|
|---|
Category:CORRESPONDENCE-LETTERS
MONTHYEARML20137B1321997-03-12012 March 1997
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W/Stated Changes,Including Changing of Radiation Safety Officer from Fj Shipko to Jn Klingensmith & Indication That Ide No Longer in Effect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
[Table view]
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:OUTGOING CORRESPONDENCE
MONTHYEARML20137B1321997-03-12012 March 1997
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
[Table view] |
Text
a
.e .
AUG 211986 License No..SNM-1319 Docket No. '070-01342 Control No. 105811 Coratomic, Inc.
ATTN: John R. Klingensmith P.O. Box 434 Indiana,' Pennsylvania 15701 Gentlemen:
Please find enclosed an amendment to your NRC Material License.
Please review the enclosed document carefully and be sure that you understand all conditions. If there are any errors or questions, please notify the Region I Material Licensing Section, (215) 337-5239, so that we can provide appropriate corrections and answers.
Please be advised that you must conduct your program involving licensed radioactive materials in accordance with the conditions of your NRC license, representations made in your license application, and NRC regulations. In ,
particular, please note the items in the enclosed, " Requirements for Materials Licensees."
Since serious consequences to employees and the public can result from failure to comply with NRC requirements, the NRC expects licensees to pay meticulous attention to detail and to achieve the high standard of compliance which the NRC expects of its licensees.
You will be periodically inspected by NRC. A fee may be charged for inspections in accordance with 10 CFR Part 170. Failure to conduct your program safely and in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in prompt and vigorous enforcement action against you.
This could include issuance of a notice of violation, or in case of serious violations, an imposition of a civil penalty or 'an order suspending, modifying or revoking your license as specified in the General Policy and Procedures for NRC Enforcement Actions, 10 CFR Part 2, Appendix C.
8610060493 860021 REG 1 LIC70 SNM-1319 PDR OFFICIAL RECORD COPY ML SNM-1319/LTR - 0001.0.0 08/18/86 K18
..; , 1 O O Coratomic, IAc. 2 We wish you success in operating a safe and effective licensed program.
Sincerely, Original Signed Byf' Jenny M. Johansen Jenny M. Johansen, M.S.
Nuclear Materials Safety Section B Division of Radiation Safety and Safeguards
Enclosures:
- 1. Amendment No. 20 2.- Requirements for Materials Licensees
- 3. 10 CFR Parts 2, 19, 20, 70, 71, and 170 i
(
ORSS:RI Johansen/bc 8/)#l/86 OFFICIAL RECORD COPY ML SNM-1319/LTR - 0002.0.0 08/18/86 i