registration Certificate is filed with the U.S. Nuclear
Regulatory Commission.
Printed or Typed Name and Title of Applicant

Signature

Date

WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC
BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS. 18 U.S.C. 1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO
ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.
NRC FORM 483 (MM-DD-YYYY)

CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
§31.11 General license for use of byproduct material for certain in vitro clinical
or laboratory testing.
(a) A general license is hereby issued to any physician, veterinarian in the practice of
veterinary medicine, clinical laboratory or hospital to receive, acquire, possess,
transfer, or use, for any of the following stated tests, in accordance with the provisions
of paragraphs (b), (c), (d), (e), and (f) of this section, the following byproduct materials
in prepackaged units:

(2) The general licensee shall store the byproduct material, until used, in the
original shipping container or in a container providing equivalent radiation
protection.
(3) The general licensee shall use the byproduct material only for the uses
authorized by paragraph (a) of this section.

(1) Iodine-125, in units not exceeding 10 microcuries each for use in in vitro clinical or
laboratory tests not involving internal or external administration of byproduct material,
or the radiation therefrom, to human beings or animals.

(4) The general licensee shall not transfer the byproduct material except by
transfer to a person authorized to receive it by a license pursuant to this chapter
or from an Agreement State, nor transfer the byproduct material in any manner
other than in the unopened, labeled shipping container as received from the
supplier.

(2) Iodine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or
laboratory tests not involving internal or external administration of byproduct material,
or the radiation therefrom, to human beings or animals.

(5) The general licensee shall dispose of the Mock Iodine-125 reference or
calibration sources described in paragraph (a)(7) of this section as required by §
20.2001.

(3) Carbon-14, in units not exceeding 10 microcuries each for use in in vitro clinical or
laboratory tests not involving internal or external administration of byproduct material,
or the radiation therefrom, to human beings or animals.

(d) The general licensee shall not receive, acquire, possess, or use byproduct
material pursuant to paragraph (a) of this section:

(4) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each for use in in vitro
clinical or laboratory tests not involving internal or external administration of byproduct
material, or the radiation therefrom, to human beings or animals.
(5) Iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or
laboratory tests not involving internal or external administration of byproduct material,
or the radiation therefrom, to human beings, or animals.
(6) Selenium-75, in units not exceeding 10 microcuries each for use in in vitro clinical
or laboratory tests not involving internal or external administration of byproduct
material, or the radiation therefrom, to human beings or animals.
(7) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05
microcurie of iodine-129 and 0.005 microcurie of americium-241 each for use in in
vitro clinical or laboratory tests not involving internal or external administration of
byproduct material, or the radiation therefrom, to human beings or animals.
(8) Cobalt-57, in units not exceeding 0.37 megabecquerel (10 microcuries) each for
use in in vitro clinical or laboratory tests not involving internal or external
administration of byproduct material, or the radiation therefrom, to human beings or
animals.
(b) A person shall not receive, acquire, possess, use, or transfer byproduct material
under the general license established by paragraph (a) of this section unless that
person:
(1) Has filed NRC Form 483, "Registration Certificate --In Vitro Testing with Byproduct
Material Under General License," with the Director, Office of Nuclear Material Safety
and Safeguards, by an appropriate method listed in § 30.6(a) of this chapter, and has
received from the Commission a validated copy of NRC Form 483 with a registration
number assigned; or
(2) Has a license that authorizes the medical use of byproduct material that was
issued under part 35 of this chapter.
(c) A person who receives, acquires, possesses, or uses byproduct material pursuant
to the general license established by paragraph (a) of this section shall comply with
the following:
(1) The general licensee shall not possess at any one time, under the general license
in paragraph (a) of this section, at any one location of storage or use, a total amount of
iodine-125, iodine-131, selenium-75, cobalt-57 and/or iron-59 in excess of 7.4
megabecquerels (200 microcuries).
1

(1) Except as prepackaged units which are labeled in accordance with the
provisions of a specific license issued under the provisions of § 32.71 of this
chapter or in accordance with the provisions of a specific license issued by an
Agreement State, or before November 30, 2007, and the provisions of a specific
license issued by a State with comparable provisions to § 32.71 that authorize
manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3
(tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to
persons generally licensed by the Agreement State or the State with comparable
provisions to § 32.71.
(2) Unless the following statement, or a substantially similar statement which
contains the information called for in the following statement, appears on a label
affixed to each prepackaged unit or appears in a leaflet or brochure which
accompanies the package: 1
This radioactive material may be received, acquired, possessed, and used only
by physicians, veterinarians in the practice of veterinary medicine, clinical
laboratories or hospitals and only for in vitro clinical or laboratory tests not
involving internal or external administration of the material, or the radiation
therefrom, to human beings or animals. Its receipt, acquisition, possession, use,
and transfer are subject to the regulations and a general license of the U.S.
Nuclear Regulatory Commission or of a State with which the Commission has
entered into an agreement for the exercise of regulatory authority.

NAME OF MANUFACTURER

(e) The registrant possessing or using byproduct materials under the general
license of paragraph (a) of this section shall report in writing to the Director,
Office of Nuclear Material Safety and Safeguards, any changes in the information
furnished by him in the "Registration Certificate --In Vitro Testing With Byproduct
Material Under General License." Form NRC -483. The report shall be furnished
within 30 days after the effective date of such change.
(f) Any person using byproduct material pursuant to the general license of
paragraph (a) of this section is exempt from the requirements of parts 19, 20, and
21, of this chapter with respect to byproduct materials covered by that general
license, except that such persons using the Mock Iodine-125 described in
paragraph (a)(7) of this section shall comply with the provisions of §§ 20.2001,
20.2201, and 20.2202.

Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979.

NOTES
1 A State to which certain regulatory authority over radioactive material has been transferred by formal agreement, pursuant to section 274 of the
Atomic Energy Act of 1954, as amended.
2 Material generally licensed under this section prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.
3 A new triplicate set of this Registration Certificate, NRC Form 483, may be used to report any change of information furnished by a registrant as
required by §31.11(e).
If larger quantities or other forms of byproduct material than those specified in the general license of 10 CFR 31.11 are required, file NRC Form 313,
"Application for Materials License," to obtain a specific byproduct material license. The application and registration forms are available at the following
link: https://www.nrc.gov/reading-rm/doc-collections/forms/