ML13083A152
| ML13083A152 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/2018 |
| From: | NRC/OCIO/GEMSD/IMSB |
| To: | |
| References | |
| Download: ML13083A152 (2) | |
Text
NRC FORM 483 U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0038 EXPIRES: 04/30/2021 (04-2018)
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 REGISTRATION CERTIFICATE -- IN VITRO TESTING to receive the byproduct material. Send comments regarding burden estimate to the Information Services Branch (T-2 F43), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by WITH BYPRODUCT MATERIAL UNDER e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0038), Office of Management and Budget, Washington, DC 20503. If a GENERAL LICENSE means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
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 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.
Telephone Number (Include Area Code) (Input 10 numeric numbers)
The above-named clinical laboratory.
E-mail Address The above named hospital.
Veterinarian in the practice of veterinary medicine.
Instructions 4. Registration A. Submit this form to:
Registration Number:
Director, Office of Nuclear Materials Safety and Safeguards ATTN: Materials Safety Licensing Branch MS: T-8E18 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.)
B. In the box above, print or type the name, address (including ZIP Code), telephone number, and e-mail address of the (If this an initial registration, leave this space blank -- number to registrant physician, clinical laboratory, hospital, or veterinarian be assigned by NRC. If this is a change of information from a in the practice of veterinary medicine for whom or for which this previously registered general license, include your registration registration form is filed. number.)
- 5. If place of use is different from the address listed in No. 1, give complete 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 Federal and State Materials and Environmental Management Programs 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 (04-2018)
CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
§31.11 General license for use of byproduct material for certain in vitro clinical (2) The general licensee shall store the byproduct material, until used, in the or laboratory testing. original shipping container or in a container providing equivalent radiation protection.
(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, (3) The general licensee shall use the byproduct material only for the uses transfer, or use, for any of the following stated tests, in accordance with the provisions authorized by paragraph (a) of this section.
of paragraphs (b), (c), (d), (e), and (f) of this section, the following byproduct materials in prepackaged units: (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 (1) Iodine-125, in units not exceeding 10 microcuries each for use in in vitro clinical or or from an Agreement State, nor transfer the byproduct material in any manner laboratory tests not involving internal or external administration of byproduct material, other than in the unopened, labeled shipping container as received from the or the radiation therefrom, to human beings or animals. supplier.
(2) Iodine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or (5) The general licensee shall dispose of the Mock Iodine-125 reference or laboratory tests not involving internal or external administration of byproduct material, calibration sources described in paragraph (a)(7) of this section as required by § or the radiation therefrom, to human beings or animals. 20.2001.
(3) Carbon-14, in units not exceeding 10 microcuries each for use in in vitro clinical or (d) The general licensee shall not receive, acquire, possess, or use byproduct laboratory tests not involving internal or external administration of byproduct material, material pursuant to paragraph (a) of this section:
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 (1) Except as prepackaged units which are labeled in accordance with the clinical or laboratory tests not involving internal or external administration of byproduct provisions of a specific license issued under the provisions of § 32.71 of this material, or the radiation therefrom, to human beings or animals. 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 (5) Iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 laboratory tests not involving internal or external administration of byproduct material, (tritium), selenium-75, iron-59, cobalt-57, or Mock Iodine-125 for distribution to or the radiation therefrom, to human beings, or animals.
persons generally licensed by the Agreement State or the State with comparable provisions to § 32.71.
(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. (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 (7) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 accompanies the package: 1 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 This radioactive material may be received, acquired, possessed, and used only byproduct material, or the radiation therefrom, to human beings or animals.
by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not (8) Cobalt-57, in units not exceeding 0.37 megabecquerel (10 microcuries) each for involving internal or external administration of the material, or the radiation use in in vitro clinical or laboratory tests not involving internal or external therefrom, to human beings or animals. Its receipt, acquisition, possession, use, administration of byproduct material, or the radiation therefrom, to human beings or and transfer are subject to the regulations and a general license of the U.S.
animals.
Nuclear Regulatory Commission or of a State with which the Commission has (b) A person shall not receive, acquire, possess, use, or transfer byproduct material entered into an agreement for the exercise of regulatory authority.
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 NAME OF MANUFACTURER number assigned; or (e) The registrant possessing or using byproduct materials under the general (2) Has a license that authorizes the medical use of byproduct material that was license of paragraph (a) of this section shall report in writing to the Director, issued under part 35 of this chapter. Office of Nuclear Material Safety and Safeguards, any changes in the information furnished by him in the "Registration Certificate --In Vitro Testing With Byproduct (c) A person who receives, acquires, possesses, or uses byproduct material pursuant Material Under General License." Form NRC -483. The report shall be furnished to the general license established by paragraph (a) of this section shall comply with within 30 days after the effective date of such change.
the following:
(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 (1) The general licensee shall not possess at any one time, under the general license 21, of this chapter with respect to byproduct materials covered by that general in paragraph (a) of this section, at any one location of storage or use, a total amount of license, except that such persons using the Mock Iodine-125 described in iodine-125, iodine-131, selenium-75, cobalt-57 and/or iron-59 in excess of 7.4 paragraph (a)(7) of this section shall comply with the provisions of §§ 20.2001, megabecquerels (200 microcuries). 20.2201, and 20.2202.
1 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/