ML20247H583
| ML20247H583 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Christopher Jackson AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210203 | |
| Download: ML20247H583 (4) | |
Text
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May 17,1998 Smith-Glynn-Callaway Medical Building ATTN: Catherine K. Jackson 3231 South National Avenue
. Springfield, MO 65807-7396
Dear Ms. Jackson:
This letter verifies the receipt of the completed NRC Form 483 dated February 24,1998. 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 0024. 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, d
T;aci Kime, Acting Registration Specialist Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards f/
l DISTRIBUTION:
l SBaggett IMNS r/f NEO3-l l
l DOCUMENT NAME: P;UACKSON.483 l
T1 receive e copu of this document, indicate in the box: "C" = Copy w,thout atta hment/ enclosure "E" = Copy with attachment / enclosure
'N" = No copy l
OFFICE MSB l
l l
NAME TKimefj/t__,
soy #
DATE 5////98' f///vp3r OFFICIAL RECORD COPY moon 9805210203 980517 l
ai.4 NRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION APPMoVED EY OMS: No.MSo403e N
EXPtREs s.8148 qs,
. l4 M Y O 7 'i i, ~~'d
- GSTa4MED BURDEN PER JREePoNsE TO COMPLY WrrH THIS I
S INFoRMATioN CG.LECTioN REQUEST: 7 MaNUTES. THE VAUDATED 3
REGISTRATION CERTIFICATE-in vitro TESTING ~
"fj'"^" o"P.vil0 ^'t i!u^ER "U'n'e* EoEs'TOS s
TN WITH BYPRODUCT MATERIAL UNDER' E"EcrsEE'"No "" o'e"N""O'TE"^OLo'R"*'oN s
o n
AND RECORDS M GENERAL LICENSE ReoutuoRY coANAoEMblT BRANCH (MNB8 7714). U.S. NUC uiss.oN. WAss,NoroN. oc 2osr.saxn. ANo To THE PAPERWORK' REDUCrioN PROJECT ~($15o.co2e). OFFICE OF 5
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MANAoEMENT ANo BuDoET, WASHINGTON. DC -
Section 31.11 of 10 CFR 31 satabNshes a 'geheral Scense authorizing 'physicialis,'cEnical laboratories, hospitals [an' vetenna'riansMthepract6ce of d
veterinary rnedicine to possess certain hman quantities of byproduct rnaterial for b Muro chnical or laboratory tes(s not ' involving the interna! or extemal administration of the byproduct material of the radiation therefrom to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, hospital, or veteriorian in the practice of veterinary medicine, has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with a registration number,
- 1. NAME AND ADDRESS OF APPLICANT (Seeinsfrucson 3.B. bedow)
- 2. APPLICATION (Check one box only)
I hereby apply for a regetrabon number pursuant to 10 CFR 31, Sectxin Smith-Glynn-Callaway Medical Building 31.11, for use of byproduct materials for St. John's Phyaicians & Clinics A. Myself, a duly licensed physician authortzed to desperse drugs in 3231 South Nat$onal> Avenue v
' the praebee'af maeshe J
3 2
Springfield, Missouri 65807-7396 x
B. The above-named ennicallaboratory.
TELEPHONE NUMBER (hclude Aree Code)
C. The above named hospital
[y/ b QM - O 37 T D. Veterinarian in the practice of veterinary medicine 3.
INSTRUCTIONS:
- 4. REGISTRATION A. Submit this form in duplicate to:
REGISTRATION NUMBER:
Medical, Academic and Commercial Use M dd2I
/g REC
'o$
Safety Branch (6 H3)
- DMsion of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commisoson
'n S U. b.. Nuclear Regu]atory Washington, DC 205554001 5
ij Comicsion (At NRC, a registration number wiu be assagned and a validated copy of NRC Form 483 win be retumed.)
)'
4
/
)
O B. In the box abJve, print or type the name, address (including ZIP SteVon L. i,p,gett
$/ /& /98 Code), and telephone number of the registrant physician, clinical Of Ws an irsi6a/ regisba#on, have Ws space blank - number to be s
laboratory, hospital, or veterinarian in the procuee of veterir.ary assisped by NRC. //Ws is a change ofinforma6on frorn a preMiously medicine for whom or for which this registration form is flied.
regpstered general #conse, hedude yourregisfra6on number.)
- 6. If place of use is different from address lated above, grve complete address:
- 8. CERTIFICATION l hereby certify that:
~ A.
Al information in this registrahon certificate is true and complete m
B.
The registrant has appropriate radiation measuring instruments to cany out the tests for which byproduct rnaterial will be used under the general license of 10 CFR 31.11. The tests wlH be performed only by personnel competent in the use of the instruments and in the handhng of the byproduct materials.
C.
I understand that Commission regulations require that any change in the information fumished by a registrant on this registration certificate be j
reported to the Director of Nuclear Matenal Safety and Safeguards within 30 days from the effective date of such change.
1 i
D 1 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 rogstrant is required to comply with those provtssons as to aH byproduct material which he receives, acquires, possesses, uses, or transfers under the general license for which this Registrabon Certificate is filed with the U.S. Nuclear Regulatory Cwe Li.
l PRINTED OR TYPED NAME AND TITLE OF APNLICANT SIGNATURE OF APPLICANT DATE Catherine K. Jackson. Laboratory Manaver u
/C M[
2/24/98 WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO civil AND/OR CRIMINAL l
PENALTIES.
NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO' THE NRC BE COMPLETE AND I
I ACCURATE IN ALL MATERIAL RESPECTS. - 18 U.S.C. SECTION 1001 MAKES IT A CRIMINAL OFFENSE TO 1
MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.
fote FORM 4e3 (3-93)
a COesDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
$ 31.11 General license for use of L _
meterials for certain in -
selenium-75,and/or iron 59 in excess of 200 microcuries, vitro clinical or laboratory testing.
(2) The general licensee shall store the byproduct materiM, until used, in the original shipping container or in a container providing (a) A general license is hereby issued to any physician, veterinarlen equivalent radiation protection.
l in the practius of veterinary medicine, clinical laboratory or hospital to (3) The general licenses shall use the byproduct meterial only for receive, acquire, possess, transfer,or use, for any of the following stated the uses authertzed by paragraph (a) of this section.
tests, in accordance with the provisions of paragraphs (b), (c),(d), (e),
(4) The general licensee shall not transfer the byproduct material and (f) of this section, the follomeing byproduct materials in prepack.
except by transfer to a person authorized to receive it by a license
. aged units:
pursuant to this chapter or from an Agreement State,1 nor transfer the (1) lodine-125, in units not e=ra=8ing 10 microcuries each for use byproduct material in any manner other than in the unopened, labeled in in vitro clinical or laboratory tests not involving internal or external shipping containst as received frorn the supplier, administration of byproduct material, or the radiation therefrom,, to (5) The general licensee shalf dispose of the Mock lodine 125 human beings or animals.
reference or c#bretion sources described in paragraph (a)(7) of this (2) lodine 131, in units not exceeding to microcuries each for use section as required by $ 20.301 of this chapter.
< in in vitro clinical or laboratory tests not involving internal or external (d) The general licensee shall not receive, acquire, possess, or use administration of byproduct material, or the radiation therefrom, byproduct material pursuant to paragraph (a) of this section:
(
ts human beings or animals.
(1) Except as prepackaged units which are labeled in accordance (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 of external 32.71 of this chapter 'or in accordance with the provisions of a administration of byproduct material, or the radiation therefrom, specific license issued by an Agreement State that authorizes manufar.-
. to human beings or anirnals.
ture and distribution of lodine.125, iodine-131, carbon 14, hydrogen-3 (4) Hydrogen 3 (tritium), in t. nits not exceeding 50 microcuries (tritium), selenium-75, iron 49 or Mock todine-125 for distribution to
- each for use in in vitro clinical or laborotory tests not involving internal,
persons genemlly licensed by the Agreement State.
or external administration of byproduct material, or the radiation (2) Unless the following statement, or a substantially similar therefrom, to human beings or animals, statement which contains the information called for in the following (5) fron 59,in units not exceeding 20 microcuries each for use in in statement, appears on a label affixed to each prepackaged unit or vitro clinical or laboratory tests not involving internal or external appears in a leaflet or brochure which accompanies the package:2 administration of byproduct material, or the radiation therefrom, to This radioactive material may be received, acquired, possessed, and
' human beings or animals.
used only by physicians, veterinarians in the practice of veterinary (6) Seienlum-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 external or laboratory tests not involving internal or external sominirtration of adrninistration of byproduct material, or the radiation therefrom, the material or the radiation therefrom, to human beings or animals, to human beings or animals, its receipt, acquisition, possession, use, and transfer are subject to the (7) Mock fodine-125 reference or calibration sources,in units not regulations and a general license of the U.S. Nuclear Regulatory Com-Exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of mission or of a State with which the Commission has entered into an americium-241 each for use in in vitro clinical or laboratory tests not agr eement for the exercise of regulatory authority.
. Involving Intemat or external administration of byproduct meterial, or
' the radiation therefrom, 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 Name of manufacturer i (a) cf this section unless that person:
(1) Has filed NRC Form 483," Registration Certificate-in Vitro (e) The registrant possessing or using byproduct materials under the Testing with Byproduct Motorial Under General License," with the general license of paragraph (a) of this section shall report in writing to Director of fJuclear Material Safety and Safeguards, U.S. Nuclear the Director of Nuclear Material Safety and Safeguards any changes Regulatory Commission, Washingten, D C. 20555, and received from in the information furnished by him in the Registration Certificate-in
< the Commission a validated 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 osys after the (2) Hos a license that authorizes the medical use of byproduct effective date of such change.3 (f) Any person using byproduct material pursuant to the general meterial that was issued under Part 35 of this chapter.
license of paragraph (a) of this section is exempt from the requirements (c) A person who receives, acquires, possesses or uses byproduct material pursuarrt to the general license estabilshed by paragraph (a) of of Parts 19, 20 and 21 of this chapter with respect to byproduct th'a section shall comply with the following:
materials covered by that general license, except that such persons (1) The general licensee shall not possess at any one time, pursuant
. using the Mock fodine 125 described in paragraph (a)(7) of this section i
. to the general license in paragraph (a) of this section, at any one loca-shall comply with the provisions of 20.301,20.402 and 20.403 of I
tion of storage or use, a total amount of iodine 125, iodine 131,
. this chapter.
NOTES 8 A State to which certain regulatory authority over radioactive material 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 labels authorized by the regulations 'in effect on January 1, 1975.
3A new triplicato set of this Registration Certificate, NRC Form 483, may be used to report any change of information furnished by a registrant as required y $ 31.11(e),
if larger quantities or other forms of byproduct material than those specified in the general license of 10 CFR 31.11 are required, an "Applica-l tion for Byproduct Meteriel License /* NRC Form 313 should be filed to obtain a specific byproduct material license. Copies of application and j
reg 6stration forms may be obtained imm the Medical, Academic and Commercial Use Safety firanch (6H3), Division of industrial and Medical Nuclear
. Safet(, United States Nuclear Reguletory Commission, Washington, DC 20555.
e P1IYSICIANS & CLLNICS Smith-Glynn-Callaway Medical Building To Whom It May Concern:
Please send us an updated copy of our NRC license The directorship of this laboratory has changed to Catherine K. Jackson and our name has changed. It is now Smith-Glynn-Callaway Medical Building, St. John's Physicians & Clinics. The copy we currently have was faxed to us and is not legible.
You may fax the updated license to us at 417-885-0864. Your prompt assistance will be appreciated.
Thank you, wV Catherine K. Jackson, Lab atory Manager Smith-Glynn-Callaway Medical Building St. John's Physicians & Clinics l
3231 South National Avenue
- Springfield, Missouri 65807-7396
- 417-883-7422 A um,+r of use swm ups.,n aars spinst u,uu n
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