ML20247H649
| ML20247H649 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Uychoco E AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210219 | |
| Download: ML20247H649 (3) | |
Text
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' MIy 17,1998 5
Chambers Clinical Laboratories
' ATTN: Elizabeth Uychoco 669 Chambers Street Trenton, NJ 08611-3795
Dear Ms. Uychoco:
This letter verifies the receipt of the completed NRC Form 483 dated April 16,1998. 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 689. 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.
l' 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 Office of Nuclear Material Safety and Safeguards
/
DISTRIBUTION I
SBaggett IMNS r/f NEO3 DOCUMENT NAME: P:\\ CHAMBERS.483 Tm receive a cop r 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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NAME TKimeJjk.
NO3re r DATE 5//7/98.-
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OFFICIAL RECORD COPY 9805210219 990517 PDR RC SSD PDR j
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a NRC FORM 483 U. S, NUCLEAR RE;ULATORY COMMISSION APPROVED SY OMB: No. 3160 0038 EXPlREs 8-3146 g
ESTIMATED BURDEN PER RESPONSE TO COMPLY WfTH THis INFORMATON cOLLECTON REQUEST: 7 MINUTES THE VAUDATED
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^S REGISTRATION CERTIFICATE --In vitro TESTING
"'$*L"'7s ivPRc"8fT u'AT^"&L O *THE Es % "NT s
R WITH BYPRODUCT MATERIAL UNDER
'""fu'e' irs' Re%'REN' ' '"" *'""ETTe"SEEN5 "*Ts
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c URDEN E AND RECORDS MANAGEMEttr BRANCH (T.e F33). US NUCLEAR GENERAL LICENSE REGULATORY CCWSSON. WASHNGTON. DC 20555.oM AND To THE PAPERWORK REDUCTON PROJECT (315o-0028). OFFICE oF 3
MANAGEMENT AND BUDGET. WASHINGTON. DC 20503 Secten 31.11 of 10 CFR 31 establishes a general licenne 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 intemal or external administrated of the byproduct material t,r the radiation therefrom to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not tuthorized until the physician, chnical laboratory, hospital, or veterinarian in the practice of veterinary medicine, has filed NRC Form 483 and received from the Commission a vahdated copy of NRC Form 483 with a registraten number.
1 NAME AND ADDRESS OF APPLICANT (SeeinstrucDon 3.B. below) m L
- 2. APPLICATION (Check one box only)
(!,fff} Af/ M 12.3 bbNhML WMMQ l hereby apply for a registration number pursuant to 10 CFR 31, Section 31.11, for use of byproduct materials for:
3 6 Cf ' Ct/ A N dE Aid S7SC ST A. Myself, a duty hcensed physician authorized to disperse drugs in the practice of medicine.
b O M @ /7 N NI-OFN/-3796 k B. The above-named chnicaHaboratory.
TELEPHONE NUMBER (include Aree code)
C. The above named hospital.
f6Oi)'%8-7MCD D VWennanan in the practice of veterinary medicine.
- 3., INSTRUCTIONS:
- 4. REGISTRATION A. Submit this form in duphc' ate to:
REGISTRATION NUMBER:
Medcol, Academic and Commercial Use
- " "' %'O 609
/
. Safety Branch (T-8 F5) s JDivision of industrial and Medcal Nuclear Safety
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( Office of Nuclear Material Safety and Safeguards
\\U.S. Nuclear Regulatory Commission g
U.S. Nuc1ea* Pcgulatorv Comm, I
Washington, DC 20555-0001 e
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s
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t of NRC F4rm 483 will be retumed.)
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(At NRb, s. registration n' mber will be assigned and a vahdated copy u
py S
N
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, B. In the box above, print or type the name, address (including ZIP Code), and telephone number of the registrant physician, chnical (if this an initial registrabon, leave this space b!ank - number to be laboratory, hospital, or veterinarian in the practee of veterinary assigned by NRC. If this is a change ofinformation from a previously l
medmine for whom or for which this registration form is filed.
f*G'stered general # cense, include your registration number.)
- 5. If place of use is different from address hsted above, give complete address:
- 6. CERTIFICATION I hereby certrfy that:
A.
All information in this registration certificate is Lue and complete.
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B.
The registrant has appropriate radiation measuring instruments to carry out the tests for which byhuct material will be used under the general
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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 furnished 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 I have read and understand the provtsions of Section 31.11 of NRC regula'ons 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 heense for which this Registration Certificate is filed with the U.S. Nuclear Regulatory Commission.
PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE F APPLICANT DATE f fD!/ OFilfED 1}T/KU/fiQ & u g d f'
& IWEE WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAV'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 (1.eS)
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' CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
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- 1.
y ' { 31.11 General license for use of byproduct materials for certain in
' selenium-75, and/or non 59 in escess of 200 microcuries.
s ' vitro clinical or laboratory testing.
(2) The general licensee shail store the byproduct materiat, until
'used, in the original shipping conta!ner br in a coritainer providing.
I ta) A'genarsi license is hereby issued to any physician,veter nar an equivalent radiation protection? !
i i in the practice hf veterinary medicine,clinicallaboratory or hospital to (3) The general licensee shall use the byproduct material only for rective, acquire, possa'as, transfer,or use, totany.df the follovving stated,
. the uses authopted by paragraph (e) of this pection.,,
. I estsi n accordance with.the provisions of paragraphs (b), (c),(ct), (e),
- 14) The general licensee shall not transfer the byproduct material,
.I t
i and (f) of this section, the fol6owing byproduct materials in prepacle except by tran>fer to a pe,rson authorind to receive it by a license pursuant to tNs chapter.or from an Agreement State,I nor transfer the' -
' aged unitst
) 4 N1) todine 125, in units not exceeding 10 microcuries each for use byproduct rnaterial in any manner other than in the unopened, tabeled l In in vitro clinical or laboratory tests not involving internal or external shipping container as received from t_ e supplier,
- i h
- administration-of byproduct material,-or the radiation therefrorm to (5) Tha general licensee,shall dispose of the Mock lodine 125 '
' human beings or animals?
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.C reference or calibration sources described in paragraph'ia)t7) of this )
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y:. (2) todine-131, in units not exceeding 10 microcunes each for use 3 section as seguired by @ 20.301 of this chapter.
3 j in in v.itro clinical or laboratory tests not involving internal or external (d) The general licensee shall not receive, acquire, possess, or use i '
' adrpinistratlon;of byproduct material, or' the radiation therefrom, byproduct material pursuant to paragraph (a) of this section:
to human beings or animais.
(1) Except as prepackaged units which are labeled in accordance l
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- l-(3) Carbon 14, in urnts not exceeding to microcuries' dch' for use with the provmions of a specific license issued under the provisions of In in vitro clinical or laboratory tests not involving Internal or external 5 32.71 of this chapter or in accordance with the provisions of 3 $
- administration of byproduct material, - or the - rad;ation theref rom, specific license issued by an Agreement State that authorizes manufac {
a ture and distribution of iodine 125, iodine-131, cart on-14, hydrogen-3
- i to hurhan beings or animals.
4tr tium), selenium 75, iron.59 or Mock todine-125 tor distribution to ~
'(4)' $drceri'3 (tritfum)flh unitrnot exceeding 50 microcuries -
"P each for use In'in vitro clinical or laboratory tests not involving internal persons generally licensed by the Agreement State. '
tf l or external, administration' of byproduct material, or the radiation (2) Unless the following statement,' or a substantially similar :
! therefrom,to human beings or animals.
statement which contains the information celled for in the following :
I (5) Iron 59,1n units not exceeding 20 microcuries each for use in in statement, appears on 'a labet affixed to each prepahk aged' unit or 4 a leaflet or brochure which accompanies the package) '
f vitro clinical or laboratory tests not involy!ng internal or external appears in administration of byproduct material, or the rad!ation therefrom, to This radioactive material may be received, acquired, possessed, and j j
used only by physicians, veterinarians in the practice of veterinary "
human beings or animals.
3.
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- 16) Selenium 75, in un ts not exceeding 10 mlerocuries each for use '
modicine, clinical laboratories or hospttats and only foHn vitro chnica!
S in in vitro clinical or laboratory tests not invorving internb! or external or laboratory tests not involving inter' at or external administration of l n
administration of byproduct material, or tb9. radiation therefrom, tio material or the radiation therefrom, to human beings or arumals.
to human beings or anirr.alsJ its receipt l acquisition, possession, use, and transfer are subjec to the l (7) Mock lodine 125 reference or calibration sources, in units rrot regulatioris and a general license of the U.S. Nuclear Regulatory Com-exceeding 0.05 microcurie of lodine-129 and 0.005 microcurie af mission or of a State with which the Commission has entered into an americium-241 each tor use in in vitro clinical or laboratory tests not agrrement for the exercise of regulatory authority, i
involving internal or external administration of byproduct material, or I ' the radiation therefrom, to human beings or animals.
- (b). A. parson shall pot rective, acquire, ho$sess, use or tra,nsbr
, byproduct material under the general license estataished by paragraph Name of manufacturer (a) of this section unless that person:
(1) Has filed NRC Form 483, " Registration Certincate-In Vitro (e) The registrant possessing or using byproduct materials under the Testing with Byproduct Materia 0 Under General. Ucense," with the -
general.hcense of paragraph la) of this section shall report.in writing toj
~ Director of Nuclear Materia! Safety and Safeguards, U.S, Nuclear '
'the Director of Nucker Material Safety and Safeguards any changes {
Regulatory Commission, Washington, D.C. 20055, and received from in the information furnished by him in t e " Registration Certificate-f n,
h i the Commission a validated copy of NRC Form 433 with registration vitro Testing with Byproduct Material Under General License," NRC number assigned, ur Form 483. The rrport shall be furrnshed within 30 days after the l
- (2) Has-a license that. authorizes,the medical use of byproduct etfective rime of such change.3 li) 3materialthat was issued under Part 35 of this chapter.
(f) Any person using byproduct material pursuant to thA Deneral
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' { ' material pursuant to the general license established by paragraph (a) of~
bcense of par'agraph (a) of this section is exempt from the requirements (c) A person who receives, acquires, possesses or uses byproduct j
of Parts 19, 20 and 21 of this chapter with respect to byproduct l e this section all c ip'y with the following;
.materwis covered by that general license, except that such persons,
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.e general licensee shall.not possess at any one time, pursuant.
using the Mock lodine 125 described in paragraph (a)(7) of this section
[ to the general license in paragraph (a) of this section, at any one loca-shall coniply with the provisions of 20.301, 20.402 and 20.403 of i
- tion. of storage or use, a totel amount.of lodine 125, iodine 131,
. this chapter r i
NOTES
.3 A State to which certam regulatory authority over radioactive material has been transferred by formal agreement, pursuant to section 274 of the; Atomic Energy Act of 1954,as amended.
j JMaternal generallygIlcensed und.er th.is section prior to January 19,1975.may bear. labels aut.horlied, by the regulations in ef fect on January 1, 19 E A now triplicate set of. th'is Registration Certificate, NRC' Form 483, may be used to report any cha'nge information furnished by a rehist' rant,
' J j ' ss required by 31.11(e);
if larger quantitles or other forms of byproduct material than those specified in the general license of 10 CF R 31,11 are required, an f'Applicad
, tion for Byproduct Material License ll NRC Form 313 should be filed to obtain a specific byproduct material license, Cophs of application and
} registr' don forms may be obtained from the Medical, Academic and Commercial Use Safety Branch (6H3), Djvision of :ndustria' and Medical, Nuclear
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Safety, U. nited States Nuclear Regulatory Commission, Washington,DC 205b5/
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