ML20209B050
| ML20209B050 | |
| Person / Time | |
|---|---|
| Site: | 07002223 |
| Issue date: | 04/01/1981 |
| From: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20209B053 | List: |
| References | |
| 119544, NUDOCS 8104230423 | |
| Download: ML20209B050 (3) | |
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U. S& CLEAR REGULATORY COMMISSP)
" , " " , APR G 1981 w MATERIALS LICENSE U Am:ndmrnt No. 02 g ,4 ~ .:A V* r*
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and
'Iltle 10, Code of Federal Regulations, Chapter 1, Parts 30, 31, 32,33,34,35,36,40 and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to persons authorized to receive it in accordan,ce with the regulations cf the applicable Part(s); and to import such byproduct and source materia'. 'Ihis license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regula-tions and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
$censee In accordance with letter dated ^
February 24, 1981
- 1. Goddard Memorial Hospital
- 3. License number SNM-1621 is amended 909 Sumner Street in its entirety to read as follows:
- 2. Stoughton, Massachusetts 02072 March 31, 1986
- 4. Expiration date ce r 070-02223 5 Reference No.
- 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee special nuclear material 8 form may possess at any one time unster this license A. Plutonium (Principal A. Sealed Source (s) A. 7.5 grams (30 individua:
radionuclide Pu-238) sources not to exceed 250 milligrams each)
B. Plutonium (Principal B. Sealed Source (s) B. 2.25 grams (10 individu:
radionuclide Pu-238) sources not to exceed
! 225 milligrams each)
- 9. Authorized use Implantation in humans as a component of Coratomic Model C-101 nuclear powered cardiac pacemakers for clinical evaluation purposes.
B. Implantation in humans as a component of Cordis Nuclear Omni-Stanicor Model 184A nuclear-powered cardiac pacemakers for clinical evaluation purposes.
CONDITIONS
- 10. Licensed material shall be used culy at Goddard Memorfal Hospital, 909 Sumner Stree Stoughton, Massachusetts.
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U. S. Ng. EAR REGULATORY CO.\lN11SSIO NIATERIALS LICENSE Lneine Number SNM-1621__ _
- Supplementary Sheet De m Reference No. 070-02223 CONDITIONS Amendment No. 02 (ccatinued)
- 11. The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients or otherwise in use.
- 12. The licensee shall not receive or transfer in any single transaction, 1 gram or more of plutonium 238 contained in nuclear powered pacemakers without notifying the Division of Safeguards, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, and, in addition, completing and distributing Form NRC-741 as required by Section 70.54 of 10 CFR Part 70.
- 13. The licensee shall report to the Material Licensing Branch, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear pacemaker patiant, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. A written report giving details of the adverse reaction and/or malfunction shall be submitted within 30 days.
14 The licensee shall report to the Material Licensing Branch, U.S. Nuclear Regulatory Commission, Washington, D. C. 20555, within 10 days, loss of contact with a nuclear pacemaker patient.
- 15. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient; and procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient.
- 16. Except as specifically provided otherwise by this license, the licensee shall possess and use licensed material described in Items 6, 7, and 8 of this license in accordance with statements, representations, and procedures contained in letter dated February 24, 1981 signed by Sandra J. Souza, Associate Administrator, Goodwill M. Stewart, M.D., Paul V. Jameson, M.D., David F. Hyatt, M.D., Unrrison Black, M.D., and Keshaudas Pahuja, M.D. The Nuclear Regulatory Commission's regulations shall govern the licensee's statements in applications or letters, unless the statements are more restrictive than the regulations.
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-BETWEEN: William 0. Miller, Chief 86 FE8 26 ' A7:14 License Fee Management Branch Office of Administration u s . .c i I. FEE t1?f f bn.g ,
Regional License Section -
Material Licensing Branch
.FCMS, Office of Nuclear Material Safety & Safeguards '
LICENSE FEE TRANSMITTAL -
'A. REGION -
- 1. APPLICATION ATTACHED '
Applicant / Licensee: b 'O dd Q/ld k M @ Bo Application Dated: *
[4ffs Control No.: f License No.: -
h/I)- 2/ 7/ ~ 82 413
- 2. FEEAfTACHED ~
Amount:
Check No.:
- 3. COMMENTS Signed Date B. . LICENSE FEE MAtlAGEMENT BRANCH -
- 1. fee Category and Amount: @7C - da DO-09(.fb4/[2Ch
- 2. Correct Fee Paid. Application may be processed for:
Amendment , /
Renewal License Signed -p )c m Date & p /'((f
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