ML20151D884

Forwards Amend 20 to License SNM-1319.Fee Paid

ML20151D884
Person / Time
Site:	07001342
Issue date:	08/11/1987
From:	Klingensmith J BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC
To:	Gerard Jackson NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM)
Shared Package
ML20151D793	List: ML20151D790 ML20151D860 ML20151D884 ML20151D926 ML20151D953
References
107573, NUDOCS 8804140489
Download: ML20151D884 (1)

Text

e O

O

.. p,..

Bi6 control Technology, Inc.

w inaian sgmg j

d"$"AA"."WJ"MTA August 11, 1987 Ms. Glenda Jackson License Fee Management Branch Division of Accounting and Finance Office of Adninistration and Resources Management U. S. Nuclear Regulatory Commission Washington, DC 20555

Dear Ms. Jackson:

RE:

License Number SfN-1319 Control Number 107573 We are enclosing a check in the amount of $120 payable to the U. S. Nuclear Regulatory Commission.

We are also enclosing a copy of Amendment No. 20 to our license.

This copy indicates the changes which we are requesting in License Number SNM-1319.

We would also appreciate a clarification as to the reason for Condition 14 in the license.

Since rely, h l? hl >..Nt y

Jbhn R. Klingensmith Patient Records Specialist Enclosures T

S

~'

~

L 8804140409 070910 7,,,,,,,,,, hy pgDQ f. s 0

il(li.) y'of

.l REo1 LIC70 SNM-1319 EUN "051R RECORD COPY" ADVANCED TECHNOf OGY SERVING MEDICINE

• ~

.,/

MATERIALS LICENSE haendment No. 20

' h Pursuant to the Atomic Energy Act of 1954, as ameaded, the Energy Reorganization Act vf 1974 (Pubhc Law 93-438), and Title 10 I

ll Code of Federal Regulations: Chapter I, Parts 30,31,32,33,34,35,40 and 70, and m reliance on statements and representations heretofore made by the licensee, a license is hereby issuej authorizing the licensee to recse, acquire, possess, and transfer byproduct, g

source, and special nuilear material designated below; to use such rnaterial for the purposeo) and at the place (s) desigr,sted below;to 4 deliver or transfer such material to persons autherlied to receive ;t in accordance with the regulations of the applicable Part(s). This lt h

l license shall be deemed to contain the conditions speci0eJ in Section 183 of the Atumic Energy Act of 1954. as amenjeJ. and is f

subject to all applicable rules, regulations and orders of the Nuc! car Regulatory Commission acw or hereafter in effect g conditions speci0ed below.

4 I

~ ljcensee 4

l

@j In accordance with letter dated I

July 10 1986 I

W M' mme,4 13. trense nu,mbe' ShM-1319 i s arrended in q,

Coratomic, Inc.

g y%

J e, its entirety to read as follows:

t i; 2. P.O. Box 434

~~~ ~-~~~-~

~

~FI I

Indiana, Pennsylvania 15701 September 30. 1990 j

4 lariIttn ddle i

r. Dcd et or 31 l

5 y__

l Rtrm ac w 070-CIN2 q

( 6. l<yprodust. source..awor

7. che moi,aa rm c5p a 5 mumum armuniinat acnee 9

wemi nuelnr amtero!

form rm ; %m at an,t one time p^)

I' h

u u er u L m e

( A. Pluttnium (Principal A. Scaled scurces A. 'ot to excced 250 y

p

[!

radionuclide Pu-238)

(Plutonium t:atterie:)

-ilhgrans cf ru-238 per scaled scurce; 29s grces p

d tctal

.W B. Plutenium 238 B. Scalcd neutron source 3, 4.72 curies kj (Fonsanto)

(175 milligraras)

W

. h, a

y d

d 9.

Authorized t.se

};;

A.

(1)

Fcr t se as a ccepcnent in asurbled Corutetic 131 C-101 p:cer&rs and as a pj compcnent in the asse:rbly scrafacturing) of (cr;toni; v N1 C-lM P I

pace.Tancrs; ter cistribution to medical institutians at.thorizea ta receive N;

c

']i pacerakers pursuant to the ter.r.s ar.c ccriditions cf a spec:fic litese issud h

by the hucleer %galatcry Comission or an Bree en State, hy' (2)

For recovery as a concr.ent cf explantec (erste.mic "tet! C-100. C-101 and

?q C-101-P pacema6ers trar.s: erred fror snecific lituaces.

1 v

(3) for stcrage er disestably and re-furbi:hing of the batter / sevcc frcn p;

Coratomic l:occi C-1GC, C-101 cnd C-101-F pac c ah rs.

p J

p\\

! B.

For use as a calibri. tion scurce.

C0hDIT10h5 N

.D j 10.

Licensed raaterial shall be used only at the licensca's facilitics. 3C0 Indian g

j 5pring Road, Indiana, Pennsylvania.

1 11.

Licensed raterial shall be used by, or under the supervis ton ef, individuals who y

I have completed the training prograrr. as outltrrd in the icitor dated August 19.19E5 N

(

i and have Leen designated by

u. m.f,,,,-. n, e d i a t i e r. S a f e ty Of f i c e r,g e d i r A L u J.J d P

i s.s+

y$

&l d / /Df/GZ'~~

,L*

rErk~GW42%Mr.1Enr e=.u -=

casEr:r:c:tsir.ra.wi.n::.mu:. e.w udi N

I.

pr l i u m m t= [ )

k wm.

i

/-

MATERIALS Li SE

~%M-1319 v

p jl SUPPLEMENTARY SHEET IF i

/

070-01342 y

f

~

3 i

Amendrrent No. 20

'>L L

th (continued)

CONDITIONS E

l l e G re. Frec..u..n,c.. N

{

. i

12. As six month interval CoTa'tE @ ne~. shall collect and tally data from all medical 6

l I institutions with respect to:

(a) accountability, removal and recovery, i

I I (b) duration of satisfactory perfomance or the time of service t'efore malfunction, k

I and (c) nature of rnalfunction (if appropriate) cf all implanted Coratomic f

(

Model C-100, C-101, and C-10lP nuclear-powered pacemakers.

Within ninety (90) days of the six rconth period ending fet:ruary 28 or August 31, one copy of the report h

g g,

shall be sent to the U.S. Nuclcar Eegulatory Cc mission, Divisten of Fuel Cycle and Material Sefety, Material Licensing Branch, Washington, D.C.

2CE55.

A seccnd cery p/

o i

t of the report shall be sent to the U.S. Nuclear Regulatory Ccmissien, Region 1, d

1 Nuclear Materials Safety Section, 631 Fark Avenue, hing of Prussia, Pennsyhania t

6 19406.

o

--....-)

d' g_ ; m rs. t en W s5 4

g i 13. Coratwie, Tridhail reintain records of the 2 edict! instituticns apprend ty the

[;j g

t 4

FDA for participatien in ILE G CMIC4. A2 ar.d the date. of FDA's opprovai uf each s

, j,,..a

v., N.P instituticn.

1 2,.w cor

..t.i

,m,..

N

...n.., m e,

4 m

1.,.<, w. m p

e

. s st f 14.

This licensed cces rot authorizc tk irplantation ef'picer.alers inte humans or I.

j enimals.

y 4-i.1 4 15.

A(1) Any sealed snurces cr dctactor cells spcificd ir Itecs 7.f, er c 7.E shall be i

{4 tested for leak ge and/or cer.tc inatwr at intervals not t. e x c o:: e,r.cnths.

F Any scurce or detector cell receised from ar.:.th r persen eich is r.ct N,

' i accc:rpenitd by a certificate indicatir; that a test was perferrec within

)

C tonths tefore the trarsfet acil not be tut into use urtil tast(d.

%]

4 (E) h;tr.ithstardir.; the periedic 't at tn t re';uircd L; this c:rfi'icn, ag g

g%

lictnred sealed rctrce or detir:ce ccil is e t.;t trcr n '.* i: n ttats f

L when the tource cr detectnr (t il cen a f ri :M r.i.r: :uries ni let-. c ' tu te y

i d n d; C T garJa cr'I'ing Iraterill cr II' "icrscur ics cr let 5 Of clp 3 g j t t j ru, I

material, f

w eid B.

Any sealed scurce cr detecttc cCi ir mr:g m rct t;ir.3 2 : r. d c.e c d y

not bc tested, M.en the scuro :r c.tt:ta < ell i ra,1 cc c l ro. tit rage q

for u;e cr trans cr 'o e%tkr p.

nr. it d.'I teste:.. ic a se er transfer.

!y l

sL y

d*;

i M

C.

h test shall te n m.t,1e W tcc,;,

c..;c r

e af f. L '.?

c i c m c u i,

,t h

Cf radicactive t .: riel cr tl t tet-79),

the c;g reg,ci3. ;,e

• j 4}

prennce of C, :A :.it cccurie ~ ru ta e f ; r, s ; ale ccrit u.ctia ), t..e

!,1

[

scurce or catector cell shall bc rex m. 'rc. sar, ice e.nd ctcent:c.irated,

b]

it repaired, er di: rosea ct in accordance i.itt l'.misiica r(ruletions.

A h

t!

rcrort shall t.t filed within E days ct U a. ! ate the leak test rnult i:,

l',

j inswn with the U.S. huclecr Regulator; C m i:sien, Region I, /ITN:

Chief,

.ft j

huclear Materie.ls !af ety and Safeguards Cranch, C1 Park Avenue, Kirg cf ip 4

Prassia, Pennsylvema 19406. lhe rep'rt

".11 sMity the saurce it.volu d.

d f

the itst results, ar.d corrective action then.

Recorcs of lean test M

results shall t>e kept In units cf micr wries and s hall be riaintair.ed f ar t'

f ir:s c t wn tly ti e Cer..i ss ic r.

Rectrus *Ly te d;spcscd of following 4'

Comi s s ien insrection.

p 4l; 4

d 9

1 d

\\

AntimT. rdr_u.trm2m r&*. rcradact. ' nan tcrt! JL. r m L-J.nrmnT;rm? cyci rt.. ura rc t ch i

wp ca_s

~

3 or 3

eerd put J

Lkena c :mter j

.,e MATERIALS L

'SE SNM-1319

[

~

/

SUPPLEMENTARY SHEET ik 070-01342 lb I

/

d Amendment No. 20

))

4 j

(15. continued)

CONDITIONS j

4 q

D.

Tests for Icakage and/or contamination shall be performed by the licensee

>' i, 4

or by other persons specifically licensed by the Comissien or an Agree-N ment State to perform such services.

i 4

[ 16.

The licensee may transport licensed material in accordance with the provistoris g

of 10 CFR Part 71, "packaging and Transportation of Radioactive Material".

f

(

y 17.

The licensee shall conduct a physical inventory every 6 ranths to acccunt for ik' f

all sources and/or devices received and pos:essed under the license.

Fecords 11 il of inventories shall be maintained for 2 years fro ~, thi date of each inventory.

p*]

'4l P'W 4 18.

Except as specifically prosiccd othtreise in thit 11cen;e. the licensee stall q

concuct its prcgram in accordance with the stas: ents, repilentations, and

'y A

4!

procedures contained in the decur,ents inclaiir.c ar.y encicscres, lis t(d belcw.

9 41 The Nuclear Regulatory Cc=.issian's regulation; 3hcIl govern uricts the st3te-

,1) t i

rnents, representatior.s and procedJreb in tr.O llCer ce's appliCdtion ahd Cerre-(i

,pendence are rcre restrictive thar the ra;ulatic:s.

t.'

(I A.

Application dated Iaf 2, 190E p'bl

>jl

(

B.

Letter d,2tec Ausu:,t 19,IED l

C.

July 10. 1956 t

>i

' k.'

i, e

$j J1 t

i 9

,f

+l.

}

El i

r!

{

'b c

Y Ll

(

ki C

i.!

4

)!

$q f

Pi h,

1:

1 it N

i Pt 4

S 6

I F

i 9

4 f o r t.t r '). 5. h.c l t.a r i ccp h t "ry Co.m : s i ch

(

9

,1 4

al k Late AllC 2 1 G25 El, 3

sy

2. vn

.ot?t' *r0 y

4 m'; C it N 3 t u t' i t i '.

it

[

t,OIPd5 k' I O ! 'l ", N 0 f) 1 (!

pl

'.a

[ b erar w veva tcrra re u i m rarrrrererrrr u,ra tlhg Lt~ '

3;J. ' t i l. v l s ;r, ; g

'(6

+ n. :

l

r.r.rcu r.r.r.ict.r.rmrx ti

.r

,