ML20247H300
| ML20247H300 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | George M AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210124 | |
| Download: ML20247H300 (3) | |
Text
{{#Wiki_filter:- f**- M:y 17,1998 1 Mumtaz George, M.D. Royal Oak Medical Center i 5130 Coolidge Highway Royal Oak, MI 48073 Dear Dr. George-1 l This letter verifies the receipt of the completed NRC Form 483 dated April 20,1998. 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 6309. When making changes to any of the information on the form, please reference the registration number and address ine 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, I si Traci Kime, Acting Registration Specialist Materials Safety Branch Division of industrial and Medical Nuclear Safety l Office of Nuclear Material Safety { and Safeguards ) DISTRIBUTION: SBaggett IMNS r/f NEO3 ) DOCUMENT NAME: P:\\ GEORGE.483 ) T, receive e copy of thle document. Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy I OFFICE MSB l l l l l NAME TKime di G %f# DATE 5//7/98 f/## OFFICIAL RECORD COPY o -300Co d 9905210124 990517 l PDR RC e t SSD PDR f f a-_--_----------- u
Y ?f W 0 AA {.. ~ NRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OhE5: NO. 31504036 EXPIRES: 640-qf -{ .p iy Esemmend burden per response to compty we m.m mandatory informen REGISTRATION CERTIFICATE -In vitro TESTING * *"Zl"*, ',',,t'"T,",w".",d" '"' '* M*de"""".".,' l?O ) ^,, -- 1 er 1,shded,.em. - - i,,,r , non e R.,,,,,,,, ""' "***" w""."C'."0038)' E"'*fs's2, "e'd ( WITH BYPRODUCT MATERIAL UNDER 4 s Paperwork Reduchon Prosect (3150 . ofhce er Management and, i gg g gg g g. [ w E-E- EJ wE-Budent, Washmgton, DC 205o3. NRC may not conduct or sponsor, and a pereen a not requwed ta respond to, a sc:lochon er mlormabon unless it l dupiays a curroney vahd OMB control number ard ' l-Section 31.11 of 10 CFR 31 estabhshes a general license authorizing physicians, clinical laboratories, hospitals, and veterinarians in the practice of l j [ vetennary medicine to possess certain small quantities of byproduct material for in Wrro clinical or laboratory tests not invoMng the internal or external l l administration of the byproduct material or the radiation therefrom to human beings or animais. Possession of byproduct material under 10 CFR 31.11 is not l authorized until the physician, clinical laboratory, hospital, or veterinarian in the practice of veterinary rnedicine, has filed NRC Form 483 and received from the I l Commesion a validated copy of NRC Form 483 with a registrahon number. l
- 1. NAME AND ADDRESS OF APPUCANT (See instruccon 3 8. below)
- 2. APPUCATION (Check one box only) j I.- cU\\4 M 43 borCtJ k.4 31 3 fw M W M e r l hereby apply for a rogstration number pursuant to 10 CFR 31, Secten l
4 4 Mook. a duly licanud phpican authorized to depww @gs in 513 ci c,ooIidy c l@uay y l @uf9I oeK n1) 4 9oT1
- P"*****'"*d'***
[2(/M ') B 9, *,9 % oo B. The above-named clinicallaboratory. l TELEPHO5E NUMBER pncludehe Codd C. The above named hospital l D Vetennanen in the practice of veterinary medicine-l' 3. INSTRUCTIONS:
- 4. REGISTRATION A. Submit this form in duplicate to:
I REGISTRATION NUMBER: ,1 Medscal, Academic and Commercal Use 6309 1 tA" "'%o. Safety Branch (T-8 F5) l Division of industrial and Medical Nuclear Safety / US NuC.lcar Regdatory. Com. g Office of Nuclear Material Safety and Safeguards [ .n. f - U.S. Nuclear Reguistory Commesson 5 y l Washmgton, DC 20555-0001 d't' 4 / l (At NRC, a regstrabon number will be assigned and a validated copy Steven I/. facett[pr." S/ g /98' -t l of NRC Form 483 will be returned.) B. In t's box above, print or type the name, address (including ZIP l l Code), and telephone number of the regetrant physician, clinical @s an N#alW, dem Ws space blank - number to be i I laboratory, hospital, or veterinarian in the practice of veterinary assigned by NRC. If thlis /s a change of Wbrma60n hom a proWously medecine for whom or for which this regetration form is filed. regustered generaf #com, include younogwa#on number)
- 6. If place of use is different from address lated above, give complete address:
j i
- 8. CERTIFICATION I hereby certify that:
A. All informaton in the regatration certificate is true and complete. t B. The registrant has appropriate radiation rnensunng instruments to carry out the tests for which byproduct material will be used under the general l license of 10 CFR 31.11. The tests will be performed only by personnel competent in the une of the instruments and in the handling of the byproduct matenals C. ' 1 understand that Commission regulabons require that any change in the informahon fuminhed 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 1 have reed and understand the provisions of Section 31.11 of NRC'reguishons 10 CFR 31 (reprinted on the reverse side of this form); and l ) underetend that the regatrant is required to comply with those provleions as to all byproduct meterial which he receives, acquires, possesses, uses, or transfers under the general liconee for which this Regatraten Certificate is filed with the U.S. Nucteer Reguistory Commisson PRINTED OR TYPED NAME AND TITLE OF APPUCANT SIGNATURE O APP CANT DATE j jff, G b K d ~ ly g 4'cl~a Q if 'z o-98 WARNING: FALSE STATENENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CML AND/OR CRIMINAL PENALTIES. NRC REGUI.ATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE CONPLETE AND ACCURATE IN ALL MATERIAL RESPECTS. '18 U.S.C. SECTION 1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTlWENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTc.R WITHIN ITS JURISDICTION. =c-=4 g s 2 L----
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W. t CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31,11 l { 31,11 General license for use of byproduct materials for certain in Wenium 75, end/or iron 59 in excess of 200 rnicrocuries. l (2) The general hcensee shall store the byproduct material, until I vitro clinicsi or laboratory testing. used, in the original shopping container or in a coritainer providing l i tal A general license is hereby issued to any physicfan, veterinarian equivaient radiation protect on. in the practice of veterinary medicine, clinical laboratory or hospital to (3} 7he general Ikensee shall use the byproduct materlat only for ' receive, acquire, possess, transfer, or use, for any of the following stated the uses authotized by paragraph (a) of th's section. t2sts, in accordance with the provisions of paragsphs (b). (c),(d), (c), (4) The general licenses shall not transfer the byproduct rnaterial ' l pnd (f) of this section, the fo!!onmg byproduct materials in prepack-ancept by transfer to a person authorired to receive it by a license putscant to this chapter or from an Agreement State,I nor transfer the l aged units: (1) lodine 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 snipping contasner as received from the supplier. l administration of byproduct materiet, or the radiation therefrom, to (5) The general heensee shall dispose of the Mock lodine 125 reference or callbration sources described in paragraph (a)(7) of this humart beings or anirnals. (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 administration of byproduct material, of the radiation therefrom, byproduct material pursuant to paragraph (a) of this section: j l j; (1) Except as prepackaged units which are labefed in accordance l to human beings or animais. . (3) Carbon-14, in units not esceeding 10 microcuries each for use with the provisions of a sDecihc license issued under t e provisions of h in in vitro clinical or laboratory ts;ts not involving internal or 'aternal' { 32.71 of this chapter or in accordance witt) the provisions of a administration of byprodut material, or the radiation tlwef rom, specinc ncense issued by an Agreement State that authorges manufac-ture and distribution of iodine 125, iodine-131, carbon.14, hydrogen.3 to human beings or animals. (4) Hydrogen 3 (tritium), in units not eaceeding 50 microcuries (tretium), seieruum-75, iron 69 or Mock todine-125 for distribution to l eech for use in in vltro clinical or laboratory tests not involving internat perses genera!!y licensed by the Agreenent State. or eatmenel adminstration of byproduct material, or the radiation (2) Unless the following statement, or a substantiaHy similar f statement which contains the information Cahed for in the fo!iowing therefrom, to human bemgs or anima;s. (5) Iron 59, in units not exceeding 20 micrce.uries each for use in in statement, appears on a label affixed to each prepackaged ur* or vitro cFinical or laboratory tests not involving internal or external appears in a leaflet or brochure which accompanies the package 9
- c. administration of byproduct materiet, or the radeation therefrom, to This radioactive material may be received, acquired, possessed, and I
used only by physicians, veterinarians in the practice of veterinary human beings or animals, (6) Selenium-75, in units not exceeding 10 microcuries each for use medicine, clinical laboratories or hosoitais and only for 16 vitro climcal in in vetro clinical or laboratory tests not involving internal or external or laboratory tests not invoMng Internal or external administration of administration of byproduct material, or the rad ation therefrom, the material or the radiation therefrom, to human beings or f.nimals, to human beings or animals. Its receipt, acquisition, posser,sion, use, and transfer are subject to the (7) Mock lodine-125 reference or calibration sources, in uruts not regulations and a general beense of the U.S. Nuclear Regulatory Com-exceeding 0.05 microcuria of lodine 129 and 0 005 microcurie of mission or of a State with which the Commission has entered into en americium 241 each for use in in vitro clinica! or laboratory tests not agreement for the exercise of regulatory authority. l Involving internal or external administration of byproduct metersal, or { the radiation therefrom, to human beings or animals. l (b) A person shall not receive, acquire, possess, use of transfer byproduct m.sterial under the general license established by paragraph Name of mar.uf acturer (a) of thls section unless that person: (1) Has filed NRC Form 483, ' Registration Certifieste-in Vitro (e) The registrant possessing or using t yproduct materials under the Testing with Byproduct Material Under General Utense," with the genera hcense of parag aoh (a) of this section shall report 6n writing to Dhetor. of Nuclear.MatenaLSafety and Safeguards,. U.S. Nuclear the Director of Nuclear Materisi Safety and Safeguards any changes Regulatory Commission, Wash.ngton, O C. 20555, and received from in the information furnished by him in th6 Registration Certificate-in the Commission a validated copy of NRC Form 483 with registration Vitro Testing whh Byproduct Material Under General License," NRC numter assigned; or Form 483. The report sha!! be furmsnad within 30 days after the (2) Has a license that authorizes the medical use of byproduct effective date of such change) J material that wasissued unde < Part 35 of this chapter. (f) Any person using byproduct materia: pursuant to the general l (c) A person who receives, acquires, possesses or uses byproduct hcense of paragraph (a) of this section is e>empt from the requirements material pursuant to the general license established by paragrcph (al of of Parts 19, 20 end 21 of this chapter wit h reFDect to byproduct this section shah comply with the following: materials covered by that general licen%P, eNCept that suCh persons (1) The general licensee shall not possess at any one tima, pursuant using the Mock fod<ne-125 described in paragraph (alt 7) of this section to the general license in parugesph (a) of this section, at any one loca-shau comply with the provisions of { 20.301,20.402 and 20.403 of tion of storage or use, a total amount of iodine 125, iodine 131, this chapter. NOTES 3A State to which certain regulatory murhority over radioactive material has been transferred by formal agreement, pursuant to sectron 274 of the Atomic Energy Act of 1954,as amended. < 2Materint generally bcensed under this section pr6or to Janus'y 19,1975 may bear tabels authorized by the regulations in effect on January 1, 1975. A new triplicate set of this Reghtration Certific' te, NRC Form 483. may be used to report any change of information furnished by a registrant 8 a es required by { 31,11(el If larger quantitles or other forms of byproduct meterial than those specified in the Deneral license of 10 CFR 31.11 are required, an "Applica-tion for Byproduct Materia! Ocense," NRC Form 313 should be filed to obtain a sone:fic 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 Commissien, Washington, DC 20555. p, .}}