ML20154B223
| ML20154B223 | |
| Person / Time | |
|---|---|
| Issue date: | 09/29/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Pokriefka R External (Affiliation Not Assigned) |
| References | |
| SSD, NUDOCS 9810050133 | |
| Download: ML20154B223 (3) | |
Text
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Sspt:mber 29,1998 Michigan infection Care Association ATTN: Dr. Richard A. Pokriefka, D.O.
4321 Metropolitan Parkway Sterling Heights, MI 48310
Dear Dr. Pokriefka:
This letter verifies the receipt rf the completed NRC Form 483 dated September 23,1998. This form is a condition of the general license under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.
l The form has been assigned registration number 9149. 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, N
Traci Kime, Secretary Materials Safety Branch Division of Industrial and Medical Nuclear Safety
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Office of Nuclear Material Safety and Safeguards DISTRIBUTION:
SBaggett IMNS r/f NEO3 d DOCUMENT NAME: A:\\Pokriefk.483 l
To receive a copy of this document, indicate in the boa:
"C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N* = No copy l
l OFFICE MSB NAME TKimedd _
DATE 9/29/98 OFFICIAL RECORD COPY 9810050133 980929 PDR RC SSD PDR l
NRC FonM 4al U.S. NUCLEAR REGULATCRY COMMISSION APPROVED oMe: NO. 3150C338 (4 tot e
EXPlREs: 2-2943 ESTIMATED BURDEN PER RESPONSE To COMPLY WITH THIS REGISTRATION CERTIFICATE-in vitro TESTING EINTs"E'au'NEaEN EsEEE v"El%5os$o"4 WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE CEts"Aa UE0t"^'aYE*MIssEN^*EsEo"o[o'fkoE To NICYOI MAEGEM N AN E
Hi T N C
20503.
Section 31.11 of 10 CFR 31 establishes a generallicense authorliing physicians, clinical laboratories, hospitals, and veterinarians in the practice of veterinary medicine to possess certain small quantitles of byproduct material for in ritto clinical or laboratory tests not involving the Internal or external administration of the byproduct material of 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 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.
M ichf' m 1&c N W" '"
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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:
f g'g Q g 9' Q (Check one box only) ggllf}(;h6\\)lbt
-A. Myself, a duly licensed physician authorized to dispense drugs Y
in the practice of medicine.
B. The above-named clinical laboratory.
j C. The above-named hospital.
D. Veterinarian in the practice of veterinary medicine;
- 1. INSTRUCTIONS:
A. Submit this form in triplicate to:
- 3. R EGIST R ATION Medical, Academic and Commercial Use Safety Branch (6H3)
Division of Industrial and Medical Nuclear Safety REGISTRATION NUMBER:
Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 9149 Washington, DC 20555
[g nEo%
(At NRC, a registration number will be assigned y -
M f.S. NUCIE R REGULATORY and a validated copy of NRC Form 483 will be S
CGNISSION returned.)
aj B. In the box above, print or type the name and address
,o (including ZIP Code) of the registrant physician
- ,,+
clinical laboratory, hospital, or veterinarian in the which this registration form is filed.
Steven L. Faggettr 9/ I ()/9",
practice of veterinary medicine for whom or for
.e
/
(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.)
- 4. If place of use is different from address listed above, give complete address:
4
- 5. CE RTIFICATION J
1 hereby certify that:
r A.
All information in this registration certificate is true and complete.
B.
The regiarant 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 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 Regulatory Commission.
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N Y h lDATE PRINTED OR TYPED NAME AND TITLE OF APPLICANT lS NATURE OF APPLICAN
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WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL ANblOR C;RIMINAL 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.
NHc FORM 48314401 b
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- CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31,11, 7
= @ 31.11 G5neral ficens for 'une of byproduct materials for certain in selenium 75,"anNor iron 59 in excess'of 200 microcuries.
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(2) The general licenses shall store the byproduct material, until vitro clinical or laboratory testing.
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- used, in the original shipping container or in a container providing W--
e
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, ' (al' A general license is hereby issued to any physician, veterinarian - - equivalent radiation protection.-
k-(3) The general licensee shall use the byproduct material only for f in the practice of veterinary medicine, clinical laboratory or hospital to
.the uses act5orized by paragraph (e) of this section.
9_
I receive, acquire, possess, transfer, or use, for any of the following stated y
- tests, in accordance with the provisions of paragraphs (b), (c),(d),(e),
(4) The t;eleral licenses shall not transfer the byproduct material.
and (f) of this section, the following byproduct materials in prepack-except t,y (fansfer to a person authoeirM to ceceive it by a license 4
aged units:
. j pursuant to this chapter or from an Apreement State) nor tran.sfer +he'
'(1) lodine-125;ln units not exceeding 10 microcuries each for use
- byproduct material in any manner other than in the unopenad, labeled '
---w-l in in vitro clinical or laboratory tests not involving internal or external
.. shipping container as received from the supplier.
. administration of byproduct material, or the radiation therefrom, to1
- (5),The general licensee shall dispose of the Mock' lodine-125 y
e C reference or edibration sources described in paragraph (a)(7) of this
-P human beings or animals.;
(2) lodine-131, in units not exceeding 10 microcuries each. foe use I section as required by 20.301 of this chapter.
Il } '
in in vitro clinical or laboratory tests not involving internal or external -
., (d) The general licensee shall not receive, acquire, possess,or use
_aoministration of byproduct. material, or the radiation therefrom, i byproduct material pursuant to paragraph (a) of this section:
(1) Except as prepackaged units which are labeled in accordance t a human beings or animals...
l-
- (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 'clinicalmr laboratory tests not Involvintrinternal or external ' ' @ 32.71' of this chapter or in accordarice with the provisions of a J + dadministration ' 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 ??
'(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 internal persons generally licensed by the Agreement State, or external administration of byproduct material, or the radiation (2) Uniess the following statement, or a substantially similar therefrom, to human beings or animals.
- statement which contains the information called for in the following T
(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 L vitro clinical or laboratory tests not involving internal or ext'ernal 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 i
~ (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 4
. 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 4
(7) Mock lodine 125 reference or calibration sources,in units not l regulations and a general license of the U.S. Nuclear Regulatory Com-cxceeding 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.
l sgreement for the exercise of regulatory authority.
involving internal or external administration of byproduct material, or i
the radiation therefrom, to human beings or animals.
[
. (b) A person shall not receive, acquirei possess, use or transfer g.
. byproduct material,under the general Ilcense established by paragraph Name of manufacturer
~
(1) of this section unless that person:
' 1(1) Has filed NRC Form 483, " Registration Certificate-In VitroL *
(e) The registrant possessing or using byproduct materials under the
~I 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 changes Regulatory Commission, Washington, D.C '9556, and received from in the information furnished by him in the " Registration Certificate-In L-
- the. Commission a validated copy of NRC h..m 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 3
(2) Has a license that authorizes the medical use of byproduct effective date of such change.3
'C
~ material that was issued under Part 35 of this chapter. '
(f) Any person using byproduct material pursus*nt 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
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- material pursuant to the general license established by paragraph (a) of
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this section shall compty'with the following:
of Parts 19, 20 and 21 of this chapter with respect to byproduct -
materials covered by that general license, except that such persons (1) The general licenses 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-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, lodine 131, this chapter.
NOTES 3 A State to which certaln. regulatory authority over radioactive material has been transferred by formal agreeme'n!, pursuant to section 274 of the Atomic Energy Act of 1954, as amended.
2 L Material generally licensed under this section prior to January 19,1975 may 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 l
as required by @ 31.11(e).
. If.iarger quantitles or other forms of byproduct material than those specified in the general license of 10 CFR 31.11 are required, an Applica-j,
- w x tion for Byproduct Material License /' NRC Form 313 should be filed to obtain a specific byproduct material license. Copies of application and
,4 registration forms may be obtained from the Medical, Academic and Commercial Use Safety Branch (6H3), Division of industrial and Medical Nuclear 1
L C'fety United States Nuclear Regulatory Commission, Washington, DC 20555.
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