PETN ET Solutions

October 18, 2017

Bryan Parker Materials Licensing Branch U.S. NRC Region Ill 2443 Warrenville Road Suite 210 Lisle, Illinois 60532-4352

Re: Amendment Request to NRC Radioactive Material License PETNET Indianapolis, IN License #s 41-32720-02MD and 41-32720-01

Dear Mr. Parker,

The purpose of this letter is to request an amendment to the above-referenced licenses as follows:

1. Add Heather Fry as an Authorized Nuclear Pharmacist under condition 11 B of License Number 41 -32720-02MD. Documentation of her training and experience is included in Attachment A.

2. Add Heather Fry and Mickey Latham as Authorized Users for Non-Medical Use under condition 12 of License Number 41-32720-01. Documentation of their training and experience is included in Attachment B.

PETNET believes that sufficient information has been provided for the Agency to grant this request. If you have any questions, please contact Cami Still at 317-674-5275, or cami.still@siemens-healthineers.com.

Sincerely,

Roger Moroney, CHP Sr. Manager Radiation Protection/Corporate RSO PETNET Solutions, Inc. Voice: 865-218-2595 Fax: 865-218-3018 william .moroney@siemens-healthineers.com

cc: Joel Readinger, RPh, RSO PETNET Indianapolis

PETNET Solutions, Inc. A Siemens Company

810 Innovation Drive Knoxville, TN 37932

Tel: (800) 738-0488 Fax: (865) 218-3018

RECE IV ED OCT 2 3 2017

ATTACHMENT A

ANP Documentation for Heather Fry

NRC FORM !U3A (AHP) U.S. NUCl EAR REGULATORY COMMISSION ji)W{l1~

~ .•. ; .. ·· ~~". . AUTHORIZED NUCLEAR PHARMACIST TRAINING AND J· . · · ! EXPERIENCE AND PRECEPTOR ATTESTATION \': ~ [10 CFR 35.55] ,., ......

APPROVED BY ONI3:: NO. 315().01 !D EXPIRES: 0613012019

Name o1 Pr~ Authortzad .Nuclear Pharmacist State or T errit

NRC FORU 313A (ANP) lJlll-?ll1e)

U.S. cNUCL£AR REGULATORY COUMJSSKlN

AUTHORIZED NUCLEAR PHARMACIST TRAINING AND EXPE.RJENCE ANO PRECEPTOR ATTESTATION (continued)

2. Structured Educational Program tor Proposed Authorized Nuclet~r Pharm&el!t (continued)

b. Supervised Practical Experience in a Nuclear Pharmacy.

Description of Experience Location of ~rlence/ticense or Permit Number of F a

NRC FORM 313A (ANP} IW-~

i.J.S. ffUCLEAR ltEGUl.ATORY COBISSfON

AUTHORIZED NUCLEAR PHARMACIST TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (contlnuoo)

PART U- P,RECEPTOR ATTESTATION

Note: This part must be completed by the individuars preceptor. The preceptor doos not have to be the supervising lndMdual a.s long as the preceptor provides, directs, or verlfies training and experience required, If more than one preceptor is necessary to document eyPerience, obtain a separate preceptor statemen1 from each.

First Seellon Chock one of the foUowlng:

J!oard Ctrt.!ficatlon

0 I attest that has satisfactorily completed the requirements in

10 CFR 35.55(a){1}, (a)(2), and {a}(3) and has acllleved a level of competency sufflclent to function independently as an authorized nuclear pharmacist

OR

Structumd Educational PtS!SJram

[Z] 1 attest that Heather Fry has satisfactorilY completed a 70Q.hour structured -:N-:----a~· Pm::-.)lOMd-. · ~:"':N.J'"'=· ~::--:--~:-:N:-u:~~t7-w-:::~:--=. ·=a7::!'

educational program consisting of both 200 hours of cla&sroorn and laboratory tralnlng, and practical expOOe-nce 1n nuclear pharmacy, as required by 10 CFR 35.55(b)(1) and has achieved a level of competency sUfficient to function independentlY as en authorized nuclear pharmacist.

····- - -··--·--·······----------····-··----~---··-~···-····--· Second Section Complete the following for preceptor ette• tatlon and signature:

I am an Authorized Nuclear Pharmacist for P'ETNin' Solutions tndianapolis N...;...llitf'hltrl'!'liiQy«~.l F~ ~-------·····

IN 26019363A

PURDUE UN"lVEllSITY COllEGE Of PHARMACY

AtlgUSI 23,2017

To Whom It May Ctmcern:

I wou ld like to offer this letter to verify the nuclear phanna~;y didnetic trnining progmm l~Omplctcd by Heather Pry while a student at Purdue University . During Htathcr's cnrollmtnt in the l'urdue University College of Pharmacy. she elected tu pursue the nu kar plwrmac} c!C(~tive serie.~ . in which ~ht: wn• nhlc !o complete approximMcly 224 hours of trnining in the areas of radiation physics and jnsttmnentation, mdim1on protection, math pertaining to mdioactivity, radiation biology. radiophannw .. ,cutk~ll cbcmislry and the clinical applications of tildiophnnnaccuticals. The cour11c breakdowns by hour ilre shown in th.1: t.ttf,'Ji~fttl'. lN 4190"1~2()91 u&•iJ 400>~sls r. •. l1Ml "%·1~ "'"""'rM""IIfi'P

Ruvlied Jeatk>n ·Semeator Coursns ol PerWnlng to Of Tralnl"'! Ott« red Houfll Instrumentation P-rolllctlon Radloactlvlty Biology Chemistry Rat!lopllarm.

HI-ll 0

2A 1~ 0

3 14 • 17.,$ {) 4 .5

~Nucllltlfflli!C)' IM 12.5 H 0.5 13.5 4

Total Possible Hours 45, 20 36 12.5

...uvnll>ly-~1/(>1). s--~h-blaCOO(mk!-ln""""""'~"'"""_... • .,~~">tttm.•whklt~lilfdJ!iOO:JI.n

._..,._ 11!3111'10 ~--in 11>4 h>llil.

Kat3 0 , Woolhur100n, Pharml), BCNP, FAPM Clhbl As$0datn P«>~-

Oimctor. Nucl

STATE OF INDIANA Eric J. Holcomb

Official Proof of licensure Digitally Certified Record

Personal Information

Name: Address:

Date of Birth:

L1cense Information

Number blsued:

LleenseTy~;

Statua:

!&sue date:

Expiration Oat•:

Obtained By;

Heather Michelle Fry 1 017 No1tingham Lane Kokomo, IN 4890.2

06113!1991

26026951A

Pharmacist

Active

02/13!2017

06l3012018

Examination

This licensee has met ALL requirements for licensure in the State of Indiana - including successfully passing all required exams.

For disciplinary action information, please visit our License Search & Verify sefVice at www.in.gov/pla/3119.htm. Disciplinary action will either show under Previous Action or V'tolallons. For additional information including questions regarding Disciplinary Action, contact the appropriate Board or Commission at http://www.in.gov/pla/boards.htm.

Digitally Certified on: Wed Oct 04 04:53:19 AM 'EST 2017

Training Certificate This certificate is awarded to:

Jfeatfier Pry In recognition of successful completion oft he Transportation qfRadioaet·iue "'11aterials Class,

on regulations of the United States Department ofTransporta.tion, concerning t.he legal transportation of materials designa.ted as hazardous andfoJ• achieving a passing grade.

D.O.T./Hazardous Materials Training October 1'1·20, 2016

This training is designed to ~~«.tiJ;fu t1w General~. Function·.!i'peciJic and Sqfet]J Training Requirement q/49 CFR 171J.704(A). Twd.ning was con.ducted by Siemens MedieGI &lutions Moleeular Imaging Radiologit:~Jl Compliance Department

for PBTNET Phanna~,Ine in KnaruiUe, Tennessee.

I ENS April Chanee, Sr. )tanager EHS PETNET Solutions

1~ucto~ ~mt ~nd Title \ 'dO':{! )i, f,., a· ·r "~· ' 0 l

raining Certificate This certificate is awarded to:

1£eather Pry Radiation Protection Training

for Nuclear Pharmacy Employees October u-2.0, 2016

11m training is duigned to ,sa~ the General Awarenus, .Punetion-specvic mul Sqfety lraining Requil"ement of49 CFR :t72.704(A). Training WCl8 conducted by Siemens Mediool Solutions 1\1olec:ulw Im4ging Rruliological Comp.lianoo Departm.m.tfor

i ~

PETNET Solutio ns

PE1NET Pharmaceutictdt,Inc. inKn0Jt:11t1lc, T.mn¢$$ee.

April Chance, Sr. Manager EHS

Ibstructor Name. and Title I

> ,,

~ },_..., \j (i f1 >.,\ ,;tV1i-:4V ~~ / )\ VI .s ! C

ATTACHMENT B

Cyclotron Operator Documentation for Heather Fry and Mickey Latham

Training Certificate This certificate is awarded to:

Jfeather Pry In recognition qf successful oompletion qf th.e Transportation qf Radioactiue Materials Class,

on regula.tions of the United States Department ofTran.-;portation, concerning the legal trtmsportati;;m ~fmarerials designated as hazardous a:ndfor achieving Q passing grade.

D.O.T./Hazardous Materials Training October 1:1•20, 2016

This training is designed losaJ:iJ;/jj the Geru!ralAwa:rettU$, Fl.nretion~ undScl/et}J TNlining Requirement of 49 CFR 1:;.2.704(AJ. T'l"aining was conducted by Siemms Medical SolutionsMolea~.lar Imaging RadiologicQl Compli.alt« Deparbnent

for PETNET Pharmaceuticals, Inc. in KnO%ViUe, Teruteli$C ...

ENS PETNET Solutions

Training Certificate Tltis certificate is awarded to:

Jfeatner Pry Radiation Protection Training

for Nuclear Pharmacy Employees October 11•.2 0 , 2 0 16

This training is d~ to $

SIEMENS

Ms. Heather Fry

has attended the course

Operation of the Radioisotope Delivery System •eclipse' MI8ECLIPS

from May 23, 201 7 to May 25, 20f7 at Knoxville, TN

with the following course contents:

• Principles or operatf

raining Certificate ~-This certificate is awa:t•ded to: a~J ( Q 9dici.Jy £atliam

In ,, · oogni.tit:m.. qf::.-ucces.'ifW, ccmtplction Qj' the: Tntnspol'taticn oj'RaditJtu:til:e M atcrials Class, c 't regulation. qffhe United State..

raining Certificate Tltis certificate is awcn•ded to:

:.Mick§y £atliam Radiation Protection Training

for Nuclear Pharmacy Employees October 6 • 151 2015

co

T1tis tl-aining is designed to s~ the 6cmt!tltlU!4'CV'eneas. .Flutction~o and~ 'Troininq l'Wqu~nt of 49 Ci''.R f'/:tl.704(AJ. 1'1-ainirtg ult.ll$ condueted by Siemens .MedicalS

SIEMENS

Mr. Mickey Latham

has l!ttondcd the course

Eclipse Systems Part Two MJ3ECUPS

:from May 2, 2016 to May 13.2016 at Knoxvl!!e. TN

with the following courM contents:

• Review of SafeW " Vacuum system fault recovery " lon Source diagnostics and troubleshooting • System ~libratlon$ • RF Amplifier ilesign and rebuild " RF amp tuning and troubleshooting • RF control system dlagnostieu " Targatry troubleshooting • Control system and irtterk>cks troubleshooting • Operating Softwa-re Upgrade and Maintenance

Dri:~ Global Training Center ~

Date: 13.05.2016

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