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Category:DKT 30 MTL BYPRODUCT
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20127C4141992-11-24024 November 1992 Thirty-Sixth Semi-Annual Rept for Period 920301-0831 ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20155F5661987-10-31031 October 1987 Forwards Corrected Amend 21 to License SNM-1319.Amend Corrected,Per 870922 Request.Condition 13 Std for Stated Licenses.Memo Indicating That Not Amend But Corrected Copy W/Voiding Date of 871031 Encl ML20155F5941987-09-22022 September 1987 Requests Reissuance of Amend 21 to License SNM-1319 W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20151D8841987-08-11011 August 1987 Forwards Amend 20 to License SNM-1319.Fee Paid ML20155F5991987-08-11011 August 1987 Application for Renewal of License SNM-1319,changing Company Name from Coratomic,Inc to Biocontrol Technology, Inc & Changing Radiation Safety Officer from Fj Shipko to Jn Klingensmith ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend ML20151D9261987-07-15015 July 1987 Application for Amend to License SNM-1319,changing Corporate Name to Biocontrol Technology,Inc ML20215F1611986-10-0303 October 1986 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp 70-1342/86-01 ML20215F1731986-09-18018 September 1986 Responds to NRC Re Violations Noted in Insp 70-1342/86-01.Corrective Actions:Vendor Will No Longer Ship nuclear-powered Pacemakers Internationally Under UN2911, Until Type B Package Obtained ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20215B3661986-07-24024 July 1986 Requests Fee for 860710 Application for Amend to License SNM-1319 ML20215B4001986-07-16016 July 1986 Forwards Fee for 860710 Application for Amend to License SNM-1319 ML20215B3331986-07-10010 July 1986 Application for Amend to License SNM-1319,including 4.73-Ci Pu-238 Nuclear Source.Fee Paid ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 ML20133P4361985-09-25025 September 1985 Amend 19 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety.License Authorizes Use of Pu-238 as Component in Assembled Coratomic Model C-101 Pacemakers ML20133P4491985-09-16016 September 1985 Submits Suggested Wording for First Sentence of Condition 13 of Renewed License SNM-1319,requiring Collection of Data from Medical Institutions Re Accountability,Removal & Recovery of Model C-100,C-101 & C-101P Pacemakers ML20133P4521985-08-19019 August 1985 Responds to Request for Addl Info Re License SNM-1319.Model SAC-4 Scintillation Alpha Counter & Victoreen Model 488A Geiger Counter Will Be Used ML20133P4581985-08-0505 August 1985 Advises That Unless Response to 850529 Request for Addl Info Re 850502 Application for Renewal of License SNM-1319 Received within 30 Days,Application May Be Denied & License Terminated ML20133P4641985-05-29029 May 1985 Requests Addl Info Re 850502 Application for Renewal of License SNM-1319,including Info Re Survey Meters & Counting Equipment for Alpha & Neutrons & Outline of Annual Training Lecture Subjs ML20133P4761985-05-0202 May 1985 Application for Renewal of License SNM-1319,authorizing Use of Pu-238 as Component of Coratomic Models C-100,C-101 & C-101P Pacemakers ML20133P4681985-05-0202 May 1985 Forwards Application for Renewal of License SNM-1319 ML20133P4971985-03-0404 March 1985 Ack Receipt of Request for Complete Application for Renewal of License SNM-1319 ML20133P5131985-02-15015 February 1985 Requests Addl Info Re 840405 Application for Renewal of License SNM-1319,including Clarification of Reason for Not Sending Accountability Repts Since 830630,per License Condition 13.B ML20133P5281984-11-20020 November 1984 Forwards Human Implantation Protocol for Coratomic C-101-P Radioisotope Powered Cardiac Pacer. Protocol Approved by Nrc.Hosps Applying for Licenses to Implant Coratomic Model C-101-P Pacer Will Follow Protocol ML20133P5321984-10-0404 October 1984 Ack Receipt of Application for Renewal of License SNM-1319. License Will Not Expire Until Final NRC Action Taken ML20133P5431984-04-25025 April 1984 Forwards Fee for Application for Renewal of License SNM-1319 ML20133P5591984-04-20020 April 1984 Requests Fee for 840405 Application for Renewal of License SNM-1319.Fee Required Prior to Issuance of Amend ML20133P5621984-04-0505 April 1984 Application for Renewal of License SNM-1319,authorizing Transfer of Coratomic Model C-101 nuclear-powered Pacemakers to Medical Institutions Licensed by NRC or Agreement State ML20133P4881975-11-0101 November 1975 Human Clinical Protocol for Coratomic C-101 Radioisotope Powered Cardiac Pacer ML20133P4801975-07-0101 July 1975 Human Clinical Protocol for Coratomic C-100 Series Radioisotope Powered Cardiac Pacers 1999-05-18
[Table view] Category:LICENSE
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20133P4361985-09-25025 September 1985 Amend 19 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety.License Authorizes Use of Pu-238 as Component in Assembled Coratomic Model C-101 Pacemakers 1999-05-18
[Table view] Category:SNM & AMEND TO LICENSE (DKT 70S)
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20133P4361985-09-25025 September 1985 Amend 19 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety.License Authorizes Use of Pu-238 as Component in Assembled Coratomic Model C-101 Pacemakers 1999-05-18
[Table view] Category:TEXT-LICENSE APPLICATIONS & PERMITS
MONTHYEARML20210G1761999-05-18018 May 1999 Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847 ML20128G3691996-07-21021 July 1996 Matls Licensing Package for Amend 24 to License SNM-1319 for Biocontrol Technology,Inc.Control:119960 ML20058H8081993-10-19019 October 1993 Matls Licensing Package for Amend 23 to License SNM-1319 for Biocontrol Technology,Inc.Control:113332 ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety ML20151D7901987-09-10010 September 1987 Amend 21 to License SNM-1319 for Biocontrol Technology,Inc, Amending License in Entirety ML20155F5991987-08-11011 August 1987 Application for Renewal of License SNM-1319,changing Company Name from Coratomic,Inc to Biocontrol Technology, Inc & Changing Radiation Safety Officer from Fj Shipko to Jn Klingensmith ML20151D9261987-07-15015 July 1987 Application for Amend to License SNM-1319,changing Corporate Name to Biocontrol Technology,Inc ML20215B2921986-08-21021 August 1986 Amend 20 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety ML20215B3331986-07-10010 July 1986 Application for Amend to License SNM-1319,including 4.73-Ci Pu-238 Nuclear Source.Fee Paid ML20133P4361985-09-25025 September 1985 Amend 19 to License SNM-1319 for Coratomic,Inc,Amending License in Entirety.License Authorizes Use of Pu-238 as Component in Assembled Coratomic Model C-101 Pacemakers ML20133P4761985-05-0202 May 1985 Application for Renewal of License SNM-1319,authorizing Use of Pu-238 as Component of Coratomic Models C-100,C-101 & C-101P Pacemakers ML20133P5621984-04-0505 April 1984 Application for Renewal of License SNM-1319,authorizing Transfer of Coratomic Model C-101 nuclear-powered Pacemakers to Medical Institutions Licensed by NRC or Agreement State 1999-05-18
[Table view] |
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CORRECTE0 COPY klS. NUCLEAR REGULATORY COMMISSION PAGC [_ OF 3 PAGES
- q ts-s o MATERIALS LICENSE Amendment No. 21 Pursu;nt to the AtonQ Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10.
Code of Federal Regulations, Chapter I, Paris 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations f heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p N l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to h' 1[% deliver or transfer such material to persons authorized to receive it in accord.uee withj i the h license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and .sj i subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect aad to any l l
(! conditions specified below. i Lt r Licensee l In accordance with letter dated
]i j
- 3. fulge 15 a nuab"1987, I
Biocontrol Technology, Inc. SNM-1319 is amended in i its entirety to read as follows:
g ,
2' s P.O. Box 434 - , 4. Expiration date Indiana, Pennsylvania 15701 September 30, 1990 q
- 5. Docket or gj g Reference No. 070-01342 ad
!4l 6. Byproduct, source.and/or 7. Chemical and/or physical 8. Maximum amount that licensee 3l>
h special nuclear material form may possess at sny one time /
under this license l A. Plutonium (Principal A. Sealed sources A. Not to exceed 250 l l% cadionuclide Pu-238) ~(Pl.utonium batteries) milligrams of Pu-238 per sealed source; 290 grams l4 j{
- i x total
,i B. Plutunium 238 B. Sealed neutron source B. 4.73 curies i i -(Monsanto) (275 milligrams) ;
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- 9. Authorized use lpl
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%y$A. (1) For use as a component in assembled Coratomic Model C-101 pacemakers and as a l l
{9 component in the assembly (manufacturing) of Coratomic Model C-101-P i pacemakers; for distribution to medical institutions authorizea to receive y
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! pacemakers pursuant to the terms and conditions of a specific license issued by the Nuclear Regulatory Commission or an Agreement State. pl 1
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,i (2) For recovery as a component of explanted Coratomic Model C-100, C-101 and j C-101-P pacemakers transferred from specific licensees. l i
i
,l (3) For storage or disassembly and re-furbishing of the battery source from i)p Coratomic Model C-100, C-101 and C-101-P pacemakers. p l N P
>{j B. For use as a calibration source.
I Y,*
l CONDITIONS l
Licensed material shall be used only at the licensee's facilities, 300 Indian .
l10. Spring Road, Indiana, Pennsylvania.
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A. Licensed material shall be used by, or under the supervision of, individuals l$11. l who have completed the training program as outlined in the letter dated August 19, 1985 and have been designated by Joseph N. Klingensmith, Radiation Safety
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tai Y Officer. l*
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- N R C F or m 3 7 4 A LMnse nzmber >
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$.1 . M ATERIALS LICENSE ,g , y
, SUPPLEMENTARY SHEET >
4 .
070-01342 Y
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- g CORRECTED COPY Amendment No. 21 >4 4
p)i l4-(11. continued) CONDITIONS h 8
j C. The Radiation Safety Officer for this license is Joseph N. Klingensmith, fg l 12. As six month intervals the 1icensee shall collect and tally data from all medical institutions with respect to: (a) accountability, removal and recovery, pp q
4 (b) duration of satisfactory performance or the time of service before malfunction, h l$ and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model &
i C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days of the lp six month peri 0d ending February 28 or August 31, a copy of the report shall be sent l to the U.S. Nuclear Regulatory Commission,; Region I, Nuclear Matericls Safety p 4
'4 Section, 631 Park Avenue, King of Prussia, ' Pennsylvania 19406.
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- 13. This license does not authorize the implantation of pacemakers into humans or 4
animals. p q
- 14. A(1) Any sealed sources or detector cells specified in items 7.A and 7.B shall be p; p
3 9
tested for leakage and/or contamination at intervals not to exceed 6 months. jkj i Any source or detector cell' received from another person which is not g 3 accompanied by a certificate indicating that.a. test was performed within g*
4 6 months before the transfer shall not be put-into use until tested.
Q (2) Notwithstanding the peric,dic k leak teit required by this condition, any 3 licensed sealed source or' detector;celliis exempt from such leak tests i when the source or detector cell' contains 100 microcuries or less of beta and/or gamma emitting material'or'10 microcuries or less of alpha emitting
- 4 material. g%
. pl QI B. Any sealed source or detector cell in storage and not being used need N 3
i not be tested. When the source or-detector cell is removed from storage j f
st for use or transfer to another person, it shall be tested before use or transfer, y
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k C. The test shall be capable of detecting the presence of 0.005 microcurie '
bi
$ of radioactive material on the test sample. If the test reveals the >;
1l presence of 0.005 microcurie or more of removable contamination, the E
,i source or detector cell shall be removed from service and decontaminated, f
.! repaired, or disposed of in accardance with Commission regulations. A p1
'i report shall be filed within 5 days of the date the leak test result is $
hj known with the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief. ti 4 Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of t 4l! Prussia, Pennsylvania 19406. The report shall specify the source involved, E i4 the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries and shall be maintained for hl p'
4l 4 inspection by the Commission. Records may be disposed of following p Commission inspection. >
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. ,M ATERIALS LICENSE t>ocket or Reference nun.ber h" Q'4
- FUPPLEMENTARY SHEET 070-01342 d
i CORRECTED COPY Amendment No. 21 lN i
4 (14. continued) CON 0lT10NS li l
4 i C. Tests for leakage and/or contamination shall be performed by the licensee j or by other persons specifically licensed by the Commission or an Agree- !
l ment State ta perform such services. l, 4 ;-
4
- 15. The licensee may transport licensed material in accordance with the provisions y, of 10 CFR Part 71, "Packaging and Transportation of Radioactive Material". l4 i
N j 16. The licensee stiall conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license. Records h
g 4
'a of inventories shall be maintained for 2 years.from the date of each inventory. E i>j 4
- 17. Except as specifically provided otherwise in this license, the licensee shall 3
$ conduct its program in accordance with the statements, representations, and {yl procedures contained in the documents including any enclosures, listed below, p The Nuclear Regulatory Corrmission's regulations shall govern unless the state- p
'4 is 4
ments, representations and procedures in the licensee's application and corre-spondence are more restrictive'than the regulations.
N A. Application dated May 2,1985 f B. Letter dated August 1.9, 1985 h
3 Letter dated July 10,-1986? #,
4 C.
'i D. Letter dated July 15, 1987= . N E. Letter dated August 11, 1987 g V
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'41 Y For the U.S. Nuclear Regulatory Conmission >}
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Original Signed By:
Jenny M. Johansen
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'lOdte I Nuclear Materials Safety ano lW Safeguards Branch, Region I
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