ML20214V597
| ML20214V597 | |
| Person / Time | |
|---|---|
| Site: | 07002238 |
| Issue date: | 07/31/1986 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20197F325 | List: |
| References | |
| NUDOCS 8610020347 | |
| Download: ML20214V597 (2) | |
Text
~
V
~
1
- a. - - _. - _. _
.S. NUCLEAR REGULATORY COMMISSION q
l MATERIALS LICENSE Amendment No. 02 a
- 1 E
.:1 %rsuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10.
p Cvde of Federal Regulations. Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations
- i. heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, ij source, and special nuclear material designated below; to use such material for the purpose (si and at the place (s) designated li deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This
{ 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, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
f Licensee l!
In accordance with application dated P
I
- 3. garch 12 cense numb"1986, l!
SNM-1630 is amended in I-hl Burbank Hospital its entirety to read as follows:
i
- q
'. p"XP rstig date
^
2' i,/r l
d Nichols Road f
4 i
, July 31, 1991 j
Fitchburg, Massachusetts 01420 b e
- 5. Docket or 3
'l i<
g('
Reference No.
670-02238 ij
- 8. Maximum amount that licensee
(' 6. Byproduct, source, and/or
- 7. Chemical and/or physical s
may possess at any one time g
' j
, under this license bA. Plutonium (principal A. ' Sealed Source f
A. 1.75 grams (individual l
^
[
radionuclide Pu-238)
- /
sources not to exceed 1
250 milligrams each) r d
f 1l 9.
Authorized use
..t,6 V'
ha. x,fJifftl (V J
5 Implantation in humans as a component :of Corl atomic Model C-101 nuclear-p ll L A.
0 cardiac pacemakers for clinical evaluation.
g s
'i,
. CONDITIONS.
j si'i 10. Licensed material shall'be used only at'Burbank Hospital, Nichols Road, Fitchburg, i
[
j l;,
.i 11. The specified possession limit includes all-licensed material possessed by the il licensee under this license whether in storage, implanted in patients, or otherwise in use.
j f 12. The licensee shall report to the U.S. Nuclear Regulatory Comission, Region I, 1
ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, 3
iif King of Prussia, Pennsylvania 19406, 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
- 4 -
of any nuclear pacemaker patient, and any adverse reaction and/or malfunction i
ib involving a pacemaker system, including the leads. A written report giving details of the adverse reaction and/or malfunction shall be submitted within j
30 days.
gl "e 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region 1,
'g; l
- . l ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, p
y; King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a Fj jl nuclear pacemaker patient.
$ 14. Sealed sources or detector cells containing licensed material shall not be p{
\\
[
)
opened or sources removed from detector cells by the licensee.
p l',
8610020347 860731 A *-
le ;
REG 1 LIC30
_i l'c'Xsm'atTsmew'rmvssw umTs23rgh!'
WEwiaLLTmammw=e--
- ~
. - ~
1 NRC Form 370A U.S. NU' R REIULATCRY COMMISSION I
w PAGE 2
OF 2
PAGES
^
'D ucnse number l
Docket or Reference num r SUPPLEMENTARY SHEET E
070-02238 g
F Amendment No. 02 1
(Continued)
CONDITIONS
- 15. The licensee may transport licensed material in accordance with the provisions i
of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".
B i
I
- 16. The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient. Procedures for recovery l
and authorized disposal of the nuclear pacemaker by return to the manufacturer y
shall be followed upon the death of the patient.
1 t
p -
- 17. Except as specifically provided otherwise;in this license, the licensee shall i
conduct its program in accordance with the statements, representations, and procedures contained in the~ documents including anf u closures, listed below.
l The Nuclear Regulatory Connission's regulations shall govern unless the state-g ments, representations and procedures in the licensee's application and corre-i spondence are more restrictive than the regulations.
9 I
r l
A.
Application transmitted with letter dated February 18, 1976 l
l B.
Letter dated February 13, 1981
/.'
g C.
Letter dated March 12,'1986 g
(s g
+
1)-
y R
s s-l
! s ;. g ) ( W t
t F
l j
li k
I l
F F
g I
y I
i R
For the U.S. Nuclear Regulatory Commission g
Originni Signed Byt F
h Date JUL 311986 By Nuclear haterials Safety and F
E a
Safeguards Branch, Region I
(
King of Prussia, Pennsylvania 19406 l
5
-