ML20249B943

Ack Receipt of Completed NRC from 483 Dtd 980610.Form Condition of General License Under 10CFR31.11 Authorizing in-vitro Testing W/Byproduct Matl Under General License. Form Assigned Registration Number 9141

ML20249B943
Person / Time
Issue date:	06/23/1998
From:	Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Mendiratta K AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9806250084
Download: ML20249B943 (3)

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'"s Jun. re 23,- 1998 m.

K. Virender Mendiretta 1

26699 W.12 Miif Road i Suite 201 '

. Southfield, MI 48034.

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Dear Dr. Mendiratta:

This letter verifies the receipt of the completed NRC Form 483 dated June 10,1998; This form l<

is a condition'of the general license under.10 CFR 31.11 authorizing in-vitro testing with c byproduct material under general license.

g 7The form has been' assigned regi,stration number 9141. - When making changes to any of the

information on the form, please reference the registration number and address the '

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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, d

Traci Kime, Acting Registration Specialist Materials Safety Branch Division of Industrial and -

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Medical Nuclear Safety Office of Nuclear Material Safety j

and Safeguards -

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., er mee rosi as3 U.S. NUCLEAR REGULATORY COMMISSION sPPaoVED oM3: No. 3160C038 expones-2ses

gegl, IOMIERo??EE"Ec'N"ou'EYo?e's'r ?u'**%a*s'E" N REGISTRATION CERTIFICATE-in vitro TESTING -

wears arcaaowo avaoe= estware to ras woauariou WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE SEe"la'EEka"lo'OEE"uIssIS$Usw7E?oNbs"d

$Wel d"'u:Uc2?U UE"EEEd"NE EEn**E 20 sos.

Section 31.11 of 10 CF R 31 satablishes a general license authorizing physicians, clinical laboratories, hospitals, and veterinarians in the practice of veterinary medicine to possess certain small quantities of byproduct material for in v/rro clinical or laboratory tests not involving the internal or external 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 authorized until the physician, clinical laboratory hospital, or veterinarian ir the practice of veterinary medicine, has filed NRC Form 483 and received from the Com.

mksion a validated copy of NRC Form 483 registration number.

2. APPLICATION K, VO RE do#. (16 t/D RATTA l hereby apply for a registration number pursuant to 10 *,FR 31, Section 31.11, for use of byproduct materials for:

MYI Wn t4ILVlW SoMuI A. Myself, a duty licensed physician authorized to dispense drugs in the practice of medicine.

h Mt b df] I N [ d2034 B. The above-named clinical laboratory.

C. The above-named hospital.

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D. Veterinarian in the practice of veterinary medicine.

1. INSTRUCTIONS:

3. R EGISTR ATf 0N A. Submit this form in triplicate to:

Medical, Academic and Commercial Use Fafety Branch 46H3)

REGISTR ATION NUMBER:

Division of Industrial and Medical Nuclear Safety Of fice of Nuclear Ma,terial Safety and Safeguards 9101 U.S. Nuglear Regulatory Commission WashingtQn,*DC 20555 fe neog%

(At NRC, a registration number will be assigned y=

4 U.G WLUR NMTORY end a validated copy of NRC Form 483 will be S

CW NIPSION

,j returned.)

%)d B. In the box above, print or type the name and address

,o (including ZIP Code) of the registrant physician

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g 7/'y clinical laboratory, hospital, or veterinarian in the y,yg g g practice of veterinary medicine for whom or for 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 previously registered general license, include your registration number.)

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~ 4. If place of use is different from address listed above, give complete address:

5. CE RATIFICATION 1 hereby certify that:

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 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 byproduct materials.

C.

I understand that Commission regulations require that any change in the information furnished by a registrant on this registration l

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, i

acquires, possesses, uses, or transfers under the general license for which this Registration Certificate is filed with the U.S. Nuclear Regulatory Commission.

lDATE PRINTEO OR TYPED N AME AND TITLE OF APPLICANT l SIGNATURE;OF APPLICANT 4

h.\\llRGHikit MNDI CitT9,thO

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h %\\RV WA7.NING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL ANDIOR CRIMINAL PENALTIES. NRC REGULATIONS i

REQUIRE TH AT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCUR ATE IN ALL MATERI AL 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 l

UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.

{! -. WMC FOHu 483 i4401

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CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31,11

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

vitro clinical or laboratory testing.

(2) The general licenses shall store the cyproduct material, until used, in the original shipping container or in a container providing

- (a)' A general Ilconse is hereby issued to any physician, veterinarian equivalent radiation protection.'

in the practice of veterinary medicine,clinicallaboratory or hospital to (3) The general licenses shall use the byproduct materist OM/ for receive, acquire, possess, transfer, or use, for any of the following stated the uses authorized by paragraph (a) of this section, tests, in etcordance with the provisions of paragraphs (b), (c),(d), (e),

(4) The general licensee shall not transfer the byproduct material and (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:

1 pursuant to this chapter or from an Agreement State,3 rior transfer the (1) todine-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 su'pplier, admiriistration of byproduct material, or the radiation therefrom, to

. (5) The general licensee shall dispose of the Mock lodine 125 human beings or animalsJ reference or calibration sources described in psagraph (a)(7) of this (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 rnaterial, of the radiation therefrom,

, byproduct material pursuant to paragraph (a) of this section:

to human beings or animals.

(1) Except as pmpackaged units which are labeled in accordance (3) Carbon-14, in units not exceeding 10 mlerocuries 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

@ 3M1'of this chapter or in accordance with the provlsions of a administration of byproduct meterial, or. the radiation therefrom, speciflJ license issued by an Agreement State that authorizes manufac-L.,c a d distributhn of lodine-125, lodine-131, carbon-14, hydrogen 3

- 13 human beings or animals.

n (4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (tritium), selenium 75, iron-59 or Mock todine-125 for distribution to each for use in in vitro clinical or laboratory tests not involving interns!

persons generally licensed by the Agreement State, or external administration of byproduct material, or the radiatlan (2) Unless the following statement, or a, substantially similar therefrom, to human beings or animals.

statement which contains the information called for. In the foflowing (5) f ron 59, in units not exceeding 20 microcuries each for use in in y statement, appears on a label affixed to each prepackaged unit or vitro clinical or laboratory tests not involving internal or external appears in a leaflet or brochure which accompanies the ' package:2 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, veterinarians in the practice of veterinary (6) Selenium 75, in units not exceeding to microcurles 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, to human beings or animals.

' its receipt, acquisition, possession, use, and transfer are subject to the (7) Mock fodine-125 reference or calibration sources, in units not

. regulations and a general license of the U.S. Nuclear Regulatory Com-cxceeding 0.05 microcurie of lodine 429 and 0.005 microcurie of mission or of a State with which the Commission has entered into en americium-241 each for use in in vitro clinical or laboratory tests not

agreemers 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 material under the general license established by paragraph Name of manufacturer h) of this see:lon unless that person:

(1) Has filed NRC Form 483, " Registration certificate-in Vitto (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 Nuclew Material Safety and Safeguards any changes l

ftgulatory 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 ef fective date of such change,3 material that was issumi 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 (s) 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 (1) The general licensee sha!! 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 comply with the provisions of 20.301,20.402 and 20.403 of tion of storage or use, a total amount of lodine 125, iodine 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, i

2 Material generally licensed under thls section prior to January 19,1975 may bear labels authorized by the regulations In effect on January 1 j

1975.

1 3 A nevv triplicate set of this Registration Certificate, NRC Form 483, may be used to report any change of information furnished by a registrant I

as required by @ 31.11(e),

f

, 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 registration forms may be obtained from the Medical, Academic and Commercial Use Safety Bonch (6H3), Division of industrial erw.1 Medical Nuclear l

- Sefety, United States Nuclear Regulatory Commission, Washington, DC 20555.

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