ML20205N838

Verifies Receipt of Encl Completed NRC Form 483,dtd 990331. Form Condition of General License Under 10CFR31.11, Authorizing in-vito Testing with Byproduct Matl Under General License

ML20205N838
Person / Time
Issue date:	04/13/1999
From:	Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Mcbride R AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9904190180
Download: ML20205N838 (2)

Text

r April 13,1999 Alverno Clinical Laboratories ATTN: Dr. Robeit E. McBride, M.D.

2434 Interstate Plaza Hammond, IN 46320

Dear Dr. McBride:

This letter verifles the receipt of the completed NRC Form 483 dated March 31,1999. 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 8901. 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.

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

l Sincerely, l

M/

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

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@R!M @@pp DISTRIBUTION:

IMNS r/f NEO d Ta,eorive e cop r of this document, ind4cete in the boa:

"C" = Copy without attachmentrenclosure

• E" = Copy with ettachrnentienclosure

• N* = No copy l OFFICE MSB lC l

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{NAME TKime d lDkTE 4/13/99 OFFICIAL RECORD COPY 41 130 990413 7

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clRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY Ot&L NO. 315Gco38 EXPlRES: 6-30-99 (9 961 Esbmated burden per respone to comply with this mandatory mformatKm

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n..e dre, _.s. ~orme REGISTRATlON CERTlFICATE --in vitro TESTING

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WITH BYPRODUCT MATERIAL UNDER

[Z E"'n.".*".,o"n" "*"Jn;*"' $~"EsisE " *d i""'*?

i GENERALg gd g Pop wworts Reduction Prom:t (315M038), Office of Management and e.s w L.

Budgst, Washington. DC 20503 NRc may not conduct or sponsor, and a person as not reamrod to respond to, a cohecbon of mformatun unless a despiavs a currentiy vahd OMB control number Section 31.11 of 10 CFR 31 establishes a Deneral license authortring physicians, chncal laboratories, hospitals, and veterinarians in the practice of vetennary medc#ne to possess certain small quant *ies of byproduct matenal for in Wtro clinical or laburatory tests not involving the internal or external cdministration of the byproduct material or the ndstion therefrom to human beings or animals. Possession of byproduct matenal unds 10 CFR 31.11 is not euthorized until the pnysician, c inical laboratcry. hospitat, or vetertarian in the practice of vetennary medene, has filed NRC Form 483 and :aceived from the Commission a valid (ed copy of NRC Form 483'witn a registraten number.

1. NAME AND ADDRESS OF APPUCANT (See insfruccon 3 9. below)

2. APPLICATION (Check one box only)

I Fereby apply for a registrattan number pursuant tu 10 CFR 31, Section nlVKr.O L,1! TuCd C,oraLoE'"

31.11, for use of byproduct rnaterials for-M % J t?2r' La L a 6 c.7, IhSwtrad, El A. Myself, a duty heensed physician authorized to disperse drugs in lis nonu,

%32) the pracuce of rredcine.

B. The above,1amed chnicsilaboratory.

E.EPHoNE NUMBER (McJude Asa Cope)

C. The above named hospital.

D Veterinarian in the practee of veterinary medbine 3.

INSTRUCTIONS:

4. REG!STRAT'ON A. Submit this form in duplicate to:

REGISTRATION NUMBER:

Medical, Academic and Commercial Use q~

1. p# Mooq'o Safety Branch (T-B F5)

Division of Industnal and Medical Nuclear Safety n

a C oci -

m myg Offce of Nuclear Material Safety and Safeguards

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U.S. Nuclec Requircrv Commission of Washington, DC 4AM001 Ea i

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

+0 of NRC Form 483 will be retumed.)

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A;//j,gy B. In the box above, print or type the r.ame, address (including ZIP 1rn r i,,

a Code), and telephone number of the registrant physician, clinical (tf this an initialregistrabon, leave this space blank - number to be laboratory, hospital, or veterinarian in the practce of vetennary assignedby NRC. If thisis a change ofinformaban from a previously medcine for whom or for which this registratLn form is filed.

reg'stered general Dcense, include your irgistraban number.)

6. If plan of use is different from address hsted above, give complete address:

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6. CERTIFICATION i

t hereby certify that.

A.

All information in this registration certifcate is true and complete.

B.

The registrant has appiopriate radiation measunng instruments to carry out the tests for which byproduct matenal will h

' nder the general license of 10 CFR 31.11. The tests will be performed only by personnel competent in tha use of the instruments t

.n the handling of the byproduct matenalsi C.

I understand that Commission regulations require that any change in the information fumished by a regtstrant 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.

O I have read and understand the provisions of Section 31.11 of NRC regul tions 10 CFR 31 (mprinted on the reverse side of this form); and I s

understand that the registrant is required te compty with those provtsions as to all byproduct matenal which he receives, acquires, possesses, uses, or transfers under the general license for which this Registranon Certifcate is filed with the U.S. Nuclear Regulatory Commission.

PRINTED OR TYPED NAME AND TITLE OF APPLICANT l SigNjTUR f APPL 1CAf4T DATE O

fQM jib /#h &

PR y d 1. Ici:ri @. "..

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WARNING.

FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUB,;ECT TO CML AND/OR CRIMINAL PENALTIES. NRC REGULATIONS RECUIRE 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 MNITER WITHIN ITS JURISDICTION.

1. c ro=M.as m REGISTRANT'S COPY

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CONDtTIONS AND LIMITATIONS OF GENER AL LICENSE 10 CFR 3s.11

@ 31.11 GenerM Sce%e for m af Dyprodxt magr:a's for certan in sMum75, ana'or irco 09 in erens of 200 Mcrceurin Wro c4rdcat or' hebor6 tory testint

42) The peral license' snail store the byproduct materW, ur id S nal shipping cor tener cr in a COntillner pro /G inG i

l uked, M the Ori (a) A ynera! bcense h her*y iwA to any physics, were& arm eaulveient radiation protection shal use t e! byproduct rNte&d on*y for h

in the praMice of veterincy med ch ehrmallsbo'etcry or howital to (3) T he generai Ikenwt rect ive, acqwre; poster 4 t ranshr, or usa, for any of the latiowirag stated th* ufws authonted by pa agrrph (e) of thq pction.

r tests, in occc.rdance Cth tN pro 4sions of psrapphs (b), (c),(d), tel, (4) Me generai heensee skW not trbosfer the DwroNct mcerW end if) of this sectb the fai%ng byprodact meerMs in p*epacio e4 cept by trantfer to a pe*sc,n authorirem to receive it by a f Msnse aged units:

pursuant to this cnep'er or from an Agipemera State) nar transfer th*

11) ledme 125, in unns not exceeding 10 microcodri erah for na byproduct mnteriei in any manrwr other iban M the unopraned, Wed

, in en vitro rhn! cal or laboratory tests not involverQ internal or external pppareg camasr as re(F-ved frorr the supper.

administration of byproJuo metenet or the red:ation thenfrom, tv (5 ) The enerai licensee shad dispcae of the Mock lodme425 buman bring or eni rWs.

refercrce c'r c& ration sources descr; bed it parep+ph (aH7) of tth (21 lodme 131, in unds not exceeding 10 microwries eaca f ar use section as required by 3 20 301 cf th,s chapter.

M in v'tro c'ini.;al or iabCatory tests not involag internal o aternal (d) T he gcnerrn bcensee shad not cer.cive, ocuvira. possres, or use EidfNnhtration Of b y prOht mMerial, Dr the radidtion ef ef rom, byproduct ma%rlal pdrhant to pars,Faph (d) Of this s*ction:

to human bE ngs Or ansrt'8 s.

(1) fattpt as pWckbged unds whicq gre tabekd in aCs;&ddnce y

Ci) Cwtcm14, '.n dts not exceed;rq 10 mkrocurW uch for me o th the provision. of e Secife beense mued unuer the prevalans of In in vitro ciin;CM or laboratory tests riot trivciving internal or exterriai

32,71 of this (hapter or in dcr ordance with the promions of a edmin at ratiJ 7 of byprOda(f rinter bl, cif the rUfh6t!Cn theref rom, sPcific hcenti 15s'2e'.1 by srt Agreement St af e

t hot.iethodies meaufac-f a e ant? datrit2ution of iorhan 125, inne 131, carbon 1% hyJrogend to human ben;s or enima:s.

r r its not exceed >g 50 microra.nes (tntiurr,1, t.elew m 75, iron 49 or Men lodW 125 for cinnhunon to A4) H yd apn 3 (tritium), in v

each for use W) ia vitro ctimca' or bwutory tests not Mvmvg loterr$

pesons gelierehy hcensed by the Aw*erunt Sutt n r

Lt oess the f odowing st ateme nt, or a subst a'itad f y fom ely Dr ext 0r nal eOatpnktrat'on of b'r prONct mat

• real, or the rodtation (2) t t

theref ecen, to f.unen bemgs or an.me:s.

ectement which corwins the mform tion cJed for in the f%dwinq o

151 f ron 59, M uruts ret m. reg 20 mecrocurss eco for use in in st r eme n t, acpears en a tabH af f ed te ncn pmpxaned unit er vitro c %.J! Or faboy * )ry tests not inv%/irg intert M or extembl hpp*C5 in B INfWT Or tocc hure WP tm 'ct.ompania the Mh atitc 2 Dr

lin;it ra tio q Cf hyproduct mhtf nal or the rttwio'i 11 tUetrom, to Tt.~ 4 f doac18/e materW rnau br rece vard,. ecqairrad, pmohr'd, enrj human bv4 93 rer ;mma's Ri4r4 nnly by php51C Jnt, WierinadbN m the brFtica of W W ary

@ $c'enNm 75, in urU15 riot FMcMbeg 10 rnicmturits each for aw rredese, clink:al id>o otones or hepitels end omy 6r art v<tro chracui in in wtro c: ins cr 6bmecry teats not envoMng internal or ene+nd or !abarmory t9sts not mvoNmg Internal nr eAternal admwstrapori of Ddm in dt r4 t ton Of b yprcduc t matend, Or the rssdiaison ThereirDrry thra met ef im GF t hf: rd.at ion lhereitw,10 hu mar # bein'n Dr En,rwis to human btNWJ? Gr animals its fr*npt, xqd'isition, po&ssion. um and f rDnMer ve hbi+Tt to the

17) Mork ladme 1?$ referr na or cahtntos scarces, sn urdts or regAt es ed e p-al oceng of the US Nutw Reco;amry Com mem-by 0 05 miscur:e of inne.129 and 0 005 mk rocune of mi%n or of a Sree with wnich the Csmmese has entwed mio an grnarWrn 241 m.h for w in in.itro reinica! or 4tioratory tests not apement f ar it.e e n erc Ae of r ega.atori, aut b ent y.

irwcM g iratmal or txterr.a' aJmirttrMicn of byproduct ms!eriM, cf the radistmn ineref ram, to bumen beings or anh%Is.

ib) A p*U LM 6MF not 4%, Scuu tre, pois% ose Or trWer bbrnrChh,:01 rtWt' rid! ubder ti rf 1.WrWrd fice%e estat9;@ed tJV porquDb Na n" Gim3 u t M tu dar (a) of this '#Ct;or unMb that p#rKW (1) Ha f Dvd NRC i crrn 433, 7%treion Certif ue Hn Vurs

ei Tb teWnt pmma m usma twoJur 'Ter 6% er4r t he hgg #th 8 v product Mat"rw Unas GeneM Lem we t4 9

• 8; hC N d D3 * #

Dirm or of Nuoear Motew Sa%ty and Saf ewardh US Nucioar the DW:t ar et Nscace fdateru %my eM bfyan wy cn# WT Repatory Commissbt Wantworu D C 20%5, ed reemd t orn in the mf umr be f urrnhed t v tan / nc fW.tranen CetMea -in thw Commen a vaudmed con cf NRC Form 4E3 #tn re gSt vt ion Vhr Twir.y whh Bvvo1ur We MUr&rGemM Lv" W NRC number awnca, or rum 43; Tra r e pn r' sMI be fu narmi MtNn D dm #rr the i

fitt ne 4 Fat a;t v M the wrficW v se of M perMuc+

ef 4c!we d4/ af sur.h chanm p) H,s a rwte:UI that m hsed urder PMt 35 c f this chapter DJ Aay oc cn any byo %ct more a' psrsuant to t he penoa!

U;; A perraq Who receive, gcMrer,, pone 1&s Dr uMs ITp rCxL P bte nS* Cf pespph 18 ) C f thb sectiin n + pernpt f rrirn t he r e% Femnt s TN!Pral puTa&#1t ' O the FOW frC0nk r EtMIdJhPd by or apph tal of c' Pvts to, 20 ard 21 of ths cNm wnh remect to bwoduct this sectj Jn @a4 cWp'y w hh TN foDo.wioy mge. Ma cowred by thM pwrol bcm 6*, **CepI tN! sJth perm y (1) The pnc%! Ikensa shan rot por,sess at ang o% trme, pwsst unnt; the Muck he ? 125 cem uC m pu wrop r' te H 7 j c ' t h n rce e n

• o the generO heense in par taph (a) of this $ffetiCn, itt 6n y orie IOC6 shidl cumpb wh h the pr, vocr5 *:f f 2') 3Q1. 20 4Q2 sM 2DM3 of e

tiGr' Cf $10rdf,* Cr 1,5c, a TMel UmOunt Cf iOdec 12b, lodme 131, th4 c63pt b i

NOTES 1 A Liete to which cetain reaulatory authunty over radioacitwe matenes nas been tramterred by termat rrperher", punuant to sect:On 274 of the Atomic Ertergy' Act of 1954, as arnended 2 Material generally UctesPd under thig wcton prior to January 19,1975 may ber !.htna authoned by the rem;fMiu% in ef bct on January 1,

1975,

~ 3A new trip &, ate set of tNs HeaMration Cenificate, NAC Form 480, may be und to sepsrt any mov of M rmatm f anished by a wcrent as required by [ 31.11(el if lerper ruartthies or other forms of b'rproduc' rnaterief than those spMified in itM Dener a; t, cense of 10 CFB 31 11 ve req. sed, en "AWi;o-tion for Boroduct Matenst Lit e Ne,' NRC Form 313 s%vid be fJed to Dbtain a specific byprorfuct meens ungir Copres of apphoeson W reglstration farms may b6 rsbtainett from the Med. cal, AcademK and Ccmrnerpol Ude %fety Brand (6H3L Dwson of imf astnol and M* diced Nm %r Lafety, Umred Sws Nuclear Reputatory Commissen, Washington, DC 20SES 1