ML20212P353
ML20212P353 | |
Person / Time | |
---|---|
Site: | 07002259 |
Issue date: | 11/21/1986 |
From: | Whiston P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
To: | |
Shared Package | |
ML20212P357 | List: |
References | |
NUDOCS 8701300650 | |
Download: ML20212P353 (2) | |
Text
_ _ _ _ - _ _ _ -
r ff_@_T_
j CRC Form 374 JWMWNJfiEfiESE5 emf!EfiEF1sasentiT3nhMnoEMazenMws.an5Giing
, (% 84) PACE } OF 2 PACES g
U.S. NUCLEAR REIULATO RY COMMISL40N
- MATERIALS LICENSE Amendment No. 04 E Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438). and Title 10, l g
Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations p heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, g source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to dehver 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 g conditions specified below.
p N Licensee I ii In accordance with letter dated May 16, 1986 K
Ilq 1- Copley Memorial Hospital 3. License number SNM-1634 is amended in lE!
its entirety to read as follows: f g
s -
l 2.
Lincoln and Weston Avenues d
'- ' IP Aurora, IL 60507 '
- 4. Expiration date November 30, 1991 lEj
) 3
- 5. Docket or "i g-Reference No. 070-02259 g
$ 6. Byproduct, source, and/or 7.- 7. Chemical and/or physical
' =,,8., Maximum amount that licensee E j$ special nuclear material form
- - l may possess at any one time E' A. Plutonium (Principal f ,
under this license A. 2.5 grams f
_ A. Sealed Source (s)' E:
i g radionuclide Pu-238) 3' ,
[. (10 individual y* s ; -
, . g. .; . sources not to
"~
4 Ly .; exceed 250 9 __ - h' i milligrams each)
- s. ;- ~ . . ,..
B. Plutonium (Principal !
- B. Sealed ' Source'(s) TB.2.25 grams radionuclide Pu-238)' i 'iF3 (10 individual
-.L ~,," M i 9,% sources not to 1
i~
s,
~ , .
3 J/ exceed 225
%;4 *
, 3 9 ,,
J' ' 4, x~
milligrams each) 9 C. Plutonium (Principal '/)
- C. Sealed Source (s) 4. , C. 0.84 grams f radionuclide Pu-238) _,
w (4 individual
_,1 7- 'e sources not to 4 >'
exceed 210 milligrams each) hl g .
M 9. Authorized Use A. through C. Implantation in humans as a component of nuclear-powered cardiac pacemakers y for clinical evaluation purposes.
CONDITIONS l
i
- 10. Licensed materia! shall be used only at the licensee's facilities located at Lincoln -
amd Weston Avenues, Aurora, Illinois.
- 11. The specified possession limit includes all licensed material possessed by the I licensee under this license whether in storage, implanted in patients, or otherwise lt l in use.
l l 8701300650 861121 j REG 3 LIC70 n i.
SNM-1634 PDR \ sQ i
! lb/((, COPY
(e===____.-__--_______-_____=______=______=____,
J C Form 374A U.S. NUCLEAR f.EGULATORY COMMISSION
, 2 Z 3
y races N License number 1
SNM-1634 SUPPLEMENTARY SHEET Docket or Reference number 070-02259 N
j , Amendment No. 04
- 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, i ATTN: Chief Nuclear Materials Safety and Safeguard Branch, 799 Roosevelt Road, N Glen Ellyn, Illinois 60137, 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 N
- pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. A written report giving details of the adverse reaction l
- and/or malfunction shall be submitted within 30 days.
~
- 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, I ATTN: Chief, Nuclear Material Safety and Safeguard Branch, 799 Roosevelt Road, I
- ' Glen Ellyn, Illinois 60137, within 10 days of loss of contact with a nuclear pacemaker patient. m O lQ*"Q C p [. f;
, d. B - ~
- 14. The licensee shall continue patient follow-up and replacement procedures for the
] nuclear pacemaker during the life of the patient. Procedures for recovery and
) authorized disposal of the nuclear pacemaker by return to the manufacturer shall be j followed upon the death of the patient. V a f
," w t
]
1 a 'M [
- 15. The license shall not receive or transfer in any single ~ transaction,1 gram or more
] of plutonium-238 contained in nuclear-powered pacemakers without notifying the
) U. S. Nuclear Regulatory Commission, Region III,JATTN: Chief SafetyandSafeguardsBranch,799Roosevel,tRoad,GlenEllyn,jNuclearMaterials
. cII,linois 60137, and, in k addition, completing and distributingiForm NRC-741. as required by Section 70.54 of (p.S j y Q f 1
1 16.
10 CFR Part 70 7-.
' ty K a k 7m&& ' QQ l;4 j, Except as specifNally-provided 'otherwiseiin this license, the: licensee shall
~h g
(
r
) conduct its program in -accordance Mithithe%tatements,; representations, and procedures contained in' the documents including any.; enclosures, listed below, I
3 j h The Nuclear Regulatory Commission's regulations 2shall gover'n unless the statements,
] representations and procedures in the licensee's1 application and correspondence are [
t a
more restrictive than/the regulations./ ({(~T"#
l l
A.
$'4/
~
/ [.)V /.
Letters dated March 12, 1976, November 8, 1976,';and May 16, 1986.
L
{..
l
- I V W %* > > h <
\
1 l h k
a 1
l, 1 t I 1 L )
1 p w
l For the U.S. Nuclear Regulatory Commission 1 l 1 t 1 E j Original Signed L
b
)
Date November 21, 1986 By Patricia J. Whiston E j Materials Licensing Section, Region 111
, l 1 t t
k - --- -- --- - _ - - - - , - - - - ._ -- - --- -- - - _ - _ . . om y ,C O P Y M .,,,