ML20215B366
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| ML20215B366 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 07/24/1986 |
| From: | Gerard Jackson NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Purdy D BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| Shared Package | |
| ML20215B294 | List: |
| References | |
| 105811, NUDOCS 8610060535 | |
| Download: ML20215B366 (1) | |
Similar Documents at 07001342 | |
|---|---|
Category:CORRESPONDENCE-LETTERS
MONTHYEARML20137B1321997-03-12012 March 1997
[Table view]Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp Rept 70-1342/96-01 ML20137B1521997-02-0707 February 1997 Responds to NRC 970107 NOV Re Violations Noted in Insp Rept 70-1342/96-01 on 961212.Corrective Actions:Physical Inventory Accounting for All Licensed Matl Was Completed on 970127 & Annual Rept for 1995/1996 Sent on 961226 ML20133E6351997-01-0707 January 1997 Discusses Insp 70-1342/96-01 on 961212 & Forwards Notice of Violation ML20248J4281992-11-20020 November 1992 Advises That Licensee Did Not Provide Valid Reason for Extension of Due Date of Invoice AMO2024-92,therefore Extension Cannot Be Granted ML20198E4541992-09-0303 September 1992 Requests Extension of 30-day Period Until Determination of Invoice Amount Can Be Made.Questions If Company Can Qualify for Small Entity Status ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received 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W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D8841987-08-11011 August 1987 Forwards Amend 20 to License SNM-1319.Fee Paid ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend 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 ML20206P3481986-08-21021 August 1986 Discusses Safety Insp 70-1342/86-01 on 860710 & Forwards Notice of Violation ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 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 ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 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 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 1997-03-12 Category:DKT 30 MTL BYPRODUCT MONTHYEARML20210G1761999-05-18018 May 1999
[Table view]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 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 ML20155F5391987-10-31031 October 1987 Corrected Amend 21 to License SNM-1319 for Biocontrol Technology,Inc,Amending License in Entirety 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 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 ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 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 ML20133P4681985-05-0202 May 1985 Forwards Application for Renewal of License SNM-1319 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 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 Category:OUTGOING CORRESPONDENCE MONTHYEARML20137B1321997-03-12012 March 1997
[Table view]Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp Rept 70-1342/96-01 ML20133E6351997-01-0707 January 1997 Discusses Insp 70-1342/96-01 on 961212 & Forwards Notice of Violation ML20248J4281992-11-20020 November 1992 Advises That Licensee Did Not Provide Valid Reason for Extension of Due Date of Invoice AMO2024-92,therefore Extension Cannot Be Granted ML20062A8161990-10-0303 October 1990 Discusses Telcon Inquiry 90-001 Re Activities Authorized by License SNM-1319.Renewal Application Received 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 ML20151D8601987-09-10010 September 1987 Forwards Amend 21 to License SNM-1319 ML20151D9531987-08-0606 August 1987 Requests Fee Re 870715 Application for Amend to License SNM-1319.Fee Required Prior to Issuance of Amend ML20215F1611986-10-0303 October 1986 Ack Receipt of Informing NRC of Steps Taken to Correct Violations Noted in Insp 70-1342/86-01 ML20206P3481986-08-21021 August 1986 Discusses Safety Insp 70-1342/86-01 on 860710 & Forwards Notice of Violation ML20215B3121986-08-21021 August 1986 Forwards Amend 20 to License SNM-1319 ML20215B3661986-07-24024 July 1986 Requests Fee for 860710 Application for Amend to License SNM-1319 ML20133P4451985-09-25025 September 1985 Forwards Amend 19,renewing License SNM-1319 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 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 ML20133P5321984-10-0404 October 1984 Ack Receipt of Application for Renewal of License SNM-1319. License Will Not Expire Until Final NRC Action Taken ML20133P5591984-04-20020 April 1984 Requests Fee for 840405 Application for Renewal of License SNM-1319.Fee Required Prior to Issuance of Amend 1997-03-12 |
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A4,24 W Coratomic, Inc.
ATTN: Mr. David L. Purdy President 300 Indian Springs Road P.O. Box 434 Indiana, PA 15701 Gentlemen:
This refers to your letter dated July 10, 1986, for an amendment to Materials License SNM-1319.
An amendment fee of $120 is required as specified in 6170.31(1K)of 10 CFR 170, copy enclosed. Payment should be made to the U.S. Nuclear Regulatory Consnission and mailed to my attention at our Washington, D.C.
address.
Your application will be processed by the Region I Licensing staff located at 631 Park Avenue, King of Prussia, Pennsylvania 19406. The fee, however, is required prior to issuance of the amendment. When submitting the fee, please refer to CONTROL NUMBER 105811.
Sincerely, W99 19 4 huhnes Glenda Jackson License Fee Management Staff Office of Administration
Enclosure:
10 CFR 170 cc: Region I DISTRIBUTION:
Pending Fee File Weekly Reading File Material Reading File DW/REJ/Cora "es?ein8"',"22 SNtt-1319 p nR .,
0FFICE: LFMS:ADMk LFMS:ADM8 SURNAME: SKimberley:rej GJackson DATE: 7/JJ/86 7/2)/86
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