!magin:

Prussia, 5

NRC

Copies verifying Dr,

need

D(ABSNM)

Shrewsbury,

Physicians Center New Jersey

March 7 , 2009

Materials Licensing Branch U.S. Nuclear Regulatory Commission, Region 1 475 Allendale Rd. King of PA 19406-141

Ph: 6 10.337.5000

Re: License No. 29-28041-01

Dear Sir or Madam,

This is a request for an amendment to our license to add Dr. Carl os Saenz as Authorized User-cardiac procedures.

of documents the training and experience of Saenz are enclosed.

Please feel free to contact us if you any additional information.

Sincerely,

Charles H. Rose, MA, MDSPH, Administrator Physicians Imaging Center 180 Avenue at the Common

NJ 07702

Cc: file

Enclosures

OARD OF INTERN INCORPORATED

Mnrlos Bentgnu CERTIFIED

INTERVENTIONAIL

E S T COlJMITRE INTERvENTIQNAL f- a

THE

1936

ATTESTS T H A T

H A S MET THE R E Q U I R E M E N T S OF THIS BOARD A N D IS HEREBY FOR T H E P E R I O D 2000 T H R O U G H 2010

TO POSSESS

ADDED QUALIFICATIONS IN CARDIOLOGY

ON CARDIOLOGY

BOARD OF INTERN ad~~'cfl

Mnrlos Penigno Buens THIS

D E S I G N A T E D CERTIF lED

?- CHAIRMAN AMEklc~s INTERNAL M~MCD.IE AME~ICAN BOARD INTERNAL WDICINE

sueUTCWn ON ~ ~ N I D I o V A X U R MSljAX

N W ~ 9661'7 1987

THE

INCORPORATED 1936

ATTESTS T H A T

H A S M E T T H E REQUIREMENTS OF BOARD A N D IS H E R E B Y A D I P L O M A T E I N

THE SUBSPECIALTY OF

CARDIOVASCULAR DISEASE

CHAIRMAN-ELECT BOARD OF OF

DATE NOVEMBER

0 1 / 3 0 / 2 0 0 9 P R I LPZ3

B e Saenz, MD / o f Florida Requested AYthom*(s) (char aU that

AUTHORIZED TRAINNO #AND AND PRECEPTOR A T T E S T A M

use$ de4lnwi 35,100,35.200, 35,300) [.to CfU 36.f80, 55.m9 iand 36-f9(Y

16.200 lmsphlQ h / h $ o n studies

AwmvED OMB: 5~504440 EXPIRES; 14191rnB

PARTI-~'IUIININO ~(PERIENCE (Sdwtone ofthe Ihrw method3 below)

Expadence, -ding certitbtbn, +tainedWi ye8m preceding "a"a= or hdlvldual nrwt haw obtelned reIated wntahg U U o n e w c e shoe ng expetlenoe compl@ted. Provide dates, dumfion, arb cbsd~pklon d continding t h s . " n d expwiem mhted 10 ires Qledud above.

A

k 4 e m d P M - w (state T a l t q Where tigad

using 35,500 marerials, sbp udng 35.200 skip to I1 Pre~~ptar Atwmon.

Authorized Materials - CFR or equimknt " State requireme#ds W n g authorkation fcb

-- - - -

Eluting gsneratw systams for ihe preparation of

radbadlvednrgeforima@oand kx;ak&m studies, mewring and

h e for radionudidio p e n r i e u , ~ ~ ~ - with kits prepare labeled radioat9ive d m I

I ...........*.-., *... ............., ........,.... .....-.... i. .-.." -- .....-...-. .. ....-... -..-.....-.. ......-......

Supavisor meets riaqthmnts k b ~ , wivalent A g n ~ ~ n t wm (*& J f b t @V@Yl* '

10: 40 PAX 4 0 7 8 9 4 7 1 3 6

Carlos S t a t e apply)

USER EXPERIENCE

(for under and

and I

AND

Trainingand board musthave been the 7

BY NO,

or I

the andand was the

b. If only here. If 35.100 and materials, and complete Part

I 35.380 Agreementa, user on License meeting 10 35.290.

appropriate

testing eluate

reagent to

t

.......... ............. ............ ...... .... the or I

01/30/2009 10:41 LPZ3

and

Deser$tion tocab

Sawis

perleining Same measwemgnt d

Chemlsby of bypmdud matedal ~ ~ u s ~ ) ~ ~ d f a f

Satre

T W Hours or fiahtlng:

(ccwnpletim of this is not (Ifmore Ihan supetvidng Individual lo supervised wcvk exper~nce, mvide multiple dapriss ofthi" se&n..l

t . ~ ' a n ctf Fa&&

but: X) p a r s experferrce

~ o r r ~ u s e d t o Same determine aclhrity d0S-S and perhwmin(l checks for proper qwafion suwey

PRI FAX 4078947136

a. Classroom Laboratory Training.

of Trainingof Training

as above

Mathematics to the use as aboveand radioactivity

, Same as above

as above

b. SupervisedWork Experience table required for 38.590). one Is necessary document

Permit Number of

No spec i f ic training;

as above the of

of meters

0 1 / 3 0 / 2 0 0 9 1 0 : 4 1

HRC SISA WJD) US. NUCLEAR WLSUTORY COMWSlON ('LO!mq AUfWORlZED TRAlNlNG EXPEFUENCE PRECEPTOR {conVnueQ L

Trainlnn anti Exmtfence T ~ W Ptwmed &~~ C E s s r ( m W )

Superuteed Work (continued) I

Description Locztiin af Experfen~~1/ljoense Must Pernit Facility - Exp~"ema*

i

Calculiding, measufing, safely prepadno patient cu

Dyes

subject 0 addministratlve oontrds

paevent rtwkal evsnt involving *rp DY""

byproduct material - n No pmcedures contsu'n spilled

b y p r o d r d ~ I ubn~ ayes pmper c3 No

- ..

dosages EadMve drugs ptbentsot research

L_1' '

subjects CZ1 No .,.

m-@Y-=e the preparation

I Yes

chugs for Imaging end foa&alion measuring the * Uh

far radionucI'idii purity, 'pllmssing meebJafewtrn mpnc kib b pnepam radioactlve &w Supervl6sng IndivMual f tlcensel~efmit M ~ Q supew-

~ v L ~ r - * . . :y;-,,, .............................. r .. ...,.,. " 0 , - ............................. : ..,............ -.r ----..- --.- ..--... .-- -...-,. .........,.. ........." ....,,... -..... S u ~ w Agreement State requlremnts {Gneck me).

) G Frr 35*590 mC pmvide d m e n b l b n use the

d. FM 36.600 uses mty, stop 35.1tN and 35200 ms, Part Precepfat h-.

I PAGE:

FRI FAX 4 0 7 8 9 4 7 1 3 6 LP23

FORM USER AND AND ATTESTATION

3. b. Experience.

ofExperience or Dates of Include: Number of

and human research

dosages

Using to a

use of unsealed

Using to safely and

decontamination procedures

Administering of to human

for of radioactive

studies, and testing eluate and

labeled

Number individual as an

........ ............................. !

.... .... ... . meets the requirements Mow, or equivalent

....

of training on of device.

hen. For skip to and complete

0 1 / 3 0 / 2 0 0 9 PRI 1 0 : 4 2

U.8. WUCteAR REWfATORY CbMblWiON AVTWRltEO U8ER TRAINlNQ EXPE:WENCE AND AlTESTAO# (corrtlnuod)

H - PFECEPTUR Anrs7;ATIW Node: corn- the indhriduars preceptor. prt~ceptat supmising

i n W d u a I e s l o n g ~ t R e p r e c e ~ ~ s , ~ ~ , ~ ~ ~ ~ B n d ~ ~ # m x b m p- nwmary document eyllwhce, obtain preuqbf stahmant (Not

~ i o ~ ~ ~ / h ~ ~ \

checking bates is th J Ule individual W e d g e ~ R I o n s o u g M a n d n o i a f b s G h g d o ~ i n ~ ~ ~ ~ ~ . w

Ptrst section one following each use 35.190

rd Get- satisfactorily completed requirements

hlemot~ropossd-w-

35.190@j[$) and has adtied level competency suflsclent functibn IndependenUy usar the medical autl~orked CFR S.100.

I a that - saijsfactodfy oompbted how of tralnlng I NamOrPrrooElcr~Uw

experience, including mMmwn of8 holm clasmm laboratory t r a i i wired 10 35.1W$1(1), and achii16d a oil cofqetency sufficient fundion lndependstrlly auvlorizsd user forthe medicel u s e 8uUborhed 10

D tnat - satisfactorily completed hlamofPlqPoe#1AuthOrgb(l b u r

10 35.200(a)(1) has ~ W w d r level of mymtwcy wffcient funcdion Mpendently as twthxkd usar dM medical uses authorized under 10 CFR 35.100 and 39.200.

I l that Carlos 8, Saenz, MP has Datlsfackxily ##npleted 700 hour$ of training WIOO~P~AU~~YY~~IF

eocper3enc8, hduding of80 hours c b s s m laboratory trsining. requircrd 10 #R35LWcK1), hasachimda b ~ v e l p f ~ a y s u m o i e n i f o ~ ~ l a s c m authobd user the rnediczd auhtxked rrndar 35.300 d 98.200.

m--HY -1(1--

SwmndSadbn tRe dot preoepcor ~~n sbnature:

I

PAX 4 0 7 8 9 4 7 1 3 6 LP23

AND PRECEPTOR

PART This part must be by The does nothave to be the

one Is to a separate from each.

By the below, the preceptor attesting has to fulfillthe duties of theI Check of the for requested:

Fw

has the in

10 CFR a of to asan authorized for uses under 10

Iattest has the 60 and

a of and by CFR has level to asan

under CFR 35,100.

has the requirements inI attest

CFR and to an the

attest

and a minimum of and by and

for 10 CFR

and

0 1 / 3 0 / 2 0 0 9 1 0 : 4 3

FLO-RlDA U. Chrrkes (Curry, jr., MD, FACC, fACP Ukry 3&wart4 MD, MCC, MfP

c13. Curlo, 8, S;,CX, MD, FACP W h 44. WiUb 5tv MO, WCC, FACP

'!!! 1. W'eitvw, MD, F A G FhCP Srlvrdoc N', lanu. MD, MCC, Mark R. duiaam&i, MP, F A C G FACP F d ). E:w, AWt FACc CiRup** MDr fRCC Ramon M. Term MD, FACC

I ~ t W t b r ~ ~ E d & ~ Am SandraNissen W R W r n d

101 Baulb, CCO

F A C S W . 303-541 9066

m o o ' / 0 1 9

lost H. Aria& MD, MCC hnim Ctn, MOT f&X Hani 19, MfeIa, MD, FACC Irntricia A, G t ~ m r o , WID, TACt Mtin K. CfHn, bWt FACC .&mes A. MiWG m, ICACC kt. 8. b m , MR, FMC, FACP C w t y Gooden, MMD, FACT A @ w h C. frmcescliC AID, MCC F YCAl Hector F. louaoo, MD,

A t ~ E s ' f l r , ~ ' s ~ i ~ O n c O r r u l o l e s r ~ WeW0utttbe-Wat.e applicable, We were I21 out metal item not trainiag frtrjBty. gdng b p* $uu wjdr 8onrc tidWmd i&R- tbt m y b M@d in d e ~ h i s , ~ o f ~ . ~ . S e a s v l ~ e d ~ ~ ~ ~ W n ~

fillowship thu Uniwmity IUibama under $re &&on Dr. W d Pobosl. &us beta pmcticdttg IphyxSm since 1966. Ih those 20 batr pcafiormed oves

nuoleat studis within our practice md M d a H c q M , an-rizeil ase~.

P ~ t a e m a m c H v ~ w ~ h b c r s - s s A r , S l l e n z w B X k f ~ t b b l O W ~ w e m s ing k be able to apply tbrougb Mew fq,

PRI FAX 4 0 7 8 9 4 7 1 3 6 LP23

. M.

HEART CROUP

Curtis FACP

FACC

Suite 80303

VIA

unableto as weam a I am

his at of of He a years he

7100 at which are ova-read by

01

/30

/20

09

1

0:4

2

LP23

QO 6

/01

9

PR

I FAX

40

78

94

71

36

1 1 0 : I I 4 0 7 8 9 4 7 1 3 6 LP23

V I T A E

BUSINESS Hcxida Heart Qrmtp, 1613 N. M h A w a w Odando, FL f4W) 89444%

Qm Unfuq Rosario Bop&, Colombia, -m D q p ~ : 7j726178

0 1 1 3 0 1 2 0 0 9 PRI FAX

C U R R I C U L U M

PA.ADDRESS:

32803

of South

Doctorof Medicine

0 1 / 3 0 / 2 0 0 9 F R I 1 0 : 4 4 LP23

/ 2 / 2 9 / 2 0 ~ 8 YON tJ iX d0789A7136 LP23

(conk):

LSrU Nt* Qih?w, I h B 2 ~

&3Lowshin b;l D h s e W l h i & ~ d a ' I - ~ U r n i ~ ~ t y afAlabamol Bimn&am, AI, 7fM 6!8% C h i d Cxdi010gy - 6/87; htenrdonal CariXiology.

km'can Boars( In€& M d n e S~~hpedalty Wovascular N o v d m

A d a m Bad a f ' M M . 'hkkxvwdmah ~ & o $ o g y November 8,2000

k ~ : #I cangia +a3786 Inactive k iwk 01WW W h # Q 6 2 5 8 8 'L&ve lsmd: WPZ5185 Akbma #I2383 Inactjve fim& 6120t88 Florida #MMN)J3551

PAX 4 0 7 8 9 4 7 1 3 6

8: 44

EDUCATION

Division LA

12/84

Cardiovascular

-7186

of in Disease

7,1987

1/92

Active

, ~

01/30/2009

CtXUUCUILUM Carlos 8. SLI-5 M.D. Page Three

1987-J~ne, Assistant Profasor, oft iddkk iP3i- C d W , univ-.q td- Bi~mtis&m, AL

Codabm, Caxdiobgy Sej,uhificSessS9ns 3- Sertrion. o% A m e a i c m P e i b m k i m & C ~ ' R ~ Chaiamrat, Cax&ojd$Y at Dhwy Wdd, Amciation

Member, IMda Chapter, Amm'm Hetat ,tbam&m lkridla Cbptcr, AmAmer He& Ass&ati0~3.

M ~ , , ~ H ~ ~ & , ~M&, C w h k w Q4 QA PMda Hospital, Orlaado, FL Ww Floriaa Head Group c3l&ml, Depa- o f - 1 ~ , l?ks+h llhoqitat, n

PRI 10: 44 PAX 4078947136 LP23

VITAE

EXPERIENCE:

July, 1988 Department of

Walt American Heart Board . Vice

01/30/2009

VITAL Carla 13. Saenz, bIJ, Page Pour

OFJJWERESR

Mudpt Eavedf@or: I t a d m h d slWy urse der deMve PICA,

Cb-in-* rn &id, Ph&w U.

Co-1avdgatar: 54 immmeat s a f i and edsaacy pioiPh: of Atmatah as ampared to F l u e & Ln- S i m v e and Pmwwtk when W o@bufly axdm1 prhnary ~~~ (me lIA) arkd mixed dydipbimia (type ILB).

C&Iav-: md6- do@iWlin&a, p l e m n c d , padk-9 desilgr cl'mica1 trail WBSS and e h y 35 mg mg Azimilide Dihycfmd@ fw the

PmpkjhkT-of: S- A t d F-- and/or Syinptumatirz Pmxymd ~ ~ T a c b Y y c e r d i a ,

CBPIrr*,. hvwpdiw lksm!mdzred Amblip& WuaS BY^*-%. sandomized, dbsa--'oar, pidM pup, -1ed d y to evaluate

fhe e m amlodipine on s m d d pafie& witb ecmgdve Ireart f i t h ~

PRI 10: 44 FAX 4078947136 LP23

CURRICULUM

AREAS

o fheparin

A week open label of die to

A to the of and 75 of

A double-blind, of m

~ a a d / w

01/30/2009 PRI 10:45 Lp23

X ~ N ::as FEaji 103SPC7236 LP23

CURRICUXIUM VITAE C&os 1B. Saenic, M.D. Page

@Xmstiga&1: A W d z t s d , OpmLa'bel, A d v ~ l l e d , M u l h h Phm Ill SW Of Doses OfNA-@ WNP Aw- AB ACrvnhuum h f u h hTh6

?kdmmtmD-m.

Co-InvestigaWr: Mdti-coamw, r a n d o m doub1eblird, piacebbcon@lled assesst$eeffiPxt.ofW~m~gnd~~,~~ ainal$.md;qusl i tyof

pati-& with stable, chnanir: rnxqystive beatk tJPlHAC4m II-IV)

Cdn-r: multi- c h i d td as%%s the 1 ~ - t e a n &&Y daily dose rng o f ~ d e ~ ~ ~ w ~ ~ ~ m lFJCWW v a r i d w a ~ .

CaIn- m d o W study (ICD versus no1kIICX)) msdescrteZy higfi-riek coronary @ ~ t r r z d ~ ~ ~ i s a ~ ~ r e d & i a M i n p g t i ~ w h o & v e a n I C D a ~ o o m p P n a d b ~ ~ t ~ ~ U = a .

FAX 4078947136

Five

Study Two

parallel, trial to life

in

A open label to of oral of125

A in

, ~ d

i ~ ~ ~ a ~

0 1 / 3 0 / 2 0 0 9 FRI 10:46 ~ ~ 2 3

12/z.s/acoS Earn $6 PhX 4378~4?13G a 1 3

CUBRKCUILUM VITAE Cadiis Baenz, M.D, Pagel

Cb.lnvesdg@w: W e d tWxy Trial

PrincSpall#vdgaQrc: l 9 e v w i m o f 1 w with 73anhdaad Ita Outoomes

Cdave&gabr: M-m&ceao~er, W o ~ r a m d b m i n e d , d * W t e d ~ ~ ~ - * t 8 R ~ ~ I * o f l ~ ~ w J ~ V a l s ~their P$tienta a k myocardial i-

Ce-In- &syorad Endow Lipid with E0CT

Co-hvw@m double^ mr&mizd p.behmw parallel p w snyky evaliaabg the e&c& ofdffcreat ofLU 13152512 on l&v&* dbwbs, dbfkaad + - ~ ~ ~ 1 m 3 z m r i ~ ~ p obeart fhhe .

Co*h~tt~t@br: safely the OraI Direct Tfumbin M&br H 37695 Crrmg23Prrrd vrrifla b A d j w k d Wafhh Pnvenb:on Sbroke Spbmic Embofic Events Patients Pibrillnran

FAX 4078947136

9:

B. Six

combinationin high-risk

Lowering Scanning

doses

Efficacy and Study of in the of and

m withAtrial

01/30/2009 10:46

C-CULUM VITAE Carlos B. Saenz, mlo. P w Seven

Cl3 Socgz, hxfey, Th4 Bullle, JM Cbrrr; D e a Ballom aortic val~11opMy: impact the natural ofaortic Ssenoais. S M Aa;raricaa Hemt~asodon

t 988.

4BdRaurr;a; W A ~ i ~ , ~ B r u f f e , ~ M ~ , L S ~ E&ygad?kte~eciof Heparin hfhion Fdlowing Elective Angioplasty. Submitted Arntdcan A&at'ronNTay, 19%.

SSilber,UDean,WABaey,TM13ulte,Cet$-WW~LAZ:a GM Pdm& % i t & d m m e a # j r ~ 8 @ ~ o f S i W E d l ~ ~ InuzlediateXy A.fter Curaaary Woplasty Cmpletdy Rev@- S m do R- IIm Asim&bn Mv, 1988.

CB ikaz, W&d& PH NsttEt, J C h , Baxlq, PL Whitlow AngbgmpMo morl,bl~gysnd outomno ammsy *opk@ fix uzrs$b?~ mgh, €lit&&

Resw&t98c2.;3~1)5A. Mentad @e AFCR-Soufhm Sedion Me&& New Orleans. Jamwy? 1987,

Cs NZ 33eamdh M Rfsim S Moos, NC Nan& LirniWoas Color QtmWive ~ssessrsent Mtd ~~, C!hwl&on 1985;72(SuppI, lQ:IJJ-98,

16 AZiA Mwtkg W s D,C, N4Y&

FRI FAX 4 0 7 8 9 4 7 1 3 6 LP23

WA LS in history

May,

to Heart

in Patients.

WA clinical m

at

of in of

1985.

0 1 / 3 0 / 2 0 0 9 PRI 10 :47 LP23

CUIIU[CULUM Carfoo B. Sace~z, Ma. as@ EMt

E Msin, SSG; WBed, Robie, CB Saenz, PM Gdetz;: Capbpril in the treatment UncontroffIed Essential H y p m B U I%P&S&K Lmg Tem T r m f .

C W d Ibsemh 1983;31:2.

CBS- MANocem, CJ W a v e P ~ f a n a o u s v a l ~ ~ j n s g s t i ~ ~ t h d ~ stenmi6 surgical aitn~ilopIasty* €a!m C*Map 1990.,~21(\):\&22,

CB Smm, KM Scbwa~z, $9 Sly& K Palam, Cwtxy, Ir.: l3pxieace wifh cmmsy w h p ~ b h c&td~~ dwring w m p T i d angioplasty. CatW C ~ O V ~ B Disgn 1990;Aw 20(4):276-8.

r S ~ J W ~ , C r t ~ W A E k u r ~ , ~ B u l l e t S k w e m d W * complicating ~ C O U S aortic vdvdaplasty. Qdicms Mqp 193&~*,'16[2):130-2.

CB S q WJ bgas, PLWhiflow, WA'Bdey,WPHod, h., ~ ~ , B W. hlla@dagy d Oadudve C!mmaryLesions I)urin$ M y o d d Muction: A n ~ ~ c a n d CliniGal Aasrlysb. Heart J 1987;Jm;l13(1):8449.

C l B S ; r e a z , C V ~ l B P N ; g # y ~ E . R d h l b h c m d & l - m w i t h st@* a m a ~ ~ lwdamnh, condition dies W1ymphoutaneb~J' spadmme. Arch IntGP Med 19187; 142793.

FAX 4078947136

VITAE

NW of Previously

following

RC theuseof

valve

Acute An Am

A that a

0 1 / 3 0 ~ 2 0 0 9 PRI 1 0 : 4 7 PU( 4 0 7 8 9 4 7 1 3 6 ~ p 2 3

1 2 ) ? g / 2 0 ~ 8 HOW 8:47 4 0 7 8 9 4 7 1 3 6 21823

CwIos 8. Saeaz, M.D. Page

PRESENTATIONS:

w ~ g b ~ k y fa 90's" brdimRiw Plan* &st (bast C k d b 1 ~ Update, l[ndian Rivet, EL Octok, l!%%,

FAX

CURRICULUMVITAE,

Nine

the

letterlapplication m u m &(- ( -9 / / j /-)

-LP-Z%c -o/ d T h e ~ & okssions

witliin

for~arded & 1s

Your Number /p7 fJ 337-539E;,

(Rl)

6-96)

This is to acknowledge the receipt of your dated

, and to inform you that the initial processing which includes an administrative review has been performed.

I administrative Your application was assigned to a

technical reviewer. Please note that the technical review may identify additional omissions or require additional information.

Please provide to this office 30 days of your receipt of this card

A copy of your action has been to our License Fee Accounts Receivable Branch, who will contact you separately if there a fee issue involved.

action has been assigned Mail Control . When calling to inquire about this action, please refer to this control number. You may call us on (610) or 337-5260.

NRC FORM 532 Sincerely, Licensing Assistance Team Leader