ML20247H220
| ML20247H220 | |
| Person / Time | |
|---|---|
| Issue date: | 05/18/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Cintron E AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210100 | |
| Download: ML20247H220 (3) | |
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MIy 18,1998
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' Laboratorio Clinico Bacteriologic' ATTN:' Elsie Cruz Cintron.
P.O. Box 890-Manati, PR 00674 l.
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Dear Ms. Cintron:
l This letter verifies the receipt of the completed NRC Form 483 dated March 9,1998. This' form ll 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 9032. When making changes to any of the information on the form, please reference the registration number and address the i
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, 3
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 NEO3 7
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DOCUMENT NAMEi PSCINTRON.483 Ti receive a oop, of this document Indomte in the hos: 'C' = Copy without attachment / enclosure
- E' = Copu with attachment /erv,:losure
- N" = No copy l
l l-l l
OFFICE MSB.
L NAME TKimeL//f l
DATE 5//g/98 OFFICIAL RECORD COPY 2000Et I
l l
9805210100 980518 f
FDR RC e
SSD POR l
NRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMe: NO. 3150403e EXP1ZE3 3-3148 ESTIMATED BURDEN PER RESPONSE TO COMPLY WITH THIS INFORMATION COLLECTION REQUEST: 7 MINUTES THE VAUDATED REGISTRATION CERTIFICATE --in vitro TESTING "MS O, L*,@^'T i!ATEnaL TJ'dfo*SJ' '
" ^" *'"
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WITH BYPRODUCT MATERIAL UNDER
' oms RES'*Na 7URoEN EETTE""hdM O
GENE L LICENSE AND RECORDS MANAGEMENT BRANCH (MNBB 7714), u s NUCLEAR REGULATORY COMMISSON. WASHINGTON. OC 20555o001. AND To THE PAPERWORK REDUCTION PROJECT Q15o4026). OFFICE OF MANAGEMENT AND BUDGET. WASHINGTON DC 20503 Secten 31.11 of 10 CFR 31 establishes a general license authonzing physicians, clir cal laboratories, hospitals, and veterinarians in the practice of n
veterinary medicine to possess certain small quantities of byproduct material for h utro cHnical or laboratory tests not invoMng the intamal or extemal administration of the byproduct material or the radiation therefrom to human beings or anunals Possession of byproduct material under 10 CFR 31.11 is not authortred untH the physician, clinical laboratory, hospital, or vetertarian in the practice of vetennary medicine, has filed NRC Form 483 and recolwd from the Commission a valldated copy of NRC Form 483 with a repatrabon number.
- 1. NAME AND ADDRESS OF APPUCANT (Seeinstruccon 3.B. below)
- 2. APPUCATION (Checic one box only)
LABORATORIO CLINIC 0 BACTERIOL0GIC0 1 hereby apply for a registrabon number purnuant to 10 CFR 31, Section SABANA SECA 31.11, for une of byproduct meteriais for-CARR. 866 ESQ. 867 BO. SABANA SECA A. Myself, a duly Heensed physician authortzed to disperse drugs in l
TOA BAJA, PUERTO RICO 00952 the prache. of medicine (p1 ace Of use)
X B. The abovesnamed cilnicallaboratory.
TELEPHONE NUMeER @cAdk hw CodW C. The atmo named hospital D. Valennenen in the orect6ce of vetennery medicene I
3.
DISTRACTIONS:
- 4. REOlSTRATION A. Submit this form in duplicate to:
REGISTRATION NUMBER:
u*=i, Academic and Commercial Use 4032
[#pm Rtog Safety Branch (6 H3) b DMeion of industrial and Medical Nuclear Safety o
I t U.S. Nuclear Regulatory Office of Nuclear Metenal Safety and Safeguards U.S. Nucieer Reguistory Cornmission 4
o Commission washington, DC 20555 0001 5
j f
k * *
- t' (At NRC, a registration number wiH be assigned and a validated copy
/
,(
of NRC Form 483 wiu be retumed.)
B. In the box above, prirt or type the name, address (including ZIP Steven Bag e 5/ # /98 Code), and telephone number of the regtstrant physician, chnical Of this an Mfef repatre, leave this space blank-numberto be laboratory, hospital, or vetennanen in the practice of veterinary asered by NRC. //this is a change of Wbrmaton ham a prowouafy medicine for whom or for which this repetrabon form is filed.
regedored generaf fconae, bdido your repetraton number)
- 5. If pinos of use is different from address hated atme, pm compie address MAILING ADDRESS P.O.
BOX 890
- MANATI, PUERTO RICO 00674 TRTJPHONE NUMBER ( 787) 854-5024
- 8. CERTIFICATION 1 hereby certify thet:
A.
AI information in this registration certificate is true and complete.
B.
The repatrant has appropriate radiaton measuring instruments to carry out the tests for which byproduct material wel be used under the general lloonee of 10 CFR 31.11. The tests wm be performed only by personnel competent in the use of the instruments and in the handling of the l
byproduct materials.
l C.
I understand that Commission reguishons require that any change in the information fumiehed by a registrant on this ragsstrabon certificate be reported to the Director of Nuclear Matenal Safety and Safeguards within 30 days fmm the effective date of such change l
l D 1 have read and understand the provisions of Section 31.11 of NRC regulebens 10 CFR 31 (reprinted on the reverse side of this form); and l l
understand that the repatrant is required to comply with those provisions as to aR byproduct material which he receives, acquires, poseeeems, uses, or transfers under the general license for which this Registration Certifica'e is filed with the U.S. Nucieer Regulatory Commineion PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIG U E OF PLICANT DATE Elsie Cruz Cintr6n 03-09-1998 Laboratory Director WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE dBJECT TO CIVIL AND/OR CRIMINAL I
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 483 043) b
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4-e,
CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11
$ 31,11 General license for use of byproduct mate-lals for certain in ascensum-75, and/or iron SS in aw of 200 mannenntes.
vitro clinical or laboratory testing.
(2) The general thanume shmII saare the byproduct samterial, until used, in the original shipping h or in a comasinar proveding (e) A general license is hereby issued to any physician,voterinarion esasholent redimaton pe===,.ame in the practice of veterinary medicine, clinical laboratory or hospital to
' (3) The ganaral lionnese shmII asse the byproduct material only for receive, acquire, possess, transfer, or use, for any of the following stated the uses authorized by parupaph (e) of this massion.
tests, in accordance with the provisions of paragraphs (b), (c),(d),(e),
(4) The general licensus shall not transfer the bypsodues numerial and (f) of this section, the following byproduct materials in propeck.
encept by taansfer to a person asthoriand to rammiue it by a license aged units:
pursuant to this chapter or fuoan an Ayemment State,8 nor teensfer the (1) lodine 125, in units not exceeding 10 microcuries each for use bys reduct meterial in any ensanar other then in the ennapaned,ishaled in in vitro clinical or laborotory tests not involving internal or external shipping container as received fseen 30ee supplier.
administration of byproduct material, or the radiation therefrom, to (5) The general licesimme shall allspass of teus Mask lassine 125 human beings or animals, reference or emigwation suusens stumergued in penapuph (eH7) of this (2) lodine-131, in units not exceeding 10 microcuries each for use section as required by { 20.301 of this c% spear, in in vitro clinical or laboratory tests not involving internal or external (d) The general finsnuno shall not receius, acquire, p-=== or usa administration of byproduct material, or the radiation therefrom, byproduct meterimi puruunne to paragrugsh (a) of this sectisse:
to human beings or animals.
(1) Except as ps=r=*=g==8 units unleich are lahsted in ascentonce (3) Carbon 14, in units not exceeding 10 microcuries each for use seith the an- _ of a specific liennus i=====8 under the psovisions of in in vitro clinical or laboratory tests not involving internal or external
$ 32.71 of this chapter or in ammoedenu uutth the penWaions of a administration of byproduct material, or the radiation therefrom, specific lisanos immsed buy an Agramment Staae t0ist authorsums manufac-to human beings or animals, aste and distribution of iodine 15, iodine-131, cation-14, hydrogen-3 (4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries Itritium), smeansusn-75, bes>4iB er Meek todine 15 ter siistrasution to each for use in in vitro clinical or laboratory tests not involving internoi persons generally hamnand ipy the Asseusnesst Stase. -
or external administration of byproduct meterial, or the radiation (2) Unless the follouring sesamment, or e edustantingly similar tnerefrum, to human beings or animals, sea.tament vehich sentains the infonnation suited for in the foltouving (5) f ron 59,in units not exceeding 20 microcuries each for use in in statement, appsers on a hinst sNhund to amah psspeakaged unit or vitro clinical or laboratory teste not involving inteme' or external appsers in a leaflet or brushnere ushleh amemmpanies the package:2 administration of byproduct material, or the radiation therefrom, to This radioactive materini musy be somstuud, maqubed, poemmesed, and human beings or animals, used only by physistans, enterineptuns in the prestias of esterinary (6) Selenium-75, in units not exceeding to microcur6es each for use pnadicine, clinical laboratories or haupitets asus osdy ter in vetro clinical in in vitro clinical or laboratory tests not involving internal or enternal or laboratory tests not inuelvene inearnal or enemmel ashusinistration of administration of byproduct material, or the radiation therefrom, the material or the radiation thesehesn, to human beings or animals.
to human, beings or animals.
Its runstet, seguisition, pommission, asse, aunt transfer ase subiess to the (7) Mock fodine-125 reference or calibration sources,in units not regulations and a general liennes of steo U.S. Deusemur Reguissory Com-cxceeding 0.05 microcurie of iodine 129 and 0.006 microcurie of mission or of a State wetth uuhish the Cnensission has entered into an americium-241 each for use in in vitro cilrfcol or laboratory tests not agreement for tfie esercise of sepstatory authority, involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animelt.
(b) A person shall not receive, acquire, poosses, uso of transfer byproduct meterlet under the general license established by peregraph Dimme of sunnuducturer (1) of this section unless that person:
(1) Has filed NRC Form 483, Registration certificate-in Vitro (e) The registrant possamusne or using tyytwoduct neuterials under the Testing with Byproduct Material Under General License /* with the general licenss of permeraph tal of tteis ametion shall report in euriting te Director of Nuclear Meterial Safety and Safeguards, U.S. Nuclear the Director of Nucimer Material Esfuty and Safegimuuls any changes Regulatory Commission, Washington, D.C. 20655, and received frorn in the information furnished try him in the *% registration Cartinesto. in the Commission a validated copy of NRC Form 483 with registration Vitro Testing outth Byproduct Meterial Under Generad t.inense," NRC number sesigned; or Form #3. The report shall be furselshed usethin 30 simys after the (2) Hos a license that authorizes the medical use of byproduct offective siste of such ehenen.3 material that ws: issued under Part 35 of this chapter.
(f) Any person using tyypressunt suietertui pierusent to the general (c) A person who receives, acquires, possesses or uses byproduct license of paragraph (e) of teils smetion is omanspt inom the restuirements meterial pursuant to the general licones established by peregraph (a) of of Ports 19, 2 and 21 of this cdiepter seeth respect to L. ' -
this section shall comply with the following:
meterials covered by tenut ganarel Ilmense, amespa siist escit persons (1) The general licensee shall not possess et any one time, pursuant using the Mock todino.125 sisscresud in parasseh imH7) of semis section to the general license in peregraph (a) of this section, at any one loca-shall comply wrtth the psosimions of { 20.301,20.402 and N.403 of i
tion of storage or use, a total amount of lodine 125, iodine 131, this chsener.
NOTES I A Stste to which certain reguletory authority over radioactive material has been transferred by formal eyeomerit, pursuant to section 274 of the Atomic Energy Act of 1964, as amended.
2Meterial generally licensed under this section prior to January 19,1975 may beer labets author 6 red by the reguistions in offuss on January 1, 1975.
3A nerv triplicate set of this Registration Certificate, NRC Form 483, may be used to report any change of information furnehad try a registrent as required by @ 31.11(el.
s if larger quantitles or other forms of byproduct meterial then those specified in the general license of 10 CFR 31.11 are requiresi, an "Applice-tion for Byproduct Material License," NRC Form 313 should be filed to obtain a specific byproduct r storial license. r'ar== of application and a
registration forms may be obtained from the Medical, Academic and Commerciel Use Safety Branch (6H3), Division of Industrief enst Medical Nuclear
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Sefety, United Stetes Nuclear Regulatory Commission, Washington, DC 20656.
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