ML20217G135
| ML20217G135 | |
| Person / Time | |
|---|---|
| Issue date: | 10/18/1999 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Ketels C AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9910210194 | |
| Download: ML20217G135 (2) | |
Text
_j Octob:r 18,1999 g_
Shores Medical Associates, PLLC !
ATTN: Clarita S. Ketels, D.O.
ie 25200 Little Mack St. Clair Shores, MI 48081
Dear Dr. Ketels:
This letter verifies the receipt of the completed NRC Form 483 dated October 4,1999. This form is a condition of the generallicense under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.
The form has been ass'gned registration number 9172. When making changes to any of the i 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 assistal.ce, please contact me at (301) 415-8140.
Sincerely, S
Traci Kime, Registration Specialist Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards-DISTRIBUTION: - -
IMNS r/f NEO3 d b DOCUMENT NAME: H:\TRACl\Ketels.483.
T9,eceive a copy of this document,indicato in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure *N* = No copy OFFICE MSIB l l l NAME TKimed DATE 10//f/99 i OFFICIAL RECORD COPY
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9910210194 991018 PDR RC
- SSD PDR
a NRC (ORM 4BT (0 90) U.S. NUCLEAR REGULATORY COMMISSION APPROVED OMa; No. 31504038 10 0FH 31 E XPlREs. 2 29 93 ESTIMATED BURDEN PER RESPONSE TO COMPLY WITH THIS REGISTRATION CERTIFICATE-in vitro TESTING EESTs"E*REERTEN EsEYEEE Ne*o^a"M$o"N WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE OELEd*EE'n" tor ^*' $*Miss'c"4TsfN?to[o'EiE5I AND To THE PAPERWORK REDUCTtoN PROJECT (3150403BL OF FIC E OF M AN AGE ME NT AND BUDGET. WASHINGTON. DC 20503.
Section 31.11 of 10 CFR 31 establishes a generallicense authorizing physicians, clinicallaboratories, hospitals,and veterinarians in the practice of ve medicine to possess certain small quantities of byproduct material for in vitro 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 autho.ized until the physician, clinical laboratory, hospital, or veterinarian in the practice of veterinary medicine, has filed NRC Form 483 and received from the Com.
mission a validated copy of NRC Form 483 registration number.
- 2. APPLICATION SHORES MEDICAL ASSOCIATES, " LC , l hereby apply for a registration number pursuant to 10 CFR 31, CLARITA S. KETELS, D.O. Section 31.11, for use of byproduct materials for:
25290 LITTLE MACK # " "
ST. CLAIR SHORES, MI 48081 Myself, a duly licensed physician authorized to dispense drugs in the practics of medicine.
B. The above named clinical laboratory.
- .. . .s 4 i . , , . , . ,. C. The abovemamed hospital.
- D. Veterinarian in the practice of vetennary medicine.
- 1. INSTRUCTIONS:
A. Submit this form in triplicate to: 3. REGISTR ATION Medical, Academic and Commercial Use Safety Branch (6H3)
Division of industrial and Medical Nuclear Safety REGISTR ATION NUMBER:
Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission (M 7
Washington, DC 20555 gR REo
' (At NRC, a registration number wl11 be assigned j g rm m"- m m mvm _ '
y< 4 %, _ , m.
cnd a validated copy of NRC Form 483 will be ; e S returnedJ rn hj o
B. in the box above, print or type the name and address (including ZIP Code) of the registrant physician k ***** ,o*g
/
clinical laboratory, hospital, or veterinarian in the - /.
f practice of veterinary medicine for whom or for which this registration form is filed. (d A d 'NiN" b' ^ N! F (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 generallicense, include your registration number.)
4.11 place of use is different from address listed above, give complete address:
, 5. CERTIFICATION I hereby certify that:
A. All information in this registration certificate is true and .:omplete.
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 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.
C. I understand that Commission regulations require that any change in the infonnation furnished by a registrant on this registration certificate be reported to the Director of Nuclear Material Safety and Safeguards vvithin 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.
acquiresi 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 l SIGNATURE OF APPLICANT lDATE CLARITA S. KETELS, D.O. g'[hgy, j /bd )g) /0 77 WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE TH AT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE 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 UtilTED STATES ASi3 ANY MATTER WITHIN ITSJURISDICTION.
NRC FOHM dif 314 90) a
nr ,, w ~w v n, . , p .
4 i
4
> CONDITIONS AND LIMITATIONS OF, GENERAL LICENSE 10 CFR 31.11
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selenium 75, and/or iron 59 in excess of 200 microcuries.
$ 31.11 General Pcense for use of byproduct meterials for certeln in (2) The general licensee shall store the byproduct material, until
~
vitro chnicat or laboratory testing. 4
- .- , _ ..+ . .- . . . used, in the original shipping container or in a container providing equivalent radiation protection.
. k)[A general licNse is herebh issued to any physician, veterinarian
- : in the practice of seterinary medicine, clinical laboratory or hospital to (3) The general licensee shall use the byproduct material only for receive, e. quire, possess, transfer, or use, for any of the following stated - the uses authorized by paragraph (a) of this section, tests,in accordance with the provisions of paragraphs (b), (c),(d), (e), (4) The general licensee shall not transfer the byproduct material
- "and (f) of this's'oct'on, the following byproduct materials in prepacks except by transfer to a person authorlied to receive it by a license aged units: -
pursuant to this chapter or from an Agreement State,1 nor transfer the (1) lodine-125;ln 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, i . cdministration of tsyproduct material, or the radiation therefrom, to (5) The general licensee shall dispose of the Mock lodine 125 I human beings or animals. . .
reference or calibration sources described in paragraph (a)(7) of this (2) loc'ine 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 licenses shall not receive, acquire, possess, or use administration of byproduct rnatorial, or the radiation therefrom, byproduct material pursuant to paragraph (a) of this section:
to human oeings or animals. "
4 y (1) Except as prepackaged units which are labeled in accordance
- (3) Carbon 14, in units not exceeding 10 microcuries each for use 2 with the provisions of a specific license issued under the provisions of "In in vitr3 clinical or laboratory tests not involving Internal or external ~' N 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 lodine 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 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 a therefrom, to human beings or animals. ~ statement which contains the'Information called for in the following (5) f ron 59,in units not exceeding 20 microcuries each for use in in : statement, appears on a label offixed to each prepackaged unit or vitro clinical or laboratory testt not involving internal or external appears in a leaflet or brochure which accompanies the package:2 sdministration 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 10 microcuries each for use , medicine, clinical laboratories or hospitals and only for in vitro clinical 3
in in vitro clinical or laboratory tests not involving internal or external t or laboratory tests not involving internal or external administration of administration of byproduct material, or the radiation therefrom, ' the material of 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 lodine-125 reference or calibration sources,in units not regulations and a general licensehf the U.S. Nuclear Regulatory Com-cxceeding 0.05 microcurie of lodine.129 and'O.065 microcurie of mission or of a State with which the Commission has entered into an
.smericium-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 material under the general license established by paragraph Name of rnanufacturer
{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 Safegurds, U.S. Nuclear the Director of Nuclear Meterial Safety and Safeguards any changes Rigulatory Commission, Washington, D.C. 20555, and received from in the Information furnished by him in the " Registration Certificate-In the Commission a vaildated 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 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 p . 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 inall comply with the following: materials covered by that general license, except that such persons (1) The general licensee.shall not possess at any one time, pursuant using the Mock todine.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 f
r tion ' of storage or use', a total amount of lodine 125, lodine 131, this chapter,
. , NOTES
' 1 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 by the regulations in effect on January 1, i 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
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[ ' as rehulred by { 31.11(e).
4- 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 s registration forms may be obtained from the Medical, Academic and Commercial Use Safety Branch (6H3), Division of industrial and Medical Nuclear I ' Sufety, United States Nuclear Regulatory Commission, Washington, DC 20555.
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