ML20247H312
| ML20247H312 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210130 | |
| Download: ML20247H312 (3) | |
Text
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Mry 17,1998 :
K 1
Brookdale Clinical Laboratory
. 2 South Summit Avenue Hackensack, NJ 07601
Dear Sir:
This letter verifies the receipt of the completed NRC Form 483 dated February 25,1998. 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 8550. 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, b
Traci Kime, Acting Registration Specialist Materials Safety Branch.
Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety
.and Safeguards DISTRIBUTION p.
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SBaggett IMNS r/f NEO3
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4 S1 Chanrm of Artdr - c NRC FORM 483 U. S. NUCLEAR RECULATORY COMMISSION t.PPROVED DY OMB: NO. 3150-0338 EXPIRES: 6-30-99 m
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colleebon,oguest 7 mmutes The valeated,ogstration senes as evwenc.e REGISTRATION CERTIFICATE --In vitro TESTING
- *"1*%e*,*,'*fo, "*J"l','",e',**,"'",';',""J' Z'e'."o,,*'*U' WITH BYPRODUCT MATERIAL UNDER n'"%""*".,".".,n,",*O
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GE E L LICENSE Budget. Washmpton, oC person a not, equi,ed. 2o503 NRC may not conduct o, sponsor. and a
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4 displays a cune,itly veld OMB control number Section 31.11 of 10 CFR 31 establishes a general license authonzing physicians, clineal laboratories, hospitals, and veterinarians in the practice of vetsrinary medcine 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 tuthorized until the physician, clir,ical laboratory, hospital, or veteriarisn in the practce of vetennary 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 instruction 3.B. below)
- 2. APPLICATION (Check one box only) h d d C M /h [ 8 b / N h [
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I hereby apply for a registration number pursuant to 10 CFR 31, Section 31.11, for use of byproduct materials for:
dU M 8 () /q M / 7~ hg *g, A. Myself, a duty licensed physician authorized to disperse drugs in e
the practce of medicine, bM NC
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x B. Tne ammed ci,nicanaborato,y.
TELEPHONE NUMBER (fncfwe A/os Code)
C. ' The above named hospital.
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@ Z7 - 00 46 D veterinarian in ene pracice of vetennary medmine 3.
INSTRUCTIONS:
- 4. REGISTRATION A.
Submit this form in dupicate to:
REGISTRATION NUMBER:
Medcal, Academc and Commercial Use
/*/* "C%o Safety Branch (T-8 F5)
Division of ladustrial and Medcal Nuclear Safe'y RR yME MLAN Q2MEON Offee of Nuclear Matenal Safety and Safeguards U.S. Nuclear Regulatory Commission
- r j
"t Washington, DC 20555-0001 -
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8"D (At NRC, a registration number will be assigned and a validated copy J~
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e f)g((g of NRC Form 483 will be retumed.)
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f B.
In the box above, print or type the name, address (including ZIP Kim er1y all k2-90 Code), and telephone number of the registrant physician, clincal (If this an inibalregrstradon, leave thts space blank - number to be taboratory, hospital, or vetonnarian in the practce of veterinary assigned by NRC. At this is a change ofinformaton from a previously medictne for whom or for which thss registration form is filed.
regrstered generaliconse, include your registra00n number.)
- 5. If place of use is different from address listed above, give complete address:
M CL6tm
- 8. CERTIFICATION I hereby certify that:
A.
All information in this registration certifcate is true and complete.
The registrant has appropr$ste radiation measuring instruments to carry out the tests for which byproduct material will be used und B.
Icense 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 Commission regulations require that any change in the information fumished by a registrant on this registration certifierte be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the effective date of such change.
D. I 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 generat icense for whch this Registration Certifcate is filed with the U.S. Nuclear Regulatory Commission.
PRINTED OR TYPED NAME AND TITLE OF APPUCANT SIGNATURE OF APPUCA T
/
DATE M A H A G o o tA f/(. HA A/
(% W. %Hl># g LA e,.
s ve eA V t s o g
- L WARNING: FALSE STATEMENTS IN THIS CERTIFIC. ATE MAY BE SUBJECT TO CIVIL 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 483 (696)
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4 CONDITIONS AND LIMITATIONS OF G'INERAL LICENSE 10 CFR 31,11
~ $ 3L11 Generhi license for we of byproduct nistorials for certain in scienium 75, and/or iron 59 m e= cess of 200 microcuries.
yltro clinical or laboratory testing.
(2) The general licenses shall store the byproduct material, until
. used, in the ceriginal shipping conta;ner or in a container providing -
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(a) A general license is hereby issued to any physician,veterinar an equivalent rwJiation protection.
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in the practica of veturinary medicine, clinicallaboratory or hospital to (3) The general licensee shall use the byproduct materlat only for
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receive, acquire, possess, transfer, or use, for any of the following stated the uses authorited by paragraph (a) of this sectlon.
tests,in accordanca with the provisions of paragraphs (b), (C),(d),(e),
(4) The ganaret licensee shall not transfer the byproduct meterial rnd (f) of this section, the following byproduct materials in prepack-except by transfer.to a. person authorlied to receive it by a Ucense pursuant to this chapter or from an Agreement State,1 not transfer the aped units:
byproduct material iti sey manner other than in the unopened, labeled (1) todine 125, in units not exceeding 10 rnicrocuries each for use
. In in vitro clirucal or laboratory tests not involving internal or external shipping container as received from the supplier, 4
administration of byproduct rnatorial, or the radiation therefrom, to (5) The general, licensee shall dispose of the Mock lodine-125 reference or calibration sources described in paragraph (al(7) of this human beings or antmats, (2) todme-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 enternal
_ {d) The general. licenses shall not receive, acquire, possess, ort use administration of byproduct material, or_ the radiation therefrom, byproduc1 met'erial 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 microcurles each for use with the provisions of a specific license issued under the provisions of
'1
. 'in in vitro clinical or laboratory tests not involving internal or esternal
$ 32.71 of this chapter or in accordance with the, provisions of a adrrHnistration of byproduct material, or the radiation therefrom,'
s;secific ticense issund by an Agreement State that authorizes manufac.
to human beings or animals.
ture and distribution of lodine-125, iodine-131, carbon 14, hvorpgen.3 d4) Hydrogen 3 (tritiurn), in units not exceeding 50 microcuries (tritiur *, seiernam 75, irorv69 or Mock lodine 125 for distribution to each for use in in vitro clinical or laboratory teste not in olving internal persons generally licensed by the Agreement State.
v or external administration of byproduct rnaterial, of the radiation (2) Unless tt.e following statement, or a substantially similar therefrom,to human beings or anima 1 statement which contains the mformfation called for in the following -
(S) Iron 59,in unlis not exceedrng 20 microcuries each for use in in statement, appears on a label affiaed to each prepackaged unit or vitro clinical or laboratory tests not involving internal or external appears in a leaflet or brochure which accompanies the pacitage:2 administration of byproduct material, or the radiation therefrom, to This radioactive material may be recewed, acquired, possessed, and human beings or animals.
useri only by physicians, veterinarians in the practice of veterinary (6) Selenium-75, in units not exceeding 10 microcuries each for use medicine, clinkal laboratories or hospitals and only for in vitro clinical in in vitro clinical cr laboratory tests not involving internal or external or laboratory tests not involving internal or esternal administration of i
administration of byproduct rnaterial, or the radiation therefrom, the material or the radletion therefrom, to hu.han beings or animals, to human beings or animals.
Its receipt, acquisition, possession, use, and transfer are subject to the (7) Mock lodme 125 reference or rislibrat6on sources, in units 'not regubttons 'and a General license of the U.S. Nuclear Regulatory Com-exceeding 0.05 microcurie of 'lodme-129 and 0 005 microcurie of missann or of a State with which the Commission has entered into an americium-241 each for use in in vitro clinical or laboratory tests not
=areement for the exercise of reDulatory authority.
involving internal or external administration of byproduct rnaterial, or the radiation theref rom, to human beings or animals, (b) A person shall not receive, acquire, possess. use or transfer byproduct material under the general license established by paragraph Name of manufacturer h) of this section unless that person:
(1) Has filed NRC form 483, " Registration Certificate-in Vitro (e) The registrant possessmg or using byproduct materials under the l
Tcsting with Syproduct Material Under General License /' with the general license of paragraph (a) of this section shat) report in writing to,
Director of Nuclear Material Safety and Safeguards, U.S. Nuclear.
the Director of Nuclear Material Safety and Safeguards any. changes Regubtory Commission, Washington, D.Cc 20555, and r ceived from in the information furnished by him in the " Registration Certificate-in l
the Commission a validated copy of NRC Form 483 with registration Vitro Testing with Byproduct Material Under General License," NRC l
number assigned; or Form 483. The report shall be furmshed within 30 days after the (2) Has a license that authordes the medical use of byproduct effective date of such change) 1 material that was issued under Part 35 of this chapter,
. (f) Any person using byproduct rnaterial pursuant to the peneral (c) A person who receives, acquires, possesses or uses byproduct hcense of paragraph (a) of this section is epempt from the requirements materlat 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 fo!Iowing:
materia's covered bV that general license, except tiet such persons (1),The general licensee shall not possess at any one time, oursuant
. using the Mock lodine 125 described in paragraph (aH7) of this section j
to the general license in paragraph (a) of this'section, at any one local shall cornply with the prodsions of Q 20.301,20.402 and 20.403 of
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'tlon of storage or use, a tota'l amount of lodine 125, lodine 131, this chapter.
)
I NOTES
,. 1 A State to which certain regulatory authority over radioactive insterial has been transferred by formaf agreement, pursuant to sectron 274 of the Atomic Energy Act of 1954, as amended.
s,
2NL terial generally licensed under this section prior to January 19,1975 may bear labels authorized by the regulations kn effec;t on January 1,
' 1975.
Ui
' J A new triplicate set of tMs"Regiuratica Certificate, NRC Form 483, may'be used to report any change of information furnished by a reDistrant as required by { 31.11(c). '
l-If isrger Quentitles or other forms of byproduct material than those specified in the general license of 10 CFR 31.11 are required, an "Applica-tion for Byproduct Material License /1NRC Form 313 should be filed to obtain a specific byproduct material license, t.;opies 01 application and registration forms may be obtained from the Medkal, Academic and Commercial Use Safety Branch (6H3), Division of industrial and Medical Nuclear Safety, United States Nuclear Regulatory Commission, Washington, DC 20555, i
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