ML20247H674

Verifies Receipt of Completed NRC Form 483 Dtd 980402.Form Re Condition of General License Under 10CFR31.11 Authorizing in-vitro Testing W/Byproduct Matl Under General License. Form Assigned Registration Number 1823

ML20247H674
Person / Time
Issue date:	05/17/1998
From:	Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Marcial M AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9805210226
Download: ML20247H674 (2)

Text

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, May 17,1998 l

Las Marias Reference Lab., Inc.

ATTN: Manuel A. Marcial, MD FCAP Ave. Munos Rivera Rio Piedras, PR

Dear Dr. Marcial:

This letter verifies the receipt of the completed NRC Form 483 dated April 2,1998. This form is a condition of the general license under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under generallicense.

The form has been assigned registration number 1823. 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, Traci Kime, Acting Registration Specialist Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards DISTRIBUTION: f I; SBaggett IMNS r/f NEO3  !

DOCUMENT NAME: P:\MARCIAL.483 To rective a copy of this document, Indicate in the box: 'C' = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE MSB l l _

NAME TKime (_//i Ov<'

DATE _5//498 @

OFFICIAL RECORD COPY

'OOCC.2 9805210226 900517 PDR RC

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APPROVED oms: No. 315oo038 l FORM 483 U.S. NUCLEAR REGULATORY COMMISSION E XPlR ES: 22993 1

ESTIMATED SURDEN PER RESPONSE To COMPLY WITH THis INFoRMATION COLLECTION REoVEST: 7 MIN. FORWARD coM-uENTs REoARDmo sURDEN EsriuAre To TsE ,NeoRMAT,oN REGISTR ATION CERTIFICATE-in vitro TESTING "^ ^" ' "

SEE"'NELATo"R7'E*MIss'"N S GT W o 06 WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE AND To THE PAPERWORK REDUCTION PROJECT (3150 0038),

OF FICE oF MANAGEMENT AND BUDGET, WASHINGTON, DC 20501 stion 31.11 of 10 CF R 31 establishes a general license authorizing physicians, clinical laboratories, hospita's, and veterinarians in the practice Gficine to possess certain small quantities of byproduct material for in virro clinical or laboratory tests not involving the Internal or extern 7 the byproduct material or the radiation therefrom to human beings or animals. Possession tssion a villdIted copy of NRC Form 483 registration number.

2. APPLICATION LAS MARIAS REFERENCE LAB., INC. I hereby apply for a registration number pursuant to 10 CFR 31, Section 31.11, for use of byproduct materials for:

AVE. Hun 07 HIVERA (Check one box only)

R1U YIEDRAS, P.n.

A. Myself, a duly licensed physician authorized to dispense drugs in the practice of medicine.

x B. The above named clinicallaboratory. ,

C. The above-named hospital.

D. Veterinarian in the practice of veterinary medicine.

INSTRUCTIONS: I

h. Submit this form in triplicate to: 3. R EGISTR ATION Medical, Academic and Commercial Use Safety Branch (6H3) REGISTRATION NUMBER:

Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Pc1 l J

Washington, DC 20555 p REoy,

[\ o .

(At NRC, a registration number will be assigned yq, 4U sclear W latO( CO: u .

and a validated copy of.NRC Form 483 will be  ; () S ,

returned.)

' 3 @ 'g([,n up l l n

%%b* V ,Lo(G

@. In the box above, print or type the name and address ,

(including ZIP Code) of the registrant physician / ,/

• * 'J,*

' -P clinical laboratory, hospital, or veterinarian in the , . .

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practice of veterinary medicine for whom or for MM u J+W _N l!

which this registration form is filed.

(if this is an initial registration, leave this space blank - number to be assigned by NRC. If this is a change ofinformation from a paviously registered generallicense, include your registration number.)

L If place of use is different from address listed above, give complete address; n/c

5. CERTI FICATION l hereby certify that: ' - .

I A. All information in this registration certificate is true and complete.

B. The registrant has appropriate radiation measuring instruments to carry out the tests for which byproduct material will be used under I

i the general license of 10 CF R 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. N / l i

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 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 hAN0fY'*T.N N b"AL hu FCAP PRINTED OR TYPED NAME AND TITLE OF APPLICANT l SIGNATURE OF APPLICANT lDATE

& ' f ~/ /,

WARNIN2: FALSE STATEMENTS IN THIS CERTIFICATE 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, I

mRc FORM as3 neon REGISTRANT'S COPY

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CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11

@ 31,11 General license for use of byproduct materials for certain in selenium 75, and/or iron 59 in excess of 200 microcuries.

vitro clinical or laboratory testing. (2) The general ficensee shall store the byproduct material, until used, in the original shipping container or in a container providing (a) A general license is hereby issued to any physician, veterinarian equivalent radiation protection. l in the practice of veterinary medicine,clinicallaboratory or hospitalto (3) The general licenses shah use the byproduct material only for receive, acquire, possess, transfer, or use, for any of the following stated the uses authorized by paragraph (a) of this section.

13sts, in accordance with the provisions of paragraphs (b), (c),(d. (e), (4) The general licensee shall not transfer the byproduct material snd (f) of this section, the following 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 an Agreement State,I nor transfer the (1) lodine-125, in units not exceeding 10 microcuries each for use byproduct material in any manner other than in the unopened, labeled )

in in vitro clinical or laboratory tests not involving internal or external shipping container as received from the supplier, l administration of byproduct material, or the radiation therefrom, to (5) The general licensee shall dispose of the Mock lodine-125 human beings or animals. )

reference or calibration sources described in paragraph (a)(7) of this 1 (2) lodine-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 external (d) The general licensee shall not receive, acquire, possess, or use administration of byproduct material, or the radiation therefrom, byproduct material pursuant to paragraph (a) of this section:

to human beings or anirnals. (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 internal or external 32.71 of this chapter or in accordance with the provisions of a administration of byproduct material, or the radiation therefrom, specific license issued by an Agreement State that authorizes manufac-to human beings or animals. ture and distribution of iodine 125, iodine-131, carbon-14, hydrogen-3 ,

(4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (tritium), selenium 75, iron-59 or Mock lodine 125 for distribution to I each for use in in vitro clinical 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 fofiowing (5) Iron 59, in units not exceeding 20 microcuries each for use in in statement, appears on a label affixed to each prepackaged unit or i vitro clinical or laboratory tests not involving internal or external appears in a leaflet or brochure which accompanies the package:2 l administration of byproduct material, or the radiation therefrom, to This radioactive material may be rec Pived, acquired, possessed, and human beings or animals. used only by physicians, veteri arians 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 clinical in in vitro clinical 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 human beings or animals. I to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the (7) Mock todine 125 reference or calibration sources, in units not regulations and a general license of the U.S. Nuclear Regulatory Com-exceeding 0.05 microcurie of lodine-129 and 0.005 microcurie of mission 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 agreement for the exercise of regulatory authority, involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals, (b) A person shall not receive, acquire, possess, use or transfer byproduct materlaf under the general license established by paragrap5 Name of manufacturer (a) of this section unless that person:

(1) Has filed NRC Form 483, Registration Certificate-In Vitro (e) The registrant possessing or using byproduct materials under the Testing with Byproduct Material Under General License /' with the general license of paragraph (a) of this section shall report in writing to Director of Nuclear Material Safety and Safeguards, U.S. Nuclear the Director of Nuclear Material Safety and Safeguards any changeL Regulatory Commission, Washington, D.C. 20555, and received from in the information furnished by him in the " Registration Certificate-In the Commission a validated copy of NRC Form 483 with registration Vitro Testing with Byproduct Material Under General License," NRC number assigned; or Form 483. The report shall be furnished within 30 days after the (2) Has a license that authorizes the medical use of byproduct effective date of such change 3 material that was issued under Part 35 of this chapter. (f) Any person 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 exempt from the requirements material 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 following: materials covered by that general license, except that such persons l (1) The general licensee shall not possess at any one time, pursuant using the Mock fodine-125 described in paragraph (a)(7) of this section to the general license in paragraph (a) of this section, at any one loca- shell comply with the provisions of @ 20.301,20.402 and 20.403 of tion of storage or use, a total amount of iodine 125, lodine 131, this chapter.

NOTES 3 A 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.

2 Material generally licensed under this section prior to January 19,1975 may bear labels authorized b) 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 es required by @ 31.11(e).

If larger quantities 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," NRC Form 313 should be filed to obtain a specific byproduct material license. Copies of application and l registration forms may be obtained from the Medical, Academic and Commercial Use Safety Branch (6H3), Division of Industrial and Medical Nuclear Safety, United States Nuclear Regulatory Commission, Washington, DC 20555.

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