ML20196A300
| ML20196A300 | |
| Person / Time | |
|---|---|
| Issue date: | 11/25/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Horwitz T AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9811270109 | |
| Download: ML20196A300 (3) | |
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November 25,1998 MidState Medical Center ATTN: Theodore Horwitz, CEO 435 Lewis Avenue Meridan, CT 06451 Dec.-
I. Horowitz:
This letter verifies the receipt of the completed NRC Form 483 dated August 13,19bJ, in which we did not receive until November 24,1998. This form is a condition of the general license unaer 10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.
The form has been assigned registration number 9152. 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
Traci Kime, Secretary j
Materials Safety Branch Division of Industrial and i
Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards DISTRIBUTION:
SBaggett IMNS r/f NEO3dC.
DOCUMENT NAME: h:\\traci\\horowitz.483 Ta receive a copy of tt's document, indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N* = No copy I! OFFICE MSB l
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UAME TKime @
DATE 11/24/98 j
OFFICIAL RECORD COPY l
i 9811270109 981125 PDR RC SSD PDR I
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I NiC FORM 4e3 U.S. NUCLEAR REGULATORY COMMISSION APPRovEo oMa; No.sisoccas 9y, EXPlRES: 22943 ESTIMATED euRoEN PER RESPONSE To COMPLY WITH THl3 REGISTR ATION CERTIFICATE-in vitro TESTING ele"E**ao*EIERTr"N IsSYEE ETAl?"*In"8Eo"J
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WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE Eu"#Et TE#c"Els'"N."Esd"~a"oNI'ohnEt
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Section 31.11 of 10 CFR 31 establishes a general license authorizing physicians, clinical laboratories, hospitals, and veterinarians in the practice of veterinary
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medicine to possess certain small quantitles of byproduct material for in vitro clinical or laboratory tests not involving the internal or extemal administration i
cf the byproduct material or the radiation therefrom to human beings or animals. Posse',sion of byproduct material under 10 CFR 31.11 is not authorized i
until the phys %n, clinical laboratory, hospital, or veterinarian in the practice of veterir ary medicine, has filed NRC Form 483 and received from the Com-mission i validated copy of NRC Form 483 with a registra ton number, i
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1 NAME AND ADDRESS: (SEE ITEM l.A.) '
- 2. APPLICATION
,'HIDSTATE MEDICAL CENTER 1 hereby apply for a registration number pursuant to 10 CFR 31, j
' O 5 LEWIS INENUE Section 31.11, for use of byproduct materials for:
- "'# " 'd MERIDEN, CT 06451 A. Myself, a duly licensed physician authorized to dispense drugs in the practice of medicine.
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B. The above-named clinicallaboratory.
X C. The above-named hospital.
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TELEPHONE NUMBER: (203) 694-826O o+
D. Veterinarian in the practice of veterinary medicine.
- 1. INSTRUCTIONS:
_I.A. In the address box above, print or type the name and
- 3. REGISTR ATION address (including ZIP Code) of the registrant physician
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clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine for whom or for REGISTRATION NUMBER:
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'which this registration form is filed.
4152
.B. Submit this form and the two yellow copies to:
c,#" "'49 Medical, Academic and Commercial Use W M M. NUCLE!@ RrcirLA-Safety Bram.h16H3)
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Division of Industrial cnd Medical Nuclear Safety k
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Office of Nuclear Materiai 'Mety and Safeguards M
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i U.S.' Nuclear Regulatory Commission '
Washington, DC 20555 k
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. (At NRC, a registration number will be assigned and a I # j [<9 validated copy of NRC Form 483 will be reto ed.)
VAllDATED FOR THE i
U.S. NUCLEAR RE"3ULATORY COMMISSION '
C. Retain the Registrant's Copy (white copy)
DATE for your files.
(If this is an initial registration, leave this space blank - number to be l
assignedby NRC. If this/s a change ofinformation from a previously 1
registeredgenerallicense,includa yourregistration number.)
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- 4. If place of use is different from address listed above, give complete address:
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- 5. CE RTIFICATION I hrreby certify that:
A. ~All information in this registration certificate is true and complete.
B. ' The registrant has appropriate radiation measuring 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 instruments and in the handling of the byproduct materials.
C.C 1, understand that Commission regulations' require that any change in the information furr' bed by a registrant on this registration g certificate be reported sto the) Office of, Nuclear Material Safety and. Safeguards witpirt,d days. from the effective date of such r
D."fihange.l'have read and understand the provisions of Section 31.11 of NRC regulatiens 10 CFR m printed o form); and I understand that the registrant is required to comply with those provisions as to ah - ' roduct material which he receives, acquires, possesses, uses, or transfers under the general license for which this Registration Certi1 ste is filed with the U.S. Nuclear
', Regulatory Commission.
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. o PRINTED.OR TYPED NfE AND TITLE OF APPLICANT l SIGNAT fff APPLICANT jDATE NI
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August 13, 1998 piefoeor. n$tz
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FALSE STATEMENTS IN THIS CERTIFICATE MAY BE hiJi[ JECT TO CIVIL ANf/dR CRIMIN[ PENALTIES. NRC R CARNING:
' REQUIRE THAT SUBM8SSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS.18 U.S.C. SECTION 1001 MAKES Ei 7T 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[URISDiCTION. j c-NRC form da3 (e-91)
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- - CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11-a,
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selenium-75, and/or iron 59 in excess of 200 microcuries.
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' @ 31 ti General mense'for use of byproduct snatorials for certain in (2) The general licensee shall store the byproduct material, tutil vitr3 clinical, or laborotory testi,ng.7 Nsed,' in the original shipping container or in a c%iner providing '.
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[(a) A general license is hereby lasued to any' physician,veterinarien -
equivalent radiation protection.
. (3) The general licensee sh% ase the byproduct material only for-
? In the practice of voterinary medicine, clinical liboratory or hospital to the uses authortred by paragraph (a) of this section.
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[ receive, acquire, possess, transfer, or use, for any of the following stated (4) The generst licensee shall not transfer the byproduct material
, tests,in accordance with the.prowlslons of paragraphs (b),(c),(d),(e)J i'
0 and (f) of this section, the following byproduct materials in prepack-except by transfer to a person authorized to receive it by a license pursuant to this chapter or from en Agreement State,3 nor transfer the
" aged units:;
- (1) lodie125,' in ' units not exceeuing 10 microcuries each for use byproduct material in any manner other than in the unopened, labeled
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In in vitro clinical or laboratory tests not involving internal or external.
shipping container as received from the suppfler.; 4
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(5) The general licensee shall dispose of the Mock Jodine-125 administration cf byproduct mmterial, or the radiation therefrom, to reference or calibration sources described in paragraph'(a)(7),of this l1 m human beines or animaiso 1
(2) lodine-131, in units not exceeding 10 microcuries each for use :
section as required by @ 20.301 of this chapter.
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~ in 'in" vitro clinical or laboratory tests not involving internal or external (d) The general licenses shall not receive, acquire, possess, or use M
cdministration of byproduct matertal, or:the radiation therefrom, byproduct material pursuant to paragraph (a) of this section:
5 to human beings or animals.
(1) Except as prepackaged units which are labeled in accordance l
. (3) Carbon 44/in units not exceeding 10 microcuries each for use; with the provisions of, a specific license issued under the provinic ns of
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@ 32.71 of this chapter or in accordance with the provlslons of a
. In.in vitro clinical or laboratory tests not involving internal,or external ' specific license issued by an Agreement St. ate that' author administration of byproduct material,o or the radiation therefrom, ture and distribution of lodine-125, iodine-131, carbon 14, hydrogtn.3 Eto human beings'or animals.
(4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (tritium), selenium:75, iron-59 or. Mock todine-125 for distribution o persons generally licensed by the Agreement State.
each for use in in vitro clinical or laboratory tests not involving internal i
cr external' administration of byproduct material, or the radiation (2) Unless ' the following statemeni, or. a substantially similar statement which contains the information called for in the following therefrom, to human beings or animals..
d (5) f ron 59,in units not exceeding 20 microcuries each for use in in statement, appears on a label affixed to each prepackaged unit or i
vitro clinical or laboratory tests not involving internal or external appears in a leaflet or brochure which accompanies the packaged This radioactive material may be received, acquired, possessed, and
- administration of byproduct material, or the radiation therefrom, to
'$7 human beings or animals.
used only by physicians, veterinarians in tile practice of veterinary
. (6) Selenium 75, in units not exceeding 10 microcuries each for use medicine, clinbal laboratories or hospitals and only for in vitro clinicel
' In In vitro ' clinical or laboratory tests not involving internal or external or laboraterv tests not involving internal or external administration of g.;
4 administration of byproduct rverial, or the radiation therefrom, the material or the radiation therefrom, to human beings or animals.
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Its receipt, acqu!sition, possession, use, and transfer are subject to the
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L M human beings or animals.
") Mock lodine-125 reference or calibration sources,in units not regulations and a generaf license of the U.S. Nuclear Regulatory Com-exceed!ng 0.05 microcurie of lodine-129 and 0.005 microcurie of mission or of a State with which the Commission Sas entered into en s
f-americium-241 each for use in in vitro clinical or laboratory tests not agreement for the exercise of regulatory authority, involving internal or external administration of byproduct material, or t
~ " rbs ndiain therefrom,'to human beings or animals.
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'(b) A' person shall not' receive, acquire,~ possess, use or transfer Name of manufacturer byproduct material under the general license established by paragraph
.r L i' -- (a) of this section unless that person:
(1) Has filed NRC Form 483, "Registrau.n Catificate-in Vitro (e) The registrant possessing or using byproduct mateilats under the f
I. J Testing with Byproduct Material Under General License /* with the general license of paragraph (a) of this section shall report in writing to i
Director of Nuclear Material Safety and Safeguards, U.S. Nucles' the Director of Nuclear Material Safety and Safeguards any changes s
Reguktory Commission, Washington, D.C. 20555, and received from in the information furn!shed by him in the " Registration Certificate-in i
^ the Commission a ' validated copy of NRC Form 483 with registration -
Vitro Testing with Byproduct Material Under General License /',NRC p
number assigned;or _.
Form 483..The report shall be furnished within 30 days after the
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(2) Has a license that authorizes the medical use of byproduct ef fective dste of such change.3
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material that was issued under Part 35 of this chapter.
(f) Any person using byproduct material pursuant to the general I
'(c) A person who receives, acquires, possesses or uses byproduct license of paragraph (a) of this section is exempt from the requirements
}j cmeterial pursuant to the general license established by paragraph (a) of of Parts 19,22 and 21 of this chapter with respect to byproduct materials covered by that general license, except that such persons
.l q thle section shall comply with the following:
(1) The general licenses shall not possess at sny one time, pursuant using the Mock lodine-125 described in paragraph (a)(7) of this section t.
to the general license in paragraph (a) of this section at any one loca-shafl comply with the provisions of @ 20.301,20A02 and 20.403 of fa tion of storage or use, e total amount of. lodine 125, lodine 131,4 this chapter.
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. NOTES
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5 8 A State to which certain regulatory authority over radioactive material has been transferred by formal agreement, pursuarM to section 274 of the g'
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. Atomic Energy Act of 1954, as amended, p
IMaterial generally licensed under this section prior to January,19.1975 may bear labels authorized by the regulations in effect on January 1' i*
'N 1975c
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- A new triplicate se[of this R691st' ration Certificate, NRC FErrrih, may be used to report any change of information hurnished by a registrant h
qas required by @ 31.11(e).
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. If larger quantitles or other forms of byproduct material than thosekpecifled in the general license of 10 CFR 31.11 art required, an"Applicas
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I tion for Byproduct Material Ucense," NRC Form 313 should be filed \\o obtain a specific byproduct material license. Copies of application and g
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. registration, forms may be obtained from the Medical, Academic and 0.,mnprcial tJse Safety Branch (6H3) D. vision of Industrial and Medical Nuclear
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Safety, United States Nuclear Regulatory Commission, Washington, DC 2025.
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