ML20216H189
| ML20216H189 | |
| Person / Time | |
|---|---|
| Issue date: | 09/30/1999 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Behenna D External (Affiliation Not Assigned) |
| References | |
| SSD, NUDOCS 9910010315 | |
| Download: ML20216H189 (2) | |
Text
Sept;mber 30,1999 I
Quest Diagnostics j
~ ATTN:^
Donald B. Behenna ;
Radiation Safety Officer 400 Egypt Road Norristown, PA 19403
Dear Mr. Behenna:
1 This letter verifies the receipt of the completed NRC Form 483 dated September 30,1999. This form is a condition of the generallicense under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.
The form has been assigned registration number 2219. When making changes to any of the l information on the form, please reference the registration number and address the l 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, N
Traci Kime, Registration Specialist .
Materials Safety and inspection Branch
' Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety' >
and Safeguards DISTRIBUTION: ,
IMNS r/f NE03d.'
DOCUMENT NAME: H:\TRACl\Behenna.483 Ta receive a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE MSIB l l l l NAME TKime , f(
DATE 9/30/99 OFFICIAL RECORD COPY
\
9910010315 990930 PDR STPRG ESGPA PDR 1 ,
NRC FORM 483 . U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 31504038 EXPIRES: 6 30-99 (o ree)
Eshmated burden per response to comply with the mandatory mtormaton collecten request 7 mmutes The vahdated registrebon serves as evidence REGISTRATION CERTIFICATE --In vitro TESTING ",'"""",
.y rod c ',,2"'"",,,""*7,"non'* "L'?rl "u'F'l's*rn"a'*;' ;*e WITH BYPRODUCT MATERIAL UNDER O*,," T' ","l"l ""."s'h n," ion'" *"' """*"ll,sIE. ".*d."'t
Paperwork Redueban Prored (31500038), Omco of Management and GENE L LICENSE Budget. Washington, DC 205o3 NRC may not conduct or sponsor. and a l person is not required to respond to. e collechon of informabon unless it !
duplays a currently vahd oMB control number Section 31.11 of 10 CFR 31 establishes a general license authonzing physicians, clinical laboratories, hospitals, and veterinarians in the practice of ,
veterinary medicine to possess certain small quantities of byproduct material for in vltro clinical or laboratory tests not invoMng the intemal or extemal l administration of the byproduct material or the radiahon therefiom to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinicallaboratory, hospital, or veteriarian 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 ADORESS OF APPLICANT (SeeinstrucDon 3.B. below) 2. APPLICATION (Check one box only)
, I hereby apply for a registration number pursuant to 10 CFR 31, Section Q@St D.iQ'nOS t ICD """ 31.11, for use of byproduct materials for:
400 Egypt Rond A. Myself, a duly licensed physician authorized to disperse drugs in l Norriotown, PA l'%C3 the practee of medicine. l
)( B. The above-named clinicallaboratory.
l TELEPHONE NUMBER (Anclude Aree Code) C. The above named hospital.
D Veterinarian in the practce of vetennery medicine
- 3. INSTRUCTIONS: 4. REGISTRATION A. Submit this form in dupicate to:
REGISTRATION NUMBER:
Medcal, Academic and Commercial Use Safety Branch (T-8 FS)
Division of Industrial and Medical Nuclear Safety Offee of Nuclear Material Safety and Safeguards y'
[# 8 8 4 u4 o
n U S. Nuclear Regulatory Commission g g Washington, DC 20SS5 0001
- e (At NRC, a registration number wiH be assigned and a validated copy t of NRC Form 483 will be retumed.)
- +0 .
B. In the box above, pnnt or type the name, address (including ZIP DOC 1 0 ^t b
' p ce Ir- t l
Code), and telephone number of the registrant physician, clinical (if this an inloalregistradon, Jeave this space blank - number to be laboratory, hospital, or veterinarian in the practice of veterinary assigned by NRC. If this is a change ofinIbrmahon from a previously medcine for whom or for which this registration form is filed. registered generalicense, incdude your regrstrabon number.)
- 5. If place of use is different from address listed above, give complete address: I e
f
- 8. CERTIFICATION I hereby certify that:
A. AH information in this registrabon certifcate is true and complete.
, 4 B. The registrant has appropriate radiation rnessuring instruments to carry out the tests for which byproduct matenal 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 matenals.
C. I understand that Co ,md iur, regulations require that any change in the information fumished by a regratrant on this registration certifcate be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the effective date of such change D l have read and understand the provisions of Sechon 31.11 of NRC regulations 10 CFR 31 (repnnted on the reverse side of this form); and I understand that the registrant is required to compty with the s e provisions as to all byprodud material which he receives, acquires, =mm, uses, or transfers under the general license for which this Registration Certiflcate is filed with the U.S. Nuclear Regulatory Commission.
PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE OF APPLICANT DATE K 4 7 8 % 25o WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CML AND/OR CRIMINAL L Mw &T 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.
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CONDITIONS AND LlhtlTATIONS OF GENERAL UCENSE 10 CFR 31,11
'31.11 General licensi for use of byproduct materials for certa;n in senium-75, and/or iron 59 in excess of 200 microcuries.
vitro clinkal or laboratory testing. (2) The generat Ocensee sheit store he byproduct material, until used, in the origina; shippmng contbiner er eiq a cwd a6ner providing (a) A general hcense is hereby issued to any physician, veterinarian euunglent radiation protection, in the practica of veterinary medicine, clinical laboratory or hospital to (3) The general licensee shall use the byproduct material only for receive, acquire, possess, transfer, or use, for any of the following stated the uses authorized by preraph (s) of this section.
1:sta, in act:ordance whh the provisions of paragraphs (b), (c),(d), (e), (4) The generet licensee shan not transfer the byp-oduct material cnd (f) cf this section, the fo!!owing 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 en Agreement State,I nor transfer the (1) lodine 125, in units not exceeding 10 microcuries aach for use byproduct material in any manner other than m tha unopened, labeled itt in vitro chnical or laboratory tests not involving internal or external shippinD comainar as received f rom tbs supplier, administration of byproduct materiat, or the radiation therefrom, to (t) The general licensee shall dispose of the Mock todine-125 human beings or animala, reference or calibration sources described ln paragraph (aH7) of this (2) lodme 131, in units not exceeding 10 microcuries each for use - section as required by 20.301 of this chapter, in in vitro clinical or laboratory tests not involving internal or asternai (d) The general hcensee shalf riot receiva, acquire, pussoss, or use administretion of byproduct material, or the radiation therefrorn, byproduct material pursuant to paragraph (a) of this section; to 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 heense issued under the provisions of in in vitro cilriical or laboratory tests not involving internal or external { 32.71 of th:s chapter or in accordance with the provisions of a aiministration of byproduct rnaterial, or the radiation theref rorp, sr+cific bcense issued by an Agreement State that authorires manufac-to human beings or animals. ture and distribution of ioding 125, iodere-131, carbon.14, hydmgen-3 (4) Hydrogen '3 (tritium), in units not exceeding 50 microcuries (tr tium), seienium-75, iron-59 or Mock ladine 126 for distribution to each for use in in vitro c!inical or laboratory tests not involving internal persons generehy bcensed by the Agreement State.
or er.ternal administration of byproduct material, or the rediation (2) Unless the f ollowing sta tement , or a subst antially similar therefrom, to human bemgs or animals. statement which contDins the information cahed for ln the fo!!owing (51 fron 69,in units not exceeding 20 microcuries each for use in in st at ement , appears on a label affixed to each prepackaged unit or vitro clinical or laboratory tests not involving internal or external appears in a leafwt or brochure which accompanies the package) administration of byproduct matarsul, or the radiation therefrnm, to This radioactwo material may be received, ocquired, posr.essrrd, and human beings or animals. uswd only by physicians, veterinarians in the practice of veterinary 1 (6) Selenium-75, in units not exceeding 10 microcuries euch for use medicine, clinicat laboratories or hospitals and only for in vitro clinical in in vitro ct:mical or laboratory tests not involving intertial or external or laboratory tests not invoMng internal or external administration of administration of byproduct materia ( or the raidaation therefrom, the material or the radiation 1.heref rom, to human baaings or animals.
its receipt, acquisition, possession ust and transfer are subject to the to human beings or anirnata, (7) Mocir toJine 125 reference or calibration sources, in unets not reWations and a general license of the U.S. Nuclear Regulatory Cnm- J excending 0.05 microcurie of lodine-129 and 0 005 microcurie of mission or of a State with which the Commission has entered into an I americium.241 each for use in in vitro clinical or latsoratory tests not agreement for the exercise of regulatory authority. i invoMng internat or external adrninistrailon of byproduct materiat, or l the radiation theref rom, to _ human beings or animals.
(b) A person shall not receive, ecquire, possess. use or transfer byproduct material under the geeneral license estubHshed by paragraph Name of rnanuf acturer j (a) of this section unless that person I (1) Hss filed NRC f orm 453, "Hegistration Certificate-In Vitro (e) The regtstrant possesseng or using byproduct materiols under the Testing with Bypmduct Material Under General Ucense,' with the general hcense of peregraph (a) of this section shaf t report in writing to Director of Nuclear Matenal Safety and Safeguards, U.S. Nuclear the Director of Nuclear Material Safety and Safeguards any changes Regulatory Commission, Washmgto.n, D.C. 20555, and recr;ived f rom in the informat son turnished by him in tnc " Reg <stration Certificate-In !
the Commission a vandated copy of NRC Form 483 with registration Vivo Testing with Byproduct Material Under General Ucense." NRC l number assigned; or Form 483. The report shall be fi2rnished within 30 days ofter the (2) Has a license 1het authorl2es the medical use of byproduct effective date of such change) meterial that was inued under Part 35 of this chapter. (f} A,y perrAn using byproduct material pursuant to the general (c) A person who receives, acquires, possesses or uses byproduct license of paragraph (a) of this section is esempt from the requirements material pursuant to the general license estahlshed by paragraph (al of of Parts 19, 20 and 21 of this chapter with respect to byproduct this section sha!! comply with the fo!!owing: materials covered by that general license, e xcept t hat such persons (1) The general licensee shall not possess at any one time, pursuant using the Mock lod.ne 125 desenbed in paragraph (aH7) of this section to the general hcense in paragraph (a) of this section, at any one loca- shall comply with the provlsions of { 20.301,20 402 and 20.403 of tion of storspe or use, a total ' amount of iodine 125. lodme 131, thes chapter, NOTES I A State to wnich certein regulatory author 6ty over radioacttve 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 pnor to January ID,1976 rnay bear labels authorized by the requictions in ef fect on January 1, 1975.
3 A new triplicate set of this Registration Cenificate, NRC Form 483, may be used to report any change of Information furnished by a registrant as requtred by 31.111e).
If larger uuantities or other forms of byproduct material than those spec 6 fled in the general license of 10 CFR 31.11 are required, an "Applica-tion for Byproduct Material License," NRC Form 313 should be filed to obtain a specific byproduct material license. Copies of apphcation and registration forms may be obtained from the Medicat, Academic and Commercial Use Safety Branch (6H3), Division of industrial and Medical Nuclear Safety, United States Nuclear Reguistory Comminion, Washington. DC 20555.
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