ML20247H477
| ML20247H477 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Calvosuares Y AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210175 | |
| Download: ML20247H477 (2) | |
Text
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May 17,1998 Laboratorio Clinico Amelia ATTN: Yolanda Suarez-Calvo Calle Eider #917 Country Club San Juan, PR 00924-2336
Dear Ms. Suarez-Calvo:
This letter verifies the receipt of the completed NRC Form 483 dated March 26,1998. This forrn 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 9139. 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, e
I f.
Traci Kime, Acting Registration Specialist Materials Safety Branch Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards DISTRIBUTION:
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SBaggett IMNS r/f DOCUMENT NAME:
Ta receive a copy of this document, indicate in the bos: 'C' = Copy without attachment / enclosure
- E* = Copy with attachment / enclosure
- N" = No copy OFFICE MSB l
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l NAME TKime di Qhraf DATE 5//7/98 J/P OFFICIAL RECORD COPY I
!000g 9005210175 980517 PDR RC SSD PDR
NRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION g.PP2oYED BY OMB: No. 31504038 EX11REs 8-3186 g
ESTIMATED BURDEN PER RESPONSE TO COMPLY WITH THIS INFORMATION COLLECTION REQUEST 7 MINUTES THE VAUDATED
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REGISTRATION CERTIFICATE --In vitro TESTING E%% OF L"Rs^,cT J ^"eL O'TnE Reo%i'T s N
WITH BYPRODUCT MATERIAL UNDER
's'u'E trs'REGS'DTN3 B' ' '"' *J"EsETE T0 TstiNFTu7T%
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I I IN CE AND RECORDS MANAoEMENT BRANCH (T.e F33). us NUCLEAR Uk G L LIwh wE REGULATORY COMMISSION. WASHINGTON, DC 20555-0001. AND TO THE PAPERWORK REDUCTION PROJECT (31500026). OFFICE OF t
l MANAGEMENr AND BUDGET. WASH!NGTON. DC 20503 Sean 31,11 of 10 CFR 31 establishes a genetJI licer ce authorizing physicians, clinical laboratories, hospitals, and veterinanans in the practice of veterinary medicine to possess certain small gaantities of byproduct material for in vitro clinical or laboratory tests not invoMng the intemal or cxtemal administration of the byproduct material or the radiation therefrom to human beings or animals. Pot. session of byproduct material under 10 CFR 31.11 is not Cuthorized until the physician, clinical laboratory, hospital, or veterianan in the practice of vetennary medicine, has' filed fKC Form 483 and received from the Commission a validated copy of NRC Form 483 with a registration number.
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- 1. NAME AND ADDRESS OF APPLICANT (See instruebon 3 B. below)
- 2. APPLICATION (Check one box only)
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l hereby apply for a registration number pursuant to 10 CFR 31, Section 31.11, for use of byproduct materials for:
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A. Myself, a duty licensed physician authonzed to disperse drugs in '
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j the practice of medicine.
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&B. The above-named clinicallaboratory.
TELEPHONE NUMBER (include hee Code) /
C. The above named hospital.
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D Vetennarian in the practice of veterinary medicine 3.
INSTRUCTIONS:
- 4. REGISTRATION
+
/. Submit this form in duplicate to:
REGISTRATION NUMBER:
Medical, Academic and Oommercial Use M 39
- p* Moog Safety Branch (T-8 FS) o Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards 8
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US 1. clfar Regulatory Com U.S. Nuclear Regulatory Commission -
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b Washington, DC 20555-0001 e
(At NRC, a registration number will be assigned and a validated copy b-of NRC Form 483 will be retumed.)
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otevenL.R$w~tt 5/ $ /93 B. In the box above, print or type the name, address (including ZIP Coue), and telephone number of the registrant physician, clinical (if this an initialregistration, leave this space blank - number to be laboratory, hospital, or veterinarian in the practice of veterinary assigned by NRC. If this is a change ofinIbemacon from a previously medicine for whom or for which this registration form is flied.
rejstered generalEconse, include your registration number.)
- 5. If place of use is different from address listed above, give complete address:
- 6. CERTIFICATION 1 hereby certify that:
A.
All information in this registration certificate is true and complete.
.+
4.
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B ~ The registrant has n'ppropriate radiation measuring instruments to carry out the tests for which byproduct material 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 byptoduct materNs.
C.
I understand that Commission regulations require that any change in the information furnished by a registrant on this registration certificate be reported to 15c 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 general license for which this Registration Certificate is filed with the U.S. Nuclear Regulatory Commission.
PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGNATURE OF APPLICANT DATE O I h r>I m y 0
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NARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT IO CIVIL AND/ON CRI' INAL M
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 D 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 (1-145)
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CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11 y 31.11 General license for use of byproduct materials for certain ic ?
- telenium.75, end/or iron 59 3rt excess of 200 miciocuries.
(2) The general 1,icensee shail store the byproduct rtiatoria', until f
witra ctinicat or taboratory' testing.
'used, in the orliginal shipping container or in a container providing 4
y -
(a) A general license is hereby issued to anV physician, veterinarian equ' valent radration protectiony j
j in the practice of veterinary medicine,clinicallaboratory or hospital to (3) The genersi licensee shall use the byproduct material only for l
'receite, acquire, possessitransfer, or use, for arty of the following stated
<the uses authorized by paragraph (a) of this section.,
. tests; in accordance with the provisions of paragraphs (b), (c),(d), (el, (4) The general licensee shall not tran<,fer the byproduct material
! and (f) of this section, the following byproduct materials in prepack -
' except by. transfer.to a perspn authorired to receive it by a ikense
' aged bnits:
pursuant to this chapter or from an Agleement Str,te) nor transfer the (t) iodine-125, in units not exceeding 10 microcuries each for use - byproduct material in any manner other than in the unopened,.labefed l
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, in in vitro clinical or laboratory tests not involving internal or external shipping container as received f rom tha supplier,
, lodine 125 j
- 4. administration of.byproduce material, or the radiation therefrom, to,
- 15) The general Jicensee shall dispose of the Mock reference or ca!lbration sources descr1 bed in parastraph (a)(7) of this human beings or animals.
'(2) lodine-1'11, in urnts not exceed ng 10 microcuries each for use section as required by 20.301 of this chapter,
, in in vitio clinical or laboratory tests not involving internal or external (d) The general licensee shall not receive, acquire, possess, or use admiristrstion of byproduct material, or th6 radiatio n t heref rom, 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 license issued under the provisions of in in vitro clinical or laboratory tests not involving triternal or external
% 32.71 of this chapter or in accordance with the provisions of a administration' of byproduct material, or the radiation therefrom, r specific license issued by an Agreement State that authorizes manufac.
(
ture and distribution of iodirse-125, iodine-131, carbon.14, hydrogen.3 j to human beings or animals.
(4J Hydrogen '3 (tritium), in ' units not exceeding 50 microcuries (tritium), selenium-75;)ron-59 or Mock todine-125 for distribution to.
' each for use in in vitro cMnical or laboratory tests not involving internal persons generally licensed by the Agreement State, 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 called for in the following (5) fron 59,in units not exceeding 20 rr'crocuries each for use in in stat ement, appears on a label af fived to each prepackaged unit or f vitro clinical or laboratory tests not involving internal or external appears in a.eaflet or brochure which accompanies the package)
~ administration of byproduct material, or the radiation therefrom, to This radioactive material may be received, acquired, possessed, and '
human beings or animals, used only by physicians,- hterinarians in the practice of veterinary -
(6) Selenium 75, in units not exceeding 10 microcuries each for use medicine, clinical laboratories or hospitals and only for in vitro chnical.
in in vitro clirucal or laboratory tests not involving internal or external or laboratory tests not involving internal or external administration of '
administration of byproduct material, or the radiation therefrom, the material or the radiation therefrom, to hurnan beings or animals.
lts receipt, acquisition, possession, use, and transfer ^are subject to the to human beings or animals, 4
(7) Mock lodine-125 reference or calibration sources, in units not regulations and a general hcense of the U.S.- Nuclear Regulatory Com.
4 exceeding 0.05 microcurie of iodine 129 and 0.005 microcurie of mission or of a State with which the Commission has entered into an <
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$ americium 241 each for use irl in vitro clinical or laboratory tests not.
agreement for the exercise of regulatory authority.
involving internal or external administration of byproduct rpaterial, or f the radiation therefrom, to human beings or animals.
~ (b) A person shall.not Jeceive, acquire, possess, use. or transfer byproduct material under the general license established by paragraph
. Name of manuf acturer 2
(a) of this section unless that person:
4 (1) Has filed NRC Form 483, " Registration Certihcate-In Vitro (e) The registrant possessmg or usms byproduct materials under the :
g Testing with Byproduct Matwrest Under General License,' with the
+eneral bcense of paragraph la) of.this section shall report in Wuting to f Director of. Nuclear Material Safety and Safeguards, U.S. Nuclear -
.the Director of Nuclear Material Safety and Safeguards any changes Regutatory Commission, Washington, D C. 20555, and received from in the information furnshed by him in the " Reg,stration Certificate-in ;
- . the Commission a va?idated copy of NRC Form 483 with registration Vitro Testing with Byproduct, Material Under Gene al License," NRC number assigned: or Form 483. The report shall be furnished within 30 days' atter the.
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. (2) Has a license that authorizes the medical use of byproduct.
ef fective date oi such change)
, mater al that was ssued under Part 35 of this chapter.
(l) ' Any person using byp oduct (naterial pursuant to the general i
i (c) A person who receives, acquires,' possesses or uses byproduct license of paragraph (a) of this section is exempt. f rom the requiremer*ts j material pursuant to the general hcense established by paragraph (a) of of Parts 19, 20 and 21 of this chapter with respect 'to byproduct I
. this section shall comp'y with the following; materials covered by that general license, except that such persons -
s (1) The general licensee shall not possess at any onetime, pursuant using the Mock lodine 125 described in paragraph (a)(7) of this section !
c to the general license in paragraph (a) of this section, at any one loca shall comply e.ith the provisions of h 20.301, 20 402 'and 20.403 of '
tion of storage or use, a total amount of iodine 125, iodine 131, this chapter,-
r' a
NOTES tA State to which certain regulatory authority over radioactive material has been transferred by formal agreement, pursuant to section 274 of the Atomic Energy Act of 1954, as amended.
JMaterial generally licensed u1 der this 6ection prior to January 19,1975 rnay bear labels authorized by the regulations in effect on January 1, 1975..
3A new triplicate set of this Registration Certificate, NRC Form 483, may be used to report any change of information furnished by a registrant
- as required by @ 31.11(el.
Iflarger quantitles or other forms of byproduct meterial than those specified in the general license of 10 CFR 31.11 are required, en "Applica--
t tion for Byproduct Material License," NRC Form 313 should be filed to obtain a. specific byproduct material license, Copies of application and registratiori forms may be obtained from the Medical, Academic and Commercial Use $afety Eiranch (6H3), Division 'of industrial and Medical Nuclear I
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Safety, United States Nuclear Regulatory Commission, Washington, DC 20555.
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