ML20247H388
| ML20247H388 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Wahab I AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9805210151 | |
| Download: ML20247H388 (3) | |
Text
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May 17,1998 Dearborn Medical Laboratory-ATTN: lbrahim Wahab, Ph.D.'
10801 W. Warren Ave.
Dearbom,
MI 4812G
Dear Dr. Wahab:
This letter verifies the receipt of the completed NRC Form 483 dated April 20,1998. This form 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 9136. When making changes to any of the E 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, h/
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) lI
- DOCUMENT NAME:
To sensive e cop ' of this document indicate in the boa: 'C" = Cooy without ottachment/ enclosure "E" = Copy with attachment / enclosure *N" - No t w y OFFICE MSB l l l
' l l NAME TKime 7Ai .
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DATE 5////98 >/'/N OFFICIAL RECORD COPY
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l NRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150 0038 EXPIRES: 6-3099 Esbmeted burden rer response 2 comply with the mandatory mformat on
( collection request 7 m,r.utes The vahdated registration se#wes as owdence REGISTRATION CERTIFICATE -In vitro TESTING "r,*"lfc*t ,, ',,M"",d 1',",,',o' % ,"l.*,'",,""O',0e'~'%
WITH BYPRODUCT MATERIAL UNDER '"*""f" T,'.n,",*"" "','s*,',G'"' o**"'"2$s'sS'l ".'d n, "'7' Paperwork Reduction Protect (3150 0038), othce of Management and GENE L LICENSE Budget. Washmgton, oC 20503 NRC may not conduct et sponsor. and a
,( person as not requered b recemd to, a collechon af mformanon unless it displays a curroney valid OMB control number Section 31.11 of 10 CFR 31 estabhshes a general heense authonzing physicians, clinical laboratories, hospitals, and veterinarians in the practice of veterinary medicine to possess certain small quantities of byproduct material for in vftro clinical or laboratory tests not involving the intemal or extemal administration of the byproduct material or the radiation therefrom to human beings or animals. Possession of byproduct materlat under 10 CFR 31.11 is not j authonzed 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 registration number. '
- 1. NAME AND ADDRESS OF APPLICANT (See instruebon 3.B. below) 2. APPLICATION (Check one box only) j i hereby apply for a registration number pursuant to 10 CFR 31, Section DML (pedrbo'rn. Medi, cal Labpratory)
. r 31.11, for use of byp oduct materiais for:
Ibrahim Wahabs Ph.D. A. Myself, a duty licensed physician authorized to disperse drugs in 10801 W. Warren Av1 the practice of medicine.
Dearborn,
MI 48126 mB. The above-named chnicailaboratory.
C. The above named hospital.
g } g daAmeco")
D Vetennanan in the practice of vetennary medicine g gg, 4. REGISTRATION A. Submit this form in Juphcate to:
REGISTRATION NUMBER: '
Medical, Academic and Commercial Use ,
Safety Branch (T-8 FS) 9139 Division of industrial and Medical Nuclear Safety /ga nro y" ' #
1 p
,d Office of Nuclear Material Safety and Safeguards y" -
" N-n '
g U.S. Nuclear Regulatory Commission g g Washington, DC 20555-0001
- g (At NRC, a registration number will be assigned and a validated copy of NRC Form 483 will be retumed.)
B. In the box above, print or type the name, address (including ZIP
- h. 30 t 1. $/ h /rA Code), and telephone number of the registrant physician, clinical (if this an ini#alregistra00n, leave this space blank - number to be laboratory, hospital, or veterinarian in the ptactice of vetennary assigned by NRC. If this is a change ofin/brmadon from a preWously medicine for whom or for whsch this registration form is filed. registered gensralIcense, include your registrabon number.)
- 5. If place of use is different from address hsted above, gtve complete address:
miA
- 6. CERTIFICATION, _, _ _
i hereby certify that: q A. All information in this registration certificate is true and complete.
B. The regestrant has appropnate radiation measuring instruments to carry out the tests for which byproduct matenal will be used under the general license of 10 CFR 31.11. The tests will be peti ~ormed only by personnel competent in the use of the instruments and in the handhng of the byproduct materials.
C. I understand that Commission regulations require that a change in the information fumished by a registrant on this registration certificate be reported to the Director of Nuclear Matertal 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 regulatior.410 CFR 31 (reprinted on the reverse side of this form); and I understand that the registrant is required to compty with those provisions as to all byproduct material which he receives, acquires, possesses, uses, or transfers under the general heense for which this Registrahon Certificate is filed wtth the U.S. Nuclear Regulatory C ;mmission.
- PRINTED OR TYPED NAME AND TITLE OF APPLICANT St ATU E OF APPUCANT DATE 3 % M id W M O- h
- k CA..N O AO %
WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CML AND/OR CRIMINAL PENALTIES. NRC REGU!.ATIONS 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.
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o *e u CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFH 31.11 wienium-75, and/or iron 59 in excess of 200 microcuries.
@ 31,11 Generaf !! cense for use of byproduct materials for certeln in vitro clinical or laboratory testing. (2) The general licensee shall store the byproduct material, until -
used, in the original shipping container or in a container providing la) A general Ucer.se is hereby issued to say physician, vets. inarian equivalent redation protection.
In the practics of veterinary medicine, clinical laboratory or hospital to (3) The generaf licenses shall 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, tests,in accordance with the provislans of paragraphs (b), (c),(d),(e), (4) The genera! ileensee shall not transfer the byproduct material and (f) of thir, section, the fo!!owmg byproduct materials in prepaa- except by transfer to a person authorized to receive et by a license aged units: .
pursuant to this chapter or from an Agreement State / nor transfer the (1) lodine 125, in units not exceeding 10 microcuries each for use byproduct meterial 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 suppher, 1 administration of byproduct rnaterial, or the radiation therefrom, to (5) The general hcensee shad dispose of the Mock lodine.125 human beings or anlrnals, reference or calibration sources described in paragraph (a)(7) of this (2) Iod no-t31, in units not exceeding 10 microcuries each for use section as required by { 20.301 of this chapter. -
in in vitro clinical or laboratory testa not involving .nternal 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 animals. (1) Except as prepackaged units which are labeled in accordance (3) Carbon-14, in unas not exceeding 10 microcuries each for use with the provisions of a specific heen6e issued under the provisions of -
_ in in vitro clinical or laboratory tests nor involving internal or enternal $ 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 anin.als. ture and distribution of lodine-125, rodine 131, carbon.14, hydrogen 3 (4) Hydrogen 3 (tritium), in units not exceeding 50 microcuries (trhiumi, se6enium-75, iron-59 or Mock todine 125 for distribution to
, each for use in in vitro clinical or 1sboratory tests not involving internal persons generaHy ficensed by the Agreement Stste.
or external administration of byproduct material, or the radiat6on (2) Unless the following st at ement , or a substantially similar therefrom, to human bemgs or animais. statement which contains the information called for in the following (5) iron S9,in units not enceeding 20 microcuries each for use in in 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 packaged administration of byproduct material, or the radiation therefram, 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 exceed.ng 10 microcuries each for use medicine, chnical laboratories or hospitals and only for in vitro clinical in in vitro clinical or laboratory testo not involving internal or external or laboratory tests not involving internal or external administration of administration of byproduct materia?, or the radiation therefrom, the material or the f adiation therefrom, to hurnan beings or anirnals, to human bemgs or animals. Its receipt, acquisition, possession, use, and transfer are subject to the (7) Mock lodine-125 reference or calibration sources, in units not regulations and a Deneral license of the U.S. Nuclev 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 laborotory tests not agreement for the exercise of regulatory authority.
invofvmg internal or extemal administration of byproduct material, or s the radiafon theref rom, to human beings or animals.
(b) A person shall not receive, acquire, possess. use or transfer byproduct material unther the ger.eral license established by paragraph Name of manuf acturer (s) of this section unless that person:
(1) Has filed NRC Form 483, " Registration Certificate-in Vitro (e) The registrant ponessing or using byproduct rnaterials under the Testing with Bvproduct Material Under General Licensa," with the general license of paragraph (a) of this section shall report in writing to Director of Nuclear Material Sa fety and Safeguards, U S. Nuclear the Director of Nuclear Material Safety and Sdegards bny changes Regulatory Commission, Washmgton, D.C. 20555, and received from 'in the information,fu,rn#shed by him in the " Reg.stration Certihcate-in the Commission a validated copy of NRC Form 4E3 with registration Vitro Testing with Byproduct Material Under General thense " NRC number assigned; or Form 483. The report sha!! be furnished within 30 days after the (2) Has a ficense that authorires the medica! use of byproduct effective date of such change) meterial 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 ue:S byyrrxtuct license of paragraph (a) of this section is esempt from the requiremems material pursuant to the general license established by paragraph (al of of Parts 19, 20 and 21 of this chapter with respect to byproduct this section shall comply whh the following: materials covered by that general license, except that such peisons (1) The ger.eral licenses shari 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 parag-sph (a) of this section, at any one loca- shall comply with the provluons of @ 20.301,20,402 and 20.403 of tion of storage or use, a total amount of iodme 125, lodine 131, this chapter.
NOTES 3 A State to which certairt reguistory authority over radioactive material has been transfer. red by 6rmal agreement, pursuant to section 274 of the Atomic Enargy Act of 1954, as amended. ,
IMaterini generally ficensed under this section prior to January 19,1975 may bear labels authorized by' the regulations in effect on January 1, 1975,
's A new trip!!cale set of this Registration Certificate, NRC Form 483, may be used to report any cha'nga of information furnished by a registrant as required by @ 31.11(e).
9 af iarger quantitles or other forms of byproduct materiet than thpse goecif)ed in the general license of 10 CFR 31.11 are required, an Applica-tion for Byproduct Materiet License," NRC Form 313 should be filed to obtain a apncific byproduct maternal license, Copies of application and registration forms may be obtained from the Medical, Academic and Commercial Use Sofety Branch (OH3), Division of industrial and Medical Nuclear Safety, United States Nuclear Regulatory Commission, Washington, DC 20555.
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