Gallagher, Carol

Subject: FW: RE: Opportunity to provide information on 1-131 Patient Release Topics

Attachments: Scan0046.pdf; Scan0047.pdf; Scan0048.pdf

From: Van.Nostrand, Douglas [mailto:Douglas.Van.Nostrand@medstar.net] l

Sent: Wednesday, February 10, 2016 12:36 PMTo: Howe, Donna-Beth <Donna-Beth.Howe@nrc.gov>

Subject: [External_Sender] RE: Opportunity to provide information on 1-131 Patient Release Topics

Donna-Beth:

Here are three additional forms. One a release form, the second an informed consentform mandated by our institution, which I don't like at all, and the third is our triplicatewritten directive form.

The previous set of attachments I sent, the patient instruction manual and patient book inthe US mail, and these three should do it for us.

Van

Douglas Van Nostrand, MD, FACP, FACNP....• _.

Director, Nuclear Medicine ...Professor of Medicine, Georgetown University School of MedicineWashington Hospital Center ....••-110 Irving Street, N.W. oSuite GB 60BWashington, D.C. 20010Office: 202-877-0300Fax: 202-877-6601E-mail: douglas.van. nostra nd~medstar. net

From: Howe, Donna-Beth [Donna-Beth. Howe@nrc.gov]Sent: Friday, February 05, 2016 4:59 PMTo: Van.Nostrand, DouglasSubject: RE: Opportunity to provide information on 1-131 Patient Release Topics

Dr. an ostrndSUNSI Review Complete

Template = ADM - 0131 E-RIDS- ADM-03

Add= >-sL••)C(•

I contacted you last year to participate in NRC's 0MB clearance application to collect information on Sodium 1-131 Patient Release topics. NRC appreciates your comments on the 0MB clearance efforts. We received theclearance and published the Federal Register Notice asking for information on November 16, 2015. I haveattached a copy of the Federal Register Notice for your information.

Although the information collection period officially ends on February 16, 2016, we can still considerinformation submitted after this date.

The focus of this information gathering effort is to obtain: information that patients believe will help themunderstand the 1-131 (also referred to as Radioactive Iodine (RAI)) treatment procedures, the physician's orlicensee's/permittee's best practices when making informed decisions on releasing RAI treatment patients, andinformation provided to patients on how to reduce radiation doses to others.

The FRN discusses the four main information collection topics:

A. Web Site Information;B. Patient/Licensee Acknowledgement Form and Best Practices in Making Informed Decisions on

Releasing Patients Treated With I-131 Based on Radiation Exposure Considerations;C. Guidance for Released Patients; andD. Brochure for Nationwide Use.

Each topic includes a discussion of the kind of information NRC hopes to collect. Suggested topics andquestions are intended to be general and open ended so that NRC can obtain the best possibleinformation. NRC is asking responders to provide information based on their own experiences and is notasking anyone to perform research or develop new products. The FRN provides instructions on how to submitthe requested information to the NRC and that it should be submitted by February 16, 2016.

As a representative of a large medical facility, NRC is particularly interested in hearing from large practiceswith diverse patient situations and in receiving information on web sites that provide patients with good medicalinformation on hyperthyroid and thyroid carcinoma treatment concerns.

I hope you and your institution will consider participating in this information collection effort. Participation is

voluntary.

If you have any questions don't hesitate to call me at (301) 415-7848

Donna-Beth Howe, Ph.D.U.S. Nuclear Regulatory Commission

2

8. NOTICE

8.1 Any communication, including notice, consent, authorization or directives required or permittedto be given by the terms of this Agreement, shall be given in writing and delivered by personaldelivery, facsimile transmission or mail, postage prepaid at the following addresses:

To the Consultant:

To DRAXIMAGE:

Division of Nuclear Medicine, Suite GA60BWashington Hospital Center110 Irving Street, N.W.Washington, D.C. 20010 USAAttention: Dr. Douglas Van Norstrand

16751 Trans-Canada HighwayKirkland, Quebec H9H 4J4 CanadaAttention: PresidentFax number: (514) 694-9295

With a copy to the Legal Department at the same address. Fax number: (514) 630-7159.

9. LANGUAGE

The Parties hereto have expressly requested that this Agreement be drafted in English. Les

parties aux pr~sentes ont express~ment requis que cette entente soit rddig~e en anglais.

IN WITNESS WHEREOF, the Consultant andAgreement to be, executed by their respective dulyof [,X 4 , 2015.

DRAXIMAGE have eaclh caused thisauthorized representatives this IL day

JUBILANT DRAXIMAGE INC.

Bly:

Title:

Doug

By:

Title:

~las V n Nostrand A

______________________ )fld2~& 4~ ~LdJJkAI2

Page 5

SCHEDULE C

CONFIDENTIAL and ASSIGNMENT of INTELLECTUAL PROPERTY AGREEMENT

This Confidentiality and Assignment of Intellectual Property Agreement (this "Agreement") is made andentered into as of__December 7th 2015 by and between Douglas Van Nostrand, M.D.

("Individual"), domiciled at 3 8cO I~ifo(C Z'/ V' iŽ6%' • 0 P•A f4•DOt,. ,J) 2112 •

a service provider of Jubilant Draxlmage Inc. ("DR•XMGE") and IRAXIMAGE.For other good and valuable consideration, including but not limited to the Individual's retention of hisservices by DRAXIMAGE and compensation by DRAXIMAGE under the terms of any applicableservices contract, DRAXLMAGE and Individual covenant and agree as follows:

1. Definitions

"Confidential information" means any confidential or proprietary technical, scientific, financial,commercial, manufacturing and any other valuable information, in whatever form, support or media, suchas, without being limitative, trade secrets, know-how, formulae, research results, methods, discoveries orother information, processes or machines, inventions, research projects, management information systemsand computer programs, information about costs, profits, markets, sales, plans for future developments,client lists and any other information to the extent not available to the public and considered to beconfidential by DRAXIMAGE or that DRAXIMAGE has received in confidence from a third party.

2. Confidentiality

(a) Unless otherwise required by law, the provision of his services or expressly authorized byDRAXIMAGE, the Individual shall not at any time during or after his provision ofservices, whether directly or indirectly, in any capacity whatsoever, disclose, expose orcommunicate nor allow any disclosure, exposure or communication of any ConfidentialInformation in the possession of DRAXIMAGE or one of its affiliates, as owner orotherwise, that the Individual has taken cognizance of during the provision of hisservices, to any natural or legal person, entity, body corporate or any third party, nor useor allow to be used such Confidential Information for their own interest or for the interestof a third party, or in a way that is detrimental to DRAXIMAGE or the owners of theConfidential Information. Without limiting the generality of the foregoing, the Individualcamnot disclose the Confidential Information to the media, the financial community, to acompetitor or to any regulatory authority without the authorization of the President ofDRAXIMAGE, nor use the Confidential Information in order to make any stockexchange dealings.

(b) Confidential Information in any form, including any reproduction of such ConfidentialInformation, will remain the exclusive property of DRAXIMAGE or the third party

Page 6

on DRAXIMAGE premises and the Individual shall assume all risk of such injury or damage while onDRAXIMAGE premises.

9. Lan~uas~e

C'est • la demande expresse des parties que le present contrat a •t r&.lig• en langue anglaise. The parties

hereto have expressly requested that this Agreement be drafted in the English language.

I ACKNOWLEDGE THAT, BEFORE SIGNING THIS AGREEMENT, 1 WAS GIVEN AN OPPORTUrNITY TO READ IT,

EVALUATE IT AND DISCUSS IT WITH MY PERSONAL ADVISORS AND WITH REPRESENTATIVES OF

DRAXIMAGE.

HAVING READ AND FULLY UNDERSTOOD THIS AGREEMENT, I have executed this Agreement on the

j_•dayof 9•¢L kj, eeot ,2015.

JUBILANT DRAXIMAGE INC.

By:

Title:

Date:

Page 9

C¸y,

Release Calculations for 1-131

Mam-eal Inrtil Dose Rl~e: tshr@ I a

Bod 06Iedal ng RFe:le 6196 (letw sa4ao m e o a

A.,,pmved 7 yos l ¥o Thyroldel 0fi•o Ao,,dvt4 7.9 n'tCT~hyaiaa HNaf Irk 806 days

334Teh, o l~t al Ud. Intpd Nhar I.a• ......... ays~1

ThytidalWolalee Half 't ier[ d (itm NC Ntt¢ , 0GE-1493 Table 4.6)

Thyroidal Erodlece Hal Uf: 7.31 dy

1sfin36 Dose l~ieisal foe Hliglset Dose lodlodoa NRC Dose Rate Assamopton Based with Etlsae 42•o HalF4f-li

Tuau Cuim~uatud iEus# Wtltm$t

eIm lgih D66~t 4llqW ,

0.71Z

lu'st4.516l 4.IS~t

0.14.1

0J33lI%OIlO'4,I

IAB

IllllI1O

4

3

263

NUREC-155 Volume 9. Rev. 2,1-131 Rio Retentios and Ellm. Parametersfor Elyperthyrok~lsm, Thtyroid Ablation, and Thyroid Cancer

Purta ItaF-Ufe Fraia H,.elf-LifD F-I TbI (daYel F-2 Tb {daysl)

Hyeilyoii 0.1 0.33 0.9 10nd 0,2 0.33 0.1 II

TI,2 sreil Ablatios 0.3 0.33 0.7 200.4 0.33 0.6 200.3 0,23 0.3 250.6 0.33 0.4 400.7 0.33 0.3 63

_________ 0.13 0.33 80lttitlal Uptake Fracllie

Couodled Teal Decay Gatara lata Effeir te eDose Coaarsao• Feeler Atlvity HalFlife Oraopaery

0.136 54.56 2.2 130.0 0.18 0.750

All Patients will remain under surveillance in a ieadlined room for 4 hours.Ilserefore, the reduction otradlatloel dose to the public would be : t3.ut rem.

0.156

A3 a result, the net dose received by the public from the initial 8 houn 0.077 remn.

Extrath~yroldal Uptake Fraction

C usmololed Total Detey Oooas Exsreod~oelde Elfeiss

Dose Cea/seele Feelor Aeteityl HIFl. DriOccpanecy Doily lHtsdayle oI pif.) ~ r tKm'sd•h~ m2• (r' •• Ftseltion I'a10.006 34,36 2.2 142.1 0.32 0.350 114 60.060 54.26 2,2 142.1 0.32 0.200 1/5 4.00.037 34.36 22 1421 6 .32 0.167 1/6 40.044 34.36 2.2 142.1 0.32 0.14"1 117 0.40.043 34.3•6 2.2 142.1 0.32 0.123 Ill 30.031 34.36 3.2 142.1 033• 011 1 /9 2.70.034 34.36 2.2 142.1 0.32 0.106 11lO 2.40.029 3d 5 2.2 1421. 0.33 0,013 1/13 20.014 34.56 2.2 142.1 0.32 0.042 1/241

Thyroldal Uptake Fraction

D~es Covoe~sl Fa~er AcIrmty Htdf-Ir Oeerusa DorIs Inday,

0.017

0.0720.0620.03s0.13490.0440.0360.010

343634.36

34.5634.5434.5634,56

2.22.2-32.22.32.22.22.2-2.

7.97.97.91.97.91.97.97.079

7.317.317.313,317.317.31"/317.317.3'

0.2500.2O00.1670.1430.1230.11l0.10o0.013o.042

1/4

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1/24

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Apyse',ednyr

S

I .* I S *~ 5' I & 5.'.* 3 . 4

P otential AlternativesInstead of 1311 therapy, you have several alternative approaches such as (1) no treatment withmonitoring of your thyroid cancer with imaging studies and blood tests such thyroglobulin levels, (2)e xternal radiation therapy, and/or (3) chemotherapy.

Basic Information1. The nature of the condition that led to the need for the test or procedure is your thyroid cancer.

2. The likely result without this test or procedure is possible return or progression of your thyroidcancer.

ii] Blood/blood products are required for this procedure. Separate consent for blood has been completed.xi Blood/blood products are not required for this procedure.

Provider's Statement

I have explained the nature of the test or operation, benefits, alternatives, risks, and likely result withoutthis test or procedure with the patient and/or other decision-makers.

Signature of Physician/Designee Obtaining the Patient's Consent Date/Time

Print Name:_______________________

Patient's Consent

The nature of the test or procedure, benefits, alternatives, risks, and likely result without this test orprocedure have been explained to me. I have had an opportunity to ask questions and have had my questionsanswered to my satisfaction. I voluntarily give authorization and consent for the test or procedure describedabove to be performed by my physician or other qualified health professionals.

Patient's Signature DateiTime

Patient's Designee or Substitute / Relationship to Patient Date/Time

Witness Date/Time

INFORMED CONSENT FOR MEDICAL TEST OR PROCEDURE FORM 2423 09/10/10 pgx 2 of 2CON# 108 Title: 1-131 Theranv for Thvroid Cancer AnDroved 1/25/11...... ... - ............... r'J ...... • ............. r• .....