ML20217G267
| ML20217G267 | |
| Person / Time | |
|---|---|
| Issue date: | 10/18/1999 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Asfaw E AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9910210240 | |
| Download: ML20217G267 (2) | |
Text
1 October 18,1999
. Detroit Medical Center "ATrN: Elizabeth Asfaw, Administrator Clinical Laboratories, Inc.
240120* Street -
Detroit, MI 48216
Dear Ms. Asfaw:
This letter verifies the receipt of the completed NRC Form 483 dated October 6,1999. 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 assigned registration number 4650. 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,
/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 NEO DOCUMENT NAME: H:\\TRACl\\Ketels.483 7a receive e copf of this docuenent, Indicate in the boa: *C' = Copy without attachment / enclosure "E" = Copy with attachment / enclosure
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NRC Form da3 U.S. NUCLE AR REGULATOR Y COMMIS$60N Approvio by G AO 3%
38.Ro36o REGISTRATION CERTIFICATE-IN VITRO TESTING Jo CFR 3)
WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE
. Section 31.11 of 10 CFA 31 estabhshes a general licer.se authorizing physicians, chnical laboratories, and hospitals 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 authorized until the physician, clinical laboratory, or hospital has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with registration number, e
e Detroit Medical Center Clinical Laboratories,
- 3. I hereby apply for a registration number pursuant to
@31J1.10 CFR 31 for use of byproduct materials for TDC.
(please check one block only) 2401 20th. Street O a. Myself.a duly ticensed physician authorized to dispense drugs m the practice of medicine.
' Detroit, MI.
48216 3 b. The above-named eiinicar iadoratory.
O c. The above-named hospital.
- 4. To be completed by the Nuclear Regulatery Commission.
INSTRUCT 10NS Registration number 4 6 5 0
- 1. Submit this form in tripheate to:
Office of Nuclear Material Safety and Safeguards FORTHEU.S.NU,GMTanacDSQLATORYCOMMISSION RR ATTN: Radioisotopes 1 icensing Branch S
U.S. Nuclear Regulatory Coramission y
Washington. D.C. 20555 E
.E
- 2. Please prmt or type the navne and address (includ.
k
- C[
ing zip codel of the registrant physician, chmcal i
laboratory. or hospital for whom or for which 10//[/9f * * *
- this registration form is filed. Position the first Traci "
lettet on the address below the left dot and do (If this is an initial regis ration, leas e this space blant - number to be not ex1end the address beyond the right dot. (At assigned by NRC. If thss is a change of mformation from a pres iousiv NRC, a registration number will be assngned and regustered generallicenser. include your registration numberJ '
a vahdated copy.cf NRC 1-orm 483 will be re-turned.1
- 5. If place of use is different from address in Item I, please give complete address:
- 6. Cerufication:
I hereby certify that; All mformation in this registration certificate is'true and complete.
s.
- b. The registrant has appropriate radiation measuring mstruments to carry out the tests for w hich 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 handimg 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 Safeguarda within 30 days from the effective date of such change.
J
- d. I have read and understand the provisions of Section 31,11 of NRC regulatiet 10 CFR 31 (reprinteJ on the reverse side o. this form).
{
and I understand that the registrant is required to comply with those provisions a to all byproduct rnaterial which he receives, acquires.
powesses.uses.or transfers under the general beense for which this Registration Certificate is filed with the Nuclear Regulatory Commission.
l Date /04~99 By 0)
IAA f 1
(/.
Signature of pedfr6n fihng form f// 7 A 8CTH ASM W * /lOHHW//7AM02, Printed name and title or position of person fihng form WARNING-18 U.S.C.,Sectic>n t001; Act of June 25,1948;62 Stat. 749;makes it a criminal offense to make a willf ully f asse statement or representatson to any department or agency of the Un ted States as to any matter within in jurisdiction.
i CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31,11
$ 31.11 General license for use of by oduct Refulatory Commission, Washington, D.C.
(1) Except as prepackaged units which are 20 55, and received from the Commission a labeled in accordance with the provisions of a materials for certain in vitro clinical or labora-i tory testing.
validated copy of NRC Form 483 with regis-cific license issued under the provisions of l
tration number assigneg or until he has been 32,71 of this chapter or in accordance with i
(a) A general license is hereby issued to authorized pursuant to 9 35.14(c)of this chap-e provisions of a specific license issued by an any physician, clinical laboratory or hospital ter to use bypro uct material under the general Agreement State that authorizes inanufacture j
to receive, acquire, possess,ttsnsfer,or use, for license in this 31.11. The registrant shall and distribution of iodine 125, iodine.131 j
any of the following stated tests in accordance furnish on NRC orm 483 the following infor-carbon 14, hydrogen 3 (tritium), or iron-59 4
' with the provisions of paragsaphs (b),(c),(d),
mation and such other information as may be for distribution to persons generally licensed (e), and (f) of this section, the following by-required by that form:
by the Agreement State.
product materials in prepackaged units:
(1) Name and address of the registrant; (2) Unless the following statement, or a (1) lodine 125,in units not exceedmg 10 (2) The location of use;and substantially similar statement which contains microcuries each for use in in vitro cimical or (3) A statement that the registrant has ap-the information called for in the following laboratory tests not involving internal or ex.
propriate radiation measuring instruments to statement, appears on a label affixed to each ternal administration if byproduct material, carry out in vitro cimical or laboratory tests prepackaged unit or appears in a leafleg or or the radiation therefrom, to human beings with byproduct materials as authorized under brochure which accompan es the package:
or animals.
the general license in paragraph (a) of this This radioactive material may be received, (2) lodine 131,in units not exceeding 10 section, and that such tests will be performed acquired, possessed, and used only by physi-1 microcuries each for use in in vitro clinical or only by personnel competent in the use of cians, chmcellaboratories or hospitals and only laboratory tests not involving internal or ex.
such instruments and in the handimg of the for in vitro chnical or.aboratory tests not ternal administration of byproduct material.or byproduct materials.
involving internal or external administration of the radiation therefrom, to human beings or (c) A person who receives, acquires, pos-the material, or the radiation therefrom, to animals sesses or tises byproduc* matenal pursuant to human beings or animals. Its receipt,acquisi-(3) Carbon 14, in units not exceeding 10 the generallicense estabhshod by paragraph (r.)
tion, possession, use, and transfer are sutket microcuries each for use in in vitro clinical or of this section shall comply with the following: to the regulations and a generallicense of the laboratory tests not involving internal or exter-(1) The general licensee shall not possess U.S. Nuclear Regulatory Commission or of a nal administration of byproduct material, or at any one time, pursuant to the general license State with which the Commission has entered the radiation therefrom, to human beings or in paragraph (a) of this section, at any one into an agreement for the exercise of regula-animals.
location of storage or use, a total amount of tory authority.
(4) Hydrogen 3 (tritium),in units not ex-iodine 125, iodine 131, and/or iron 59 in ex-ceedmg 50 microcuries each for use in in vitro cess of 200 microcuries.
Name o' ' 'manu'f'a'ctu'rer f
chnical or laboratory tests not involving inter-(2) The generallicensee shall store the by-nal or external administration of byproduct product material, until used, in the original (e) The registrant possessing or using by-material.or the radiation therefrom,to human shippmg container or in a contamer providing product materials under the general heenw of beings or animals, equivalent radiation protection.
paragraph (a) of this section shall report in (5) Iron 59, in units not exceeding 20 (3) The general licensee shall use the by-writing to the Director of Nuclear Material microcunes each for use in in vitro clinical or product material only for the uses authorized Safety and Safeguards any changes in the in-laboratory tests not involving internal or ex-by paragraph (a) of this section.
formation furmshed by him in the "Registra-ternal administration of byproduct material.
(4) The general heenset shall not transfer tion Certificate-In Vitro Testing with By-or the radiation therefrom, to human beings, the byproduct material except by transfer to a product Material Under General License." NRC or animals.
person authorized to receise it by a heense Form 483. The report shall be furnished uith-(b) No person shall receive, acquire, pos-pursuant to this chapter or from an Agreement in 30 days after the effectise date of such 8
sess, use or transfer byproduct material pur-State,' nor transfer the byproduct materialin change suant to the general license estabbshed by any manner other than in trie unopened, if) Any person using byproduct material paragraph (a) of this section until he has filed labeled shipping container as received from the pursuant to the general hcense of paragraph (a)
NRC Form 483, " Registration Certificate-In suppher.
of this section is exempt from the require-Vitro lesting with Byproduct Material Under (d) The generallicensee shall not receive, rnents of Parts 19 and 20 of this chapter with General License," with the Office of Nuclear acquire, pcaess, or use byproduct material respect to byproduct materiah covered by that Material Safety and Safeguards, U.S. Nuclear pursuant to paragraph (a) of this section:
general heense.
NOTES
' A State to which certain regulatory authority over radioactive material has been transferred by formal agreerr=nt, pursuant to section 274 of the Atomic Energy Act of 1954, as amended.
8 Material generally licensed under this section prior to January 19,1975 may bear labels authorized by the reFulations in effect on Januar> 1.
.1975
- A new triplicate set of this Regration Certificate, NRC Forr's 483. may be used to report any change of information furnished by a registrant as required by $31.Ilte).
If larger quantities or other forms of byproduct material than those specified in the generallicense of 10 CFR 31.11 are required, an "Appli-cation for Byproduct Materir.1 License," NRC Form 313, should be filed to obtain a specific byproduct matenal beense. Copies of application and registration forms may be obtained from the United States Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Radio-isotopes Licensing Branch, Division of Fuel Cycle and Material Safety.
PRIVACY ACT STATEMENT Pursuant to 5 U.S.C. 522a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93 579),the following statement is fur-nished to individuals who supply information to the Nuclear Regulatory Commission on Forms NRC-482 and NRC 483. This information is maintained in a system of records designated as NRC 3 and described at 40 Federal Register 45334 (October I,1975).
- 1. AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C 2111 and 2201(b)).
- 2. PRINCIPAL PURPOSE (S) The information is evaluated by the NRC staff pursuant to criteria set forth in 10 CFR Parts 20-36 to determine whether the appheation conforms to the requirements of the Atomic Energy Act of 1954,as amended, and the regulations of the NRC, for the issuance of a registration certificate authorizing the use of byproduct material for medical use or in vitro testing,
- 3. ROUTINE USES The information may be used: (a) to provide records to State health departments for their information afid use; and (b) to provide information to Federal, State, and local health officials and other persons in the event of incident or exposure for purposes of their mformation, investigation. and protection of the public health and safety. The mformation may also be disclosed to appropriate Federal.
State, or local agencies in the event the information indicates a violation or potential violation of law and in the course of an administrative or judicial procee. ling. In addition, this information.may be transferred to an appropriate Federal, State, or local agency to the extent relevant and necessary for an NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you.
- 4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL OF NOT PROVIDING INFORMATION Disclosure of the requested information is voluntary. If the requested information is not furnished,however,the registration certificate,or amendrnent thereof, will not be processed.
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