ML20210R065
| ML20210R065 | |
| Person / Time | |
|---|---|
| Site: | 03019521 |
| Issue date: | 01/09/1987 |
| From: | Riedlinger B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | |
| Shared Package | |
| ML20210R071 | List: |
| References | |
| 50-19913-01, 50-19913-1, NUDOCS 8702170313 | |
| Download: ML20210R065 (4) | |
See also: IR 05000199/2013001
Text
-_-y--------------------------------L_--_-_----_-_--__g
13 82> PAGE OF PAGES
l u.s. NUCLEAR REIULATO?.Y COMMISSION
[
Amendment No. 10
l MATERIALS LICENSE l
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10,
g Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations g
I heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer bypraduct, j
i source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to r
I deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This L
I license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is I
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any
l
( conditions specified below. CORPECTED COPY
I lL
Ucensee II
I In accordance with letter ;l
I
dated March 4, 1986 !
l
l 1. Ketchikan General llospital 3. Ucense number 50-19913-01 is maended in il
i its entirety to read as follows:g[
l .~
[
l 2. 3100 Tongass Avenue A ;1
-
'~ , s ,
i
I
I
Ketchikan, Alaska 99901
cx
1 '.I~ 4. Expiration date January 31, 1987 I
[
l
-
5. Docket or [
l \' Reference No. 30-19521 g
I 6. Bypioduct, source, and/or ' 'O 7. Chemical and/or physical m 8. Maximum amount that licensee l
I special nuclear material form [may possess at any one time L
l Q . under thislicense
f
A. Anybyproductmatebal A. Any radtopharmaceutical A. As necessary for uses
l listed in Groups I and ?1isted in Groups I and II t
authorized in (
g
II of Schedule A, f of Schedule'A, Sect!on , ( Subitem 9.A. [
l
I
Section 35.100 of.
10 CFR 35 ' ~
<>
35.100 of 10 CFR 35)
.
< '
_
u
L
[
$n ..
-
_. ~
I
B. Any byproduct mateifal <B. . Any" form listed in Group III B.< 2 curies of each
l ; " (of Schedule A, Sectjon 35.100 byproduct material f
listed in Group 111 3 g
of Schedule A, W , of 10 CFR c *
35 e q authorized in [
l Section 35.100 of O ,
,/ .
Subitem 6.B. L
1 10 CFR 35 -
'
O '<> l
a
,
yr ( ,
,
.
[
C. Any byproduct material 50.. Any '
. C. 3 millicuries of each I
11sted in Section 31.11(a)"/ s byproduct material t
of 10 CFR 31 , authorfzed in t
Subitem 6.C. I
l
I D. Xenon 133 D. Gas or gas in solution that D. 50 millicuries I
1s the subject of an active
l (1.e., not withdrawn or f
g
t
I terminated) "New Drug L
I Application" (NDA) approved L
I by FDA or an active (i.e., I
I not withdrawn, terminated or I
l on "cifnical hold") " Notice of f
l Clafmed Investigational Exemption g
i for a New Drug" (IND) that has L
I been accepted by FDA L
1 L
I i
l
I jl
1
I
0702170313 860709
REG 5 LIC30
hI
I S0-19913.o1 PDR I
I L
- ------------------y .............., ,;g, gag; g
==============================_=== --......_.....q
Regorm JMA U.S. NUCLE A? C EEULATORY cOMMISSF)N . 2 y 4 y l
ucinse n:mber l
50-19913-01 1
MATERIALS LICENSE
'"*"#'""" '
SUPPLEMENTARY SHEET l
,
-
030-19521
l
L
'
Amendment No. 10 l
, CORlGCTED70PY l
> I
"
6. BYPRODUCT, SOURCE, AND/0R 7. CHEMICAL AND/OR PMYSICAL 8. MAXIMUM AMOUNT THAT LICENSEE I
'
SPECIAL NUCLEAR MATERIAL FORM MAY POSSESS AT ANY ONE TIME
I
l UNDER Tl!IS LICENSE !.
I
- E. Phosphorus 32 E. Any soluble phosphate E. 10 millicurfes l
,
that has been manufactured,
l
.
labeled, packaged, and
'
distributed in accordance f
- with a,. specific ifcense issued l
~ pursuant to(Sect' ion'32.72 of [
10.CFR'32 or a s'phdifis license I
g' issued to a manufacturer:)y yan I
,
Q(j AgreementStatepursuanttol
equivalent state regulations v~ j
I
g
p
q%~ - ,
9. Authorized use (g i j .j '
l
f,, Sdx W,y; "* I
A. Section 35.100 I
AnydiagnosticprocedurelistedsGroupsIandII,of/ScheduleA,k/
of Title 10, Code bof Federa17Reguistions'.5 ) I
' ( 'J . <
-B.
d $ i I/ /"
'
V t
Preparation and use of radiopharmaceuticals- for any diagnostic procedure listed
O I
t
in Group III of Schedule (A; Section:35.100ofLTitle,10,CodeofcFederal L
Regulations. g [*[ f
Qi)
aw, %-n-ld) - ~ fu f- f:qUq . .- e- l
C. In, vitro studies.
'
Y
_
s
[
'; y c . m ,, -
t r~ ; ,
.
(",)
[
i
D. For blood flow and'p,ulmonary/ function-studies. ' zy [
y', u Wl 'Q ;if
Fortreatmentofpolycythemiavera, leuk;(kbandbonemetastases.
ea
.
fQ l
I
E.
' (/_
-
s %> I
f CONDITIONS %*
,O' ,A 3
a [', C
q f y a, '
t
10 Licensed material shall be used only at Ketchikan General !!ospital, 3100 t
i
Tongass Avenue, Ketchikan, Alaska.
I 11 The licensee shall comply with the provisions of Title 10, Chapter 1, Code of [
l Federal Regulations, Part 19, " Notices, Instructions and Reports to Workers; l
l Inspections" and Part 20, " Standards for Protection Against Radiation". I
I I
l 12. Licensed materf al listed in Item 6 above is authorized for use by, or under the l
l
supervision of, the following individual (s) for the materials and uses indicated f
I' g
I Zeke L. llendricks, M.D. Groups I, II, and III t
I In vitro studies i
I Xenon 133 L
Phosphorus 32 as soluble phosphate for l
l treatment of polycythemia vera,
l
l 1eukemia, and bone metastases y(
l
i
lIr
I 'g
umununumi w ww m m m m m m w asa mm m w a m ra mini ha w:m mi n a m m m mmr
.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ __ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ .
-
yu=. 9----------------------___-..-m__.... ...,_________
- l orm3MA U.S. NUCLEN'J CE!ULATIRY COMMISSION , 3 g, 4 ,
I I uc=se nrmber i
50-19913-01 1
I MATERIALS LICENSE
"'" "
SUPPLEMENTARY SHEET
,
0 95
I
f
L
l'
'
Amendment No. 10 l
ll CORRECTED 70PY l
I
l
7-
l CONDITIONS
l
l
l
l Arthur K. liarris, M.D. Groups I, II, and III [
l In vitro studies l
I
l Xenon 133 l
l Phosphorus 32 as soluble phosphate for
treatment of polycythemia vera, l
g
l leukemia, and bone metastases g
I - n r- 1
I 13. For a period not to exceed sixty ,(60)$ days in$ny/ calendar year, a visiting i
! N physician is authorized to uschlice'n'ed s material'fsr' human use under the terms I
t
l of this license, providedQhe' visiting physician: ^M/ l
,
l
O
(a) lias the prior written permission of the hospital's Administrator and its
6 t
l
I
I
Medjeal IsotopesTCommittee, and
,% CN f)
M<f L
I
l
I (b) Is specifica11y' named as?a. user on a Nuclear Regulatory Commission if cense l
l authorizing hum'an use,4a'nd t \ _ _ /6> b
I
Q
'
q t- 6 /w ) / f[ . (
l (c) Performsonlyfthoseprocedure]sfor%hichhelisspecifjeally^authoriz [
l
l
Nuclear Regulatory Commission (license. \ )) f ? d t
! b (M '_ Al 12 - ./ f < L
The licensee shall' main'tainf for iinspectioniby[tlie"Commis'sion, c'6[les of the
'
I
l written permissio'ri"specifled;in, subites (s) above 'and' of Jthe license (s) I
l
q specified in subitems (b) and. (c) abovel.] jThese, records :shall.be' maintained for [
l five (5) years from'the time: the licenseesgrants'.its? permission'under [
- I subitem (a) above.'O' 7-d w/ s // W
l 1
y] b (,/ /lp M 4 la h L
l
l
l 14. The licensee is authorized to hold radis 6tive mate'ial with a physical r I
! half-life of less than'65' days for decay;fn-storage befote/ disposal in ordinary I
trash provided: '/ a W h
i
I A. Radioactive waste to be disposed ~of
,
e
in this manner shall be held for decay
t
t
I a minimum of ten (10) half-lives.
' '
L
'
l
l Prior to disposal as normal waste, radioactive waste shall be monitored to
l B.
determine that its radjoactivity cannot be distinguished from background l
l l g
'
I with typical low-level laboratory survey instruments. All radiation labels t
will be removed or obliterated. L
,
l l
l C. Generator columns shall be segregated so that they may be monitored I
l separateJy to ensure decay to background levels prior to disposal. l
I L
i 15. Effluent from the xenon 133 charcoal trap shall be tested for the presence of t
I xenon 133 af ter every ten patient procedures, in order to assure that the device i
I is functioning properly and that filter saturation has not occurred. I
,
, I
i l
i I
,
I L
l l g
I
, I
i I
4
TmisuraLaLauradaJuususurmammusumusususuuur.suaws = = = = = = = =
-
c_
= =3= = = = = = = = = = = = mR.*EDEf!E1EL'AMETitTETA*2Te"TG?2'3?EENFA?2fEh 4
9
R orm 374A U.S. NUCLEAR CEGULAToRY COMMISSION , y ._ 4 , y
Lic:nse tmber l
-01
MATERIALS LICENSE " '""'""* ' l
EUPPLEMENTARY SHEET h
+ 030-19521
B
f
Amendment No. 10 g
CORRECTED ~COPT h
R
- CONDITIONS g
5
5
16. The license shall include the reference standards described below when y
performing dose calibrator accuracy tests: >
N
Dose Calibrator Reference Standards N
>
Radionuclide Calibration Accuracy
Ac tivi ty g., l
, n . %. s
90 microcuries or more'V7
o' (] ff Within i 5%
l
Cobalt 57 Onc'millicurie or more V7 s Within i 5% N
p
y~ .p
, 3 p
17. Except as specifically provided otherwise in this license,fthe licensee shall ,
conduct its program in,accordance with the statements, representations, and
-
^
p
procedures contained.,in the documents including any enclosures, listed below. p
The Nuclear Regulatory Commission's regulations shall govern unless the >
statements, representations'and. procedures in the' licensee's application and >
correspondence are more restrictive than the re'gu1'ations. NJ E
- ' ; ,e > ..
(, >
-7 ., "e p
< '
'
A. Appifcation dat'd e October 27',(1981, ' , ;( } e.
.
'
p
- B. Model ALARA Piogram contained.In' Appendix 0.~.-
i of Regulatory Guide 10'.8 (Rey; 1)x , /, ' '
C. Letter dated July 28, 1983 y (l;
(.f,,* ' -
'
_
7-
D. Letter dated September 29/1983,a 4 j , j!f 4gt.
'
[-
- E. Letter dated March 13, 1984?
3
\ i l'! W ;-
,
. ,-
' f
y
"
l F. Telegram dated July 5, 19.84 L*/ , ' ,
/e.J
- i G. Letter dated October. 16,'1985' ( /, 's
"
.! . I)t
Il 19, 1985 4 i p;' h
i 11. Letter
I. Letter dated
dated November;20,1985
Decembes
'- p NUm - f
18 The Radiation Protection 0$ficer'for,the activities authorized by this if cense
'
l'i
is Dr. Zeke L. IIendricks.
'
,y 7l l>
l >>
.
@>
>
>
>
>
>
N
FOR TIIE U.S. NUCLEAR REGULATORY COMMISSION
original signed by B. A. Ried11nger ;p
D;te July 9, 1986 By p
Deth A. Riedlinger p
IIcalth Physicist (Licensing) >
Nuclear Materfalo Safety Section
Region V Il p,
R
P
'>
JuuRwaam1MukTaram' ALT.TmT;suavaraT.truraT;nvemaameras.vaJawmT;swar;sirar;sLT;
- - - - -