Hill, Carol

From: Sent: To: Cc: SubjE~ct: Attachments:

Mary Beery [mbeery@frontiercancer.com] Friday, November 18, 2011 12:46 PM Hill, Carol Murnahan@nrc.gov; Justin Sherman AmendmentRequest AmendmentRequest1.pdf; AmendmentRequest2.pdf; AmendmentRequest3. pdf

Attached is a request to amend our license #25-29392-01 (Frontier Cancer Centers and Blood Institute.)

Thank you, Mary

Mary C. Beery, CLS (NCA), MHA Chief Operating Officer Frontier Cancer Center 406-238-6901 406-670-4363 (cell) 406-238-6961 (fax)

REC D

NOV 11 2011

IDNMSi

CONFIDENTIALITY NOTICE: The Information contained in this message is confidential information intended only for the use of the individual or entity named above. If the reader of the message is not the intended recipient, or the employee or agent responsible to deliver it to the intended recipient, you are hereby notified that any release, dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, please notify the author immediately by replying to this message and delete the original message.

1 5 7 6 2: e 5 ~.

CANCER CENTER ,\ N I) 1\ L 0 () n INS TIT \: I I

Date: November 18,2011

US Nuclear Regulatory Commission

Re: Radioactive Materials License No. 25-29392-01

Dear Sir or Madame:

RECEIVED

NOV 2 1 2011

IDNMS

We respectfully request an amendment to our license in order to add yttrium 90 (gOy) in the chemical form of 90Y-labeled ibritumomab tiuxetan (goY-Zevalin) for radioimmunotherapy of non­Hodgkin's lymphoma. Zevalin was developed by IDEC Pharmaceuticals and the Biologic License Application was approved by the Food and Drug Administration on February 19, 2002. Zevalin falls within the category described in 10 CFR 35.300, Medical Use of Unsealed Byproduct Material for Which a Written Directive is Required.

Please note that this application applies only to therapeutic use of gOY-Zevalin. The current Zevalin regimen also includes use of l11ln-Zevalin as an imaging agent. The 11lln-Zevalin imaging dose would be administered and whole body scans performed at St. Vincent Hosptial, License No. 25-07553-01. After scans have been completed and biodistribution/tumor uptake confirmed, the gOY-Zevalin treatment dose will be administered at our facility.

If the Food and Drug Administration approves a Zevalin regimen that omits the use of 1111n_ Zevalin with a whole body scan, the 90Y-Zevalin treatment dose will be administered at our facility as usual.

Authorized Users

Each dose will be delivered as a unit dose for patient injection. Doses will be administered by the licensed Authorized User (AU), Dr. Joni Buechler-Price. (NRC form 313 attached)

Possession Limit

The requested possession limit is:

- 200 mCi 90y Ibritumomab Tiuxetan

The administered gOy dose will be either 0.3 or 0.4 mCi/kg (depending on patient weight and baseline blood platelet count). not to exceed 32 mCL

$576 85

Ordering. Receipt, Opening and Preparing for Administration

A written directive from the AU physician will be obtained prior to ordering any therapeutic dose. The RSO shall ensure inventory control and supervision of safety tasks. Existing procedures will be used for RSO review of associated delegated tasks and inventory tracking.

The 90Y-Zevalin will be received from an authorized nuclear pharmacy in unit-dose (liquid in syringe) form, ready for administration. All packages will be received, surveyed and opened in accordance with our standard operating procedures for this activity as stated in the RMl. These tasks will be conducted in the Hot Lab. Personnel who handle these materials will be properly monitored with individual monitoring devices (body and extremity).

The syringes will be appropriately shielded (e.g., Lucite or acrylic) to minimize exposure during handling. Once the radiopharmaceutical has been logged in, the dosage amount will be checked against the written directive, communicated to the APU, and stored until use in the Hot Lab.

Dose Administration

An injection station (i.e., small table) will be set up in either injection room 1 or injection room 2. The injection station will be covered with plastic backed absorbent paper. The floor underneath the site of injection will also be covered.

The patient will be identified using two methods of identification (e.g., driver's license and social security number). For female patients, verification of the patient's pregnancy and/or lactation status will be determined prior to administration of the dose.

All doses will be administered in the injection station by the AU. Personnel administering the dose and/or attending the dose administration of 90y -Zevalin will wear appropriate radiation monitoring devices (ring badges and whole body dosimetry as appropriate). 90Y-Zevalin will be infused either by direct IV infusion from the syringe by hand or by use of a metered syringe pump. Appropriate Lucite or Plexiglas shielding will be utilized.

Post-Administration Survey

After the procedure is completed, surveys of the area and equipment will be performed and recorded. Contaminated areas will be secured and/or cleaned as appropriate and consistent with our previously-approved RML licensing conditions. Contaminated eqUipment and materials will be placed in storage in the Hot Lab for decay for at least ten half lives, after which time they will be surveyed with a GM survey instrument calibrated with a pancake probe. If radiation levels are indistinguishable from background (when measured in a normal background area), the materials may be discarded in routine trash, provided all radiation labels are removed or obliterated. Precautions related to activities such as handling contaminated items or excreta, use of shielding, labeling, etc., will also be incorporated into our radiation safety training program.

$576385

Patient Release

gOY-Zevalin is administered on an outpatient basis. The amount of administered gOy meets the criteria specified in Column 1 of Table 1 of NRC Regulatory Guide 8.39 for release of patients based on administered activity. The following instructions will be provided to patients to minimize exposure to family members and the general public:

• During the first 3 days after administration: Wash hands carefully with soap and water after using the toilet

Immediately clean up spilled urine and dispose of blood-contaminated material so that it will not inadvertently be handled by others • Use condoms for sexual relations during the first 7 days after goy -Zevalin administration

Expansion of Radiation Protection Program

Precautions related to safe handling of unsealed radioactive materials will be incorporated into our existing radiation protection program. In addition to the procedures described above, we commit to implementing those model procedures of NUREG-1556, Vol. 9 that are directly applicable to GOY-Zevaiin use, specifically:

Appendix L - Model Procedures for an Occupational Dose Program Appendix 0 - Model Procedures for Ordering and Receiving Packages Appendix R - Model Procedure for Area Surveys Appendix T - Model Procedure for Safe Use of Licensed Material Appendix X - Model Procedure for Waste Disposal by Decay-In-Storage and

Licensed Material Return

We hope that this information is sufficient for you to complete a timely review of our amendment request. Please contact Justin Sherman at 406-238-6883 if you require any additional information.

Sincerely,

7V<"O~o Mary Beery Chief Operating Officer Frontier Cancer Center

Zevalin Treatment Procedure:

.. Only soY-Zevalin will be administered at this site. 111ln-Zevalin will be administered at St. Vincent Hospital (RML#). The patient will receive SOY·Zevalin 7 - 9 days after receiving 1111n_ Zevalin.

.. A "Time our procedure is to be performed where the patient's identity is verified by two methods.

.. The treatment is to be administered in one of the injection room suites. • The patient is to receive IV infusion of 250 mg/m2 of Rituximab. • The patient is to receive an IV injection ofsoY-Zevalin over 10 minutes.

o 0.4 mCilkg for patients with normal platelet count o 0.3 mCi/kg for patients with platelet count of 100,000 -149,000 platelets/mm3.

o Patients with platelet count of less than 100,000 platelets/mm3 will not be treated. o The maximum allowable dose ofsoY-Zevalin is 32.0 mCL

• A plastic bag for contaminated items should be available as well as paper tissues. • The patient shall sit at a table covered with adsorbent pads and adsorbent pads should also

cover the floor beneath the patient. • The patient will be given verbal instructions which outline basic procedures to maintain safety

to themselves and the general public.

$; 5 7

N I CANCER CENTER AND L\LOOD INSTITUTE

1315 Golden Valley Circle Billings, Montana 59102 November 18, 20 J 1

U.S. Nuclear Regulatory Commission 615 East Lamar Boulevard, Suite 400 Arlington, Texas 76011 A I 25

Dear Sirs,

IVED

NOV 2 1 2011

lDNMS

Please amend our NRC License 25-29392-0 I (Frontier Cancer Centers and Blood Institute) to Add Dr. loni Buechler-Price as an Authorized User for 35.300 (Zcvalin and 1-131) Add Zevalin for radioimmunotherapy Add I-13 I for direct radioisotope therapy

Documentation is attached.

Thank you,

:;:.:>

7 717J00 Mary Beery Chief Operating Ot1icer Frontier Cancer Center 406-238-690 I mbeel'\t(i{l froll tiercancer.com

flTI,[,TNGS CENTEIl

1315 coldell I1Ii1e), Circle' llilJil1Xs . . \IT 59102 'fd: {4(6) 2:lH·liNO • hlx: (fJ()6/ 238·6280

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rh576385 BUrn; CENTER

,/{}(i ,~flU1h Ci:lrN • /1(11(':' Mnntllllo t,9701 'f(:/: {:ION 72.}·26/(; • 1-:1.'\: (,;ob) 723·261:;

NRC fORM 31~ (AUT) p.2OO9l U.s. NUCLEAR REGULATORY COMMISSION

AUTHORrzED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

(for uses defined under 36.300) APPROVED BY' OMB: NO. 3150.0120

EXPIRES: m1t.i1012 [10 CFR 36.390,35.392,35.394. and 35.396)

Name of Proposed AuIhOJized U&eI' 1 Slal& or Tenftory Wlere Licensed ~ __ ~,,~ ~~tA..\.a.l1.~.!.~~_ .. __ . __ .. J. vt(~.""-ttL~~ . ____ . _____ _ Requested Authorizatlon(s) (check all that apply):

f2135.300 Use of unsealed bypnxfuct material for which a wrtHen directive is required

OR

035.300 Oral acfmlnla1rallan of sodium IOdide 1-131 requiring a written cIIrectlve in quanUIies less than or equaJ to 1.22 gigabecquerele (33 millicurles) 1'm35.300 Oral adminJsbalion of sodium iodide 1-131 raquiring a written dlrecllve In quantities grealerthan 1.22 ~ gfgabecquerels (33 mmlcurles) .m 35.300 Parenteral administration of sny bet&emllter, or photon-emiHing radlonudide with a photon energy less thai 150 keV for which a written directive Is required 035.300 Parenteral administration of any other radlonuc/lde for which a written directive is mqulred

PART I - TRAINING AND EXPERIENCE (Select one of the three methods below)

• Training and ecperience. Including board certification. must have been obtained within the 7 years preceding the date of appflcatlon or the individual must have related conllnulng education and experience sInce the required training and experience was completed. Provide dates, dUration, and description of conlinulng educallon and eXperience related to the uses checked above. o 1. @oard Certlflcatfon

B. ProVide a copy of the board certification. b. For 35.390, provfde documentaUon on supervised clinical case experience. The lable In section S.c. may be used to document this experience. c. For 35.39B, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables In sections 3.0., S.b., and 3.c. may be used to document this experience.

d. SkIp to and complete Part II Preceptor Attastellon

~2. CUrrent 36.300. 35.400. gr 35,600 Autborlyd User Seeking AddlUonai Authorization a Authorized User on Malerials Uc:ense under the requirements below or

equivalent Agreement stale requirements (check all that apply):

ri{s.390 [J 35.392 [] 35,394 0 35.490 i las.sao b. If currently authorized for a subset of clinical uses under 35.300, provide documentation on addillonal "required supervised case experience. The table In aeetlon 3.c. may be used to document this experience. Also provide compleled part 1/ PreceplOr Attestation.

c. If cunently aulhodzed under 35.490 or 35.690 and requesting authorization for 35.398. provide documentation on classroom and laboratory training, supervised work mcperlence, and supervised dlnJcaJ case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this expelfence. Also provide completed Part II Preceptor Attestation.

PAaE1

NRC fORM '1M (AUT) 13-2IIl!Il u.s. NUC1.EAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR AnESTATlON (continued)

O~1b ~\"t.t.~ u::C\~s. I-Mat-h-e-m-8-IiCS-p-a-I1B-InJ-ng-to-t-he-~\.IIo\\~"Sa." e<' \~~~ use and measurement of I\~ radioactivity s.~t;:\.t. C'-'\'l>:5Q,

UW\"~~", Cf Il\ - l't\'Uo,c.,. ~A'TI.c" e f'C\t1~~ \/2C~ a,~ A~ I "r1/'2JtAJl. 2..a \\to.. ~ ,"(Lcd\

1 1'I~<3> I/~ ·~I~ ! ~"es \I~-~/~!

Radlallon protection

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NRC FClRM313A (AUl) U.s. HUCUiAR IUiGULATORYCOMMISSION ~~ AUTHORlZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (conUnued) 3. Im'nlngagd experience for Prop09ed Authorized User (contlnUed)

b. SUpervised WOd< Experience (continued) SIJJ)eMsing Indvidoal :UcenseIPermit Number Illl1lng 8UperWlitl9 individual as an

:autflol'imd uIICr

.. ~. w_, , ........... ,. .......... ~ .... - ...... ~ • • • ••••••••• ~ ., -' .,.. • • o 35.390 ~ WiIh experience administering dosages of:

o .35.392 ~ 0 Oml Na.I-131 requiring a Wljtten cflt'ElClive in quantities less than or equal to 1.22 o a5.394: gleabeequere18 (33 millicunes) : 0 Oml Nal·131 In quantities greater than 1.22 glgabecquarels (33 mIllicuries) o 35.396 ~ 0 Parenteral admfnlslraUon of beta-emltter, or photon-emitUng radlonUCIlde wIlh If photon : energy less than 150 keV requiring a written directive Is required ~ 0 Parenteral administration of any ottler radlonucWde requiring a written dlrectlve

~"·s~~~·,tQd·UHiiOOsthavit';~,jmh;8d~dOiiot.itiihaswid~riecateQOrY~ __ ~4i·the·b,~u~J ... requllGllng alllhodzed UIef Bta1Us.

c. Supervised Clinical Case Experience If mOl& than one supervising individusJ Is nec&SS8J}' to dOcurrnmt supervisa<J work experience. provlda mtI1lfpl8 copl8S of this page.

DescriptIon of Experience

Oral administration of sodium Iodide "'131 requlring a written dlrecUvaln quanfHles less than or equal to 1.22 glgabGcquerels (33 mflllcurles)

Oral admlnletratJon of sod'lUm iodlds.1-131 requiring a written directive In qusnntleS ~ than 122 gTgMecqlIerel& (33 mDllcur1es)

ParenleraI admlniStmtlon of any beta-emltter, or photon-emit1lngradlonucllde WIIh a photon energy less than 150 kaY for whleh a written directiw is requIred

Parenteral admlniatratfon of

Nttmber of Cases Involving Personal LocaUon of Experience/Ucense or Permit Dates of Participation Number of Facility experience-

U~\\l~\.~ 0(: lQ~P. \\O'a..?l"'U\\1:o ~ w~\.c.s/

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~~\.~\..t.'\. ~ \.~ l-\O~\.'("\.S. ~t) CU~\.<.s. f!

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\\-01 -z008

ll-1..0 .l.ClS 0' ~oq- ZbOtt

1~ tIC -1..001 1-z.q • "lW't 2- \1·l.O\.'h

1'2 -Zlt - 'Z. Oi)

Co-\\ -UO'l any ether radfonuclide far if; wntcha written drrecUve Is required

(Uall1l!llcctudldaa)

PACE. 3

$576385

NRCPOU,1JACAUTJ u.s. NUCUAR REGULATOKY CCJaIlIIION ~ AUTHOR1ZED USER TRAINING AND IXPERIENCI AND PRECEPTORATTElTATlON (continued)

3. Tralnl. and Experf'DC! fgr Pmpgud Aulharlyd User (conlfnued) c. Supervised CInJcaI caae Experience (canlInued)

............ I. • ••• .. ....................................... ,. I ................... * ••. -, • • • .. • • •.. , • o 35.390 ~ Wdh experience admlnlatl!lring dosages of: o 35.392 ~ 0 Oral Nal-131 raqulrino 8 wrIIen dlrdvaln quantlt1e8 lela than or equal to 1.22 o 35.394: glgabecquerels (33 nill/k:urfes) o 35.398 ~ 0 Ond ,..1-131 in quantities greater than 1.22 glg8becquerulo (33 mJlCUtfeI) : 0 Parentend lIdminIStJa1ian ~ betIHrniI:ter, or pholon-emltllng radIonUcIde wfIh 8 pIID40n . energy less than 150 keV requlrfng a written dIrective fa required ~ 0 PantnteraI admfnlstrallan of IIny other radlonucllrte mqulrlng a written diJectIve ......... , ......................... .

.. SupeMslnaAldlGdZrd UIet rnuaI have expedenoe n &daIlnIIIaIIIlo~ In the un dosIIQ& cateooJY Gl'ClIIQariH aile IndIvIdni requedn; IUIhodad userSllJlls.

d. Provide completed Part II Preceptor Atteatatlon.

PART U - PRECEPl'OR ATrESTA110N Note: this part must be completed by the Indlvlduara preceptor. The pf8C8pt.cr daas not haveto be the aupen.illng IndMclualalOng 88 tha preceptOr prDvkfas, dncta, or veriIII8 trainIng and mcperfanca required. If mora than one pteceptar Is necelGary to doCuMnt experIenc&, obtain a separate pl1!lCeptar atetement from each.

8y CheCking tha boxes belOW, the pteCeptQr Is attesflng that the Individual has knowledge ttl fuffln the duUea of the position sougbt and not attesting 10 the individual'S -general cflnlcal compeIency ••

firat Sectron Check one oftlla folloWing far each nqul8Hd authDrtzaUon:

For 35.310:

o I all .. liteR

raqlinJmenla In 3S.~(1I)(1).

T!!Jnlna and l!JU'd!!!C! o I attest thai ~~'Fe -"'(E=

lCIIMofPlllpllUd ~ u ....

OR

has I8tisfactorlly complatad the 700 hours of tl'lllnlng

and experience. including a minimum of 200 houl'S of Classroom and laboraUIry tnmJng, u required by 10 CPR 35.390 (b)(1).

NRC FORIIStM CAUl) U.s. fWCU!AItlll!8ULATORY CDalIS8lON ~

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTeSTATION (continued)

pracgtgr !!!nIJt1qn (contfnued)

FlnstSal:llon (continued)

For uaa f1dtntlcal Attestation 8Iatemeot ReR!lnfless atTAinIng and Eprimca P!thW!V);

o I attest that ...4()~ ~~\U. .. ~E: HI_cl,.....~UIlt

nlabandory training. 88 raqWed by 10 em 35.392(c)(1)., and the supet'V1sed work and ClInical cue experience raqulled In 35.392(c)(2).

For aSM Odentfcal Alt!!tatlon statam8nt _IEdIt. of Trafnlng and Eg!rImca Pathway);

0 1 alteatthat d~\ ~-Jj...c;e. NnII cll'rIlpoMd AIIIIoIIIId UMr

has aatiafactorily completed the 80 hours clcla&wom

and IabOI'8tGry trai'Ifng. as required by 10 CFR 35.394 (eX1), end the supervised work and clinical case experfence required In 35.394(c)(2).

~ ................... -... -...........................••....... Second SectIon

has salisfactorlti col'\'1pleted the required clinical case

expetience required In 35.39O(b)(1)(i)G II&fed below:

0181 Nal-131 nHluJrfng a wlltten dltectlve frI quantities less than or equal to 1.22 91gabecquel'8l1 (33 mlllicurles)

6Q. Oral Nal-131 In quantiUB8 greater than 1.22 glgabecqu8rals (33 mlllicuries)

~Patenteral admInlstndlon 01 bebJ.emftter, or photon-emltting radionuctlde wiIh iii phaton energy lela than 160 keY naqulring. wrIten clbBcHve Is requIred

----: Parenteral administration of any oIhar radJonuclide raqukfng a written drecIive

•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

ThIrd SectIon

o I atIest that ~\ l!Ni;C,Yd F'-l1zMc. .... CIII~~U..,

function hdependanlly as an authorized user for.

o Oral NaI-131 raqulrfng a written dltec:tlve In quantilles less than or equal 10 1.22 glgebecquetels (33 milcurles)

~ Oral Nal-131 In quantities gl8Bter than 1.22 gfgabecquerala (33 rRIIlcurfes)

~P8nmI8raI admkdsUalion ofbela-emiUer, or photon-emIHIng radionucllda Wih a photan energy lesslhan 150 keY requiring 8 written dlJ'edlve Is raqulhld

o PaI8l'lfenll adnMlBtratfon of any other radIonucllde requiring • written dlrecllve

JlR:GPOMlI11A(AU1) u.s. NUCUAR R&GUU.'fOIIlY COMIIS8ION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR A1TESTA'TlOH (continued)

Fourth 8ac11Dn

ForUM'; Cungt 31-or H .• lulbodpd Ul!rj

o I attest that ~~ 1>¥wf'~lr're ..... ~PrapIII8dAlllllDriud UKr

Is an authorized user under 10 CFR 36.490 Of 35.aao

or eqUiValent Agreement State requirements. hu satlafactorlV completed the SO houra of daaIoam and IabOIalalytranlng. as required by 10 CFR 36.398 (d)(1). and the supervised work and ditlcaJ case uperience reqWed by 35.3aS(d)(2). and baa achieved a lawl or CCJq)atency IUfIldent to function IndependerlUy 81 an authorized user far.

~ Parenteml admJnIaWtIon of any bela-emlUer. Of photon-emiHing mdionudicfe with a photon enBlgy less than 1:50 UN for which II written directive Is required

o Pal'llltlnl admlllllballon of eny other radionucUde far which a Wlitten directive fa required

OR

has S8Usfactorily complalad the baard ce.rtlficaUon ---::ItImo~cf~PtG=JI_::-::d:-::IUJ":':::::~oW=u::: ... ::---

o Isteat 1haI

requirements of 35.398(c). hu satlefadorily completed Ihe 80 hours of claslmam and IabanltoIy training requlrad by 10 CFR 36.396 (d)(1) and the 8upelVlsed WOrk and clinical ease eJCperience required by 35.398(d)(2), and has achieved a level of competency lIufficfent to funcIion Independently as an aulhorlzecf user far.

o Parentef8' administration of any b8ta-emltter, or photofl.emittlng radlonucllde with " photan energy ilia than 150 keV fDrwhlch a written dlredive Is raquked

o Psrantand admJnstratlon 01 any ather radlonucllda rar which a wrilfan cllrectiYe Js requfred .•................................... __ ............... _ ... . fifth Ie.n Comp1lte the folloWIng for preceptcr atI8Btatlon and efgnature:

~ maat Uta requfrementa beloW. or equivalent Agreement State requirements, 88 an autharlzad user for:

~.390 035.392 0 35.394 036.398

o I have epedence admlnlslerfng dosages In the falawlng calejlaries far Whfch the propased Authorized UUr Is requestitg authotIzatlon.

o Ond Nal-131 requiring a wrIteR directive In qualiitles lees Ulan or equal to 1.22 gfgabecquerels (33 milIcurtaa)

o Oral NaJ.131 in quantilles gruter Chan 1.22 gtgabecquerels (33 milleuri.)

o Panmtenll admIRlstmIion of be\lHmlllar, Of phcton-emltinQ radlonucUde with a phOton energy less than 1tiD ICDV requiring a wriIIon d118C11Ve 18 required

o Parenteral afmInlslnllfon of any cthet radlonucllde requlrtng B wriIten dlrectiva

.IV I

CANCER CENTER AND BI.OOD INSTITUTE

Date: November 18,2011

US Nuclear Regulatory Commission

Re: Radioactive Materials License No. 25-29392-01

Dear Sir or Madame:

RECEIVED

NOV 2 1 2011

DNMS

We respectfully request an amendment to our license in order to add Iodine 131 C3l l) in the farm of Sodium Iodide 1-131 fordirect radioisotope therapy of hyperthyroidism and thyroid cancer. Sodium Iodide 1-131 falls within the category described in 10 CFR 35.300, Medical Use of Unsealed Byproduct Material for Which a Written Directive is Required.

Authorized Users

Each dose will be delivered as a unit dose for patient injection. Doses will be administered by the licensed Authorized User (AU), Dr. Joni Buechler-Price. (NRC farm attached)

Possession Limit

The requested possession limit is:

- 300 mei Sodium Iodide 1-131

Ordering. Receipt, Opening and Preparing for Administration

A written directive from the AU physician will be obtained prior to ordering any therapeutic dose. The RSO shall ensure inventory control and supervision of safety tasks. Existing procedures will be used for RSO review of associated delegated tasks and inventory tracking.

The Sodium Iodide 1-131 will be received from an authorized nuclear pharmacy in unit-dose (capsule of solution in vial) form, ready for administration. All packages will be received, surveyed and opened in accordance with our standard operating procedures for this activity as stated in the RML. These tasks will be conducted in the Hot Lab. Personnel who handle these materials will be properly monitored with individual monitoring devices (body and extremity).

The vials will be appropriately shielded to minimize exposure during handling. Once the radiopharmaceutical has been logged in, the dosage amount will be checked against the written directive, communicated to the APU, and stored until use in the Hot Lab.

Dose Administration

An injection station (i.e., small table) will be set up in either injection room 1 or injection room 2. The injection station will be covered with plastic backed absorbent paper. The floor underneath the site of injection will also be covered.

The patient will be identified using two methods of identification (e.g., driver's license and social security number). For female patients, verification of the patient's pregnancy and/or lactation status will be determined prior to administration of the dose.

All doses will be administered in the injection station by the AU. Personnel administering the dose and/or attending the dose administration of Sodium Iodide 1-131 will wear appropriate radiation monitoring devices (ring badges and whole body dosimetry as appropriate). If the radiopharmaceutical is administered in capsules they it be transferred to the patient's mouth by tipping from a small shielded (>1 cm Pb) container. If the radiopharmaceutical is administered as an oral solution (50 ml), it will be sucked up through a straw from the shielded vial by the patient. The vial should be flushed with water several times.

Post-Administration Survey

After the procedure is completed, surveys of the area and equipment will be performed and recorded. Contaminated areas will be secured and/or cleaned as appropriate and consistent with our previously-approved RML licensing conditions. Contaminated equipment and materials will be placed in storage in the Hot Lab for decay for at least ten half lives, after which time they will be surveyed with a GM survey instrument calibrated with a pancake probe. If radiation levels are indistinguishable from background (when measured in a normal background area), the materials may be discarded in routine trash, provided all radiation labels are removed or obliterated. Precautions related to activities such as handling contaminated items or excreta, use of shielding, labeling, etc., will also be incorporated into our radiation safety training program.

Patient Release

Sodium Iodide 1-131 will be administered on an outpatient basis. The amount of administered Sodium Iodide 1-131 meets the criteria speCified in Column 1 of Table 1 of NRC Regulatory Guide 8.39 for release of patients based on administered activity. An instruction sheet will be provided to patients to minimize exposure to family members and the general public. The instruction sheets are attached.

Expansion of Radiation Protection Program

Precautions related to safe handling of unsealed radioactive materials will be incorporated into our eXisting radiation protection program. In addition to the procedures described above, we commit to implementing those model procedures of NUREG-1556, Vol. 9 that are directly applicable to gOY-Zevalin use, specifically:

Appendix L - Model Procedures for an Occupational Dose Program Appendix 0 - Model Procedures for Ordering and Receiving Packages Appendix R - Model Procedure for Area Surveys Appendix T - Model Procedure for Safe Use of Licensed Material Appendix X - Model Procedure for Waste Disposal by Decay-In-Storage and

Licensed Material Return

We hope that this information is sufficient for you to complete a timely review of our amendment request. Please contact Justin Sherman at 406-238-6883 if you require any additional information.

Sincerely,

7U-(rc0-"'?J Mary Beery Chief Operating Officer Frontier Cancer Center

N I R CANCER CENTER i\ 0: I) I\! 0 0 I) j f\; sri ! () I i

RADIOACTIVE IODINE (1-131) THERAPY FOR ABLATION OF REMAINING FUNCTIONING THYROID TISSUE

IN THE BODY AFTER THYROID CANCER SURGERY

You have been prescribed by your physician( s) to receive radioactive iodine-I 3 I (I-I3l) therapy. Stable or nonradioactive iodine is a substance that is present in "iodized" salt and some types of food you eat every day. Iodine is used by the thyroid gland in your neck to make thyroid hormone.

Iodine-13I (I-131) is a radioactive form of iodine, which can be taken by mouth as a capsule or solution in a small glass of water. The 1-131 is absorbed and goes into your blood stream. A portion of this ]-131 will then localize in functioning thyroid tissue. You will be given a low iodine diet to decrease stored iodine in your body so that morc radioactive 1-131 will be taken up by the residual tissue.

For several weeks 1-131 gives otT radioactivity that iJ~jures thyroid cells that take up the I-131. Most of the damage to the thyroid cells takes place over a period of about I to 3 months.

Most patients do not have any discomfort or any side effects from the dose of radioactive I~131 that is given. Some patients experience temporary soreness in the neck due to intlammation in the salivary gJands which may also cause a dry mouth and altered taste if severe. You will be instructed to che\v gum or eat hard candy between meals to stimulate secretion of saliva for at least one week.

Most of the radioactive 1-131 that is not taken up by thyroid tissue or neoplasms will leave the body in the urine over the next 2~3 days. To help keep the levels of radioactivity in the bladder as low as possible, you should drink extra water or other fluids for the next 2 days and empty your bladder every 1 to 2 hours while you are awake.

Radioactive I~ 13 I is not given to any patient who might be pregnant. It is our policy to request a pregnancy test of all women who are able to have children.

You will be instructed by your physician as to when you should resume taking thyroid tablets. A scan may be done following the therapy just before you go home to show the lina! localization of I~ 131. A follow-up scan may also be scheduled somc timc in the future (about one week) to look for any remaining neoplasm.

~~576385

RADIOACTIVE IODINE (1-131) THERAPY FOR ABLATION OF REMAINING FUNCTIONING THYROID TISSUE IN THE BODY AFTER THYROID CANCER SURGERY -Page 2

In order to help minimize any unnecessary radiation exposure to family and members of the public the following guidelines are provided below.

For 2 Days Following Administration .. Sleep alone. .. Generally maintain a prudent distance from others (6 feet). .. Have few visits from family and friends. .. Avoid public transportation or long car trips with others. .. Have sole use of the bathroom. • Drink plenty of fluids. • Launder towels, bed linens and clothing separately.

For 7 Days Following Administration • Avoid open mouth kissing, and utilize a condom when having sexual intercourse. • Avoid prolonged close physical contact with children less than 18 years of age and

pregnant women. Otherwise, generally maintain a distance of 3 feet.

• Wash your hands frequently with soap and plenty of water. • Flush the toilet 2-3 times after each use. e Do not share eating utensils. • Avoid becoming pregnant for three months following administration of 1-131.

If you have any questions about this treatment, please ask the physician prior to the therapy. If you have any questions or concerns after you leave the Frontier Cancer Center, please contact your physician, Phone (406) 238-6290.

Location to which patient will be released: __________ _

I have read this explanation or had it read to me and understand it.

Date Patient Signature

N I CANCErt CENTER t\ "D II! 0 U I) I "', [ I T l ii !

RADIOACTIVE IODINE (1-131) THERAPY FOR AN OVERACTIVE THYROID GLAND

You have been prescribed by your physician(s) to receive radioactive iodine-I31 (1-131) therapy to treat an overactive thyroid gland. Stable or nonradioactive iodine is a substance that is present in "iodized" salt and some types of f{)od you eat cvery day. Iodinc is used by the thyroid gland in your neck to make thyroid hormone.

Iodine-131 (1-131) is a radioactive form of iodine, vvhich can be taken by mouth as a capsule or solution in a small glass of water. The 1-131 is absorbed and goes into your blood stream. A portion ofthis 1-131 will then localize in functioning thyroid tissue.

The remaining 1-131 is removed {rom the blood stream by the kidneys and leaves the body in the urine over the next 2-3 days. To help keep levels of radioactivity in your bladder as low as possible, you should drink extra water or other tluids for the next 2 days and empty your bladder every I to 2 hours while you are awake.

For several weeks 1-131 gives olTradioactivity that injures thyroid cells that take up the I~ 13 I. Most of the damage to the thyroid cells takes place over a period of about I to 3 months.

Although we would prefer to administer jllst the right amount of therapy to return you to a normal thyroid function, this is fi'equently not possible. You may develop temporary or permanent hypothyroidism (underactive thyroid gland) following the 1-131 therapy. This can occur as early as 3 to 4 months after treatment or several years after. Therefore, you will need periodic medical examinations and measurements of the amount of thyroid hormone circulating in your blood for an indefinite period. If your gland becomes permanently underactive (hypothyroidism), you will need to take thyroid pills daily throughout your life.

The toJlowing are signs of an underactive thyroid gland: gaining weight, feeling cold compared to those around you, noting that you arc becoming less energetic or are slowing down, a deeper pitch of the voice and constipation.

Occasionally the first therapy dose orI-131 will not stop the thyroid gland from making too much thyroid hormone. If this should occur. another 1-131 therapy can be given.

Radioactive 1- 131 is not given to any patient who might be pregnant. It is our policy to request a pregnancy test of all women who are able to have children.

RADIOACTIVE IODINE (1-131) THERAPY FOR AN OVERACTIVE THYROID GLAND -Page 2

In order to help minimize any unnecessary radiation exposure to family and members of the public the following guidelines are provided below.

For 7 Days Following Administration • A void prolonged close physical contact with children less than J 8 years of age and

pregnant women. Maintain a distance of 3 feet from them except for brief periods of contact.

• Wash your hands with plenty of water each time you use the toilet. • Flush the toilet twice after each use. • Do not share eating utensils. • Avoid becoming pregnant for three months following administration of 1-13 J.

If you have any questions about this treatment, please ask the physician prior to the therapy. If you have any questions or concerns after you leave the Frontier Cancer Center. please contact your physician, Phone (406) 238-6290.

Location to which patient will be released: __________ _

I have read this explanation or had it read to me and understand it.

Date Patient Signature

$57'6385

N I CANCER CENTER :\ N I) 1\ L () U II I N ~ T I I l' I F

Procedure for Receiving and Processing Packages that Contain Radioactive Material

1. Put on gloves to prevent hand contamination. 2. Visually inspect the package for any sign of damage (e.g., wet or crushed). If damage is noted,

stop the procedure and immediately notify the RSO (or the designee of the RSO if the RSO is not present).

3. Monitor the external surfaces of a labeled package for radioactive contamination, unless the package contains only radioactive material in the form of a gas or in special form, as defined in 10 CFR 71.4.

4. Monitor the external surfaces of a labeled package for radiation levels, unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in 10 CFR 71.4 and Table A to 10 CFR Part 71.

5, Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels, if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.

6. Remove the packing slip. 7. Open the outer package, following any instructions that may be provided by the supplier. 8. Open the inner package and verify that the contents agree with the packing snp. 9. Check the integrity of the final source container. Notify the RSO (or the RSO's designee) of

any broken seals or vials, loss of liquid, condensation, or discoloration of the packing material. 10. If there is any reason to suspect contamination, wipe the external surface of the final source

container and remove the wipe sample to a low-background area. Assay the wipe sample to determine if there is any removable radioactivity. An appropriate instrument with sufficient sensitivity will be used to assay the sample. For example, a Nal(T1) crystal and rate meter, a liquid scintillation counter, or a proportional flow counter may be used for these assays. The detection efficiency will be determined to convert wipe sample counts per minute to diSintegrations per minute. Note: a dose calibrator is not sufficiently sensitive for this measurement. Take precautions against the potential spread of contamination.

11. Check the user request to ensure that the material received is the material that was ordered. 12. Monitor the packing material and the empty packages for contamination with a radiation

detection survey meter before discarding. If contaminated, treat this material as radioactive waste. If not contaminated, remove or obliterate the radiation labels before discarding in in­house trash.

13. Make a record of the receipt.

N I CANCER CENTER AND HIOO!) INSTITUTE

Emergency Procedures in the Event of a Radiopharmaceutical Spill 10 CFR Part 20, Section 20.1101

Title 17, CCR. Section 30255

Minor Spills «1.0 mCi y-90)

1. NOTIFY: Notify persons in the area that a spill has occurred. 2. PREVENT THE SPREAD: Cover the spill with absorbent paper. 3. CLEAN UP: Use disposable gloves and remote handling longs. Carefully fold the absorbent paper and pad. Insert into a plastic bag and dispose of in the radioactive waste container. Also insert into the plastic bag all other contaminated materials such as disposable gloves. 4. SURVEY: With a thin window GM or scintillation survey meIer, check tile area around tile spill, hands, and clothing for contamination. 5. REPORT: Report incident to the Radiation Safety Officer (RSO).

Major Spills

1. CLEAR THE AREA: Notify all persons not involved in the spill to vacate the room. 2. PREVENT THE SPREAD: Cover tile spill with absorbent pads, but do not attempt to clean it up. Confine the movement of all personnel potentially contaminated to prevent the spread. 3. SHIELD THE SOURCE: If possible, the spill should be shielded, but only if it can be done without further contamination or without significantly increasing your radiation exposure. 4. CLOSE THE ROOM: Leave the room and lock the door(s) to prevent entry. 5. CALL FOR HELP: Notify the RSO immediately. 6. PERSONNEL DECONTAMINATION: Contaminated clothing should be removed and stored for further evaluation by the RSO. Inhe spill is on the skin, flush thoroughly and then wash with mild soap and lukewarm water. 7. The RSO will supervise the cleanup of the spill and will complele the radioactive spill and decontamination report.

Name and Telephone Number Radiation Safety Officer: Justin Sherman, MSBS office: (406) 238-6883 Authorized User. Joni Buechler-Price, MD office: (406) 238-6874

cell: (419) 618-3466 cell: (406) 633-3032

RADIOACTIVE SPILL REPORT

This spill occurred at _:_a.m.p.m. On_'_I_. Room __ .

Instrument used to check for personal contamination: Meter model: _ Meter SIN: _ Probe model: _ Probe SIN: _

Personnel Present Personnel Contamination Results·

On the back of this sheet, indicate any personnel decontamination, additional monitOring, or care instituted.

Survey the spill area to identify hot spots and begin decontamination. When finished, conduct a post­cleaning contamination wipe test.

Radioisotope present or suspected in the spill: __ mCi of ____ _

Brief deSCription of the accident:

Brief deSCription of follow-up actions taken to prevent recurrence:

Name: _______________ Date: _________ _

CANCER CENTEIZ ,\ N D 1\ L () () DIN '; ! I T l:t r

Policies/Procedures for the Administration of Radiopharmaceuticals for the Treatment of Cancer

1-131 Treatment Procedure:

III A "Time Out" procedure is to be performed where the patient's identity is verified by two methods.

o The patient is to read, understand, and sign a post-treatment instruction form, which outlines basic procedures to maintain safety to themselves and the general public.

o The patient is to change into a gown for treatment. III The person administering the treatment is to wear scrubs, protective gloves, a hairnet, and a

surgical mask. o The treatment is to be administered in the HDR suite. III A plastic bag for contaminated items should be available as well as paper tissues. It The patient is asked to sit at a table covered with adsorbent pads and adsorbent pads should

also cover the floor beneath the patient. III If the radiopharmaceutical is administered in capsules they should be transferred to the

patient's mouth by tipping from a small shielded (>1 cm Pb) container. III If the radiopharmaceutical is administered as an oral solution (50 ml), it should be sucked up

through a straw from the shielded vial by the patient. The vial should be flushed with water several times.

o The patient shall drink several glasses of water to clean the mouth. o Immediately after the radiopharmaceutical has been administered, the following information

should be recorded: activity (mCi) given, date administered, and results of patient radiation surveys.

III After the capsule(s)/solution has been swallowed, the patient is to remain in the treatment chair for fifteen minutes.

II After fifteen minutes, the patient is asked to leave the treatment room and change back into their regular clothes. A radiation survey is to be immediately conducted, which includes a survey of the floor, trash, packaging materials and the hands and feet of the person administering treatment. The survey should result in background levels of radiation.

(I All radiation surveys shall be documented and records shall be maintained. o The patient may be released if the maximum dose rate at 1 m from the patient is :5 7 mRlhr

(per NRC RG 8.39). " The patient will be given an instruction form which outlines basic procedures to maintain safety

to themselves and the general public.

$576385

NOV 21 2011 This is to acknowledge the receipt of your letter/application dated

NO V 1 8 2011 ,and to inform you that the initial processing, which includes an administrative review, has been performed.

DATE

~0h~re were no administrative omissi~ns. Y~ur applic.ation. will be assi~n~d to a tech~ical reviewer. Please note that the technical review may Identify other omissions or require additional information.

D Please provide to this office within 30 days of your receipt of this card:

The action you requested is normally processed within CJ 0 days.

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

Your action has been assi~ned Mail Control Number 5763 d~) When calling to inquire about this action, please refer to this mail control number. You may call me at (817) 860-8103.

NRC FORM 532 (RIV) (10-2010)

BETWEEN:

Accounts Receivable/Payable and

Regional Licensing Branches

[ FOR ARPB USE 1 INFORMATION FROM L TS ,.. "

Program Code: 02121 Status Code: Pending Amendment

Fee Category: 7C Exp. Date: 08/31/2020

Fee Comments: Decom Fin Assur Reqd: N

License Fee Worksheet - License Fee Transmittal

A. REGION

1. APPLICATION ATIACHED Applicant/Licensee: FRONTIER CANCER CENTERS AND BLOOD INSTITUTE

Received Date: 11/21/2011 Docket Number: 3038298

Mail Control Number: 576385 License Number: 25-29392-01 Action Type: Amendment

2. FEE ATIACHED / Amount:

Check No.: / I

3. COMMENTS

Signed:

Date:

B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered I I

1. Fee Category and Amount:

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

Amendment:

Renewal:

License:

3. OTHER ______________ _

Signed:

Date: