ML20211A550
| ML20211A550 | |
| Person / Time | |
|---|---|
| Issue date: | 08/20/1999 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Gordon R AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9908240070 | |
| Download: ML20211A550 (3) | |
Text
August 20,1999 b Robert J. Gordon, D.O.
965 South Main Street Plymouth, MI 48170
Dear Dr. Gordon:
This letter verifies the receipt of the completed NRC Form 483 dated August 16,1999. This form is a conditiori of the gereral license under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.
Th9 form has been assigned registration number 9170. 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, b[e Regi ISpecialist Materials Safety and inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards DISTRIBUTION: p IMNS r/f NEO3J DOCUMENT NAME: H:\TRACl\Gordon.483 T+ ,eceive a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure *E" = Copy with attachment / enclosure "N" - No copy OFFICE MSIB l l NAME TKime DATE 800'99 OFFICIAL RECORD COPY 1
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l 23003 9908240070 990820 PDR RC
- SSD PDR
i NRC FORM 483 U. S. NUCLEAR REGULATORY COMM:SSION APPROVED BY CMB. NO. 3150-0038 EAPiRES. 6 33 99 '
m Enumated burden per resumse to compty with this randatory mformahon e . ~e.t me. no , dated, ego.. .e.a.. ~
REGISTRATION CERTIFICATE -in vitro TESTING l',"L"ff 7 C
- L** % ;ll;" Z "Jl"e* C WITH BYPRODUCT MATERIAL UNDER lTe,"7l% ""'ms"O **a!**f,"' o *IEsME 'a'd i""5 Paperwork Reductior Prmect (3150-0039). Olhee of Management and GENE L LICENSE Budget. Washmpsort, DC 23503 NRO may not conou:t or sporw and a person it f,ot fequNed to itspond 10, e CoH00 ton of m%rmation uNeE6 it displays a currently vand OMB control numt>er Section 31.11 of 10 CFR 31 establishes a general hcense authonzing physicians, clinica: laboratories, hospitals, and vetennanans in the pra:tice of veterinary medicine to possess certain small quantities of byproduct material for in vitro clinical or laboratory tests not involvity the intema or extemal 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 cuthorized until the physician, clinical laboratory, hospital, or veteriarian in the pract)ce of vetennary 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 instruebon 3.B. below) 2. APPLICATION (Check one box only)
I hereby apply for a registration reimber pursuant to 10 CFR 31, Section RobM t' J . CONIO7, P.O. 31.11, for use of byproduct matenaS for:
65 South rain 'tnvt A. Myseif, a duly heensecMsician autnortzed to disperse drugs in
]! ly ouLn, n 1
+ ,1 E ,
the practice of medicine.
B. The above-named clinicallaboratory.
TREPHONE NUMBER pnclude hos Cod *) C. The above named hospital.
D. Veterinarian in the practice of veterinary medicine
- 3. INSTRUCTIONS: 4. REGISTRATION A. Submit this form in duplicate to:
REGISTRATION NUMBER:
Medcal, Academic and Commercial Use mm l Safety Branch (T-8 FS) N W: !
Division of industrial and Medical Nuclear Safety // " % q'o{ nd w % i vcm "o-i l 'im Office of Nuclear Material Safety and Safeguards [ 7, U.S. Nuclear Regulatory Commission g j i Washington, DC 20555-0001
- I e l (At NRC, a registration number will be assigned and a validated copy ,
of NRC Form 483 will be retumed.)
- / . r
\ldi 's jp N B. In the box above, print or type the name, address (including ZIP nm" "i m ?/JO e (if this an ini#alregistradon, leave this space blank - number to be Code), and telephone number of the registrant physician, clinical ;
laboratory, hospitol, or veterinarian in the practice of veterinary 683/Dned by NRC. If this is a change ofinibrmabon from a previously I medicine for whom or for which this registrathon form is filed. registered generalicense, include your registrabon number)
- 5. If place of use is different from address listed above, give complete address:
- 6. CERTIFICATION I hereby certify that:
A. All information in this registration certifcate is true and complete.
B. - The registrant has appropria's radiation measunng instruments to carry out the tests for which byproduct material will be used under the general Icense 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.
l C. I understand that Commissiort regulations require that any change in the information fumished by a registrant on this registration certifcate 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 (reprinted on the reverse side of this form), and I understand that the regetrant is required to comply with those provisions as to all byproduct matenal which he receives, acquires, possesses, uses, or transfers under the general Icense for which this Registration Certificate is filed with the U.S. Nuclear Regulatory Commission.
PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE OF APPLICANT DATE
,,v m ,_ n ., r, n T , .'1 '4 WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CML AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE 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 DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.
NRC FORM 483 (N16)
REGISTRANT *S COPY L i
CONDITIONS AND LIMITATIONS OF GENERAL UCENSE 10 CFR 3L11
{ 31.11 Generi Menu fcr use ci byproduct erre@s for cuta n m se um 4 om 'or ,ru! < 9 ;n extens av 200 mic,oories 'l v tro ctirsa! or booratcry testing (2) The ro- M b esee tham ste c the byrvodurr mneriM, ur til vr,n in the or%r.m vn p+rg contamer or m a cc :+aer prov,dag (a) A general hcense is hemt:y b3ued to any phystan, veturinere tyviva mtrad on L onct -on.
j in the practie of vartt rmary medkine, CUnMa' %c'atory or hospithI to (2) Tre gem 'M " ve shed we the twproduct veria! omy f or i receive, acqMre, possess, trans+cr, or ur,u, 'or ry of the foibw ing es:r:J the uses au tho, eed b y py y W.(a)et t h e se:,t ion, .
tests, in tccordancE a nh t% provistors of pe'eW-N M , M. y. . (.p, , g4, . yhe pe,a ie re'shWnc*treW t% n W m % g and (f) of th's sectien, tv fonowerg byprodxt rnatersis in preaack eFCfp Dv tra N tC 3 Ie' SON adIboNMI IU IeCNU U by 0 MEDI apd u4ts- pc smt ta f rus cwer : r f rom an Are'. nent Stee 3 r,c r transfer the (1) lodine-125, in units not eneeding 10 micrccurmi each for ae 6 3 pmc ct tNieda' in ey mamier ot*wr thar in the u"openwi,4bee d .
1 in in vriro c!Maa! of tsuOrenry Ints r.ot invoirig interno' or extemai s h :p,WN ccri s er a remved f rom the ssp;4r, admimst ation of bypecduct materui, or the e achat;on there f rorn, to (b) The gvera' heere
- shad dispose of t r.e Mock lod;ne-125 hume bedn9h or sn.mMa referent e or cofibvion sourm cescotmd m paraprmh u)(7) of th's (2) icir+131, in units not esceedmg 10 microcunn each for ue mtion as moseu m j 20 301 of th's chamet in in vitro chnma! or Uboratory tests nLt invoMng in'ema! or e>,ter (at i rm gm rm mee shW not reem weauW, posuess, or use administradon of b yprod uct ma'er 4 cr INe radiation themfrorn, byprodat mater ,a: p.aam to paraproh !a) of th,s sos ion.
to human beings or an. mms (1) E uept n ;"w b ri-d uMts ahen am lamed in accordance (3) Carbon-14, m uMM not excerdma 10 microcones eeth br vre w 't h t he pm vaoni c.* a suafic cen,e uurd unaer the proveraons of in in piirp (hp4cd or lbODrb!Ory ters tot invDMng internal Or (!stempi J 2. ) j af t%5 g ri mt pr Or m deontaore with the prov:pon5 Of a !
adm init r at io n of byp roduct mater na;, ,,r the radwiten thstref rem . specta icev i s ad t v en A'reement Dre t hat authonres raanste to human Legs ore vna;s. Nre and c!htr %t en af It4,ne 125 ex%t 131, cubonl4, hydrogen-3 1 (4) HyPagen 3 f trittuN ,n units not onetim 50 mbocudes tir it bW p ene E, nn-59 or Mnck LMine 12f; W 6tocution to l Mch for use in in yhro chnkai or isboratory f ests oct invoMng ir'teme pe som w nraby huvd by t he Aprwment StMe. l or t(ternal admirnt ration of byproGtt materiM, Or 'he ratation (2) U ran t h+; f #omnp statement to .: subp a"riWiy simdar tneref rom, to hunwn beings or ernm(s n em ent C kh rimtw the into'metion ta>l tur in the fo! ion mg (6) troq 59, en unit s not esteedmq 20 microcurms each for un in in m en srt. A.pecs on a ialW afh ad tn wh ino ckged un,t or Wtro cilMal or laborat or y tests not Irwcming ;ntemM or everrwl e pm r s in a hM or tm hure which accorncame. the p d a d j c'iministra' ion ci by pro &ct trater d or the r d.ation e t heref rorn, to lho run*ct e crM er W ma r be ter.eW1, acquired possesed, and 1 human bmngs er aNmais u-mt o % by p h y si' ns, veerincr'ar s in the prm t v.e of vetennary M) GeWrvn M, m umts not 6mteedq 10 microcuries e#:h for uc treJe an chmcM moratnoes er hospitWs of onN for m Utro cirmcal in in v?tro c4neal or labor 6tary tests not mvolvmg intemal or eatems of Mo=nwry ints not inwoh <ng ir ternd nr exterrW adm mstrat eno of artmi%3a t e n of b y p rcduct materJ. or t r e r actat e n t her efre m , the rr aW u t he w.tauon th"ef rom, to human bMem or an mma.
to twman bemg4 or anPvts. Its rOpt, witMt or, pommo. um ed transf m are subjf ct to the l (7) Ma< k lodse4 25 re4rence or cM brution sween. in on ts rGt rWri9ns eM a pvre bcense of the US Nuciur ReguWory Cum-exeechng 0 05 m% curie of bd a 129 and 0 Ot 5 mkracura of mimor c. r ef a Dm sh whicri the Corrmitsm hs, eramj into an emencium 241 each ter use in in vitm cMica' or laboeator y tests not e yt-em nf Mr t h w n.e of re9v W ory A tnonl y, involeg interr.a! or external admbstraficn of t yprodset trateria!, er the radianon thP4f ROT, TJ bdmp IMn.js or aqird6.
M A persco sbd! not rec *e, acade, porsast use or trs
- bi p Wuc t ma'erW under the genva' Ikense establised by pareraph rJyne of rnersfi t ru rer W of tNs section ud-ts that persun.
(1) Has f ed NBC Form 423 "Repstrasn Cert +ficate-In Vhra (e) TNr rem nt owes @a or us>ng byomdstt m erm4 unner the Testing w;th Byprodun MatrW Unaer Genew License,' n ch tM pred licum of p-varh M of to.s ser;on shad report m writmg to Dhee or cf N.scw MeerM Lf et y and Salman4,US N x Mer tho D ec a of N a v Meteriai Lfet y aqd Sefegards am changes Regu* ate ry Commdo% Mi%n9to% D C. ?MR and ro ewd from in the 1. fmi%: ion torn *d t., him M the " A t gm rotion Certibcate-in the Commion a valdmed copy of NRC Form 483 mth rey nica V4tro Tec q mth DWrvlet Metmu' Uncher Geneal Leen s e " AHG numtw ess g,r$1, or r c em Stj T ne repar! snmi be ifurras-d wirNn 30 d3vs af ter the C) Has a licme that autho ins the m'd cd c;p c t byp odxt ef fect h e drr of s h chanP: 3 metmal tSt was Irwi une f an 35 cd ths : w <r Ib Arv pm i 9 byprtdoet mater + pursst to the generW kl A pe so, who "c %. araces. rmew t 0 uses bmrod act Ocem t
- popph W a f t% secten a empt from t hr rewiremerits rnatar;a! pusuant ta the gensW i;c*rse estMAshed by proeph (a) of M Peu 19 ~ T end 21 t]f tms choter WW respect ta byprodsct t.bs mien sMI cmp'y wnh tu fouewmg marerws cured t y rf at g % M htene, except t hat such persons (1) The pncral ik cve shal not pawi,s si ar y eme time, pa vent r unng the Mock ixtme 125 dmcribed m persgraph W!7) c f t% sr ctico to the pnerd Mcense in prograph (O of this sectbn Et sny one !cca- M compn veh tbo pc sens of { 20 201,20 400 and 20 403 of tion of storage et um, a tota amour *t of lodir e 125 o o r 131. th s %pter NOTES 1 A S:.te to wNch c ertain regu'alory euthorrt y over radeoactsve rnater"!! has beren trens4rt Mi by foirnd agreeme.ry, p.>rsuant to vction 274 of the Atomic Energy Act c-f 1954 u amer.ded.
MaterW rnvily licensed under this Semon prior to January 19,1975 may boar label authonzed by th* repuiatens m effect on January 1, 1975.
3 A new 9tip'icce set of this R4strat,on Certitae, NRC Form 483, may be used to mport 6ny change of information turnuhed by a registract I
es rendred Lv $ 31.111e).
If :arger quantit.es or other farms of byprodxt material tt en those Wif ad m the g':nerM Sctose of 10 CF H 31 11 W rNuired, an "Apphca-tion for Cyproduct MateriC License," NRC f orm 313 shovd be fned to obtem a r.pmhc b, product material bcense Cop 6es of appbcanon and registradon forms fnsy be obtaired frorn the Medical Aci+demic and CommerciM Use Sate:y Branch (GH3), D%sion of Irdustr6? and Medical Natiest Saf ety, United States Nuclear Regulatory Commission, Washington, DC 20G55.
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