ML20247H596
| ML20247H596 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Levan L External (Affiliation Not Assigned) |
| Shared Package | |
| ML20247H602 | List: |
| References | |
| SSD, NUDOCS 9805210206 | |
| Download: ML20247H596 (3) | |
Text
i
.O ** M y 17,1998 I
Continental Assays Corporation ATTN: Dr. Leon W. Levan One Science Court Madison,WI 53711
Dear Dr. Levan:
This letter verifies the receipt of the completed NRC Form 483 dated April 9,1998. This form is a condition of the general license under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under generallicense.
The form has been assigned registration number 8922. 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, h
Traci Kime, Acting Registration Specialist Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
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DOCUMENT NAME: P1EVAN.483 Te enomhse e onw of this document indcate in the bos: *C" = Copy withou't attachment / enclosure *E' - Copy with attachment / enclosure "N* = No copy OFFICE MSB l- l l l l NAME' TKime '/f 5 %f#
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NRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION APPnoveooyous No.sieseems N y expate3 s.aias s ?@ ,M
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+< - K M.i / N;) EsTaAATED - auRDEN T pen " RE8poNoE ' TO ' ccMPti WITH Ties INFORMATION COLLECTION REQUEST. 7 MINUTES. THE VALIDATED REGISTRATION CERTIFICATE-in vitro TESTING . "70s" ",'ayO^erLgi'" S a
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._WITH BYPRODUCT MATERIAL UNDER1 M .'nE5a % *eu'no"e"N ElE E"^ o Y a E ton
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GENERAL LICENSE n-- -* '
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ur- 3 s i THE PAPERWORK REDUCToN PROECT (31500028); OFFICE OF MANAGEMENT AND BuOGET.. WASHINGTON. DC 20603. . 4 Section 31.11 of 10 CFR~31 establishes' a general license authorizing physicians, clinical laboratories, hospitals, and ' veterinarians'in the' practice of votarinary med6 cine to possess certain smaR quantities of byproduct material for in Wfro clinical or laboratory tests not invoMng the intomat or extemal 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 authortred until the physician, clinical laboratory, hosptal, or veterinarian in the practice of veterinary, medicine, has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with a regi:.tration number.
- 1. NAME AND ADDRESS OF APPLICANT (See Instrucson 3.8. bebw) 2. APPLICATION (Check one box only)
I hereby apply for a registration number pursuant to 10 CFR 31, Section Continental Assays Corporation 31.11, for use of byproduct materials for:
(subsidiary of Bone Care International) A. Myself, a duly licensed physician authortzed to disperse drugs in One Science Court the practice of medicine.
Madison, WI 53711 a s. 7n,,,, n, e ci,nic,n no,,,,y.
SELEPHONE NUMBER (IncAwe hus Code) C. The above named hospital.
(608) 236 250r) D Veterinarian in the practice of veterinary medmine
- 3. INSTRUCTIONS: 4. REGISTRATION A. Submit this form in duplicate to:
REGISTRATION NUMBER:
Medical, Academic and Commercial Use Safety Branch (6 H3) 3922 DMaion of industrial and Medical Nuclear Safety /ps neog'o Offee of Nuclear Matenal Safety and Safeguards y* #g o
U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 E tj U.S. Duclear Regulatory
- Comission (At NRC, a registration number will be assigned and a validated copy of NRC Form 483 tvill be retumed.)
k** A B. In the box above, print or type the name, address (including ZIP St L. q t 5/ M /93 Code), and telephone number of the registrant physcian, clinical (t/ fhis an inleaf tegistradon, leave this space blank - number to be laboratory, hospital, or veterinarian in the practce of veterinary assigned by NRC. If this is a change ofintbrmadon ham a proWously medicine for whom or for which this registration form is filed. I'9'sterod genera / Aconse. include your registra6on number.)
- 5. If place of use is different from address 1:sted above, give complete address:
- (same)
- 8. CERTIFICATION j i hereby certify that; j A. All information in this registration certifcate is true and complete.
B. The registrant has appropriate 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 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 fumished by a registrant on this regatration certifcate be l reported to the Director of Nuclear Material Safety and Safeguards wkhin 30 days from the effective date of such change. j D 1 have read and understand the provisions of Secton 31.11 of NRC regulators 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 Regetrabon Certifcate is filed with the U.S. Nuclear Regulatory Commisosan PRINTED OR TYPED NAME AND TITLE OF APPUCANT SIGNATURE OF APPLICANT DATE Leon W. IcVan, Ph.D.
Di. rector, Assay Development . f , [# April 9,1990 WARNING: FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CIVIL AND/OR CRIMINAL 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.
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. . i CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11 -
$ 31,11 General license for use of byproduct materials for certain in selenium-75, and/or iron 59 in excess of 200 microcuries, 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 (a) A general license is hereby issued to any physician, veterinarian equivalent radiation protection.
, in the practice of veterinary medicine, clinical laboratory or hospital to (3) The general 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 tMs 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 section, the following byproduct materials in prepack- except by transfer to a person authorized to recehre it by a license j aged units: puriuant to this chapter or from an Agreement State,I nor transfer the i (1) ladine-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 supplier, administration of byproduct material, or the radiation therefrom, to (5) The general licensee shall dispose of the Mock lodine-125 human beings or animals. reference or calibration sources described in paragraph (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, j 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 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 units not exceeding 10 microcuries each for use with the provisions of a specific license issued under the provisions of f in in vitro clinical or laboratory tests not involving internal or external 32.71 of this chapter or in accordance with the provisions of a l; 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 iodine-125, iodine-131, carbon-14, hydrogen-3 (4) Hydrogen 3 (tritium), in units not exceeding 60 microcuries (tritium), selenium-75, iror>69 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) Unless the following statement, or a substantially similar therefrom, to human beings or animals, statement which contains the information called for in the following (5) fron 59,in units not exceeding 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 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 10 microcurles each for use medicine, clinical laboratories or hospitals and only for in vitro clinical in in vltro 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 lodine-125 reference or calibration sources, in units not regulations and a general license of the U.S. Nuclear Regulatory Com-exceeding 0.05 microcurie of iodine 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 vitio 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 materlat under the general license established by pacegraph Name of manufacturer (a) of this section unless that person; (1) Has filed NRC Form 483, " Registration Certificate-in Vitro (e) The registrant possessing or using byproduct r.taterials 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 Nuclear Material Safety and Satqluards any changes Regulatory Commission, Washington, D.C. 20555, and received from in the information furnished by him in the "Regir. ration Certificate-in the Commission a validated copy of NRC Form 483 with registration Vitro Testing with Bvproduct Material Under General License," NRC number assigned; or Form 483. The report shall be furnished wthin 30 days after the (2) Has a license that authorizes the medical use of byproduct effective date of such change.3 material that was issued under Part 35 of this chapter. (f) Any person using byproduct materirJ pursuant to the general (c) A person who receives, acquires, possesses or uses byproduct license of paragraph (a) of this section is ersrnpt from the requirements maternal 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: mater 6als covered by that general license, except that such persons (1) The general licensee shall 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 iodine 125, iodine 131, this chapter, NUTES 8 A State to which certain regulatory authority over radioactive material has been transferred by formal agreement, pursuant to section 274 of the i
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 reguistions 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 informa non furnished by a registrant as required by @ 31.11(e). ,
if larger quantities or other forms of byproduct material than those specified in the general license of 10 CFR 31.11 are required, en "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 fmm the Medical, Academic and Commercial Use Safety Branch (6H3), Division of Intlustrial and Medical Nuclesr Sefery, United States Nuclear Regulatory Commission, Washington, DC 20555.
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