ML20247H539
| ML20247H539 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Brom L External (Affiliation Not Assigned) |
| References | |
| SSD, NUDOCS 9805210189 | |
| Download: ML20247H539 (2) | |
Text
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M:y 17,1998 Lake West Services, Inc.
ATTN: Lynn J. Brom, President 36100 Euclid Avenue, Suite 190 Willoughby, OH 44094
Dear Ms. Brom:
This letter verifies the receipt of the completed NRC Form 483 dated May 2,1998. This form is a condition of the general license under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under generallicense.
The form has been assigned registration number 5082. 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, Acting Registration Specialist Materials Safety Branch Division of Industrial and Medical Nuclear Safety i
Office of Nuclear Material Safety and Safeguards
///
DISTRIBUTION:
NEO3/{
SBaggett IMNS r/f DOCUMENT NAME: P:\\BROM.483 To receive e copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure
'N" = No copy OFFICE MSB l
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A NAME TKima 7//i
/)4<,@p;* v DATE 5//7/98
- W OFFICIAL RECORD COPY "O00 3
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9805210189 990517 PDR RC a
SSD PDR
1 NRC FORM 483 i U. S. NUCLEAR REGULATORY COMMISSION APPROVED Bf OMB: NO.3150-0038 EXPIRES: 6-30-99 (9-98)
Eshmated burden per response to comply with this mandatory mformabon
. fl ( (
collecbon request 7 minutes The validated regestrabon serves as evidence REGISTRATION CERTIFICATE --in vitro TESTING
" '""fu"',f.JrMf7" Zs* ";',7n","b2*e'fnTo"#'
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WITH BYPRODUCT MATERIAL UNDER Es",*C c"',f" sea."n "'"'J***n"' E',"'"Js.*s.E "e, d f%
Paperwork Reducbon Prosset (3150 0038) crrace of Management and GENERAL LICENSE sud.t. w.snm.m. oc 2oso3 wac m., not conduct or sponsor..nd.
person is not eensed to respond to. e coheebon of mformabon unless it displays a currently vahd OMB control number Scction 31.11 of 10 CFR 31 establishes a general license authorizing physicians, clinical laboratories, hospitals, and veterinarians in the practice of veterinary medicine to possess certain small quantities of byproduct material for in vitro clinical or laboratory tests not invoMng the internal orytemal administration cf the byproduct material or the radiation therefrom to human beings or animais Possession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, hospital, or veteriarlan 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 (SeeInstruc#on 3.B. below)
- 2. APPLICATION (Check one box only)
V 6, py*
- I hereby apply for a registration number pursuant to 10 CFR 31, Section 31.11, for use of byproduct materials for:
hpfO O h M(fI(b d\\/fflMC., b l A. Myself, a duty licensed physician authorized to disperse drugs in
' " * " ' " * * * " ' ' " * * * ' " * ~
- u. h b, Oh t 0 llW%
X B. The above-namericlinicallaboratory.
7 TELEPHONE NuMsER (Include Area Codel C. The above named hospital.
( N N )%3-[)N f D. Veterinarian in the practice of vetennary medicine 3,
INSTRUCTIONS:
- 4. REGISTRATION A.
Submit this form in duplicate to:
REGISTRATION NUMBER:
Medcal. Academe and Commercial Use
/ g "Eoog 5082 Safety Branch (T-B F5)
Division of Industrial and Medical Nuclear Safety o,'
Offee of Nuclear Material Safety and Safeguards i@g. PMJCLF2 REGULAT6RY COM!IS U.S. Nuclear Regulatory Commission IC 5
Washington, DC 2055$6001"
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t
[
T (At NRC, a registration number will be assigned and a validated copy o** **
of NRC Form 483 will be retumed.)
B. In the box above, print or type the name, address (including ZIP 9
m L. b 5/ O /98 Code), and telephone number of the registrant physician, clincal 6f this anin/#alregistra60 leave this space blank-number to be laboratory, hospital, or veterinarian in the practice of veterinary assigned by NRC. // this is a change ofin/brma#on from a previously medmine for whom or for which this registration form is filed.
registered general & cense, include your registra#0n number.)
- 8. If place of use is different from address hated above, give complete address:
h(L MO
- 8. CERTIFICATION I hereby certify that:
A.
All information in this registration certifcate is true and complete.
B.
The registrant has appropriate radiahon measuring instruments to carry out it.e tests for which byproduct material will be used under the general license of 10 CFR 31.11. The tests will be performed only by personnel competent in the use of the instruments and in the handling of the byproduct meterials.
C.
I understand that Commission regulations require that any change in the information fumished by a registrant on this registration certificate be i
reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the effective date of such change.
j.
l D I have reed and understand the provisions of Section 31.11 of NRC regulations 10 CFR 31 (reprinted on the reverse side of this form); and I understand that the registrant is required to comply with those provisions as to all byproduct material which he receives, acquires, possesses, uses, or trenefors under the general license for which this Registration Certifcate is filed with the U.S. Nuclear Regulatory Commission.
PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE OF APPLICANT DATE l.,. tu hl 10fhm,
Y kw y.,Z$~-
VM$
WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CML 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 l
FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.
nacronMdas (see)
e 1
CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
$;31,11 General ficense.for me of byproduct materlofs de certain in seieruum-75, and/or iron 69 in exc.ess of 200 microcuries.
(2) The generai licensee shah store the byproduct anoterial, until i vltro clinicol or laboratory testing.
3 used, in the. original shipping containst or. in a container providing,
- (s) A goveral lkense 16 hereby issued to any physicianfveterinerian equivalent radiation potection.
.,in the practice of veterinart u.adicine, clinical laboratory or hospital to (3) The general licensee shall use the byproduct material only for -
the uses aut orlied by paragraph (a) of this sectlon,
' receive, acquire, possess, transfer, of use,
- ir any of the following stated h
i tests.In accordance with the provisions of paregiaphs.(b),'(c),(d),(e),
(4) The general I,icensee 6ha!!_not transfer the byproduct material and (t) of this section, the following byproduct materials in prepack-except by transfer '.o a p9rson authorized to receive it by a license.
pursuant to th/s chapter or from an Agreement State,3 nor transfer the aged units; \\
byproduct material In any rnanner other than in the unopened, labeled (1) lodine 425,in units not exceedmg 10 microcurles each for use
. irt in vitro c!!nical or laboratory tests not involving internal or externei.
' shipping container as recolved from the supplier.
. f administration of byproduct material, or the radiation therefrom, to
. - (5) The general licensee shall dispose of the Mock fodine425 Numan beings or animals; (reference or calibretion sources described in paragraph (a;(7) of this (2) lodine-131, e enits not exceeding 10 microcuries each for use section as requ3 red by @ 20.301 of this chapter.
.l.i irt vitro clinical or Jaboratory tests not involving internal or external (d) The general licennes shaft not receiv.e, acquire, possess, or use
, administration of byproduct materia', or.. the. radiation therefrom, byprodset material pursuant to peragraph (a)' 0f this sectionO (1) Encer as prepackaged unhs whien are laceted in accordance
. to human beings or animals.
.(3)' Carbon-14; In units not exceeding 10 microcuries'esch for use with the provisicos cf a specific license issued under'the provisions of i in in vitro clinical.or. laboratory tests not involving letema! or external N 32,71 of this chapter or in accordance with.the prov4 ions of a
> adtninisthst!nn' of. byproduct rnatoriali or the. radiatlun therefrcinj specific license issued by an Agreament Ste's that authorizes manufac.
to human beings or animals, ture and distribution of lodine-125, iodine #ti, carbon-14, hydrogen.3 (4) Hydrogen,3 (tritium), in units not twesedmg 50.nicroc : ries (tritiumif selenium-75, iron-59 or Mock todhe425 for distribution to Joach iof uns in in vitro clinical or laboratory tssts not Wvolving internet persons generally in:ened by the Agrenment State.
or external administration cl byproduct materisi, or the radiation (2)- Unless that following statement, or a subskabtlatly similar therefrore, to haman beings or animals Jarement which contains the information cahed for in the following
- 15) tron 69,in units not escr>edag 20 microcurses each for use in in statemant, appears on a label affixed to each prepackaged unit or
- r
' vitro clinical or laborstrny tuts not involving internal or external appears in a lufiet or tsrochure which acentnpanies the package;2 l administration of byproduct material, or the radiation therefrom, to This radioactive material may be ret.eived, acquired, possessed, and used only by physicians, veterinarians in the practice of Veterinary
( human beings or animals.
medicine, clinical labsatories or hospitals and only for in vitro cDnical
- (6) Selenium 275, in units not onceeding 10 microcuries each for use
, in in vitro clinical or laboratory tests not involving internal or external or kboratory tests not involving internal or external administration of
' admin (strafiors of byproduct < material, or the radiation. the efrom, the material or the radiation therefrom, to human beings or animals, to human beings or animat% '
its receipt, acquisitiory postession, use, and transfer are subject to the i
{7) Mock loc %e425 reference or calibration sources, in unets not
- regulations ad a general license of the U.S. N,uclear Regulatory Com-exceed 6ng 0.05 mi-rocurie of lodme429. 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 testa not agreement for the exercise of regulatory authority.
Invofwing Internal or enternal administr%: ion of byr;rorhict materiatior, the radiatiori therefrom, to human beings or animals?
(b) A person shall. not receive, acpuire, possess, use of hansfer byproduct material under the general ficense established by paragraph Name of ma.sufacturer
"(s)~of this section unless that person:
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(1) Has filed NRC Form 483, " Registration Certificate-in Vitro
' (e) The registrant ' possessing or using bypmduct materials under the
- Testing with Byp oduct Material Under Generat U*ense/' with the,
general license of paragraph (a) of this section shall report in writing to
. Director of. Nuclear Materlaf Safety and. Safeguards. U.S. Nuclear
, the Director of Nuclear Material Safety and Safeguards any changes
% Rigulatory Commission, Washington, D.C. 20D55, and received from in the information furnished by him in the Registration Certificate-in
! the Comm}ssion a validated copy of NRC Form 483'with registration '
Vitro Testing with Byproduct Material Under General Licentaf' NRC number assigned; or Form 483 The ' report shall be furnishad within 30 days after the
$ _ (2) Has a license that. authorlies the medical use of byproduct
' ef fective date of such change.8
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meterial that was issued under Part 35 of this chapter.
license of paragraph (a) of this section is ewempt from the requirements
, f) Any person using byproduct material pursuant to the general
(
'(c) A person who receives, acquires, possesses or uses byproduct material pursuant to the general license established by paragraph (a) of of Parts 19, 20 and 21 of this chapter with respect to byproduct '
f this section shall comply with the following:
materials covered by that general license, except that such persons
- 11) The general licenses shall not possess at any one time, pursuant using the Mock lodine 125 described in peregraph (a)(7) of this section to the general license in paragraph (a) of this section,'at any one loca-
. sha!l comply with,the provisions of $ 20.301,20.402 and 20.403 of
! tion of storage or use, e total amount of lodine 125, iodine 131, this cheter.
t NOTES
. j < 3 A State to which cerftin regulatory authority over radioactive material has been transferred by formal agreement, pursuant to sectson 274 of the
. ? Atomic Energy Act of 1954,as amended.
3
- Materla1 genera 4y, licensed under this section prior to January 1975.
19,1975 may bear labels authorized by the regulations in eifect on January 1,
~8~ A new trioticate set of this Registration ' Certificate, NRC Form 483, may be used to' report'any change of lnformattor) furnishe l by a registrant as required tiy $ 31.11(el
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4;; if larger quantities or other forms of byproduct materlat than those specified in the general ficense of 10 CFR 31,11 are required, an **Applice.
[ tion for Byproduct Materia: Ucense/' NRC Form 313 should be fl!ed to.obtain a specific byproduct materiallicense. Copies of application and
( iagishation forms may be obioined from the Medical,' Academic and Commercial Use Safety Branch (6H3), D! vision of Industrial and Medical Nuclear
- Safety; United States Nuclear Regulatory Commission, Washington, DC 205$5.
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