~al Health

June 30, 2015

U.S. NRC - Region Ill Radioactive Material Licensing 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352

Cardinal Health Nuclear Pharmacy Services Quality & Regulatory 7000 Cardinal Place Dublin, OH 43017 tel 614.757.4120 fax 614.652.4598

www.cardinalhealth.com

Re: Amendment Request for Radioactive Materials License 34-32840-01, Cardinal Health PET Manufacturing Services, East Lansing, Ml.

Licensing:

Cardinal Health 414, LLC (Nuclear Pharmacy Services and PET Manufacturing Services, hereafter Cardinal Health) requests an amendment for the above referenced license to add Steve Morcos and Scott R. Lucas as authorized users (AU) cyclotron operators. Documentation of training is attached.

If you have any questions regarding this request, please contact me at 614.757.9586.

Si~~ ~~Sullivan Manager, Health Physics Quality and Regulatory Nuclear Pharmacy Services

/dh

Enclosures: Training Documents

cc: Jason Foster, RSO, Loe. 5860 Sean Waters License File 5860 (3)

RECEIVED JUL 13 2015

~ Cardinal Health

PET Manufacturing Services Training Authorization

January 3, 2011

Cardinal Heallh Nuclear Pharmacy Services Ouauty & Regulatory 7000 Cardinal Place DubRn, OH 43017 tel 614.757.5000 faX 614.552.4598

www.cardinal.com

I have reviewed the education and training documents listed below and they meet the training requirements outlined in the PET Manufacturing Services Radiation Safety Manual, Section 9.

PET Trace Cyciotron Training (30-60-90 Day Training Documentation)

Basic Radioisotope Handling Techniques Worksheet

Didactic Training Certificate

Therefore, I authorize Steve Morcos to act as an AU/Cyclotron operator on any PET Manufacturing License that grants self-approval for Authorized Users/Cyclotron Operators. A copy of this approval letter must be kept on file at all locations where the above named individual has worked for 5 years after the last dat~ of employment.

rJ(J.PhD. -Director, Health Physics Nuclear Pharmacy Services

Cardinal Health Manufacturing Training Summary

Steve Morcos has -completed the following Cardinal Health Manufacturing training at the Van Nuys, CA cyclotron site on 12/0712010. This training was performed on a GE PETrace cyclotron by an authorized user and cyclotron operator who received manufacturer or equh1alent training on the GE PETrace cydotron.

PET Trace Cyclotron Training 1. Health, General and Radiation Safety 2. Cyclotron Theory and Physics 3. Controls and Displays 4. Operating Instructions 5. Preventive Maintenance 6. Cyclotron Software 7. Cyclotron Shielding 8. Cyclotron Documentation

100 hours FOG Chemical Synthesis

1. Chemical Syntheses Theory 2. Materials Preparation 3. Chemical Preparation 4. Coincidence Synthesis Box Preparation 5. Coincidence Synthesis Box Operation 6. Handling up to 3 Ci of FOG 7. GMP Practices 8. Production Abnormalities

60 hours Quality control

1. Radionuclidic Identification: Half-life test 2. Ph Testing 3. Chemical Purity of Fludeoxyglucose F-18 Injections: Gas Chromatography 4. Radiochemical Identity and Purity of Fludeoxyglucose F-18 Injection: Radio-TLC 5. Chemical Purity of Fludeoxyglucose F-18 Injection: Kryptofix TLC 6. Bacterial Endotoxin Testing: LAL 7. Membrane Filter Integrity Test , 8. Radionucidic Purity of Fludeoxyglucose F-18 injection: MCA Analysis 9. Sterility Testing

80 hours Radiation Testing and Equipment

1. Radiation SS.fety Training for Individuals Working in or Frequenting Restricted Areas 2. Portable Survey Meters and Wipe Tests 3. Transport and Receipt of Radioactive Materials 4. Dose Calibrator and Fume Hood

25 hours Component Materials Management

1. Receiving 2. Tracking · 3. Batch Record Compliance 4. Record Retention 5. lnventoiy

15 hours

TOTAL: 280 hours

Certification of Review of Training

I certify that I have reviewed the training and experience documentation of the above named individual ani:t have determined that the. individual has satisfactorily completed the training and experience requirements set forth in the PET Manufacturing Services Radiation Safety Training Manual.

Director, Health Physics Quality and Regulatory

RADIOISOTOPE HANDLING EXPERIENCE

Name: Steve Morcos Date 12/30/10

Document the actual use/handling of radioactive material under the supervision of an Authorized User.

MAXIMUM ISOTOPE ACTIVITY

HANDLED

F-18 . . . . 6500 mCi

N-13 500 mCi

USE See key below:

1,2,3,4,5,6,7

1,2,3,4,5,6, 7

7

EXPERIENCE Actual clock hours (Include date range

of experience} · ··720 hours

(f3!31/10-12i30/10) .120 .~9urs

(8131/.10-.12130/10)" : 2 . = 720 hours ."

·. Na:.2z =: := 200 uCi . 11-----4-·-·_· --'-----------1 .. (8~11.10-12/30110) .

:·. :·:.:::: .· .... : .. . : .·: .... : .. ·:·: :·::. . . . :

0 ••M•oO ooOo o ·.:: ~:.:.::.:-:.·· .

11--~-----·-··-··-···-··-···-· ----11--------1-· : ·:::··~::·:.::::·:.::-.:::- : ....

11------~ .. -.. -.. -. -... -. -.---1-------....1· :· . :-:.::: .. : ::: . . .. : .. ·-·. . . . . : : .. ::-::r:: :-: . . .. . :-:_ :: ::-:. -:-: : · ... :- .

.. . ...

WHERE EXPERIENCE

GAINED

Cardinal Health PET Manufacturing

Services 5805 Van Nuys, CA

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

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 appropriate, 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 or accelerator material

5. Using procedures to prevent or minimize contamination and using proper decontamination procedures

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

7. Production of radioactive materials via bombardment in a nuclear reaction.

TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Name: Steve Morcos

Location of Training I Date(s) of I Accordance

CARDINAL HEAL TH 11/18/10

DUBLIN, OH I Thru 12/20/10

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

Course Title

CARDINAL HEAL TH NUCLEAR PHARMACIST /AUTHORIZED USER EDUCATION PROGRAM

TOTAL HOURS

Signature: W>L~ Corporate Radiation $af~ty Officer

. . . BR~Ako6wN· OF cdi.JR.s'e' CONTENT iN .CLOCK. HOLJ~S) .. : : : : : ; ! '.; Total

J Clock Hours of

Radiation I Radiation I Math I Radiation I Radiopharmaceutical Physics & Protection Pertaining Biology Chemistry

Instrumentation to Radio-Course activity

200 85 58 25 32 0

200 85 58 25 32 0

Date: 12/20/1 O

RADIOISOTOPE HANDLING EXPERIENCE

Name: Scott Lucas Date: January 16, 2014

Document the actual use/handling of radioactive material under the supervision of an Authorized User.

ISOTOPE MAXIMUM USE EXPERIENCE WHERE ACTIVITY See key Actual clock hours EXPERIENCE HANDLED below: {Include date range GAINED

1,2,3,4,5,6,7 of exoerience)

1sF >1000 hours Regional Nuclear 8000 mCi 1,2,3,4,5,6,7 2/5/01 - 6/30/06 Pharmaceuticals

1sF 100 hours Cardinal Health 10,000 mCi 1,2,4,5,6,7 7/1/06- 12/31/10 NPS

13N 100 hours Cardinal Health

250mCi 1,2,4,5,6, 7 7/1/06-12/31/10 NPS

22Na >1000 hours Regional Nuclear 200 uCi 2,6 2/5/01 - 6/30/06 Pharmaceuticals

22Na 100 hours Cardinal Health

200 uCi 2,6 7/1/06-12/31/10 NPS

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

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 appropriate, 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 or accelerator material

5. Using procedures to prevent or minimize contamination and using proper decontamination procedures

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

7. Production of radioactive materials via bombardment in a nuclear reaction.

(

Cardinal Health Manufacturing Training Summary

Scott Lucas has completed the following Cardinal Health Manufacturing training at the·Columbus cyclotron site on 1212812006. This training was performed on a GE PETrace cyclotron by an authorized user and cyclotron operator who received manufacturer or equivalent training on the GE PETrace cyclotron.

PET Trace Cyclotron Training 1. Health, General and Radiation Safety 2. Cyclotron Theory and Physics 3. Controls and Displays 4. Operating Instructions 5. Preventive Maintenance 6. Cyclotron Software 7. Cyclotron Shielding 8. Cyclotron Documentation

100 hours FDG Chemical Synthesis

1. Chemical Syntheses Theory 2. Materials Preparation 3. Chemical Preparation 4. Coincidence Synthesis Box Preparation 5. Coincidence Synthesis Box Operation 6. Handling up to 3 Ci of FDG 7. GMP Practices 8. Production Abnormalities

60 hours Quality Control

l. Radionuclidic Identification: Half-life test 2. Ph Testing 3. Chemical Purity of Fludeoxyglucose F-18 Injections: Gas Chromotography 4. Radiochemical Identity and Purity ofFludeoxyglucose F-18 Injection: Radio-TLC 5. Chemical Purity ofFludeoxyglucose F-18 Injection: Kryptofix TLC 6. Bacterial Endotoxin Testing: LAL 7. Membrane Filter Integrity Test 8. Radionucidic Purity of Fludeoxyglucose F-18 injection: MCA Analysis 9. Sterility Testing

80 hours Radiation Testing and Equipment

1. Radiation Safety Training for Individuals Working in or Frequenting Restricted Areas 2. Portable Survey Meters and Wipe Tests 3. Transport and Receipt of Radioactive Materials 4. Dose Calibrator and Fume Hood

Component Materials Management I. Receiving 2. Tracking 3. Batch Record Compliance 4. Record R~tention 5. Inventory

TOTAL:

25 hours

15 hours

280.hours

Certification of Review of Training

I certify that I have reviewed the training and experience documentation of the above named individual and have determined that the individual has satisfactorily completed.the training and experience requirements set forth in the PET Manufacturing Services Radiation Safety Training Manual.

-Dave Breuning, Health Physicist Quality and Regulatory

December 28, 2006

Date

. .

Radiation Safety Officer

Certificate Awarded to

Scott Lucas recognizing completion of 40 hours of specialized instruction

February 26-March 2, 2001

Presented By

cs1-Radiation Safety Academy 481 North Frederick Avenue, Suite 302

Gaithersburg, Maryland 20877

AAHP has awarded this course 32 Continuing Education Credits, 99-00-011 ABill has awarded this course 4.5 CM Points, CM Approval #1.3421

?(~~ Raymond Johnson, CHP, PE, RSO Training Director

. . Certificate of Training

This Certifies That

Scott Lucas on March 1, 2001

-has successfully completed the

DOT Training Requirements for Shipping & Receiving

Radioactive Materials Presented By

cs1-Radiation Safety Academy 481 North Frederick Avenue, Suite 302

Gaitheciburg, Maryland 20877

Raymond Johnson, CHP, PE, RSO Training Director

------------------------------------

1 •

r nl\ nv. ·C.·VVU\J'"tV I "TV

SCOTT RICHARD LUCA$

PROFESSIONAL ACCOMPLISHMENTS • VonRoll

'• 1995. Installed and developed operating methods and proce<lures for new ICP and GFAA instruments in 50% less time than expected. Designed labcf3tory inventory control system to standard~<i vendors and minim:Ze·.costs by computer ~ng of all ordering. lnv~niory eontrol reduced overnight shipping charges by 70%· and ensured ready a~llablllty of items when n*<iect · ·

ENVIRONMENTAL CHEMIST Antech Limited Export, PA 199-4-1995

Prepared and anal)"2:ed environ!Tlentoil $ilmp~s according to EPA guidelines. Operaied and maintained ICP and ZG~AA instrumentation. Interpreted and validated elemental analysis data. Superv.iSed two laboratory tecnnfclans.

RESEARCH ASSOCIATE Univeralty pf Pittsburgh Pittsburgh, PA 1991 • 1994

Designed and inifi•ted ~ wide range ot chemistr'/, surface science. and biotechnology resaarcti projectS. Supervised and trained fNe un~raduate staff, and iwo graduate students.

·RESE~RCH ACCOMPLISHMENTS • University of Pittsburgh

·• 1994- Developed Vibrational Circular Diduoism (VCD) as a useful spectroscopk; techniQue·ror. · studying bio1c>9ically important proteins. Design~ optical instrumentation frJi FflR system and argon _

ion laser. ·

• ·1993 - Developed improved understanding of 111-V electronic deviee fabrieation and a unique process of writing galfium nitride patterns in silicon dioxide by electron impact. Published papers.

• 1~92; Designed, buil~ operated and maintained a new ultrahigh vacuum system. lrn~talled and maintained all associated equlpmeflt: Auger Electron Spectroscopy (AES), Low E:nergy Eieciron Diffractio~ (LEED). Ouadl1.lpole-Mass Spectroscopy (QMS}, X-Ray Photoelectro:i Spectroseopy (XPS) .

.. 1991 - Researched and-investigated importance of hydrogen in sllicon·surface chem!stl)'. Discovered a range ofosw surface chemical reactions of importance in semiconductor d_evice fabrication .

. TECHNICAL TRAINING

• 2000 - HPLC Tro1.1ble$hOOting, Waters Corporation, Columbus, OH • 1Sl99 ·Dea.ling With Unacce-ptabl~ Fmptoyee Behavior. SkillPath Seminars. Columbus, OH ·

• · :,996 ·ISO 14001 Le~ Auoitor Course, Envlronmeota! Resowce-center,.onsite Training • 1998- ISO 14000 Implementation, lntemational Quality end Envirorimental Services,-Onsite Training

... '1"991_· Project Managem~nt Tools and Techniques, Pro/ect Menter$, S~n Franci$CO, CA · • 1997 ~ lnte~rsonal Manag!ment Center for Values Research. Dallas, rX

Jtll'r~t,-uJ llVI\ \JO•C.I rn~ 1\111

SCOTT RICHARD LUCAS

TECHNICAL TRAINING

• 1991 • Environmentai GC/MS ChemStatlon Operation. HeWlett-PQ.Ckal'd, Atlanta, GA. • 1H6. - Conflict. Management Course, Robert Morris Conege1 Plttsb\Jl'Qh, PA • ·1996- Project Management Course. Robert Morris College, Pittsburgh, PA • 1996 - Stress Management Course. Robert Morris College, Pittsburgh, PA

.. • 19.95 - ICP.Analysis Techniques, Thermo Jarren Ash, San Franci$co, CA . •· 7995- Team OevelOpmertt and Decision Making, Ronald Wallace & Associates Inc., Onsite Training

• 1995 -40 Hour HAZWOPER Training, ISO Training and Consulting, Onslte Training

EDUCATION MS ' BS

Chemistri P,hysical Chemistry Ul'liversity of Pitl$burgh PIU$DUrgh, PA

University of Pittsbi.irgh Pittsburgh, PA

INSTRUME~T ATION

Chemical Analysis

HP5890·GC . GC DetectOI'$! FIO, PIO, ECO, ELCO HP 5970; s·971, 5972 MSD HP1050HPLC Tekrnar Precept II autosampler Tela'nar2000, 3100 Concentrators TWar 2016 purge & trap sampler Varian Archon autosampler. TJA S1E, IRIS, Atom~n-16 ICP's Perkin £!mer El.AN 5000", 6000 IC?-MS's Perkin Elmer Analy&t 600 ZGr:AA Cetac· M-6QOO Hg CNAA analyzer Oionex DX.-500 Ion ohrom~tography system

· .Dionex ASE (ao:;elerateO: $01Vent.extraction} Part 701 Calorimeter Metrohm· 701 f<?rl·!=ischer Titrator

Software

HP Chemstation . HP En:viro(lu£ult TJA ThermoSpec PEAAWinlab MS Word· MS Excel

. M$Atce!iS MS Powerpolnt Visual Basic 6.0

Semieenductot R&l&ted . Physical Electronics 10-155 Auger Analyitr Physical E:leytronlcs-5000 es~A system. VG GAS oµadrupole mass spactrometerf l.,eybold TurboVac pumps Vaiian Vaclon pumps

. : · ...

... ...

..... . .

, .

Fnm: (914) 757-5074 Dantil ~H-7000 Clnlinll PllCO

Dubin, OH43017

-TO: (1311129-9154

NMSS Licensing US NRC Region Ill 2443 Warrenville Road Suite 210 LISLE, IL 80532

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