ML20129C215

From kanterella
Jump to navigation Jump to search
Matls Licensing Package for Amend 6 to License SNM-1525 for General Hospital Center at Passaic.Control:123514
ML20129C215
Person / Time
Site: 07001941
Issue date: 08/13/1996
From: Michelle Beardsley
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
References
123514, NUDOCS 9609240160
Download: ML20129C215 (8)
v • d • e


Text

mmm--mm----

mmwwww-----wwww=====mmwwww====

r I

w PAGE I

OF 1 PAGES NRC FORM 374A U.S. NL_AR REGULATORY COMMISSION N

ucense Number g

I SNM-1525 I

N g

MATERIALS LICENSE Docket or Reference Number g

070-01941 g

SUPPLEMENTARY SHEET g

l Amendment No. 06 W

I The General Hospital Center at Passaic r

1 350 Boulevard E

I Passaic, New Jersey 07055 I

N I

N N

I In accordance with your letter dated July 31, 19'96, License Number SNM-1525 is hereby I terminated.

N I

U 1

R I

N 9

5 N

I m

D' C C / e z.

r-E 1 :.

't

(

f y

b d),

6 A

  • /'

W p

r,5>

0 N

y 6

N 4-)

s',

p g

q) y q,

g

~

- r.; -

g j'7

t. )

j'.

"M

(.-.l y

g y

i N

ti/

t:

i

.i O

W g

},_

. asr L,,,

g y

L, yj

,1, ex' q

g i f Q [ p* 4 * *., *

.j g

f y

-g y

,j; 14, : j r y y p;-

S M

(ff(

[f g

l h

qf>3tf,,l c3 N

v f

f

\\Q u o p) g;j' Cy l

y

/[..

5 4, y -

y U, -

g e-

,e

/

$,"Q y

,tg f1 1

i I

N I

N 1

N I

N i

I N

I I

For the U.S. Nuclear Regulatory Commission N

I i Original S%ned By:

9 AUG l 31990 i Michelle Beardsley 9

I I Date By 5

N Nuclear Materials Safety Branch 5

I Region I 5

U I

King of, Prussia, Pennsylvania 19406 1

N p

OFFICIAL RECORD COPY g'

ML 10 9 f n

9609240160 960813 I

N PDR ADOCK 07001941 m

imummmma mmm mammmmmmmmmmmar C

PDR i

O O

AUG I 31996 Thomas D'Esmond, FACHE Executive Vice President for Operations The General Hospital Center at Passaic 350 Boulevard Passaic, NJ 07055

Dear Mr. D'Esmond:

Please find enclosed Amendment No. 06 terminating License No. SNM-1525 as 3

requested by your letter dated July 14, 1996.

Your cooperation with us is appreciated.

Sincerely, original signed sy:

Michelle Been8sley Michelle R. Beardsley Division of Nuclear Materials Safety License No. SNM-1525 Docket No. 070-01941 Control No. 123514

Enclosure:

Amendment No. 06 i

i DOCUMENT NAME:

R:\\WPS\\MLTR\\TSNM1525 To receive a copy of this document. Indicate in the box:

"C" - Copy w/o attach /enci "E" = Copy w/ ettech/enci "N" - No copy N

DNMS/RI 0FFICE DNMS/RI

,3 NAME Beardsley ph[)

DATE 08/04/96 08/

/96 08/

/96 08/

/96 OFFICIAL RECORD COPY h4L1D

r E icm Im n~citre or enss Q 2et eis 2e44 tses 72 22 se

e22 p.or es l

July 31,1996 Cl f United States Nuclear Regulatory Commission g74'g/ff Region I 475 Allendale Road I

King ofPrussia, Pa., 19406-1415 THE GENERAL

^"*"'I "li"" sing Anistana swrion HOSPirAL GER T Whom it May Concern:

L AT PASS AIC l

Please be advised that the General IIospital Center at Passaic wishes to j

terminate the NRC materials license of the same name, #SNM-1525 (copy attached). AD nuclear powered pacemakens implanted under this license have been retrieved and returned to the manufacturer.

350 BOULEVA90 rat:Aic Thank you for your assistance in this matter. If you have any questions or

,1 w.tnst w ess require any further information, please contact myself or our consultant Health Physicist, Ilill McAndrew at (908) 788-9440.

HOMR'J JAstcNSri CHAinuAtt 80AP00r Govt %CAS DatMt L MAVAN't0No FAcw S'.ncerely, mts Drr Amo CMF E/ECJWE OmCEA f

d Thomas D'Esmond, FACHE Executive Vice President for Operations i

I I

so f:*

.s.

O c,

ML10 12as1Ja$$e 0FFICIAL RECORD COPY b

JUL 3 l 1996 pg g

rres[ioe.i Ma[w ni rm:Q imQ71

"'o ar22 r. c7 ci-201 91e 2c44 w-,-

gl uae renv su

.. - - n._. -

" * " S g, 1

3

( 0s-08)

U.S NUCLE AR nEcul AfoRY coMMitstoN O'-

MATERIAL.S LICENSE Amendment No. 05 i

Purusant to the Atomic Energy Act of 1954, as amended. ihe l'rrrry Peorganitation Act of 1974 Wub'ic Law 93 M. and inte in ql CWe of rederal Refuhmms. Chapter I. parts 30,31, M, 33. 34. 35. 39,40 and 7n. and in reliance on stater ients and representathins heterorme W mat by itc beentre. a het nse n, herchy issued autheriting the liccacee to recenc. acqurre, gn'sse

(,l nuclear material desyna'ed below; to ose such rnaterial (nr the pmenef s) and at the pl.iccts) designated below; m deli d

in pertont authorired to receive it m accordance w ith the regulations of ihr.ipplienhle Part(th 1his licente shall be deemed to contain the condneem k p speofied in $ntion 18 4 of the Atomic Energy Act of 1954. as amended. and is subject m all applicable rules, regulations and q Regulatory Commimon now or herenfect in effect and to acy eenditiom specified bclow 7

i

!I-g t-.

__ f U"'

f In accordance with letter dated April 4, 1991, I

I, The General Hospital Center at Passaic 3 Ucense number $NM-1525 is amended in f

its entirety to read as follows:

y

(

4 q

2. 350 Boulevard t

4 Passaic, New Jersey 07055 4 rsrtration eate July 31, 1996 li

~

I

5. Docket or 070-01941 I

q Reference No

.g 4

6. Hyproduct, snutre. and/or
7. Chemical and/or physical R. Minimum amount that hcensee II spec 6al nuclear insterial form may possess at any one time lI under this hcensc 4 A. Plutonium A. Sealed Source A. 0.5 grams (1 source b

I (Principal radionuclide not to exceed lI I

8-PU-238) 500 milligrams) l B. Plutonium B. Sealed Source B. 0.25 grams (1 source ll i

(Principal radionuclide not to exceed h

d PU-238) 250 milligrams) p Il R

1 9.

Authorired use llL i

, A.

As a component of ARCO Nuclear Model NU-5 nuclear-powered cardiac pacemaker for f

gl clinical evaluation. This authorization includes: follow up, explantation, p

g recovery and disposal, but not implantation.

i B.

As a component of Coratomic Model C-101 nuclear-powered cardiac pacemaker for j)r I

clinical evaluation. This authorization includes: follow-up, explantation, l[P I

recovery and disposal, but not implantation.

l f

COND11 IONS a

F i 10. Licensed material shall be used only at The General Hospital Center at Passaic, 350 p

i Boulevard, Passaic, New Jersey, f

4

[f I 11.

A.

Physicians responsible for follow-up, explantation and return of I

f4 nuclear-powered pacemakers to the manufacturer for proper disposal are Michael g

R. Ramundo, M.D., Hermogenes L. Ciocon, M.D., Manny E. Christakos, M.D., and h

Justin ferando, M.D.

t g

I I

tt.

.The Radiation Safety Officer for this license is Arthur Weisel, M.D.

I g

I I

it f

I

)

,L

- --. -.i y--

- ~

FPort cro wS P' ct na AT PASSIC 201 916 2044 1996 31 13859

  1. 322 I' 04 ' UU xme-mn

,-x--

n -. n-ner_.

..m m N81C Form 3744 U.S. NUCLE A2 Rf GULATOHV COMMISSION 2

3 l) y%

t n. nee number MATERIALS LICENSE SNM-1525 l

SUPPLEMENTARY SHrFT I

Amendment No. 05 P

5 p

(Continued)

CONDITIONS I

W I

12. The specified possession limit includes all licensed material possessed by the l

licensee under this license whether in storage, implanted in patients, or otherwise in use.

j i

i l

13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN: ll l

Chief, Nuclear Materials Safety Branch, 475 Allendale Ruad, King of Prussia, P

f[;

I Pennsylvania 19406, ATT: Chief, Nuclear Material Safety Branch, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of l

occurrence, the death of any nuclear pacemaker patient, and any adverse reaction q

and/or malfunction involving a pacemaker system, including the leads. A written p

report giving details of the adverse reaction and/or malfunction shall be submitted l

j within 30 days.

p W

W 14. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, I

l ATTN: Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of l

t Prussia, Pennsylvania 19406, within 10 days of loss of contact with a nuclear T

I,'

i pacemaker patient.

(_

g l

l l

15. The licensee shall continue jiatient follow up and replacement procedures for the f

I nuclear pacemaker'during the:11fe of the patient 4; Procedures for recovery and M

l authorized disposal of the, nuclear' pacemaker by ret.orn to the manufacturer shall be l

followed upon the death;2

,p ofathe patient _...

9 r

l y

Sealedsourcesordetectd;; cells'co6taininglicensedmaterialJshallnotbe p

i-i n

16.

opened or sources removed] rom sourice holders [or detector cells by the licensee.

j I

Thelicenseemaytransportl'icensed[aerialinaccordance'withtheprovisions j

l 17.

t

~

of 10 CFR 71, " Packaging and Transportation of Radioactive Material."

i

18. The licensee shall not receive or transfer in any single transaction one (1) 15

[

t gram or more of plutonium 238 contained in nuclear-powered pacemakers without l'

l notifying the Olvision of Safeguards, U.S. Nuclear Regulatory Comission, l

j Washington, C.C. 20555, and, in additinn, completing and distributing Form

{,

l NRC-741 's required by Section 70.54 of 10 CFR 70.

p lP I

i' i

i i

9 l'

l l

R l

l r

I E

b E

I F

1 lP

{+li i

I li i

l P

l>

1

$e j

_,.m__,,a ma.ma

l e _____-- - --__--,.;-

& s e,)

U.S. NL ECULATORY COMMISSION g cE 3

3 i

NEG Ftem 3 ftA or paces License number l

l SNM-1525 MATERIALS LICENSE SUPPLEMENTARY SHEET R

070-01941 g

P Amendment No. 05 1

1 6

(C:ntinued)

CONDITIONS i

i 19.

Except as specifically provided otherwise in this license, the licensee shall l

conduct its program in accordance with the statements, representations, and

[

procedures contained in the documents, including any enclosures, listed below. The Nuclear Regulatory Commission's regulations shall govern unless the statements, gl i

l representations and procedures in the licensee's application and correspondence are g!

more restrictive than the regulations.

Wli l

E t

A.

Application dated February 19, 1975 l}

j B.

Application dated November 26, 1975 gl C.

Letter dated June 16, 1977 gj D.

Letter dated November 25, 1985 ti E.

Letter dated April 4, 1991 F

t i

i l

E E

l R

l F

1 R1 Ed Ef l

F l

h i

P ll EI L

E' l

EI El l

Fj b

F E

t Et Ei El ha El El E!

Hj E1

>1 El For the U.S. Nuclear Regulatory Commission p

Original Signed By:

f JUL 191991 Jenny Johansen Date gy

[p:

Nuclear Materials Safety Branch Region I King of Prussia, Pennsylvania 19406

(===-wmmmmmp_wwrausvsamammswramunnsmrawamssJrm.'r.mssparansfd

\\

o o

(FOR LFMS USE)

INFORMATION FROM LTS BETWEEN:

LICENSE. FEE MANAGEMENT BRANCH, ARM PROGRAM CODE: 22160 ANO STATUS CODE: 0 REGION AL LIC ENSING SECTIONS FEE CATEGORY: EX 7C EXP. DATE: 20010731 FEE COMMENTS: P ACEM AK E R/ 2 9-01040-03 DECOM FIN ASSUR REQD: N LICENSE FEE TRANSMITT AL A.

REGION

[

1.

APPLICATION ATTACHED A PPLIC ANT / LICENSEE:

GENERAL HOSPITAL CENTER AT PASSAIC RECEIVED DATE:

960731 DOCKET NO:

7001941 CONTROL NO.:

123514 LICENSE NO.:

SNM-1525 ACTION TYPE:

TERMINATION 2.

FEE ATTACHED AMOUNT:

CHECK NO.:

3. COMMENTS SIGNED I

oATe

___________7A K ______

= re s t "

g d

R ED {/.__/ )

iB. LICENSE FEE MANAGEMENT BRANCH (CHECK WHEN MI

,DN 0

I

,,_ h __________ b d,

N

1.

FEE C ATEGORY AND AMOUNT:

\\

'^

l 2.

CORRECT FEE PAIO.

APPLIC ATION M AY BE PROCESSEO FOR:

AMENOMENT

______rf[_____

E~-

l RENEWAL LICENSE v1 3.

OTHER S I G N e o e fd _ C __ __ __ __ _ __ __ __ __ __

2 oATe 4

nv U:DCB 4

4%. ___

4 wWW" J

g eW HS

l i

o U

U, October 3. 1994 HEMORANDUM T0:

Thomas T. Hartin. Administrator RI Stewart D. Ebneter. Administrator. RII John B. Hartin. Administrator. RIII Leonard J. Callan. Administrator. RIV Robert H. Bernero. Director Office of Nuclear Material Safety and Safeguards FROM:

Hugh L. Thompson. Jr.

/s/

Deputy Executive Director for Nuclear Materials Safety. Safeguards and Operations Support

SUBJECT:

RECORD RETENTION REQUIREMENTS FOR TRANSFERS AND TERMINATIONS In order to address Congressional concerns regarding radioactive contamination at sewage treatment )lants, the NRC is currently revising the record retention requirements of 10 C:R Parts 20. 30, 40. 70, and 72, to ensure the long-term availability of certain licensee records when a licensee terminates licensed activities or licensed activities are transferred to another licensee.

Current regulations require licensees to maintain such records. but do not specify what happens to the records when a licensee transfers, assigns or in any manner terminates a license, and another person continues licensed activities at the same site. The existing regulations are also unclear as to the final disposition of these records when licensed activities have ceased and the license is terminated. The proposed revisions would require a licensee to transfer all records pertaining to:

(1) the decomissioning of the facility: (2) radiation doses to the public: and (3) waste disposal by release to sewers incineration. radioactive material spills, and on-site burials to the new licensee. if licensed activities will continue at the same location, or to the NRC for license terminations.

The regions are heret advised that, until such time as the rulemaking is final, no transfers or changes of ownership or license terminations are to be authorized unless all records considered important to the safe and effective decomtssioning of the facility.10 CFR 30.35(g). 40.36(f) 70.25(g), and 72.30(d); and all records concerning public dose and waste disposal, have been transferred to the person continuing the licensed activity or to the NRC for license terminations. Address any questions to Susan Greene. NMSS, at (301) 415-7843 or E-mail (SLG).

cc:

J. Taylor. ED0 J. Hilhoan. DEDR DISTRIBUTION:

PARTIAL RESPONSE IMNS-855 NMSS r/f CPaperiello EWBrach IHAB R/F IMNS Central File NRC File Center **BR&SL

    • PCV **RECHFS
    • REGDIRS
    • REGSL
    • JDE1. RII
    • JLR1 G:\\IMNS855.SLG
  • SEE PREVIOUS CONCURRENCE **E-MAILED SENT OFC IM8 IMB IMAB IMDB IMNS IMNS 4tSs NM5s NME sGreene JPiccone JGlenn FCombs EBrach CPaperiello GArlotto RBernero

'E OITICIAL RECORD COPY

Retrieved from "https://kanterella.com/w/index.php?title=ML20129C215&oldid=4252764"