ML20198P216
| ML20198P216 | |
| Person / Time | |
|---|---|
| Issue date: | 01/05/1999 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Gordon R AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9901070007 | |
| Download: ML20198P216 (2) | |
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' January 5,1999 1 I
i Robert J. Gordon, D.O. 965 S. Main Street Plymouth, MI 48170
Dear Dr. C,
ordon: This letter verifies the receipt of the completed NRC Form 483 dated December 28,1998. This form is a condition of the generallicense under 10 CFR 31.11 authorizing in-vitro testing with-byproduct material under general license. i The form has been assigned registration number 8432. 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 Regu!atory Commission, Washington, DC 20555. l I If you have any questions or need further assistance, piease contact me at (301) 415-8140. Sincerely, 1 l
/s/ j Traci Kime, Registration Specialist q Materials Safety Branch .
Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l l DISTRIBUTION: ! l IMNS r/f NEO3 w l DOCUMENT NAME: i Ta receive a copy of this document, indicate in the box: 'C" = Copy without attachment /ent.iosure 'E" = Copy with attachment / enclosure "N" = No copy l OFFICE MSB l l NAME TKime DATE 1/5/_9_9 i OFFICIAL RECORD COPY l 1 l 9901070007 PDR RC 990105 l
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i .. r NRC FORM 483y s U. S. NUCLEAR REGULATORY COMMISSION APPROVED B7 OMB; NO. 3150 0038 EXPIRES: 6-30-99 . Esamated burden per response to comply with this mandatory mformaton collection ,equest 7 mmutes. The vahdated registrabon serves as evidence
. REGISTRATION ' CERTIFICATE - in vitro TESTING * *"$*,
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1WITH BYPRODUCT MATERIAL UNDER C *"'m,"I.'f' "/"'h,n ,"i ,n**"'*I"*"EldR".*d "*7: , GENERAL LICENSE Pape4 work Reduchon Pro #ect (3150-o035). 08hce of Management and -{ sud oi. washm. ion. oc 2osos nac m., n,4 co, duct ., .ponso,. .nd . t i person is not fequired to respond 10. a collection of information unless R l displays a currently vahd OMB sontrol number.
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Section 31.11 of 10 CFR 31 establishes a general license autho,izirg physicians, cHuical laboratories,' hospitals, and v3terinarians in the practice of l-veterinary medicine to possess certain sman quantities of byproduct material for in Wtro chnical or laboratory tests not invoMng the intemal 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 authorized until the physician, clinical laboratory, hospital, or veterioden in the practice of veterinary medicine, has filed NRC Form 483 and received fnen the 3 Commission a validated copy of NRC Form 483 with a registration number. -
- 1. NAME AND ADDRESS OF APPLICANT (See Instruc6on 3.8. below) 2. APPLICATION - (Check one box orgy) 1>
I hereby apply for a registration number pursuant to 10 CFR 31, Section
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sui, f- e byproduct materiais fon ~ ~ Robert J. Gordon. D.O. l 965 3.. Main Street . A. Myself, a duly licensed physician authorized to dsperse drugs in . ~'l Hr - w ?lymouthr HIr 48h70x e. - g4 +y- ,
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\' B. The above-named clinical laboratory.
TREPHONE NuMeER (incWe Ame Code) C. The above named hospital. l D Ve%rinarian in the practice of veterinary medicine.
- 3. . INSTRUCTIONS: 4. REGISTRATION A. Submit this form in duplicate to:
REGISTRATION NUMBER: j Medical, Academic and Commercial Use fM32 Safety Branch (T-8 FS) { DMeion of Industrial and Medical Nuclear Safety . k* "%q#o 1 , Office of Nuclear Material Safety and Safeguards # t . For tne U.S. Fuctear Regula tory COniaission ,
. U.S. Nuclewr Regulatory Commission j p
. . Washmgton, DC 20555-0001
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g,L - x $ (At NRC, a registration number will be assigned and a validated copy ! of NRC Form 483 wiH be retumed ) **** ^ g Steven L. Ta[gett 2 &d # j
. 8. ' In the box above. print or type the name, address (including ZIP (( .
Code), and telephone number of the registrant physician, clinical (l/this aninidalregistra6on, leave this space, an - er to be laboratory, hospital, or veterinarian in the practice of veterinary assigned by NRC. // this is a change ofintbrma6on from a preWously medicine for whom or for which this regicration form is filed. Te9istered generalIcense, include your registra60n number.)
- 5. If place of use is different from address listed above, give complete address:
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- 6. CERTIFICATION I I hereby certify that: ,
l A.' AI information in this registration certificate is true and complete. l
' B. The regietrant has appropriate radiation measuring instruments to carry out the tests for which byproduct material win be used under the general license of 10 CFR 31.11. The testa v.ill be performed only by personnel competent in the use cf 'he instruments and in the handling of the
. byproduct i.iatettals. ,
. ;'. CJ 'l understand that Commission regulations require that any ct.ange in the information fumished 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.
k ( D I have read and understand the provisions of Section 31.11 of NRC regulations 10 CFR 31 (reprinted on the reverse side oNhis form); an understand that the registrant is required to comply with those provisions as to en byproduct material which he receives, acquires, possesses, uses, ] [ or transfers under the general license for which tr.is Registration Certificate is filed with the U.S. Nuclear Regulatory Commission. ,) PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE OF APPLICANT DATE n,.m t ' % dnn rn . I %d b l
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l L WARNING: FALSE STATEMcNTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL AND/OR CRIMINAL 1 l 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 SIATES AS TO 4 . ~ ANYMATTER WITHIN ITS JURISDICTION? V e i Nncr.onMme p.sei , a
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' CONDITIONS AND LIMITATIONS OF GENERAL LICENSE'10 CFR 31.11
@ 31.11 General lkense for use of byproduct rnatoriets for certain in selenium 75, and/or iron 59 to encess of 200 microcuries.
yitro clinical N aboratory i testing, (2) The general I;oenses shall store the byproduct material, until usod, in the original shipping container or in a container providing (a) A general license is hereby issued to any physician, veterinarian equivalent radiation pro'ection. Lin the practice of veterinary medicine, clinical laboratory or hospital to (3) The Deneral licensee shs0 use the byproduct materiel only for
; receive, acquire, possess, transfer, or use, for any of the following stated the uses authorlied by paragraph (e) of this section, tests, in accordance with the provisions of paragraphs (b), (c), (d), (e), . (4) T he general licensee shall "ot transfer. the byproduct material and (f) of this section, the fo!!owing byproduct materials in prep 9cb except by transfer to a person authorized to receive it by a license
'i eged units: . . . .
pursuant to this chapter or from an Agreement State,Lnor. transfer the
.{t) . lodir e 125,.in units net exceeding 10 microcut es l each for use - byproduct material in any manner other than in the unopencu, sabeled in in vitro clinical or laboratory tests not involving internal or external dapping contMner as received from the suppiler,
.cfministration of byproduct material, or the radiation therefrom, to . (5) The general licensse shall dispose of the Mock todine-125 -
human beings or enimals, . . reference or calibration suurces described in paragraph (a)(7) of this (2) lodine 131, in units not exceeding 10 microcurtes each for use section as required by 20.301 of this chapter. in in 'vitro clinical or laborator'y tests not involving Internal or external (d) The general leanee shall not receive, acquire, possess, or use
- cdministration of byproduct material, or the' radiation therefrom, byproduct material purwant to paragraph ta) of this section; to human beings or animals. *
(1) Except as prepackaged units which are labeled in accordance
- 13) Carbon 14, in units not exceeding 10 microcuries each for use with the provisions of a specific licensa issued under the provissons 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 tdministration of byproduct rnaterial, or the rad ation therefrom, specific license issued by en Agreement State that authorizes manufac-to human beings or animals. ture and distribution of lodine 125, iodine.131, carbon 14, hydrogen-3
- (4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (tritium), seienium-75, iron 69 or Mock fodine 125 for distribution to each for use in in vitro clinical or laboratory tests not involving internal persons genera'ly licensed by the Agreement State, or external administration of byproduct material., or the radiatlon (2) Unhss the following statement, or a substantially similar therefrom, to hurre beings or animals. statement which contains the informat!On called for in the following (5) fron 59,in units not exceeding 20 microcurees each for use in in statement, appears on a labet affixed to er,ch prepackaged unit or vitro clinical or laboratory tests not involving intemal or external appears in a leaflet or bro (hure which accompanies the packagd (dministration .uf byproduct material, or the radiarien therefrom, to This radioactive material may be received, acquired, possessed, an#4 human beings or animals. used only by physicians, veterinarians in the practice of veterinary . 16) Selenium.75, in units not exceeding 10 rnicrocuries each for use medicine, cfi%si laboratories or hospitals and only for in vitro clinical in in vitro clinical or laboratory tests not invniving internal or external or laboratory testa not involving internal or external administration of 4 cdministration of byproduct materGI, or the radiation therefrom, the material or the radiation therefrom, to human being or ernmals.
tc human beings or animats, les receipt, acquisition, possassion, use, and transfer are subject to the (7) Mock lodine 125 reference or'esilbration seurces, in units no' u 'ations and a generei ticense of the U.S. Nuclear Regulatory Com-exceeding 0.05 microcurie of lodine 129 and 0.005 microcune of w ,2n or of a State with which the Commission has entered into an smericium-241 aach fw use in in vitro clinical or laboratory tests not
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agreement for the exercise of regulatory authority, invotving Internal or external administration of byptr, duct m% rial, or
. the radiation therefrom, to human beings or animals.
(b) A person shall not receive, acoulre, possess, use or transfer byproduct material under the general license established by paragraph Name of manufacturer (1) of thinoction unless that person: (1) Has flied NRC Form 483, " Registration Certificate-In Vitro ' (e) The registrart possessing or using byproduct materials under the Tcsting with Byproduct Matenal Under General License, with the general license of paragraph (a) of this section shall report in writing to Director of Nuclear Materla! Safety and Safeguards, U.S. Nuclear the Derector of. Nuclear MateriM Safety end Safeguards any changes Regdetory Commission, Washington, D.C 20555, and received from in the idormation furnished by him in the " Registration Certificate-in the Commission a niidated 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 tho (2) Has a license that authortres the medical use of byproduct effective date of such change) material that.was 16:ued under Pan 35 of this chapter. (f) Any penon using byproduct material pursuant to the general
' M A person'who receives, acquires, possesses'or 'uses byproduct license of paragraph (a) of this section is exempt from the requirements p (wterial pur. uant to the general license established by paragraph (a) of of Parts 19, 20 and 21 of t'nis chapter with respect to byproduct
' f his section shvi ccmply with the follow!ng: materials covered by that Deneral license, except that such persons (1) The geneet licenseo shalt not possess at any one time, pursuar;t using the Mock lodine 125 described in paragraph (a)(7) of this section lo the general !!cerde in paragraph (a) of this section, at any one locaJ shall comply with the provisions of @ 20.301,20.402 and 20 403 of lion cf storege or use, n .otal amount of lodine 125, iodine 131, this chapt er.
NOTES , 1 A State to which certain reNatory authority over radioactive metenal has been transferred by formal agreement, pursuant to section 274 of the Atomic Energy Act of 1954, as amended. 3 Material generaYy licensed under this section prior to January 19,1975 rnay bar labels authorized by the regulations in effect on January 1, 1975,' _ 3A' riew trfpilcate set of this Registration Certificate, NRC Form 483, may be u' sed to report any change of information furnished by a regist' rant as required by @ 31,11(e), if larger quantities or ottier forms of byproduct materief than those specified in the general hcense of 10 CFR 31,11 are required, an "Applice-
. tlov> for Byproduct. Material Ucense/ NRC Form 313 should be filed to obtain. a specific byproduct material license. Copies of appketion and rgistration /orms (nay be obtained fenm the Medical Academic and Commercial Usa Safety Branch (GH3), Division of indus* rial and Medical Nuclear Safety, Urdted States educler Regulatory Commission, Washington, DC 20555, a f}}