NRC FORM 483

(06-2021)

U.S. NUCLEAR REGULATORY COMMISSION 

6. Certification

NRC FORM 483 (06-2021)

2. Application (Check one box only)

APPROVED BY OMB: NO. 3150-0038 EXPIRES: 05/31/2024

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. 

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.

The above-named clinical laboratory.

The above named hospital.

Veterinarian in the practice 

of veterinary medicine.

Instructions 4. Registration

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

(At NRC, a registration number will be assigned and a validated copy of 

NRC Form 483 will be returned.)

In the box above, print or type the name, address (including Zip Code), 

telephone number, and e-mail address of the registrant physician, 

clinical laboratory, hospital, or veterinarian in the practice of veterinary 

medicine for whom or for which this registration form is filed.

A. Submit this form to:

Registration Number:

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

be assigned by NRC. If this is a change of information from a 

previously registered general license, include your registration 

number.)

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

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.

B. 

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 e-mail to Infocollects.

Resource@nrc.gov,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; e-mail: 

oira_submission@omb.eop.gov. 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.

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

Business Telephone Number (Include area code)

Business E-mail Address

5. If place of use is different from the address listed in No. 1, give complete business address.

Signature Date

REGISTRATION CERTIFICATE -- 

IN VITRO TESTING 

WITH BYPRODUCT MATERIAL UNDER 

GENERAL LICENSE

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 e-mail to MSHD.Resource@nrc.gov; or by writing the Office of 

the Chief Information Officer, U.S. Nuclear Regulatory Commission, 

Washington, DC 20555 -0001.
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:

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

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/ 

(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.

(d) The general licensee shall not receive, acquire, possess, or use byproduct 

material pursuant to paragraph (a) of this section:

(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).

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

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