ML20198F414
| ML20198F414 | |
| Person / Time | |
|---|---|
| Issue date: | 12/23/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Langhorst S MISSOURI, UNIV. OF, COLUMBIA, MO |
| References | |
| SSD, NUDOCS 9812280114 | |
| Download: ML20198F414 (3) | |
Text
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l December 23,1998 l
The' Curators of the University of Missouri
- ATTN
- Dr. Susan M. Langhorst.
.. Radiation Safety Officer Environmental Health and Safety
' Columbia,' MO 65211-3050
Dear Dr. Langhorst:
P This letter verifies the receipt of the completed NRC Form 483 dated December 15,1998.~ This form is a condition of the general license under 10 CFR 31.11 authorizing in-vitro testing with l~
byproduct material under general license.
L The. form has been assigned registration number 9151. 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.
f, Sincerely, 3
Traci Kime, Registration Assistant Materials Safety Branch' Division of industrial and Medical Nuclear Safety 1
Office of Nuclear Material Safety i
and Safeguards rl-l DISTRIBUTION:
CRaddatz IMNS r/f NEO3 h l.
' DOCUMENT NAME: h:\\traci\\langhorst.483
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' Ta receive a copy of this document, indicate in the boa: "C" = Copy without attachment! enclosure
- E' = Copy with attachment / enclosure "N" = No copy OFFICE.
MSB.
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NAME TKimee Jg DATE 12/23/98 '
OFFICIAL RECORD COPY I
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95tC FORM 483.
U. 8, NUCLEAR REOut.ATORY COMMISSION i ArenovEnLvossut asneo.oese p.
EXPtREs 3-91 M i
ESTIMATED BURDEN PER RESPONSi TO COMPLY WITH TH6s INFORMATION COLLECTION REQUEST: rhaNUTES. THE VAUDATED
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REGISTRATION CERTIFICATE -In vitro TESTING "s3s" o", LPRO
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RWTP NT S s
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WITH BYPRODUCT MATERIAL UNDER REs" rec'fod' u'Rn"EN E'rE To"LFlO^%
GENERAL LICENSE -
AND RECORDS MANAGEMENT mRANCH $dNBB 7714). U S. NUCLEAR REoutAToRy commission. wAoNo.oroN. oC uswooi. ANo To n
THE PAPERWORK REOUCTION PROJECT (31500026), OFFICE OF MANAGEMENT AND BUDGET WASHING IIN, DC 2o603.
I 1
Section 31.11 of 10 CFR 31 estat$shes a general tones authertzing physicians, clinical laboratories l hospitals, and vetminertens in the pract6c i
veterinary medicine to possess certain smaE quantibes of byproduct malerial for h WWro clinical or laboratory tests nct invohrig the irdemal or extemet administreihei at the byproduct material or the radiation therefrom to human beings or animais. Possession of byproduct materief under 10 CFR 31.'
authorteed unts the physician, chnical laboratory, hospital, or veterlarian in the practice of veterinary medicine, has filed NRC Forri 483 and received from t s
Commlesion a vandsled copy of NRC Form 483 with a registrabon number l
i
- 1. NAME Ape ADDRESS OF APPLICANT (See fnetrucson 3.B. befow)
- 2. APPLICATION (Checkcre bowonly)
I hereby apply for a registration number purwant to 10 CFR 31, Section cfhe Curators of the unLversity of. Missouri 31.11, hr use of byproduct materials for; 4
h1 111 Jesse Hal1
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.Coluetla. O.65211 A. Myself, a duly licensed physician authottred to disperse dru0s in the practice of medicine.
4 B. The above-named clinicallaboratory.
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TELEPHONE NUMaER (hchfe Ame Cafe)
C. The above named hospital.
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(57M 882-7221 D. Veterinerien in the practice of veterinary medcine f
- 3. DISTRUCTIONS:
- 4. REG 4STRAT10N A. Submit this form in duplicate to:
REGISTRATION NUMBER:
4 -
Medcel, Academic and Comnercial Use Safety Branch (6 H3)
REa 91 %
DMeien ofindustrial and Sofety
- k 1
omos of Nuclear Material Safety and Safeguards 3
U.S. Nucieer Regulatory Commineion o U.3. Nuc.lc3r Regula ry Washington, DC 20555 0001 3
j ir ion (At NRC, a regstration number wiu be assigned and a vauduled copy
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( L t-
!l /Ik cf NRC Form 483 we be retumed.).
/
. A
. B. ' in the box above,' print or type the name, address (including ZIP
- W I
CI 1.n DCN ~ v ranch Code), and telephone number of the registrant phyeecian, cenicas (Fihis an hiest sopistration, leave this space fube laboratory, hospital, or veterinerten in the procuce of veterinary asagned by NRC. # this is a change c/hibimsfon kom a previously modoine for whom or for which this registrabon form is fled, regleforod general Aconse, inchtdo your regisinseon number)
- 6. If place of use is different from address hated above, give complete address Fertfilty Laboratories 5211 S. Prod dare RnM. (*.nliimhin, 61 0 48570 %
- 6. CERTFICATION I hereby certWy that-A.
AE information in this registration certificate la true and complete B.
The repletrant hee appropnete radiation meneuring instrumente to carry out the tests for which tgproduct material wid be used under the generat heenee of 10 CFR 31.11. The tests wel be performed only by personnel competent in the use of the instrurrents and in the hand ling of the byproduct materials 1
C.
I understand that Commiselon regulations require that any change in the information fumished by a registrant on tnis reg strabon certificate be reported to the Director of Nuclear Mateeial Safety and Safeguards within 30 days from the effective date of such cl1ange.
1D. I have read and understand the provisions of Section 31.11 of NRC regulebons 10 CFR 31 (reprinted on the. reverse side of this form); and I understand that the registrant is required to comply wth those provisions as to au byproduct material which he receives, acquires, possesses, uses, i
or trar.efers under the generallicense for which this Regletrabon Certincele is fHed with the U.S. Nuclear Regulatory Commineion PRINTED OR TYPED NAME AND TITLE OF APPUCANT SIGNATURE OF APPUCANT DATE Susan M. Langhorst, Ph.0,. OIP h/
[j T?/1 w3 I
RMistinn Safer y Of fin.r
-M bE WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL 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.
REGISTRANT'S COPY
-..I
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3 CONDITIONS AND LIGAITATIONS OF GENERAL LICENSE 10 CFR 31.11 Q 31.11 General license for use of byproduct matorises for certain in selenium-75, and/or iron Se in==== of 200 microcuries.
(2) The general incenses shall wtore the R ' a materimf, until vitro clinical or laboratory testing.
used, in the original shipping container or in a contaner presiding (a) A general license is hereby issued to any physicien,veterinarien equivalent radiation protectiosi.
In the practice of veterinary medicine, clinical laboratory or hospital to (3) The general licenses shall use ths byproduct murerial only for
' receive, acquire, possess, transfer, or use, for any of the following stated the uses authertrod by paragraph lo) of this section.
tests, in accordance with the provisions of peregraphs (b), (c),(d), le),
(4) The general licensee shall not transfer the byproduct materief and (f) of this section, the following byproduct materials in prepack-eacept by transfer to a person authorized to recewe it by a license aged units:
pursuant to this chapter or from an A -
- Suite,8 nor transfer the (1) ledine-125, in units not exceeding 10 microcuries each for use byproduct material in any manner other then in the unopened,8=M-8 in in vitro clinical or laboratory tests not involving internal or external shippeng container as received from the suppleer.
tdministration of byproduct meterial, or the radiation therefrom, to (5) The general licenses shall dispose of the Mock fodene-125
' human beings or animals.
referena or caibration sources descr#>ed in paragraph b)(7) of this (2) todine 131, in units not exceeding to microcuries each for um section as required by { 20.301 of this chapter.
In in vitro clinical or laboratory tests not involving internal or external (d) The genomi licensee shall not receive, acquire, poosses, or use administrs*lon of byproduct material, or the radiation therefrom, byproduct meterial pursuant to paragraph (a) of this section:
to human beings or animals.
(1) Except as prepackaged units which are labeled in accornance
' (3) Carbon 14, in units not exceeding 10 microcuries each for use with the provisions of a specific license issued under the provisions 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 s
. tdministration of byproduct material, or the radiation therefrom, specific license issued by an Agreement State that authorizes manufac-
- ta human beings or animals.
ture and distribution of iodine-125, iodine-131, carbon-14, hydrogen,3 (4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (tritium), solenium-75, iron 69 or Mock lodine-125 for distribution to each for use in in vitro clinical or laboratory tests not involving internal persons generally licensed by the Agreement State.
or external administration of byproduct material, or the radiation (2) Unless the following statement, or a substantisily similar l
therefrom, to human beings or animals.
statement which contains the information called for in the following (5) Iron 59,in units not exceeding 20 microcuries each for use in in statemect, appears on a label affiaed to auch propeckaged unit or vitro clinical or laboratory tests not involving Internal or externet appears in a leaflet or brochure which accompanies the package:2 l
. administration of byproduct material, or the radiation therefrom, to This radeoective material may be recewed, acquired, possessed, and human beings or animals, used only by physicians, voterineriens M the practice of wterinary (6) Selenium-75, in units not exceeding 10 microcuries each for use medicine, clinical laboratories or hospitals and only for in vitro clinical in in vitro clinical or laboratory tests not involving internal or externel or laboratory tests not inwohring internal or externel administration of administration of byproduct material, or the radiation therefrom, the material or the radiation therefrom, to human beings or anemels.
to human beings or animals.
Its receipt, acquisition, possesmon, use, and transfer are esabject to the (7) Mock lodine-125 reference or calibration sources, in units not regulations and a general licesse of she U.S. Nuclear Regulatory Com-Exceeding 0.05 microcurie of lodine 129 and 0.005 microcurie of mission or of a State with which the Commission has entered into an amIricium-241 each for use in in vitro clinical or laboratory tests not agreement for the exercise of regulatory authority, l
Involving internal or external adminletration of byproduct material, or the radiation theretrotn, to human beings or animals.
(b) A person shall not receive, acquire, possess, use or transfer
' byproduct material under the general license established by paragraph Nome of manufacturer (a) of this section unless that person:
(1) Has filed NRC Form 483, " Registration Certificate-In Vitto (e) The registrant possenssag or using byproduct n aterials under the Ttsting with Byproduct Material Under General License," with the general license of peregraph (a) of this section shell report in writing to Director of Nuclear Material Safety and Safeguards, U.S. Nucieer the Director of Nuclear Meterini Safety and Safeguards any changes Regulatory Commission, Washington, D.C. 20555, and received from in the information furnished by him in the " Registration Certificate-In tha Commission a validated copy of NRC Form 483 with registration Vitro Testing with Byproduct Meterial Under General License /' NRC number assigned;or Form 483. The report shall be furnished within 30 da s after the s
(2) Has a license that authorizes the medical use of byproduct effective date of such change.3
- material that was issued under Part 35 of this chapter.
(f) Any person using byproduct ansterial pursuant to the general (c) A person who rer:eives, acquires, possesses or uses byproduct license of paragraph (a) of this section is exempt from the requirements materlat pursuant to the general license established by paragraph (a) of of Parts 19, 20 and 21 of this chapter with respect to byproduct this section shall comply with the following:
meterisis covered by that generai license, except that such persons i
(1) The generet licensee shall not possess at any one time, pursuant using the Mock podine-125 desertmed in paragraph (a)(7) of this section to the general license in paragraph (a) of this section, at any oneloce-shall comply with the provassons of E 20.301,20.402 and 20.403 of tion of storage or use, a total amount of iodine 125, lodine 131, this chapter.
I NOTES 3 A State to which certain regulatory authority over tedioactive meterial has been transferred by formal agreement, pursuant to section 274 of the
. Atomic Energy Act of 1954, as amended.
2 Material generally licensed under this section prior to January 19,1975 may bear labets authorized by the regulations in effect on January 1, 1975.
3 A new triplicate set of this Registration Curtificate, NRC Form 483, may be used to report any change of information furnished by a registrant as required by @ 31.11(e),
if larger quantitles or other forms of byproduct material than those specified in the general license of 10 CFR 31.11 are required, an Applica-
[
tion for Byproduct Material License," NRC Form 313 sfiould be filed to obtain a specific 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 a9d Medical Nuclear Safety, United States Nuclear Regulatory Commission, Washington, DC 20555
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