ML20203A415

Verifies Receipt of Completed NRC Form 483 Dtd 990126.Form Authorizes in-vitro Testing with Byproduct Matl Under General License & Has Been Assigned Registration Number 7214

ML20203A415
Person / Time
Issue date:	02/05/1999
From:	Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Ijaz M AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9902090356
Download: ML20203A415 (3)

Text

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February 5,1999 Madison Medical Lab '

ATTN; Mohsin ljaz, M. S.C. Director 401 South Street Building 3 A Chardon, OH 44024 L

Dear Mr. ljaz:

This letter verifies the receipt of the completed NRC Form 483 dated January 26,1999. This form is a condition of the general license under.10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.

The form has been assigned registration number 7214. 'When making changes to any of the information on the form, please reference the registration number and address the correspondence to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

If you have any questions or need further assistance, please contact me at (301) 415-8140.

Sincerely, d

Traci Kime, Registration Specialist Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards DISTRIBUTION:

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i E.c FORM 483

- U.S. NUCLEAR REGULATORY COMMISSION APPROVED OMe: No. 31504:038 (84 0 10 CFR 31 E XPIREs: 2-2e413 ESTIMATED BURDEN PER RESPONI.E TO CoMPov WITH TM18 R EGISTR ATION CERTl FICATE-in ' vitro TESTING : >

Ele"s"E4"o'EEEm"!sMEE eel %"o*RM*Eo"N E

WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE CEt E a' RTE ta" tor vTIMIssENTss%7Toufo'cS0s

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AND To THE PAPERWORK REDUCTION PROJECT (31500038),

s INSTRUCTIONSITYPE OR PRINT (PRESS HARD - MULTIPLE COPlES) 3

- 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 forin vitro clinical or laboratory tests not involving the internal or external administration of the byprodF material or the radiation therefrom to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not authorized until the physmhen, clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine, has filed NRC Form 483 and received from the Com-mission a validated copy of NRC Farm 483 with a registration number.

l NAME AND ADDRESS: (SEE ITEM l.A.)

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2. APPLICATION I hereby apply for a registrati6n 11 umber pursuant to 10 CFR 31, Madison Medica 1 Lab Section 31.11, for use of byproduct materials for:

(Check one box only) 401 South St.

Bldg.-3-A A.9tMyself, a duly licensed physician authorized to dispense drugs e in the practice of medicine.

Chardon,-Ohio 44024 7 @ The above-named clinicallaboratory.

TEkdPNONE NtJMBER:-(g) 2b2@ I "" A '.

C. The above-narnasj hnenital,,

y D. Veterinarian in the practice of veterinary medicine.

1. INSTRUCTIONS:

A. In the address box above, print or type the name and address (including ZIP Code) of the registrant physician.

3. R EGISTR ATION clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine for whom or for 7214 REGISTRATION NUMBER:

which this registration form is filed.

T B. Submit this form and the two yellow copies to:

e" "'4 Medical, Academic and Commercial Use

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Safety Branch (GH3) 8"

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. Division of Industrial and Medical Nuclear Safety 5

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Office'of Nuclear Material Safety and Safeguayds g

o U.S. Nuclear Regulatory Commission r.

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Washington, DC 20555 _,,. '_~~ _- --

n%, s e s _ Larry ;y, Cetmr (At NRC, a registration number willbe assigned and a j 3 VAllDATED FOR THE

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vclidated copy of NRC Form 483 will be returned.)

U.S. NUCLEAR REGULATORY COMMISSION I

- C. Retain the Registrant's Copy (white copy)

DATE for your fiics.

(If this is an initial registration, leave this space blank -- number to be assigned by NRC. If this is a change ofinformation from a previously registered general license, include your registration number.)

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4. If place of use is different from address listed above, give complete address:

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5. CERTI FICATION

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l hereby certify that:

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A.i Allinformation in this registration certificate is true and complete.

B.

The registrant has appropriate radiation measuring instruments to barry out the tests for which byproduct material will be used under

, tha 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 undsrstand that Commission regulations require that any change in the information furnished by a registrant on this registration c:;rtificate be reported to the Office 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 { reprinted on the reverse side of this form); anc! I understand that the registrant is required to comply with those provisions as to all byproduct material which I e receives,

~ acquires, passesf,es; uses; or transfers under the general license for which this Registration Certificate is filed with the U.S. Nuclear Regulatory Commission.

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PRINTED OR TYPED NAME AND TITLE OF APPLICANT l SIGNATURE OF PPL1pA T) lDATE

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' 7AR%INGt FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE THAT SUBMl0SIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERI AL RESPECTS.18 U.S.C. SECTION 1001 MAKES

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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 a83 to. ell

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CONDITIONS AND LIMITATIONS OF CENERAL LICENSE 10 CFR 31.11

~ @ 31.11 General license for use of byproduct materials for certain in selenium-75, and/or iron 59 in excess of 200 microcuries, (2) The general licensee shall store the byproduct material, until vitro clinical or laboratory testing.

used, in the original shipping container or in a container providing -

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. "(o)' A general license is hereby issued to any physician, veterinarian equivalent radiation protection.

in the practice of veterinary medicine,clinicallaboratory or hospital to (3) Tne general licensee shall use the byproduct material only for receive, acquire, possess, transfer, or use, for any of the following stated the uses authorized by paragraph (a) of this section, tests, in accordance with the provisic7s of paragraphs (b), (c),(d),(s),

(4) The general licmsee shall not transfer the byproduct material

' and (f) of this faction, the following byproduct materials in prepack-except by transfer to a person authorized to receive it by a license pursuant to this chapter or from an Agreement State,8 nor transfer the aged units:

(1) todine-125,in units not exceeding 10 microcuries each for use byproduct material in any manner other than in the unopened, labeled in in vitro clinical or laboratory tests not involving internal or external shipping container as received from the supplier, administration of byproduct material, or the radlation therefrom, to (5) Ther general licensee shelf dispose of the Mock fodine 125 referance or calibration sources described In paragraph (a)(7) of this human beings or animals.

(2) lodine 131, in units not exceeding'10 microcuries each for use section as required by 20.301 of this chapter, in in vitro clinical or laboratory tests not involving internal or external -

(d) The general licensee shall not receive, acquire, possess, or use cdministration of byproduct material, or the radiation 15erefrom, byproduct material pursuant to paragraph (a) of this section; (1) Except as prepackaged units which are labeled in accordance to human beings or animals.

g.ap (3) Carbon 14, in units not exceeding 10 microcuries each for use with the provisions of a specific ilcense issued under the provisions of in in vitro clinical or laboratory tests not involving internal or external 32.71 of this chapter or in accordance with the provisions of a administration of byproduct material, or the radiation therefrom, specific license issued by an Agreement State that authorizes manufac-13 human beings or animalsJ ture and distribution of lodine-125, iodine 131, carbon-14, hydrogen-3 (4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (tritium), selenium-75, iron-59 or Mock todine 125 for distribution to each for use in in vitro clinical or laboratory tests not involving internal persons generally licensed by the Agreement State.

or external administration of byproduct material, or the radiation (2) Unless the following statement, or a substantially similar therefrom, to human beingt or animals.

statement which contains the information called for in the following (5) Iron 59,in units not exceeding 20 microcuries each for use in in statement, appears on a label affixed to each prepackaged unit or vitro clinical or laboratory tests not involving internet or external appears in a leaflet or brochure which accompanies the package:2 administration of byproduct material, or the radiation therefrom, to This radioactive material may be received, acquired, possessed, and human beings or animals.

used only by physicians, veterinarians in the practice of veterinary (6) Selenium-75, in units not exceeding 10 microcuries each for use medicine, clinical laboratories or hospitals and only for in vitro clinical in in vitro clinical or laboratory tests not involving internal or external or laboratory tests not invohring internal or external administration of coministration of byproduct material, or the radiation therefrom, the material or the radiation therefrom, to human beings or animals.

to human beings or animals.

Its receipt, acquisition, possession, use, and transfer are subject to the (7) Mock lodine 125 reference or calibration sources,in units not regulations and a general license of the U.S. Nuclear Regulatory Com-sxceeding 0.05 microcurie of lodine 129 and 0.005 microcurie of mission or of a State with which the Commission has entered into an tmericium 241 each for use in in vitro clinical or laboratory tests not agreement for the exercise of regulatory authority, involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals.

(b) A person shall not recolve, acquire, possess, use or transfer

,7 byproduct materiel under the general license established by peregraph Name of manufacturer i

(a) of this section unless that person:

(1) Has fil6d NRC Form 483, " Registration Certificate-In Vitro (a) The registrant possessing or using byproduct materials under the Testing with Byproduct Material Under General License," with the general license of paragraph (a) of this section shall report in writing to Director of Nuclear Material Safety and Safeguards, U.S. Nuclear the Director of Nuclear Material Safety and Safeguards any changes Regulatory Commission, Washington, D.C. 20555, and received from in the information furnished by hirn in the " Registration Certificate-in the Commission a validated copy of NRC Form 483 with registration Vitro Testing with Byproduct Material Under General License," NRC number assigned; or Form 483. The report shall be furnished within 30 days after the (2) Has a license that audorizes the medical use of byproduct effective dste mi such change.3 i

material that was issued under Part 35 of this chapter.

(f) Any person using byproduct material pursuant to the general I

(c) A person who receives, acquires, possesses or uses byproduct license of paragraph (a) of thlm section is exempt from the requirements material pursuan' to the gnneral license established by paragraph (a) of of Parts 19, 20 and 21 of this chapter with respect to byproduct this section shall comply with the following:

materials covered by that general license, except that such persons (1) The general licensee shall not posse, t any one time, pursuant using the fAock lodine-125 described in paragraph (a)(7) of this section to the general license in paragraph (a) of this section, at any one loca-shall comply with the provisions of 20.301,20.402 and 20.403 of tion of storage or use, a total amount of lodine 125, lodine 131, this chapter.

NOTES

' 3 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.

3A 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 Q 31.111e).

s If larger quantitles or otNr forms of byproduct material than those specified in the general license of 10 CFR 31.11 are required, an "Applica-tion for Byproduct Maternal License," NRC Form 313 should be filed to obtain a specific byproduct material license. Copies of application and registration forms may be obtained from the Medical, Academic and Commercial Use Safety Branch (6H3), Division of Industrial and Medical Nuclear Safety, United States Nuclear Regulatory Commission, Washington, DC 20555.

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