ML20204H105
| ML20204H105 | |
| Person / Time | |
|---|---|
| Issue date: | 03/24/1999 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | George M AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9903290007 | |
| Download: ML20204H105 (2) | |
Text
.
s.
g March 24,1999 Royal Oak Memorial Hospital i
ATTN: M. George, M.D.
5130 Coolidge Highway Royal Oak, MI 48079
Dear Dr. George:
This letter verifies the receipt of the completed NRC Form 483 dated March 15,1999. This form is a condition of the generallicense under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.
The form has been assigned registration number 9161. 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, Traci Kime, Registration Specialist Materials Safety Branch Division of Industrial and.
Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards DISTRIBUTION:
IMNS r/f NEO d DOCUMENT NAME: H:\\traci\\ george.483 Te receive e cop r of this document, Indicate in the box:
'C" = Copy without attachment / enclosure _ "E" = Copy with attachrnent/ enclosure "N" = No copy OFFICE MSB l0 l
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l NAME TKimey /C 1
DATE sis /99 OFFICIAL RECORD COPY.
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NRC FORM 483 U. S. NUCLEAR RE1ULATONY COMh3SION APPROVED BY OMB: NO. 3150-0038 EXPIRES: 6-30-99 (S oo)
Eemaled tmrden per response to comply with this mondetcry information coibnebon request 7 mmutse The vahdated registraton serves as owdence REGISTRATION CERTIFICATE -in vitro TESTING "J"O,,'e'ie%*T,.'"'l*"c'o',**e'%,"'s"%t.'"e.,'*e' '" d ""l'";* %
' WITH BYPRODUCT MATERIAL UNDER C ""' ""** w"*",',**"'E"'"$fs!E ",*d ""*%
Penetwortt Reduction Protect (31504o38). omco er Mona0ement and GENERAL LICENSE Budget, weehsigion, DC 20603. NRc may noi conduct or sponsor, and a person is not requwed to respond to, a colleebon or mrarmaban unless it dies. lows a currently vahd oMB control numter.
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SectOn 31.11 of 10 CFR 31 establishes a general license authortzing physicians. clinical laboratories, hospitals, and vetennarians in the practice of j
vote.inary medicine to possess certain small quantitbs of byproduit ma+erial for in Wrro clinical or laboratory tests not invrMng the intemal or extemal 1
ad ninistration of the byproduct material or the radsation therefrom to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not a;thonzed until the physician, chnicallaboratory, hospital, or veteriorian in the prachce of veterinary medicine, has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with a registration number.
5
- 1. NAME AND ADDRESS OF APPLICANT (Seeinstruc6on 3.B. below)
- 2. APPLICATION 4 Check one box only)
G, y p L r.r #L
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' * ^ ' ' '
I hereby apoly for a registration number pursuant to 10 CFR 31, Section 31.11, for use of byproduct materials for: '
ere,',6.. U w ').
pg A. Myself, a duty licensed physician authorized to disperse drugs in j
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L g t. y r/v,
! !? '/
the p#e of Mne.
<a e,
9 B. The above-named clinicallaboratory.
TREF.40NE NUMBER (inc6deWee Code)
C. The above named hospital.
jMG 9/@ ' UW
D. Veterinarian in the practice of veterinnry medicine.
3.
INSTRUCTIONS:
- 4. REGISTRATION A.
Submit this form in duplict.e to:
REGISTRATION NUMBE.R:
Medical, Academic and Comrnercial Use
- Safety Branch (T-8 FS)
Afd Division of industrial and Medical Nuclear Safety
+jpn neog'o Office of Nuclear Material Safety and Safeguards y
n E TE U,;S wgy gym.-
U S. Nuclear Regulatory Commission o
"g' y"+' 7^ # m
Washington, DC 20555 0001
'E (At NRC, a registration nunder will be assigned and a valideted copy
- O of NRC Form 483 will be rmumed.)
B. In the box above, print or type the name, address (including ZIP Code), and telephone number of the registrant physician, clinical (if this an hi6alregistra6on, leave this ce blank-number to be laboratory, hospital, or veterinarian in the practice of veterinary assigned by NRC. If this is a change ofin/bnnahon kom a previously medicine for whom or for which this regtetrabon form is flied.
registered generalicense, include your registra60n number.)
- 8. If piece of use is different from address Itsted above, ghre complete address:
S. CERTIFICATION I hereby certify that:
A.
All inform 6 tion in this registrahon certificate is true and complete.
B.
The registrant has appropriate radiabon measunng 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 iristnsnents and in the handhng of the I
byproduct materials.;
C.
I understand that Co... "=, regulations require that any change in the information fumished by a registrant on this registration certsficate be j
reported to the Director of Nuclear Matertel Safety and Safeguards within 30 days from the effectiva date of such change.
e i
D I have reed and understand the proviseons of Sechon 31.11 of NRC reguishons 10 CFR 31 (repinted on the reverse side of this form); and i understand that the registrant is required to comply with those provisions as to all byprcduct material which he recorves, acquires, possesses, uses, or transfers under the general license for which this Regsstrabon Certificate is filed with the U.S. Nucieer Regulatory Commission PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE OF APPLICANT,
DATE p, [-?p t (- f, A L G.
h flDh
-yL j
- i WARNING: FALSE STATEMENTS IN THIS CFRTIFICATE MAY BE SUBJECT TO CML AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE THt ~ GUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS.18 U.S.C, SECTION 1001 MAKES fT 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.
N=c ponM de3 te-ee)
REGISTRANT'S COPY t.
p-1 h
.w CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11 y 31,11 Generst Heensy for use o' byproduct materia:s for rertain in seteNum-75, and/or non 59 in e cess of 200 reicrocuries.
vitro cunicat or abcratory testina.
- (2i The generat licensee shad sto<e 'he byproduct matedal, untu used,,in the ody;nal sNpping Wotainst or in a cortain*+r providing (a) A genera # iicenso is hereby issued to any physician, veterbarise equivalent radiation protection.
In the practice of veterinary medicin+, cHnica. laboratory or hospital to (1) The genera! licensen sha!! use the byproduct material only for receive, acquire, posses 1, transfer,or use, for any of tne following statird the uw$ wthorized by paramoph (a) of this section.
I6sts, in accordance with the promions of paragraphs (bh (c),(dh (e),
l4) T he general igenn shall not transbr the byproduct rnateria!
and (f) of this section, the follomng byproduct materda in prepack.
except by transfer to a person authorized to receive it by a Mcense aged Wts:
pursuwn to this chapter or trorr en Agreernent State,I nor transfer the (1) iodine 125, in units not exceeding 10 microcuries each for use bypmduct material in any manner nher than la the unopened, labeled in in vhro cHnical or laborJtofy teste riot involv] rig internal o# 9x ternal shippmQ ContatWr 8s received ITCm the 50pp'ier.
admiMstration of byproduct iT14ter 01, or the radiation therefrom, to (5) The gueral bcensee shah disposa of the Mock fodine 125 human beings or animals _
reference or cutibration sources descdbed in pararaph (aH7) of this (2) todme-131, lit units not exceeding to microcuries each for use section as rtxtuired by } 20301 of this chapter, in in vitro clinka! or lacoratory tests not invoMng internal or external (d) The general beensei! shen not recaive, acaden, possess, or use 6dministra*lon of byproduct material, or the radiation theref rom, byproduct r strsrist pursuant to paragraph (a) of this section-to human benga or animafs.
(1) E xcept as p epackaged units which are labeled in accovdance (3) Carbon-14, in units not ewe
- ding 10 microcuries es:b fcc use with the provisions of a soecific ticense issued under the provisions of (n M vitro chnical or laboratory tests not invoMeg internal or esterna!
@ 32.71 of thn chaptee er in accordance with the provisions of a administration of byproduct material, or the radiation therWom, specific bcenso hsued t y 81 Agreement State that authorizes manuf ac '
to human beings or animMs.
ture and thstribution of iodine.125, iodine-131, carbon-14, hydrogen 3 (4) Hydrogen 3 4 trit!om), in units not exceeding 50 mir,rocuries (tr:ta.m), selenium-75, iron-59 or Mock lodine-125 fcr distribution to e6@ for use in in vitro clinical cr bboratory tests not levoMng internal pesons generahv ik enmd by the Agreement State.
- or euernal administration of byproduct material, os the radiauco
!?) Unless the foi ovnng statement, or a substantially $;milar thersfrom,'o human bWngs or snimals.
statement which contains the informat k n c80ed for in the f 0!iewing (5) Iron 59,in unDs not exceed-rg 20 microcunes each fm usa in in st at ement, apptw on a iatrl ef tived to each prepackyled unit or vitro chnica: or taboratory test s not involving internel or evernal appars in a leaflet or brochure which accompanies the packaged administration of byproduct materiel, or the tre.iiation therefrom, to This radioattive mat erial may be rersiveid, acauired, po sened, and s
human beings or animws.
us-d on y by physicians, veterinariens in the practice of vererinary (6) Sch+nium-75, in units not exceeding 10 microctaies each for use medicine, clinical laborator es or hospha;s and only for m vitro chnical in in vitro cHnical or laDoratory tests not invoiwng interr.d or everral or laboratory tests not involving hternal or external admin'stration of administration of byproduct materia, or the radiation t heref rom, the mamial or the radmion tneefrom, to haman beings or ammels, to human beings or animels.
Its reccipt, acuuisition, pc'ssession, use, and transfer ere subject to the (7) Mock fod.ne-125 refemoce or ca!ibration sources, in uruts rot twAations and a troer# !Kenu of the U.S. Nuclev Heculeory Com-exceeding 0 (Xi mn.rocurh* of iodme 129 and 0 005 microcure of mimon or of a State with which the Commispon h8s enterfd }rno an americium-241 each fer use in M v:tro dinical or heoratory terts not apreement for the exe rbe of regulator, au t hor;t y invofvhg interel or oxternaf administration cf byproduct materW, or the radistron therefrom, to human belt.gs or animals, ib) A person sha4 not /ecew, acquire, possess, u.e or t'anskt byproduct rnateriai under the general ficensa esthbMhed by carayaph Name of manuf ectu'er (a) of this taction unioss that persom (1) Has filed NRC Form 433, "RegisuaCon Certif;cate4n Vitro (c) The recastrant pnumsing or uWng t yproduct materials under tha Testing with Byproduct Mataria! UnHr General LicensC with the ganera. hcense of pararaph 10 of this section sha1
- port m wntmg to Dirsctor o' Nuclear Wiens Safety and. Sa f eguard4, U S. Nxtear tne Onctor of Naear Materal Safe'y and Safeguards any changes Regalatory CommNsion, Waeington, D.C 20555, and rw eived from in thn er.fortna%n furnishN by him in the "H9f tration Cenif dte-in the CommhuJon a vabdet, copy of NRC Form 483 with reg:stratton vivo Tritha whh Byprvjuct Worria! Under Gen
- rat Lmenw,' NRC numbe anigned; or l'orm 433 The moon shel be furnWd witNn 30 days af ter the (2) Has a license thtt autnonzes the medicC use of byprWuct effsetive date of sach charw3 rnaterial that was 15ued unde Part 35 of tNs chamer (f) Any Mrson t.smg byproduct m a wia1 portuant to t he p*'neral ic) A persoq who receives, acoJires, possesses or uns byarcduct b Mse of persgraph (d) of this section is errmpt from tfm re auirements rnaterial pursuant to tne gemoral Ucense estabGshed by paragup4 (a) of of Perts f % 20 and 21 of this chemer w i'h respect to bypmduct this 59ction shalf comp!y with tha ioHowinG-materiWs covered by that general license, *wcept thm such persons
)
(1) The generaf brenwe shaf t not, oness at arv one time, p;rpant using the Mock fodine 12S descr: bed in paragiaph (eH7) of 'his section -
to tM general license in paragraph (a) of tNs section, at eng or a loca sha!! comply with the prodsions o f. { 20.301, 20.402 and 20 403 of t;cn of storspe or use, a total amovt of iodine 125, iodine 131, th.s cha;xer.
1 tsTC$
I A State to which certaict regulatory authority over radianctive materia! has been transferred by formal agreement, pursuant to section 274 of the Atomic Energy Act of 1954, as amended 2 Material generally Ocensed under thh section prior to January 19.1975 may bear labMs authorned by the re#stkms sa *ffect on Januarv 1, 1975.
8 A new triplicate set of th'is Reghtratan Certificate, NRC Form 4SL may be used to report any chanfr of ininrmation fwnisNet by n registri,rit j
ars required by @ 31.11(e)
If larger gaantMes or other fom7s of byproduct materia! then those specified m the general ikense of to CFR 31.11 sre required, an "Applicto tion for Byproduct Materiot Ucense ' NRC Forrn 313 should be foed to ootain a soecif;c byprorNct material ikense. Capins of,pprmation and regMtration forms may be obtained from the Medical, Acadernic and Commenial Use %fety Branch (6H3), Division of intbstric and Medicm Nuclear j
Safety, United Stres N sciear Regulatory Commission, Washington, DC 20505.
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