ML20247H366
| ML20247H366 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Ansara M AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210146 | |
| Download: ML20247H366 (2) | |
Text
- _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _
e,.
- May 17,1998 l
l Mary K. Ansara Health Alliance Laboratory Services Microbiology Department 3200 Bumett Avenue Cincinnati, OH 45229
Dear Ms. Ansara:
This letter verifies the receipt of the completed NRC Form 483 dated February 18,1998. This form is a condition of the general license under 10 CFR 31.11 authorizing in-vitro testing with ,
byproduct material under general license.
l The form has been assigned registration number 9137. When making changes to any of the i 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 i Regulatory Commission, Washington, DC 20555.
If you have any questions or need further assistance, please contact me at (301) 415-8140. ;
Sincerely, 1 N
Traci Kime, Acting Registration Specialist l Materials Safety Branch Division of Industrial and '
Medical Nuclear Safety )
Office of Nuclear Material Safety g and Safeguards DISTRIBUTION:
SBaggett IMNS r/f NEO3 DOCUMENT NAME: P:\ANSARA.483p:\ chambers.483 Ya receive a copu of this document. indicate in the bos: "C" = Copy without ettachment/ enclosure "E" = Copy w,th ettachment/ enclosure *N" = No copy OFFICE MSB , l l' l l l NAME TKime Of WhW DATE spy /98 9'*'
OFFICIAL RECORD COPY 9805210146 980517 PDR RC
- 4 1-SSD PDR
l NRC FORM 483 U. S. NUCLEAR REaULATORY COMMISSION APPROVED BY OMB NO. 3150 0038 EXPIRES: 6-3o-93 Eshmated burden per response to comply with this mandatory information collection request 7 mmutes The vahdated registration serves as endence REGISTRATION CERTIFICATE --In vitro TE6 TING fy,'"Z't ,nie*"aI 7o', *',7"J" ",n** ,"J."";",[ "t, ', f*s',Z'O
",*d """*"
t WITH BYPRODUCT MATERlAL UNDER ^
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R E"""disIR E'm,""ss*,' "'a"s'n',n~,"to,"' to ,
Paperwork Reduction Protect (31500038). office of Management end GENERAL LICENSE s d.et, w.shmoion. oc 20so3 sRc r noi condoci e, sponso,. .nd .
f person ,s not reqwred to respond to. a collection of mformation unless it i esplays a currently valid oMB control number Section 31.11 of 10 CFR 31 establishes a general license authorizing physicians, clinical laboratories, hospitals, and veterinarians in the practice of vderinary medicine to possess certain small quantities of byproduct material for in vitro clinical or laboratory tests not involving 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 ruthorized until the physician, clinical laboratory, hospital, or veterinarian 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 (See Instruedon 3.B. below) 2. APPLICATION (Check one box only)
/f///Q /P AM/48 I hereby apply for a registration number pursuant to 10 CFR 31, Section
//gff/ g j///ff g g g ggfg g g y g 31.11, for use of byproduct materials for:
M' Mode 0406y' */)(+/e ymzwrv 4 4 A. Myself, a duly licensed physician authorized to disperse drugs in d AOC $M&v&- // /b' the practice of medicine.
C/A4/4.w g7f, g /ffg (=/T # A7 .
T B. The above-named clinicallaboratory.
EPHoNE NUMBER pnclude Area Code) m , C. The aoove named hospital.
h, f/J - M f - MN #d~ ~ 3/S 3 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 q' yf r Safety Branch (T-8 FS) ..
[pR R
= Division of Industrial and Medical Nuclear Safety 'o
., WCleur Regilat.ory Com,
,< . Office of Nuclear Material Safety and Safeguards [ , ,
U.S. Nuclear Regulatory Commission 5 ;r {
l Washington, DC 20555-0001
- g (At NRC, a registration number will be assigned and a validated copy
' 0
' * *
- 4p of NRC Form 483 will be returned.)
B. In the box above, print or type the name, address (including ZIP
/Y Stewn L. DUU; t 5/ / @/98 Code), and telephone number of the registrant physician, clinical (if this an ini#alregistrabon, leave this space blank - number to be laboratory, hospital, or veterinanan in the practice of veterinary assigned by NRC. If this is a change ofinformadon from a previously medicine for whom or for which this registration form is filed. registered generalicense, include your registra#on number.)
- 5. If place of use is different from address hsted above, give complete address:
y.
v,
- 6. CERTIFICATION , ;
A. All information in this registrabon 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. I understand that Commission regulations require that any change 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.
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 registrant is required to comply with those provisions as to all byproduct material which he receives, acquires, possesses, uses, or transfers under the general license for which this Registration Certificate is filed with the U.S. Nuc! ear Regulatory Commission.
PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE OF APPLICANT DATE A10/2y' k jfsv'[A U , M7 W$5C N 0 M&A6M '77/u203/0L0SY MM/Winm/T' st4 k,. I&L Y '
WARNING: FALGE STATEMENTS IN THIS CERTIFICAN hlAY 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 FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.
NRc FORM es3 (ELee)
..( e. ..
l \
- * , i L
i l I CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
$ 31.11 General licer'se for use of byproduct mater!als for cert,vn in scieniumJ5, and/or iron 59 in encess of 200 microcuries. i vitro clinical or laboratory testing. (2) The general heensee shall store the byproduct materiaf, until {'
used, in the original shipping container or in a contamer provideng (a) A general ficense is hereby issued to any physician, veterinarian equrvalent radiation protection,
.in the practice of veterinary medicine clinicallaboratory or hospital to (3) The general hcensee shall use the byproduct material only for receive, acquire, possess, transfer,or use,'or any of the foilowing stated the uses auth orized by paragraph (a) of this sectlon. I tests, in accordance with the proylsions of paragrsphs lb), (c),(d), (e), (4) Th, general licensee shall not transfer the byproduct material and (f) of this section, the following byproduct materials in prepack- except by transfer to a person authorized to receeve it by a license j
aged units: .
pursuant to this chapter or from an Agreement State,1 nor transfer th e (1) lodine-125, in units not exceeding 10 microcuries each for use byproduct materlat in any manner other thar* in the unopened, labeled in 6n vitro clinical or laboratory tests not involving internal or externa! shipping container as received from the supplier, ,
administration of byproduct material, or the radlation therefrom. to (5) The general licenses shalf dispose of the Mock fodine-125 I human beings or animals. reference or calibration sources described in paragraph (a)(7) of this l (2) lod,ne-131, in units not exceeding 10 mk:rocuries each for use section as required by 20.301 of this chapter. l
}n in vitro clinical or laboratory tests not involving internal or external (d) The general licensee shdl not receive, acquire, possess, or use
^
l administration of byprod uct material, or the radiation therefrom, byproduct material pursuant to paragraph (a) of this wetson: -
l
' to human beings or anima!: (1) Except as prepackaged units which are labeled in accordance j t (3) Carbon-14, in units not exceeding to microcuries eacn for us e with the provisions of a specific license issued under the provisions of la in vitro clinical or laboratory tests not involving internal or external 3231 of this chopter or in accordance with the provisions of a administration of byproduct rnatorial, or the radiation theref rom,! , specifsc licenze issued by an A2reement State that authorites manuf ac-to human beings or animals. ture and distribution of lodine 125, iodine 131, carbon 14, hydrogen 3 (4) Hydrogwn 3 (tritium), in units not eveaeding 50 microcuries (tritium), selenium-7S, iron 49 or f4ck ladina-125 for distribution to etch for une in in vitro clinical or laboratory tests not involving internal persons generally licensed by the Agrerment State.
or external administration of byproduct matersal, or the radiation (2) Unless the foNowir'g statement, or a substantially similar therefrom, to human beings of animals _ statement which contains the inforrnation called for in the foflowing (5) Iron 59,in units not esceeding 20 microcuries each for use in in statement, appears on a label af fixed to each prepackaged un t or vitro clinical or laboratory tests not involving internal or esternal appers in a leaflet or bror.hure which accompanies the parkage) administration of byproduct material, or the radiation therefrom, to This redinactive material rr;my be received, acquired, possessed, and human beings or ansmais. used omy by physklans, ve*erinarians in the practice of vererinary (6) Selenium 75, in units not exceeding 10 microcuries each for use medicine, clinical laboratories or hospitals and only for in vitro chnical 1 in in vitro clinical or laboratory tests not involving interner or external or laboratory tests not lnvolving internal or external administration of admin!stration of byproduct material, or the radiation therefrom, the material or the radiation therefrom, to human beings or animals. l to human beings or animals, its receipt, acquisition, possession, use, and transfer are subject to the (7) Mock todine 125 reference or caHbration sources, in units not regubtions and a general heense of the U.S Nuclear Regulatory Com- j anceeding 0.05 rnicrocurie of lodine.129 and 0 005 microcurie of mission or of a State with which the Comtnission has entered into an americium 241 each for use in in vitro clinical or laboratory tests not agreement for the exercise of regulatory authorit y.
I invotving internal or external administration of byproduct materiat, or the radiation therefrom, to human beings or animals.
(b) A person shall not receive, acquire, possess, uste or transfer byproduct material under the gereral license established by paragraph Name of manuf acturer (a) of this section unless that person: . l (1) Has filed NRC Form 463, " Registration Certificate-In Vitro (e) The registrant possessinQ or using byproduct materials uncler the Testing with Bypeoduct Material Under General Licer se," with the general heense of paragraph (a) of this section shall report in writirig to Director of Nuclear Material Safety and safeguards, U.S. Nuclear the Director of Nuclear Material Safety and Safeguards any changes Regulatory Commission, Washington, D.C. 20S55, and received from in the information furnisted by him in the Registration Certificate-In the Commission a validated copy of NRC Form 483 with registration Vitro Testing with Byproduct Materiat Under General License," NRC !
number assigned, or Form 433 The report shall be furnished within 30 days after the j (2) Has a license that authorizes the medical use of byproduct effective date of such change.8 insterial that was issued under Part 35 of this chapter. (t) Any person using byproduct material pursuant to the general (c) A person who roccives, acquires, possesses or uses byproduct lecense of paragraph (a) of this section is eFempt from the requirements material 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- materiais covered by that Deneral license, except that such persons (1) The general licensee shall not possess at any one time, pursuant using the Mock lodine 125 describad in paragraph (a)(7) of this section
- to the general license in pa'aDeaph (a) of this section, at any one loca sha!I 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, iodir<a 131, this chapter, l
NOTES i 1
A Stata to which certain regulatory authorfty over radioactive material has been transferred by formal agreement, pursuant to sectson 274 of the
' Atomic Energy Act of 1954, as amended.
2 Material genera!!y bcensed under this section prior to January 19,1975 may bear labels authorized by the regulations 6n effect on January 1, 1975.
3 A new triplicate set of this Registration Certificate, NRC Form 433, may be used to report any change of information furnished by a registrant !
' as required by @ 31.I1(el.
if larder quantities or other forms of byproduct materlat than those specified in the general license of 10 CFR 31.11 are reoulred, an "AppHco-tion for Byproduct Materia! Ucense," NRC Form 313 should be fued to obtain a specific byproduct material heense. Copies of application and -
, registrat' ion forms may be obtained from the Medical, Academic and Commercial Use Safety Branch (6H3), Division of industrial and Medical Nuclear i
- Safety, United States Nuclear Regulatory Commission, Washington, DC 20556.
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