'tiJEasternl sotopes- imm

an IRA Comparny C

100 Executive Drive, Sterling, VA 20166 * phone: (703) 787-7900, fax: (703) 787-4079 wwweasternisotopesicaim

Mr. Brian Parker, Health PhysicistNuclear Regulatory Commission, Region II61 Forsyth St. SW, Suite # 23T85Atlanta, GA 30303

0 5 r I1'?'IJanuary 6, 20 _

IrM

Subiect: Amendment Request To License # 45-25221-01MD

Dear Mr. Parker,Eastern Isotopes would like to clarify and amend the aforementioned license.

i.

1. Clarification of Ownership: This license is owned and managed by Eastern Isotope Inc. jV~giniaCorporation. Eastern Isotopes, Inc. is owned by IBA Radioisotopes, Inc. a Delaware Corpain.IBA Radioisotopes, Inc. is owned by IBA (Ion Beam Applications) SA, a Belgium compa1.<

2. The contact address for all correspondence for this license should be: =Joe Harless CZEastern Isotopes, Inc.100 Executive Drive, Suite #100Sterling, VA 20166

3. Retain Joe Harless as Authorized Signatures. Remove Mark A. Smith, CHP, as AuthorizedSignature.

4. Remove the Little Ferry address from Item 10 - Facility Locations. That site is no longer used as aradiopharmacy and no isotopes have been stored on site for some time. Final DecommissioningWipes and Surveys have been conducted and the facility has been declared free of all radioactivity.Wipes and Surveys enclosed.

5.

6.Correct the title for Mr. Ali A. Abassi, (currently listed in Item 1I B) from RPh to PharmD.Item 12 - Remove John Zehner from the list of RSOs. Add to Item 12 as Alternate RSO - JamesAlan Kostka. Credentials enclosed.

7. Add to Item 1 1B - list of Authorized Nuclear Pharmacists:John C. Chen, R.Ph.Kim C. Hosen, R.Ph.

Thank you for your attention to this matter. If you have any questions, please contact me at (704) 226-8100.

Sincerely,

C. Joseph Harless, CNMT, President, General Operations & Corporate RSO, Eastern Isotopes, Inc.Cell Phone (704) 399-0673 Fax (704) 391-9382

Enclosure: Credentials for Assistant RSO, 2 x ANPs and Decommissioning Surveys

PERSONAL INFORMATION WAS REMOVED - :BY NRC. NO COPY OF THIS INFORMATION Delivering Solutions for PETT"

WAS RETAINED BY THE NRC.N11.13SRG!2NI ?LATERIALS032

I S i . .

Decommission Report

On 06/29/2004 the Eastern Isotopes site in Little Ferry, NJ was inspected and tested forradioactive material. Meter surveys and wipe tests were done of the entire location.There was previous radioactive materials on site, which included F-18, 1-13 1, Ga-67, and1-123. There were also sealed sources (Ba-133, Co-57, and Cs-137) that were transferredto Eastern Isotopes in Somerset, NJ. The last date which any of these material was usedor received on site, was 02/02/2004. This site was found to be free of radioactivecontamination. Data is included below.

Location:Eastern Isotopes, Inc212 Gates RoadLittle Ferry, NJ 07643

Date >

06/29/2004 j5 Satyr

Sinlee Channel AnalyzerLudlum Model 2200Serial Number 17451Last Calibration: 11/26/2003Window: 80 - 880Voltage setting: 236Cs-137 Efficicncy: 0.3136LL): 105 cpmMIDA: 335 dpni or 1.50 x 104 UCi

Survey MeterLudlum Model 3Serial Number 74949Last Calibration: 10/27/2003

Zer/zPo0r1frz I?- 5'r

Pq l6F`1

Map of Wipe and Surveys

C/AŽ

9' ~1

I I-

Location on Aap WVipe - cp, Wipe - dpin Survey - mR/hr NotesBackground 228 .- 0.1 mR/hr e f

l 214 682 0.092 202 644 0.093 221 705 0.084 216 689 0.095 203 647 0.086 198 631 0.097 215 686 0.098 209 666 0.079 201 641 0.0810 . 200 638 0.08

11 210 670 0.09

12 196 625 0.0913 222 708 0.0914 209 666 0.07

15 211 673 0.0916 204 651 0.0917 220 702 0.09

18 217 692 0.0919 203 647 0.0820 196 625 0.09

21 213 679 0.0722 219 69S 0.08 __

23 204 651 0.0724 221 705 0.08

25 201 641 0.09 __

26 196 625 0.0927 199 635 0.0928 208 663 0.0829 217 692 0.0830 204 651 0.0831 199 635 0.0832 209 666 0.0933 203 647 0.08

34 206 657 0.09

35 218 695 0.0936 200 638 0.09

37 220 702 0.0838 218 695 0.0939 209 666 0.0940 205 654 0.0540 215 686 0.0642 202 644 0.0543 222 708 0.08 A a,

pa?3-f V

44 224 714 0.0645 216 689 0.0546 211 673 0.0747 227 724 0.07 -48 203 647 0.0649 215 686 0.0650 208 663 0.0751 215 686 0.0952 201 641 0.06 Iodine Glove Box53 213 679 0.05 Iodine Storage54 194 619 0.07 Iodine Storage55 199 635 0.07 Stainless Steel Storage

56 212 676 0.07 Stainless Stecl Storage57 193 615 0.08 Stainless Steel Hood58 200 638 0.0959 195 622 0.0860 219 698 0.0961 202 644 0.0762 208 663 0.0863 211 673 0.0864 198 631 0.0965 201 641 0.0766 221 705 0.0867 214 6S2 0.08 Traditional Hood68 225 717 0.07 Iodinc Exhaust69 211 673 0.07 Iodine Exhaust

64v

f1 *fL

NRC License#45-25221-01MDItem #12

FIGURE G - NUREG 1556, Vol. 13, Appendix G

RADIATION SAFETY OFFICERTRAINING IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Eastern Isotopes, Inc.Corporate Headquarters100 Executive Drive, Suite 100Sterling, VA 20166Phone (703) 787-7900Fax (703) 787-4078

Name (Last, First, Initial) Kostka, James, Alan 0o Years Experience with Eastern Isotopes to include 6 years as Lab Tech and 4 years asCompliance Manager & Assistant to Corporate Radiation Safety Officer

Location of Dates Title - Total - Bteakdown^of Co.rsteinoClockCHoursTraining Hours RP&I RP MATH RB DOT/NRC

Livermore CA June 02 RRI's Advance RAM 32 DOT 32transport by Air

Houston TX June 02 DGAC Transport by 24 DOT 24Ground

Newport MN May 02 UN Package Testing 40 DOT 40

Gaithersburg, MD May01 CSI Rad-Train RSO 40 RSO 16 6 6 6 6Training & DOT I

Las Vegas NV Feb 02 Englehardt RSO 40 RSO 16 6 6 6 6Training

Sterling VA Dec 03 Ell Annual Radiation 8 2 3 1 1 1Safety Retraining *

Sterling VA Dec 02 Ell Annual Radiation 8 2 3 1 1 1Safety Retraining *

Sterling VA Dec 01 Ell Annual Radiation 8 2 3 1 1Safety Retraining *

Sterling VA Dec 00 EIl Annual Radiation 8 2 3 1 1 1Safety Retraining *

Sterling VA Sept 94 Initial New Hire 16 4 6 2 2 2_______ .Radiation Training '

* Author and Administrator of program at El l TOTALS 44 30 18 18 114

Signature of Preceptor Radiation Safety Officer: Sign tureW {L Title: ElI Date:"I certify that the above described training/experience has been satisfactorily completed and that the individual - Corporate RSO andhas achieved a level of competency sufficient to work independently as a Radiation Safety officer." Pri t: Joe flarless Operations Xlgr.

RP&I - Radiation Protection Principles RP - Biological HazardsRB - Ionizing Radiation Units & Characteristics MATH - Radiation Detection InstrumentationNRC Regulations and Standards to include Department of Transportation DOT - Shipping Hazmat and RAM CHEM - 'radiochemistry' column eliminated.

NRC License FIGURE G - NUREG 1556, Vol. 13, Appendix G#45-25221-21MD RADIATION SAFETY OFFICERItem #12 EXPERIENCE IN HANDLING RADIOISOTOPE

(Actual use of radioisotopes under the supervision of an Authorized User or Radiation Safety Officer, respectively)

Eastern Isotopes, Inc.Corporate Headquarters100 Executive Drive, Suite 100Sterling, VA 20166Phone (703) 787-7900Fax (703) 787-4078

Name (Last, First, Initial) Kostka, James, Alan 10 Years Experience with Eastern Isotopes to include 6 years as Lab Tech and 4 years asCompliance Manager & Assistant to Corporate Radiation Safety Officer

Isotope(s) Used Maximum amount used atoany one time Locatin of Use ; Purpose of Use* Total Hours of Experience

Tc-99m Mo99 3 Ci Sterling Virginia 7, 4, 6, 1, 2, 3 3000TI-201 1 Ci Sterling Virginia 7, 4, 6, 1 1000In-i ll 100 mCi Sterling Virginia 7, 4, 6, 1 80Ga-67 100 mCi Sterling Virginia 7, 4, 6, 1 500Rb-82 300 mCi Sterling Virginia 7, 4, 6, 1 10F-18 6 Ci Sterling, Virginia 7, 4, 6, 1, 2, 3 3000I-131 3 Ci Sterling, Virginia 7, 4, 6, 1 1000Xe-133 1 Ci Sterling, Virginia 4, 6, 1 3001-123 10 mCi Sterling, Virginia 4, 6, 1 500

Co-57, Cs-137, Ba-133 5 mCi as sealed sources Sterling Virginia 2, 3, 1 300Ge-68, Sr-82, Sr-85 800 mCi as SS & Gen. Sterling Virginia 1 10

Signature of Preceptor Radiation Safety Officer: Signatury; /2 Title: ElI Date:"I certify that the above described training/experience has been satisfactorily completed and that the individual Corporate RSO andhas achieved a level of competency sufficient to act independently as Radiation Safety Officer." Print: Joe Harless Operations Mgr 1

* Purpose of Use1. Shipping, receiving, and performing related radiation surveys.2. Using and performing checks for proper operation of dose calibrators, survey meters, and other instruments used to measure photon-and high energy

beta- emitting radionuclides.3. Using and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides.4. Calculating, assaying, and safely preparing dosages for patients or human research subjects.5. Use of administrative controls to avoid mistakes in the administration of byproduct material.6. Use of procedures to prevent or minimize contamination/or use of proper decontamination procedures.7. Compounding radiopharmaceuticals for distribution to authorized recipients.

Certificate of Completionawarded to

>zfK ostka)

for participation in

Radiation Safety SeminarFebruary 4-6, 2002 - Las Vegas

presented by Engelhardt & Associates, Inc,

Susan J. Engelhardt, .S. Joshua owicz, C

6"udith Grunewald, R.N., M.S.Ralph Grunewald, Ph.D.

Dee Ann Kaiser, M.S..

.

I

Radiation Safety Officer

CertificateAwarded to

James A. Kostkarecognizing completion of 40 hours of specialized instruction

April 30-May 4, 2001

Presented By

csi-Radiationz Safety Academiy481 North Frederick Avenue, Suite 302

Gaithersburg, Maryland 20877

AAHP has awarded this course 32 Continuing Education Credits, 99-00-01 1ABIH has awarded this course 4.5 CM Points, CM Approval #13421

Raymond Johnson, CHP, PE, RSOTraining Director

Certificate of TrainingThis Certifies That

Jim Kostkahas successfully completed the 1-day course of instruction for

DOT Requirements for Transportation ofRadioactive Material

March 17, 2000

Presented By

CSI-Radiation Safety481 North Frederick Avenue, Suite 302

Gaithersburg, Maryland 20877

For

Eastern IsotopesSterling, Virginia

Raymond J nson, C.H.P., P.E.Training Director

Advanced Radioactive Materialscaging and Transportation Workc op

II

II19

moeeW Rm No.: MMO2

Dangerous Goods Advisory Council

Certigfies that

James KostkaEastern Isotopes

has been awarded 2 CEUfor successful completion of

HMT-60 1Transportation of Radioactive Materials

Initial TrainingHouston, TX June 19-21, 2002

conducted byDANGEROUS GOODS ADVISORY COUNCIL

DIREON AND TRAEG

DANGEROUS GOODS CERTIFICATIONThis is to certify

* LIJames Kostka

.has successfully completed the UN performance oriented packagingstandards program in accordance with DOT requirements for

function-specific and general awareness/familiarization training.

Presented forEastern Isotopes Inc

May 17, 2002by TEN-E Packaging Services, Inc.

GETTNSH THE STHORNRO1 666 County Road 74

b e:rtJ. TeW'Ec kNewport, Minnesota 55055Phone: (651)459-0712Wsdent Fax- (651)459-1430

'1

EEI (X)

IR1TFI T X General Awareness

X Reurret Traininq [

lX I Safety Training| X Driver Training

)ate next Dec 13, 04- I* EMPLOYEE NAME (LAST. FIRST, MIDDLE)

.Kostka Jarnes A.E MPLOYER NAME

EASTERN ISOTOPES, INC.tNWLU tr lut I IrII NUMBRrn ArUZUnr rUrUao LMYLUTtHK b t II AUUKLtbZ

Landauer Participant Number 54 100 Executive DriveJOB POSITION SITE LOCATION CITY STATE ZIP CODE

Compliance Assist. Sterling. Virginia Sterling VA 20166REGULATIONS and TRAINING INSTRUCTIONS quoted from 49 CFR 172 Subpart H

172.704(d) Record keeping. A record of current training, inclusive of the preceding two years. in accordance with this subpart shall becreated and retained by each hazmat employer for each hazmat employee for as long as that employee is employed by that employer as ahazmat employee and for 90 days thereafter. The record shall include: (1) The hazmat employee's name; (2) The most recent trainingcompletion date of the hazmat employee's training; (3) A description copyu or the location of the training materials used to meet the require-ments in paragraph (a) of this section; (4) The name and address of the person providing the training: and (5) Certification that the hazmatemployee has been trained and tested as required by this subpart.The training requirements in 172.704 and 177.816 cover four areas of training for hazmat employees. Based on the training required for theabove named hazmat employee. provide the training and testing for compliance. Satisfy the record keeping requirements in 172.704(d) bycompleting the information on this form.

NOPETO DESCRIPTION OF TRAINING/ RINR TRAINING AND TESTING CERTIFICATIONDAE LOCATION OF MATERIALS USED ADDRESS CERTIFIED BY DATE

... ., . Yearl-Requirements of the License Michael Ball Reading - onpar e pgge/ 5c-0 /

:Ii*3:*: for Annual Training Sterling. Virginia V'/ // ////

.. .-.. Test for'Basics of Radiation' TAKE QUIZ WITHOU HELP OR REFERENCEl e:- :knowledge to test out of videos. Present quiz to manager 80% go Dto step 3 1 Cke),f/z/ ,ld/

if i:iern:#2:: for correction FFAIL r80% go DOto step 2a / /

:::: te~im Tape #1 Fundamentals of Radaiton H .r80n then watch complete video wrule takgng q/,Z/ .//

:#2m. Tape #2 Radiation Risks Revisted I<jstewthoree~oneaoga .K/fS MrX/T hpeA, a #3 Radiation Safety and Common Sense if st80% then waich compiete Oraeo whule takegnu2 -/sf >i~eS,/

t2,1\ j 3tYearly Exposure Limits. your 'Right to Know' Michael Ball Reading - part of one page '1:nm#:::Where are Exposure Reports? |Ster ling. Virginia / % //X~

N :U- U theK 19 - Instructions to V

\ :.\B~e,;i # Where are the regulations kept?|

k~-(" f. ' :NRC - 10 CFR 20 - Standard for PrcItem #5:::::: Where are the regulations kept?

9 ii t4l o7Obligation to Report Unsafe\ Item #6 Conditions to the RSO

Lab Emergency Procedures

X by, 'a tc :nt Personnel and Areae 8::':: Decontamination Procedures

Survey Meter Reading

Fire Safety Booklet1::. ltei#J.-'

_

Michael Ball NKL otice to Employees E.

Sterling. Virginia VA State Notice to EmployeesMichael Ball NRC Notice to Esployees&

Sterling. Virginia VA State Notice to EmployeesMichael Ball Reading - part of one page

Sterling, VirginiaMichael Ball Reading -C pages

Sterling. VirginiaMichael Ball Reading 4 pages

Sterling. VirginiaMichael Ball Quiz - 4 pages

Sterling. VirginiaMichael Ball Read Coastal Training Booklet

Sterling, Virginia -Quiz -1I page

Ž %/' I , "~/ 13/

Wj~//3

_4 I,W:0

/z1

N

Distribution Staff: Couriers, Dispatchers and Courier Supervisors

Ell RAM Delivery Driver Training Michael Ball Reading - 4 pages / %/i/, /&:: .t enii:::: SOP for Courier on a run Sterling. Virginia //Glovebox Emergency Procedures Michael Ball Reading 2 pages

Sterling. Virginia,

All Job postions Except Couriers/Drivers

: { NEW - Radiation Safety Manual (RSM) Michael Ball Page through RSM Binder andI:: I#. 3'.: Orientation to this Refernece Material Sterling, Virginia get familiar with the materials ///////

Thi be trained and tested in accordance wit 172 Subpart

I havere em nund r'd the n erl .. e

EMPLOYEES SIGNATURE CEtfFICATION & TRAINERS SIGNATUREI1118O jk

ATTACH NECESSARY TRAINING DOCUMENTATION AND COMPLETED QUIZZESFinished quizzes and this signed cif grid should be filled under each employee's name.

Other training materials used will be riled in the front of the 'Record of Training "A" binder on site

-

X) - -

f_____ F. I G eneral Awareness_I h h X Function Specific

X Safety TraininglX Driver Training

I X Recurrent Training Date next DEC 2003EMPLOYEE NAME (LAST. FIRST. MIDDLE)

KOSTKA JAMESr-LUTLK BE.Jt

EASTERN ISOTOPES, INC.EMPLOYEE IDENTIFICATION NUM 19950301 .EMPLOYER STREET ADDRESS

Landauer Participant Number # 054 100 Executive DriveJOB POSITION SITE LOCATION CITY STATE ZIP CODE

Compliance ISTERLING , Virginia Sterling VA 20166REGULATIONS and TRAINING INSTRUCTIONS quoted from 49 CFR 172 Subpart H

172.704(d) Record keeping. A record of current training, inclusive of the preceding two years, in accordance with this subpart shall becreated and retained by each hazmat employer for each hazmat employee for as long as that employee is employed by that employer as ahazmat employee and for 90 days thereafter. The record shall include: (1) The hazmat employee's name. (2) The most recent trainingcompletion date of the hazmat employee's training; (3) A description copy, or the location of the training materials used to meet the require-ments in paragraph (a) of this section; (4) The name and address of the person providing the training: and (5) Certification that the hazmatemployee has been trained and tested as required by this subpart.The training requirements in 172.704 and 177.816 cover four areas of training for hazmat employees. Based on the training required for theabove named hazmat employee, provide the training and testing for compliance. Satisfy the record keeping requirements in 172.704(d) bycompleting the information on this form.

OMPLETION DESCRIPTION OF TRAINING/ | TRAINER/ TRAINING AND TESTING CERTIFICATIONDATE ILOCATION OF MATERIALS USED | ADDRESS CERTIFIED BY DATE. E .Requirements of the License |Mike Ball Reading - one page ..

1::-for Annual Training | Sterling, Virginia ,/ ///

a Basics of Radiation, Types of Radiation Mike Ball Reading and Review - 7 pages 2 /

2m #2::: Terms and Definitions, Units of Measure Sterling, Virginia Take Quiz - 2 pagesALARA | Mike Ball Reading -one page /Terms of the License Pertinent to Rad Safety Sterling. Virginia Give Examples of ALARA '/// /General Rules for Safe Use of Mike Ball Reading - one page %'/ /

Radioactive Materials Sterling, Virginia '///// '//// /cVisitor Procedure Mike Ball Reading -one page . j// / ///1t 6 5. Sterling. Virginia i ,/ /

Personnel Monitoring with Mike Ball Reading and Review - 3 pages 2 /"XrW 6: 'Assigned Badges Sterling, Virginia A//)///

S Personnel Monitoring with Mike Ball Reading and Review - 3 pages MO/ 7// /

#7 . Pocket Dosimeters Sterling. Virginia . / / y ,i XFederal Yearly Limits, 'Right to Know' Mike Bail l/ /

Hi #8' :: :. | Sterling, Virginia /,,4 $',. ,f

10 CFR 19 - Instructions to Workers Mike Ball NRC-Notice to Employees % /1`00M/ /+9: i Sterling. Virginia NRC Form 3 ,f0 ///%

10 CFR 20 - Standard for Protection Mike Ball NRC - Notice to Employees H ///It e~a # toSterling. Virginia NRC Form 3 A / / / / /> 7/

Obligation to Report Unsafe Conditions Mike Ball NRC-Notice to Employees /////%//i

e#11 ::::to the RSO RSO is Mike Ball Sterling. VirginiaLab Emergency Procedures Mike Bail Reading -1 pages /

#l2~. 1________________:::::_______ Sterling. VirginiaGlovebox Emergency Procedures Mike Ball Reading 2 pages %

#13' Sterling, VirginiaPersonnel and Area Mike Ball Reading 4 pages

i 1 14 ':: Decontamination Procedures Sterling. Virginia:El RAM Delivery Driver Training Mike Ball Reading - 3 pages

: is & SOP for Courier on a run Sterling, VirginiaSurvey Meter Reading Mike Ball Quiz - 4 pages 7_____'#i'6:-.'._____________ Sterling. Virginia

CER'TIFICATION & TRAINERS SIGNATURE

ATTACH NECESSARY TRAINING DOCUMENTATION AND COMPLETED QUIZZESTraining materials used will be filed in the front of the 'Record of Training' book on site

X s * - a -I X General Awareness I[X Safety Training

RECRDANCERIECA[-T3I VAFuinction Snecific l Xi Driver TrnininnDat a= ne 120

EIMP12tEE NAME ST. FIRST. MlDOLE) EMPLOYER NAME

<>od Kd, rnt . A EASTERN ISOTOPES, INC.EMPL.OYEE IDENTIFICATION NUMBER EMPLOYER STREET ADORESS

Landauer Participant Number 100 EXECUTIVE DRIVEJOB POSITION . SIT ION CITY STATE ZIP CODE

trjzsce Ass'oSterlin ) STERLING VA 20166REGULATTONS iiad TRAINING INSTRUCTIONS quoted from 49 CFR 172 Subpart H

172.704(d) Record keeping. A record of current training, inclusive of the preceding two years. in accordance with this subpart shall becreated and retained by each hazmat employer for each hazmat employee for as long as that employee is employed by that employer as ahazmat employee and for 90 days thereafter. The record shall include: (1) The hazmat employee's name; (2) The most recent trainingcompletion date of the hazmat employee's training: (3) A description copy. or the location of the training materials used to meet the require-ments in paragraph (a) of this section; (4) The name and address of the person providing the training: and (5) Certification that the hazmatemployee has been trained and tested as required by this subpart.The training requirements in 172.704 and 177.816 cover four areas of training for hazmat employees. Based on the training required for theabove named hazmat employee, provide the training and testing for compliance. Satisfy the record keeping requirements in 172.704(d) bycompleting the information on this form.Ia.. * 3 S091

COMPLETION DESCRIPTION OF TRAINING/ TRAINER/ TRAINING AND TESTING CERTIFICATIONDATE LOCATION OF MATERIALS USED ADDRESS CERTIFIED BY DATE

1211/2001 Basics of Radiation. Types of Radiation Jim Kostka Class Lecture and Review 121112001Terms and Definitions. Units of Measure Sterling. Virginia Take Quiz. Review Quiz

1211/2001 ALARA I Jim Kostka Class lecture and Review 121112001Terms of the License Pertinent to Rad Safety Sterling. Virginia Overhead

1211/2001 General Rules for Safe Use of Jim Kostka Class lecture and Review 12/1/2001Radioactive Materials Sterling, Virginia Overhead

1211/2001 Personnel Monitoring with Jim Kostka Class lecture and Review 12/1/2001Assigned Badged and Pocket Dosimeters Sterling. Virginia

1211/2001 Fed Yearly Limits. Right to Know Jim Kostka Class lecture and Review 12/1/2001Landauer Report Sterling. Virginia

12/1/2001 10 CFR 19 - Instructions to Workers Jim Kostka NRC Form 3 12/1/200110 CFR 20 - Standards for Protection Sterling. Virginia

12/1/2001 Obligation to Report Unsafe Conditions Jim Kostka NRC Form 3 12/1/2001to the RSO RSO is John Thomas Sterling. Virginia

12/1/2001 Rules and Regulations of the License Jim Kostka Class Lecture and Review 12/1/2001Location & Review of NRC License Book Sterling. Virginia

1211/2001 Visitor Procedure Jim Kostka Class lecture and Review 12/1/2001Sterling. Virginia

1211/2001 Glovebox - Emergency Jim Kostka Reading 12/1/2001Instructions Sterling. Virginia

12/1/2001 Lab Emergency Procedures Jim Kostka Location of Lab Emergency 1211/2001and Decontamination Kit Sterling. Virginia Procedures and Decon Kit / use

12/1/2001 IBA HAZCOM Review Jim Kostka Overheads and Discussion 1211/2001Sterling. Virginia

1211/2001 HAZCOM Jim Koslka Video and Booklet 1211/2001Hazard Communication Sterling. Virginia Quiz

1211/2001 MSDS for Healthcare Jim Kostka Video and Booklet 12/1/2001Read it Before You Need it Sterting. Virginia Quiz

1211/2001 MSDS Review Jim Kosika Class lecture and Review 12/1/2001MSDS for FDG Sterling. Virginia

1211/2001 Survey Meter Reading Jim Kostka Quiz 12/1/2001Sterling. Virginia _

1211/2001 Ell RAM Delivery Driver Training Jim KostkalClass Lecture and Overheads 12/1/2001& SOP for Courier on a run Sterling. Virginia Handout

Employee has been trained and tested in accordanz

/ EMPLOYEES SIGNATURE G r fARVIFICATION & TRAINERS SIGNATURE--Ice I4/V T4G. M27I00I.K

ATTACH NECESSARY TRAINING DOCUMENTATION AND COMPLETED QUIZZESMeeting materials used will be filed in the front of the 'Record of Training' book on site

ANNUAL REFRESHER TRAINING (X) - ;; ' i.,-.-.

HAZMAT EMPLOYEE TRAINING X General Awareness L..X Safey TrainingRECORD AND CERTIFICATION X Function Specific X Driver Training

X Recurrent Training Date next 12/04/2001E'.MPLOYEE NAMf (LFST. FIRST. MIDPLE) EP&IPLCYEP 'IA:.'E

K-0 -:5HT EASTERN ISOTOPES, NC.ET.IPL ' ATOI P L B EMPLOYER S.FEET ADCRE5S

100 EXECUTIVE DRIVE, SUITE #3J TE F STON SITE LOCATI9I CITY STATE ZIP :C'_

%-C STERLING VA 20166/ REGULATIONS and TRAINING INSTRUCTIONS quoted from 49 CFR 172 Subpart H

.72 704(C) Record keeping. A record or current training. inclusive of the preced;ng lto years. in accordance with this subar snail ec-a-.d and retained by each hazrrat employe- Icr each hazmat employee fcr as Icng as that employee is employed by that emplcyer as a-azrna: ernpioyee and for 90 days thereaher. The reccrd shall include: (1) Thie hazrral empIcyee's name: (2) The most recenr :ranzn;ccmpleticn date of the hazmat employee s training: (3) A descript:on copy. or 'he location of the training materials used to rrme t th.e require-ments in paragraph (a) of this secticn: (4) The name and adCress of the person providing the training: and (5) Cnfi:cat.0r. tnra tne nazna:ernctoyee has been trained and tested as recuired by this sucpar..Tce Ltain:n; requirements in 172.7C: and 177.E 6 cover four areas of tra:ninc ta haz.-rnat employees. Based on the training recutred for theacove named hazmat employee, provide the training ar.d ;esting fcr cor.liar.ce Sat!sfy tne record keeping requirements ;r. ,72.704,:C by:zrolet:r.g the InIcrmatior on this tcrm.

r.

~~~~~~,',--'''',' .',*';. . i;. . .. -- '' - .^ :.^

COMPLCTION DESCRIPTION OF TRAINING/ | TRAINER/ | TRAINING ANO TESTING | CERTIFICATIONDATE |LOCATION OF MATERIALS USED | ADDRESS I CERTIFIED BY DATE

12. C-2000 Eastern Isotopes Vehicle JJ:m Kcs:ka 1 Hencout anG rev~ew 12 0. 20C0Poyicy iSterling. Vir-inria 2_

:Z.C4.2G0 Eook!et 'Venicle Safety Jim Kostka Hanc=Lt booAiet and review 12 Ca 2000on the Job' Stering. Virginia louiz

.2.0-2CCO IDOT HAZN1AT Regulat:ons Jim oska Class Lecture anc Overheads 12 C-2C0CI Sterting, Virginia Handou! .49 CFR 172

;2 C: 20C0 Eas:ern Isotopes license-an-c jim Kostka IClass Lecture ano Overheacs 12. 0:,'2000license adclication review S~e.r!ing. Virc:n:a lecLture _

. 2 C: 25C00 Lao ar.c packaag;nc procecures IJim Kcs:ka C;ass Lec:ure arc Overheacs 2 C:A 20ccI Ito rmeet comno!iar.ce issues |Siearim.. Vir':n.:a ,Handout

5 0G2c0o0 Hazmat packaging for shipmen: | :r.!Kscka Class Lec:ure anc OverheaCs :2.02,2CCOICase Dackaoe examoles. I S;erhr. Vircnr:a I ec:ure and exarmoles

'2.COZ200G ElI RAl De!iver/ Driver Train:ng irn Kcs:ka Class Lecture and Overr~Qacs :2.0-. ZCC& SOP for Courier on a run Sterling. Virginia |Handout

2 0C.2XC0 DOT HAZLIAT Regulaions& Jim KCstka QOuiz I 2:04;200CC_ _ .oW Ell employees conl, S:etling. Virgiria I

2 C: 20CC Lao E.-nercency PRocecures Jim KasIka Lccat:cn of Lzrb Ermergency 1 2. :.20C Qland Decontamirnaor-. Kit I eSerlig Vifgin~a Proced-ires and Decon Ki.' use

:2 GA 200l0 |ooklet HOW t L;lt Nlove & I:ml Kins:ka Handout booklet and review '20A25CC

i|Carry Thirngs Sa!e v' Sterlrng. Virgir.:a ICuiz I _TAPE ;I - Fundarmentais o' Jlim Kos:ka Vice-O Quiz & Review

I __ I__ | Radiation Safety or. site Szerhlng. Virginia j i 21e1

TAPE ;2 - Rac:ation F:sKs Jim Kos:;Ka Video. Cuiz & Review: ;cE ,0 Revis.:,ec - on s;:e S~er~inc. Virginia ./ LIt'

; TAPE _3 Radiation Saret7 and Jim Kostka V Qdeo. Quiz & ReviewCommon Sense - on site Sterling. Virginia _ _ _ _

Gioveoox - Emergency Jsm Kos;ka Recading.___3_ Instructions Sterlino. Viroinia I | 11/7

AuCit for comple:ion o4 traiing Ifor Jim Kostka |Completed audit of all prior train:ng recorcstni emol vees :rainirc records ISeriinc. Vircinia on tob site r S _

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AlTT'ACH NECESSAkRY T R.\ ININ'G DOCUNIENTATI0N AND COMPLETED QLIZZESMeetino materials used will he flied in the front of the 'Record of Training' book on site

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-/General Awareness ... VSafety Trainingv Function Specific v/ Driver Training

Recurrent Training DateI NAME

EASTERN ISOTOPES, INC.IEMPLOYER STREET ADDRESS

100 EXECUTIVE DRIVE, SUITE #3STATE ZIP CODE

VA 20166STERLING

172.704(d) Record keeping. A record of current training. inclusive of the preceding two years, in accordance with this subpart shall becreated and retained by each hazmat employer for each hazmat employee for as long as that employee is employed by that employer as ahazmat employee and for 90 days thereafter. The record shall include: (1) The hazmat employee's name; (2) The most recent trainingcompletion date of the hazmat employee's training: (3) A description copy, or the location of the training materials used to meet the require-ments in paragraph (a) of this section; (4) The name and address of the person providing the training: and (5) Certification that the hazmatemployee has been trained and tested as required by this subpart.172.704(e) Umitation. A hazmat employee who repairs, modifies, reconditions, or tests packages as qualified for use in the transportation ofhazardous materials, and who does not perform any other function subject to the requirements of this subchapter, is not subject to thesafety training requirements of paragraph (a)(3) of this section.

INSTRUCTIONSThe training requirements in 172.704 and 177.816 cover four areas of training for hazmat employees. Based on the training required for theabove named hazmat employee, provide the training and testing for compliance. Satisfy the record keeping requirements in 172.704(d) bycomoleting the information on this form

COMPLETION DESCRIPTION OF TRAININGI

DATE ILOCATION OF MATERIALS USEDCUt

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ADDRESS CERTIFIED BY ,PATEINTRO TO THE COMPANY 9 feI.. Sftea Reading ,

'14 361/20 o What We Do -WhoWeAre A ,dJc t A ', v/fvT-17"' TAPE #1 - Fundamentals of 9QM Video, Quiz 8 Review

)CJro / - Radiation Safety AA . 54-f-iA, ' i,,),1 ,A7 TAPE #2 - Radiation Risks Video, Quiz & Review

lo/2____ Revisited diAg wl4 L, . ___

f1Az TAPE #3 - Radiation Safety and 9,St'T Video, Quiz & Reviewl 01)0/16 Common Sense Ar A, L/1 _

COURIER/EMPLOYEE RECORDJA P , A ge. Discussion and Checklist,-!J Po M `1 Page #1, Items 1-t4' _5X V/{A.

'Isotopes' Courier/Employee ke.1 DiuiA o and Checklistifi|ooq fi Responsibility I4-1 2 "- j -I / DiscussionandChe lis

Visitor Procedure E f h .Ie Discussion and Checklistfr) | / 2 l Pocket Dosimeter Usage S E, x;.- 1.4

Opening Radioactive Packages t, ,,CV Discussion and Checklist /__Safely ._____L v/J l

'iPZoiq*1 Customer Waste Retum A l e r J4'A- Discussion and Checklist_ 19 _ q _ Procedure vAcsQ,-,j LIA ._I_.__ _

SOP for Courier C4\, Discussion and Checklist /WM 1201 Packaging and Transport / 5 vr ) to ____;____\

Glovebox - Emergency 9 Reading__13_ _ _ Instructions -Car Signage 5-t1 ,,L.1 -, \ _ _ _

Insurance Information - Accident Reading_13____ Whatto Do & Phone#s 5hI t.'A .

'RADIATION SAFETY' Pamphlet Reading & Quiz,39pc.?CC' By'Coastal Training' 8 Qiz _ ___ ____

10 CFR PART 19 - Notice to Workers 5I K Reading 8 Quiz.

_______ ~ ~ ~ ~ VA Raig&Qi~10 CFR PART 20 -Prot Against Rad Reading 8 Quiz

$3/~*LOODBORNE PATHOGENS' J SReading 8 uiBy 'Coastal Training' < J vA/\

71t7 NEW HIRE - FINAL REVIEW & TEST A I g i Final Quiz11l 1/ 751 q I.A__ _ __ __I

ATTACII NECESSARY TRAINING DOCUMENTATION. \ 10/3OI206JK

4`17/6 e r/.I f C5 l ,Iri0k7, 1>;AS; aw, P-0R ib;/"0

December 29, 2004

To Whom It May Concern:

As of December 29, 2004 I have completed the requirements for nuclearcertification. The didactic training was done at Ohio State University, in Columbus OH,where 214 hours of classes were completed on October 1, 2004. The certificate isenclosed with this letter.

A total of 500 hours of work experience has been completed, 460 hours weredone at the Eastern Isotopes site in Somerset, NJ under the direction of Jamie Perry, 40hours were done at the Ohio State University in Columbus, OH under the direction ofGeorge Hinkle.

John Chen has achieved a level of competency to sufficiently functionindividually as an authorized nuclear pharmacist.

Sincerely,

John Chen, RPh

Jamie Perry, RPhRadiation Safety Officer

RADIOISOTOPE HANDLING EXPERIENCE

Name: John Chen. RPh Date: December 29, 2004

Document the actual use/handling of radioactive material under thesupervision of an Authorized Nuclear Pharmacist.

MAXIMUM EXPERIENCE WHEREISOTOPE HANDLED USE Actual clock hours EXPERIENCE

ACIIY See key below: (Include date range of GAINEDexperience)

I-131 1 Ci 1,2,3,4,5,6

I-123 7 mCi 1,2,3,4,5,6Ga-67 50 mCi 1,2 3,4,5,6In-il 1i 5 mCi 1,2,3,4,5,6

Ba-133 5 mCi 1,2,5 10/11/04 to 12/29/04 Eastern IsotopesCo-57 5 mCi 1,2,5 460 hours Somerset, NJF-I8 4 Ci 1,2,3,4,5,6Cs- 137 250 uCi 1,2,5

460 Total Hours

Key for "Use": the number, or numbers, entered under "Use" should correspond to thehandling experience for each isotope.

1. Ordering, shipping, receiving radioactive materials and performing related radiationsurveys.

2. Calibrating, using and performing checks for proper operation of dose calibrators,scintillation detectors, survey meters, and, if applicable, instruments used to measure alpha-or beta-emitting radionuclides.

3. Calculating, assaying and safely preparing dosages for patients or human researchsubjects.

4. Using appropriate internal controls to avoid mistakes in the labeling and/oradministration of by product material.

5. Using procedures to prevent or minimize contamination and using properdecontamination procedures.

6. Learning emergency procedures to handle and contain spilled materials safely,including related decontamination procedures, surveys and uvipe tests.

7. Eluting Tc99m from generator systems, assaying the eluate for Tc99m and for Mo99 andprocessing the eluate with reagent kits to prepare Tc99nIabeled radioactive drugs.

Authorized Nuclear Pharmacist: Date: December 29. 2004/" Jamie PerrylkPh,

THE OHIO STATE UNIVERSITYCOLLEGE OF PHARMACY

UNIVERSITY MEDICAL CENTER CENTER

A PRMNUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERIENCE

Name: John C. Chen, R.Ph. Date: October 1, 2004

Document the actual use/handling of radioactive material under the supervision of anAuthorized Nuclear Pharmacist.

RADIONUCLIDE RADIOACTIVITY USEsee below

EXPERIENCEActual clock hours

(Include date range ofexperience)

LOCATION

Mo-99Tc-99mI-1311-123Ga-67TI-201In-1IlSr-89Sm-153F-18Cs-137

10 Curies8 Curies200 mCi1 mCi25 mCi50 mCi7.5 mCi5 mCi100 mCi200 mCi0.2 mCi

1,2,3,4,5,6,71,2,3,4,5,6,71,2,3,4,5,61,2,3,4,5,61,2,3,4,51,2,3,4,51,2,3,41,2,3,4,5,61,2,3,4,5,61,2,3,4,5,6,1,2,5

9/6/04through10/1/04

The Ohio State UniversityMedical Center,Columbus, OH

TOTAL HOURS:40 hours

Key for "Use": the number, or numbers, entered under "Use" should correspond to the handling experiencefor each radionuclide.

1. Ordering, shipping, receiving radioactive materials and performing related radiation surveys.2. Calibrating, using and performing checks for proper operation of dose calibrators, scintillation detectors,

survey meters, and, if applicable, instruments used to measure alpha- or beta-emitting radionuclides.3. Calculating, assaying and safely preparing dosages for patients or human research subjects.4. Using appropriate internal controls to avoid mistakes in the labeling and/or administration of by product

material.5. Using procedures to prevent or minimize contamination and using proper decontamination procedures.6. Learning emergency procedures to handle and contain spilled materials safely, including related

decontamination procedures, surveys and wipe tests. A7. Eluting Tc99m from generator systems, assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive drugs.

Authorized Nuclear Date: October 1, 2004

The'' Ohio State UniversityCollege :of Ph-armacy

.

J

Iand

University Medical CenterDepartment-of Pharmacy

By this certificate warrants that '

. .UNIVERsITYMEDICAL.CENTER.'

J o nC. ..C he P.'has satisfactoriiy filfilled' all requirements

and completed the prescribed. course

Nuclear Pharmacy Certificate Program

fuclea~rPharmacy.Associate Professor of Pharmacy

! October 1, 2004

Dean, College of Warmacy

r~~~~_ ~ . .-r)"~

Chair; Pharmacy Practice, and Administration

� �V/10_t,_.

Ex'ecutive DirectorCouncil of Ohio Colleges of Pharmacy

,_ I- .

�WTHE OHIO STATE UNIVERSITY

COLLEGE OF PHARMACYUNIVERSITY MEDICAL CENTER MEDY

CENTIE

NUCLEAR PHARMACY CERTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name: John C. Chen, R.Ph.

lyRLOR

BREAKDOWN OF COURSE CONTENT IN CLOCK HOURSLocation of Date(s) of Course Total

Training Attendance Title ClockHours Radiation Radiation Math Radiation Radiopharmaceutical

of Physics & Protcction Pertaining to Biology ChemistryCourse Instrumentation Radioactivity

The Ohio State September 6, 2004 Nuclear 214 88 45 20 22 39University, through Pharmacy

Columbus, OH October 1, 2004 CertificateProgram

*Note: Show a breakdown of hours by institution,dates, and subjects. List each hour only once (i.e.,under the most applicable subject category)

TOTALHOURS 214 88 45 20 22 39

Authorized Nuclear Pharmacist/Authorized User: . ,- XGeorge H.& kle, RPh,MS,BCNP,FASHPFAPhA

DATE: October 1, 2004

December 15,2004Wade LooRegion IIMaterials LicensingSuite 2900101 Marietta St.Atlanta, Ga. 30323

License No. 45-25221-01MD

Dear Sir:

I am requesting a License Amendment to add Kim Hosen to our radioactivematerials license (Item 1 A on license). Kim has completed her didactictraining with The O1io State University College Of Pharmacy on October 1,2002. Her 500 hours of lab work experience was completed at EasternIsotopes, Inc. Sterling facility.

As Preceptor, I certify that Kim C. Hosen has completed her 500 hours ofhands on training and is competence to perform her duties independently.

Sincerely,

Nasr nTourkiani PharmD, B.S. ANPPreceptor / Site Training Manager

Item 1A onNRC License#45-25221-01-MD

AUTHORIZED NUCLEAR PHARMACISTEXPERIENCE IN HANDLING RADIOISOTOPE

Eastern Isotopes, Inc.

Corporate Headquarters

100 Executive Drive, Suite 100Sterling, VA 20166Phone (703) 787-7900Fax (703) 787-4078(Actual use of radioisotopes under the supervision of an authorized user or Radiation Safety Officer, respectively)

Name (Last, First, Initial) Hosen Kim Carter |Dates: 8/23/04 to 9/3/04 and 10/2/04 to 12/17/04

Maximum amount used . Total Hours ofIsotope(s) Used at any one time Location of Use Purpose of Use Experience

Molybdenum 99 15 Ci Sterling, VA 5,6,7 60Technetium 99m 15 Ci Sterling, VA 4,7 200Xenon 133 200 mCi Sterling, VA 1 40Iodine 131 350 mCi Sterling, VA 4,7 30Iodine 123 4 mCi Sterling, VA 4,7 25Thallium 201 120 mCi Sterling, VA 4,7 100Gallium 67 30 mCi Sterling, VA 4,7 25Cs 137, Ba 133, Co 57 300 gCi Sterling, VA 1,2,5 20FIB 4.5 Ci Sterling, VA 4,7 10

Total -510

Signature of Preceptor Authorized Nuclear Pharmacist: Signature: Title: Date:"I certify that the above described training/experience has been satisfactorily / Pharmacistcompleted and that the individual has achieved a level of competency sufficient Trainin Manager 12/17/2004to independently operate a nuclear pharmacy." Print: Nasrin Pourkiani PharmD, B.S, ANP -

'Purgose of Use1. Shipping, receiving, and performing related radiation surveys.2. Using and performing checks for proper operation of dose calibrators, survey meters, and other instruments used to measure

photon- and high energy beta- emitting radionuclides.3. Using and performing checks for proper operation of instruments to measure alpha and low energy beta- emiting radionuclides.4. Calculating, assaying, and safely preparing dosages for patients or human research subjects.5. Use of administrative controls to avoid mistakes in the administration of byproduct material.6. Use of procedures to prevent or minimize contamination/or use of peoper decontamination procedures.7. Compounding radiopharmaceuticals for distribution to authorized recipients.

The Ohio State UniversityCollege of Pharmacy

& ~~and ----University Medical Center UN]Department of Pharmacy MEDI

CENTBy this certificate warrants that

ni C. Hiose nL R. Ph*has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program

REM"

RSnTY"CALrER

October I1, 2004

Air o PrclPar s rofPharmacyAsso te Professor of Pharmacy

Dean, College of Phla cy

/ 4WC._~4 / ('Llk-"

ExcCIItivC DirectorCouncil of Ohio Colleges of lPharmacy

Chair, Pharmacy Practiceand Administration

I P- a~-THE 01IO STATE UNIVERSITY

COLLEGE OF PHARMACY UNIVERSIUNIVERSITY MEDICAL CENTER MCEDC

NUCLEAR PHARMACY CE'RTIFICATE PROGRAM

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name: Kim C. H-losen, R.Ph.

IR

BREAKDOWN OF COURSE CONTENT IN CLOCK HOURS QJLocation of Dale(s) of Course Total .

Training Attendance Titlc ClockHours Radiation Radiation Math Radiation Radiopharmaccutical

of Physics & Protection Pertaining to Biology Chemistry

Coursc Instrumcntation Radioactivity

The Ohio State Septcmber 6, 2004 Nuclear 214 88 45 20 22 39University, through Pharmacy

Coluiribus, OH- October 1, 2004 CertificateProgram n

*Note: Show a breakdown of hours by institution,dates, and subjects. List each hour only once (i.e.,under the most applicable subject category)

TOTALHOURS 214 88 I 45 20 322 .9

_ _ . _ �, . _... .... ... _ ....... . _S _ . _ _ . _ _ _ ... ... _ _ _ , . . .. _ .. .. _ _ ... . _ _ . _ _ , . _ __ ...

II__ ' . . . ,

Authorized Nuclear Pharmacist/Authorized User: 5q / DAIE: October 1, 2004' Gcorge Hl. 1!nkle, RPh,tSBCNP,FASlIP,FAPhA

ITHE OHIO STATE UNIVERSITY

COLLEGE OF PHARMACYUNIVERSITY MEDICAL CENTER

NUCLEAR PHARMACY CERTIFICATE PROGkAM

RADIONUCLIDE HANDLING EXPERIENCE

UUNIVERSrrYMEDICALCENTER

Name: Kim C. Hosen, R.Ph. Date: October, 1, 2004

Document the actual use/handling of radioactive material under the supervision of anAuthorized Nuclear Pharmacist.

RADIONUCLIDE RADIOACTIVITY USEsee below

EXPERIENCEActual clock hours

(Include date range ofexpcrience)

LOCATION

Mo-99Tc-99m1-1311-123Ga-67TI-201In-llISr-89Sm-153F-18Cs-137

10 Curies8 Curies200 mCiI mCi25 mCi50 mCi7.5 mCi5 mCi

00 mCi200 mCi0.2 mCi

1,2,3,4,5,6,71,2,3,4,5,6,71,2,3,4.5,61,2,3,4,5,61,2,3,4,51,2,3,4,51,2,3,41,2,3,4,5,61,2,3,4,5,61,2,3,4,5,61,2,5

9/6104through10/1104

The Ohio State UniversityMedical Center,Columbus, OH

TOTAL HOURS:40 hours

Key for "Use": the number, or numbers, entered under "Use" should correspond to the han~Jling experiencefor each radionuclide.

1. Ordering, shipping, receiving radioactive materials and peiforming related radiation strveys.2. Calibrating, using and performing checks for proper operation of dose calibrators, scintillation detectors,

survey meters, and, if applicable, instruments used to measure alpha- or beta-emitting tadionuclides.3. Calculating, assaying and safely preparing dosages for patients or human research subj ts.4. Using appropriate internal controls to avoid mistakes in the labeling and/or administration of by product

material.5. Using procedures to prevent or minimize contamination and using proper decontamina ion procedures.6. Learning emergency procedures to handle and contain spilled materials safely, includir g related

decontamination procedures, surveys and wipe tests. i7. Eluting Tc99m from generator systems, assaying the eluate for Tc99m and for Mo99 apd processing the

eluate with reagent kits to prepare Tc99m labeled radioactive drugs.

Authorized Nuclear Pharmacist:George H H ,RP S,BCNP

Date| October 1, 2004

I

I

This Is to acknowledge the receipt of your letter/application dated

//~6 /2 • , and to inform you that the initial processing whichincludes an administrative review has been performed.

a5/ 451End, K- oraP~9- Z5Z( - 1'There were no administrative omissions. Your application was assigned to atechnical reviewer. Please note that the technical review may identify additionalomissions or require additional information.

[] Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee & Accounts ReceivableBranch, who will contact you separately If there is a fee issue involved.

Your action has been assigned Mall Control Number / -< 76.When calling to inquire about this action, please refer to this control number.You may call us on (610) 337-5398, or 337-5260.

NRC FORM 532 (Rq

(6-96

Sincerely,Licensing Assistance Team Leader

(FOR LFMS USE)

INFORMATION FROM LTS

BETWEEN:

License Fee Management Branch, ARM

and

Regional Licensing Sections

: Program Code: 02500: Status Code: 0: Fee Category: 3C 2B: Exp. Date: 20130731: Fee Comments:

: Decom Fin Assur Reqd: N

LICENSE FEE TRANSMITTAL

A. REGION

1. APPLICATION ATTACHED

Applicant/Licensee:

Received Date:Docket No:

Control No.:

License No.:

Action Type:

EASTERN ISOTOPES, INC.200501123032974136276

45-25221-OlMD

Amendment

2. FEE ATTACHED

Amount:

Check No..I

3. COMMENTS

Signed Xk a

Date

B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered /_/)

1. Fee Category and Amount:

2. Correct Fee Paid. Application may be processed for:

AmendmentRenewalLicense

3. OTHER

SignedDate