ML20248F374
| ML20248F374 | |
| Person / Time | |
|---|---|
| Issue date: | 06/02/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Billings AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9806040219 | |
| Download: ML20248F374 (3) | |
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. Junn 2,1908 Sheridan Medical Laboratory 850 Val Vista Sheridan, WY -82801
Dear Mr. Billings:
This letter verifies the receipt of the completed NRC Form 483 dated May 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.
- The form has been assigned registration number 8653. When making changes to any of the l
information on the form, please reference the registration number and address the
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correspondence to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
l-l If you have any questions or need further assistance, please contact me at (301) 415-8140.
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' Sincerely, k/
Traci Kime, Acting Registration Specialist Materials Safety Branch Division of Industrial and-Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards DISTRIBUTION-SBaggett IMNS r/f LNE03d DOCUMENT NAME::
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NRC Form 483 U.S. NUCLEAR REGULATORY COZIS$ ION Approved by OMB (1241) 3150-0035 10 CFR 31 REGISTRATION CERTIFICATE-IN VITRO TESTING 13187 WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE i
l Section 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 involving the internal or external 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 authorized until the physician, clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine, has filed NRC Form 483 and received from the j
Commission a validated copy of NRC Form 483 with registration number.
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I r-4 SHERIDAN MEDICAL LABORATORY '
' ' hereby apply for a registration number pursuant' to (31.11,10 CRF 31 for urie of byproduct materials for j
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The above-named hospital.
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Veterinarian in the practice of veterinary medicine.
- 4. To be completed by the Nuclear Regulator) Commission.
- 1. Submit this formin triplicate to:
Regletration number: E-Office of Nuclear Material Safety and Safeguards ATTN: Material Licensing Branch
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U.S. Nuclear Regulatory Commission
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- 2. Please print or type the name and address
'(including r.ip code) of the registrant physician, U.S.
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clinical laboratory, hospital, or veterinarian in the g,o lan b u' M obei practice of veterinary medicine for whom or for (If th Ah m
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C s NRC, a registration number will be assisned and a a
validated copy of NRC Form 483 will be returned.)
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- 5. If place of use is different from address in Item I, please give complete address:
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- 6. Certification:
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3 hereby certifyth,at:
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- b... The registrant has appropriate radiation measuring instruments to caiy ou't he tests thr'whlhi byp'rodudm'aterhifwlllMsE1 u'rE1$ t e t
generallicense of 10 CRF 31.11. The tests will be performed only by personnel competent in the use of the instruments and in the handhng of l
the byproduct materials.
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I understand that Commission regulations require that any change in the information furnished by a registrant ' n this registration certificate o
l be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the of fective date of such change.
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I have read and unilehnd the provisions of Sec'tlon 31.11 of NItC regulations 10 CFR 31 (reprinted on the" reverse side of this form); and I ugmunderstand. that the, registraat is pguired to comply with those provialons as to all byproduct material whl:h he receives, ' acquires, possesses,
%gw. #e trar'afers under.the generallicen. se /or which this llegistration Certificate is filed. with theNpcionrAssulatory Commisalon.g,,:
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,n8 ie WARNING-IB U.S.C Section 1001; Act of June 23,1948; 62 Stat,749; makes it a criminal offense to seks aptiufully (alse statement or representation to any department or agency of the United States as to any matter within its jurisdiction.
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CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
[31.11 Generallicense for use of byproduct materials license estabbshed by paragraph (a) of this section (d) The general licenwe shall not receive, acquire, for ce-tain in vitro chnical or laboratory testmg.
until he has filed NRC f orm 483, "Registranon Cer-possess, or use byproduct material pursuan! to itficate-in \\ itro Testing with Byproduct Material paragraph ta) of this section:
(s) A general beense is hereby issced to any physi-Under Geacral License." with the Director of Nudear II) Cacept as prepe.ckaged units which are labeled cian, veterinarian m the prawce of vetermary Material Safety and Safepards, U S.
N uclear m accordance wrh the provisions of a specific license medicine, chnical laboratory or hopital to receive, Regulatory Commusion, Washington, D.C. 20535, issued under the provisnns of $32.71 of this chapter acquire, possess, transfer, or use, for any of the and received from the Commission a ahdated copy or in accordante with the provisions of a specific following stated tests, in accordance with the provi-of NRC forn 483 with registration number assigned license issued by an Agreement State that authorues sions of paragraphs (b), (c), (d), ie), and (f) of this or until he has been authorized pursuant to $35.14(c) manufacture and distribution of iodme 125, iodme-section, the following byproduct materials in of this chapter to use byproduct rnaterial under the 131, carbon-14, hydrogen-3 (tritium), selenium 75, prepackaged units:
general license in this 531.11. The registrant shall fur.
iron 59 or Mock lodine 125 for distribution to per-(1) lodine 125, ir uni's not exceeding 10 nish on N RC Form 483 the follom mg information and sons generally heensed by the Agreement State, microcuries each for use in in vitro clinical or such other information as may be required by that (2) Unless the following statement, or a substan-Laboratory tests not involving internal or esternal ad-form:
tially similar statement which contains the informa-ministration of byproduct material, or the radiation (1) Name and address of the registrant; tion called for in the following strtement, appears on therefrom, to human beings or animal;,.
(2) Thelocationof u.e; and a label affixed to each prepackaged unit or appears in (2) todine-131, in units not exceeding 10 (3) A statement that the registrant has appropnate a leaflet or brochure which accompanies the package:s microcuries each for use in in vitro clinical or radiation measurirg instruments to carry out in vitro This radioactive material may be received, ac-taboratory tests not involving internal or external ad-clinical or laboratory tests with byproduct materials quired, possessed, and used only by physicians, ministration of byproduct material, or the radiation as authorized under the general li ense in paragraph. veterinarians in the, practice of veterinary medicine, c
therefrom, to human beings or animals.
(a) of this section, and that such tests will be per- ' clinical laboratories or hospitals *anl only for in vitro (3) Carbon 14, in units not exceeding 10 formed only by personnel competent in the use of I clinical 6r~ labgratory tests not involvirig internal or I etternal administ fW ilonjaidreirom,i,rgilog p)(the enaterial or the radia microcuries each for aise in in vitro clinical or < such instruments and in the handimg of the by:woduct 3D, bOOl$n beings or animals its (c) A person who receives, acquires, possesse{s'or' receipt','acquisillon, possession, use, a mater'als. '
laboratory tests not involving internal or external ad-ministration of byproduct material, or the radiation therefrom, to human beings or animals.
uses byproduct snaterial pursuant to the general subject to the regulations and a general heense of the (4) Hydrogen 3 (tritium), in units not exceeding 50 hcense established by paragraph (a) of this section U.S. Nuclear Regulatory Commission or of a State microcuries each for use in in vitro chmcas or shallcomply with the following:
with which the Commisraon has entered into an agree-tboratory tests not involving internal or external ad-(!) The general hcensee shall not possess at any one ment for the exercise of regulatory authority, ministration of byproduct material, or the radiation time, pursuant to the general beense in paragraph (a) therefrom, to human beings or animals.
of this section, at any one locauon of storage or use, a (5) tron 59, in units not exceeding 20 microcuries total arrount of iodme 125, lodine 131, selenium 75, Nameof manufacturer and/or iron 59 in excess Jf 200 microcuries.
each for use in in vitro clinical or laboratory testa not involving internal or external administration of (2) The general licensee shall store the byproduct (c) The registrant possessing or usir:s byproduct t>yproduct material, or the radiat ao therefrom, to material, until used, in the crismal airpmg container materials under the general beense of paragraph (a) of human beings or animals.
or in a contaher providing equivalent radiation pro-this section the!! report in writing to the Director of tection.
Nuclear Material Safety and Safeguards any changes (6) Scienium-73, in units not exceeding 10 (3) The general licensee shall use the byproduct 11 the information furnished by him in the Registra-microcuries each for use in in vitro clinical or material nly f r the uses authorized by paragraph (a) tion Certificate-in Vitro Testing with Byproduct laboratory tests not involving internal or external ad-h s section.
Material Under eneral h," NRC Form 43.
ministration of byproduct material, or the radiation (4) The general licensee shall not transfer the The report shall be furnished within 30 days af ter the therefrom, to human beings or animals.
byproduct material except by transfer to a person effective date of such change.8,
^"I E' sources, in uni not c ing 0 005 icr o chapter or from an Agreement State,' nor transfer the to the generallicense of paragraph (a) of this section is lodine-129 and 0.005 microcurie of americium-241 byproduct material in any manner other than la the exempt from the requirements of Parts 19,20 and 21 each for use in in vitro clinical or laboratory tests not unopened, labeled shipping container as received of this chapter with recpect to byproduct materials covered by that generallicense, eacept that such per-involving internal or external administration of from the supplier..
byproduct matedal; or the radiation therefrom, to (51 The general licensee shall dispose of the Mock sons using the Mock lodine-125 described in human beings or animalt.
lodine-123 reierence or calibration sources decribed paragraph (a)(7) of this section shaR comply with the (b) No person sha!! receive, acquire. possets use or in paragraph (a)(7) of this section as required by provisic.as of $20.301, 20.402 and 20se03 of this transfer byproduct material pursuant to the general 820.301 of this chapter.
chapter.
NOTES I A State to which ortain 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 Inay bear labels authorized by the regulations in effect on January 1, 1975.
8 A new triplicate set of this Reg!stratiem Certificate, NRC Form 483, may be used to report any change of information furnished by a registrant as required by 931.11(c).
If larger quantitles or other forms of byproduct material than those spe%. 6d in the generallicense of 10 CFR 31.11 are requires, an **Applica-tion for Byproduct Material License," NRC Forms 3131,313M, or 313R should be filed to obtain a specific byproduct materiallicense. Copies of application and registration forms may be obtained ft m the United States Nudear Regu: story Commission, Washington,D.C. 20555, Attention:
Msterial Lloensing Branch, Division of Fuel Cycle era Material Safety.
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PRIVACY ACT S1 ATEMENT Pursuant to 5 U.S.C. 522a(c)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the following statement is fur-mished to individuals who supply information to the Nuclear Regulatory Commission on NRC Form 483. This information is maintahwd in a system of records designated as NRC 3 and described at 40 Federal Register 45334 (October 1,1975).
I, AUTHORITY, Sections 81 and 16)(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C.2111 and 2201(b)).
2.' - PRINCIPAL PURPOSE (S) The triormation is evaluated by the NRC staff pursuant to criteria set forth in 10 CFR Parts' 30-36 to determine whether the application conforms to the requirements of the Atomic Energy Act of 1954, as amended, and the regulations of the NRC, for the.
4 issuance of a registration certificate authorizing the use of in vitro testing.
- 3. - ROUTINE USES ' The'm y.g - s..information iney be used: (a) to provide records to State health departments for thNr Information a y\\s n
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provide information to Federal, State, and local health officials and other g ersons in the event of incident er exposure for purposes of their in-formation, investigation, and protection of the public health and safety. The information rnay also be disclosed to appropriate Fadcral, State, or local agencies in the event the information indicates a violation or potential violation of law a.id in the course of an administrative or judicial l
l proceeding, in adattion, this information may be transferred to an appropriate Federal, State, or ' local agency to the extent relevant and necessary Ior an NRC decision or to an appropriate Federal agency to the extent relevant end necessary for that agency's decision about you,1 1
4 WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFII!CF ON INDIVIDUAL OF NOT PROVIDING INFORMA.
- TION ", or amendment thereof, will not be processed.It is voluntary that you furnish the requested information. If the request c
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SYSTEM MANAGER (S) AND ADDRESS" Director, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission Washington, D.C. 20555.
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