INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRlCTIONS FOR COMPLETING APPLICATION.SEND "TWOCOPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW.

NRC FORM 313(3·2009)10 CFR 30. 32. 33.34. 35. 36. 39. and 40

U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0120 EXPIRES: 3131/2012

Estimated burden per response to comply with this mandatory collection request 4.3hours. Submittal of the application is necessary to determine that the applicant isqualified and that adequate procedures exist to protect the public health and safety.Send comments regarding burden estimate to the Records and FOIAIPrivacy ServicesBranch (T-5 F53), U.S. Nudear Regulatory CommiSSion, Washington, DC 20555-0001.or by intemet e-mail to infocollects.resource@nrc.gov, and to the Desk Officer. Office ofInformation and Regulatory Affairs, NEOB-tli202, (3150-0120), Office of Managementand Budget, Washington, DC 20503. If a means used to impose an informationcollection does not display a currently valid OMB control number, the NRC may notconduct or sponsor, and a person is not required to respond to, the informationcollection.

APPLICATION FOR MATERIALS LICENSE

IF YOU ARE LOCATED IN:

NUCLEAR MATERiAlS LICENSING BRANCHU.S. NUCLEAR REGULATORY COMMISSION. REGION IV612 E. LAMAR BOULEVARD, SUITE 400ARLINGTON. TX 76011-4125

APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH: IF YOU ARE LOCATED IN:

ILLINOIS, INDIANA, IOWA, MICHIGAN, MINNESOTA, MISSOURI, OHIO, OR WISCONSIN, SEll)APPLICATIONS TO:

OFFICE OF FEDERAL & STATE MATERIALS ANDENVIRONMENTAL MANAGEMENT PROGRAMSDIVISION OF MATERIALS SAFETY AND STATE AGREEMENTSU.S. NUCLEAR REGULATORY COMMISSIONWASHINGTON, DC 20555-0001

MATERIALS LICENSING BRANCHU.S. NUCLEAR REGULATORY COMMISSION. REGION III2443 WARRENVILLE ROAD, SUITE 210LISLE. IL 60532-4352

ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS:

ALABAMA, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA,KENTUCKY, MAINE, MARYLAND, MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY,NEW YORK, NORTH CAROLINA, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTHCAROLINA, TENNESSEE, VERMONT, VIRGINIA, VIRGIN ISLANDS, OR WEST VIRGINIA,SEND APPLICATIONS TO:

ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, HAWAII,IDAHO, KANSAS,LOUISIANA, MISSISSIPPI, MONTANA, NEBRASKA, NEVADA, NEW MEXICO, NORTHDAKOTA, OKLAHOMA, OREGON, PACIAC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS,UTAH, WASHINGTON, OR WYOMING, SEND APPLICATIONS TO:

LICENSING ASSISTANCE TEAMDIVISION OF NUCLEAR MATERIALS SAFETYU.S. NUCLEAR REGULATORY COMMISSION. REGION I475 ALLENDALE ROADKING OF PRUSSIA. PA 19406-1415

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE U.S. NUCLEAR REGULA TORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED'MA TERIAL IN STATES SUBJECT TO U.S.NUCLEAR REGULA TORY COMMISSION JURISDICTIONS.

1. THIS IS AN APPLICATION FOR (Check appropriate item)

! I A. NEW LICENSE

til B. AMENDMENT TO LICENSE NUMBER 11-27404-01

[. ·'1 C. RENEWAL OF LICENSE NUMBER

--_.. - -.=-:-:-:-=-:~~;::::::=:::::::::::::::;;.:;:;=:=====-~. ---_._-3. ADDRESS WHERE LICENSED MATERIAL INILL BE USED OR POSSESSED 4. NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION

2. NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)

Danny L. Davis2001 S. Woodruff suite 20Idaho Falls ID 83404

Teton Nuclear Medicine Service LLC2001 S. Woodruff suite 20Idaho Falls ID 83404

Danny L. DavisI---=TE:::-L=EP=H=ON-=EC":"N=U:-:cMB=-=E=-R---------·--- ..·--- ---- -

(208) 525-3201. . .....L.._. • ... ._

SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11" PAPER. THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE's.-RAOI(:)AcnvEMATEiiiAL--"·

a. Element and mass number; b. chemical and/or physical tonn; and c. mabdmum amountwhich will be possessed at any one time.

6. PURPOSE(S) FOR WHICH LICENSED MATERIAL INILL BE USED.

._---_ ..._-----+-- -----------_._ .._._..__....-.._._._-_.-..-.-7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR

TRAINING EXPERIENCE . 8. TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS.

.. ..- .. -_ .. __ .._. ---_._._---_--_._-_. __ _---- _._---_ _--_ _- -.- - _.__ .---9. FACILITIES AND EQUIPMENT. 10. RADIATION SAFETY PROGRAM.- --_-..-.-- .-.-..-.------. -------[-:;2 LICENSE FEES (See 10CFR 170snd SectIon 17031)-" . -"" - -- --.-_.-.---11. WASTE MANAGEMENT.

•. _. .. • ._ ....>.._ FEE CATEGORY ~~~~Js.t;>_....!_. __ "" . _13. CERTIFICATION. (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDINGUPON THE APPLICANT.

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT. NAMED IN ITEM 2. CERTIFY THAT THIS APPLICATION IS PREPARED INCONFORMITY INITH TITLE 10. CODE OF FEDERAL REGULATIONS. PARTS 30. 32.33.34.35.36.39. AND 40. AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE ANDCORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF.

WARNING: 18 U.S.C. SECTION 1001 ACT OF JUNE 25. 194662 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A INILLFULLY FALSE STATEMENT OR REPRESENTATION TOANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER INITHIN ITS JU~DICTION.

Ch:~~~ER~~Eb~:;~AN~:I~~e\ i.esc>" SI~)~ YD~·-·-·--lD~-~~·;=,i.."""'"'~l~"Ciii:=i""'G,", I~o"~-=~~R,:~,~!~,~N~~.",.~--------.- ...-...----.-..._--...--.APPROVED BY DATE

NRC FORM 313 (3.2009) PRINTED ON RECYCLED PAPER

APPENDlXC

Table C.2 Items 5 and 6 on NRC Form 313: Radioactive Material and Use(If using this checklist, check applicable rows and jill in details, and

attach copy of checklist to the appliaation.)

~s This response includes security-related sensitive information (see Section 5.2) which is included inAttachment __ and marked "Security-related infonnation - withhold under 10 CFR 2.390" "

Yes Radlonuc:llde Form or Manufacturerl Maximum Purpose' of UseModel No. Quantity

Any byproduct Any As needed Any uptake, dilution, andmaterial permitted by " excretion study permitted10 CFR 35.100 by 10 CFR 35.100.

Any imaging and"

Any byproduct Any As neededmaterial permitted by localization study10CFR 35.200 'permitted by

10 CPR 35.200.F-18 Any -- curies Production of PET

radioactive drugs under10 CFR 30.320).

0-15 Any Production of PET

-- curies radioactive drugs under10 CFR 30.32{j).

C-Il Any -- curies Production of PETradioactive drugs under10 CFR 30.32(j),

Any byproduct Any -- millicuries Any radiophannaceuticalmaterial permitted by therapy' procedure10CFR 35.300 permitted by

10 CPR 35.300.

'V" lodine-13I ' Any nmillicuries Administration of 1-131sodium iodide.

Byproduct material Sealed source or device _millicuries Any brachytherapypermitted by (Manufacturer procedure permitted by10 CFR 35.400 10 CFR 35.400.(Radionuclide ModeINQ. )

)

Byproduct material Sealed source or device _millicuries Any brachytherapypermitted by (Manufacturer procedure permitted by10 CFR 35.400 10 CFR 35.400.(Radionuclide Model No. )

_)

Byproduct material Sealed source or device _miUicuries Any brachytherapypermitted by (Manufacturer procedure permitted by10CFR 35.400 , 10 CFR 35.400.(Radionuclide Model No. )

)

Byproduct material Sealed source or device _millicuries Any brachytherapypermitted by (Manufacturer procedure permitted by10 CFR 35.400 10 CFR 35.400.(Radionuclide Model'No. J

)

C-5 NUREG - 1556, Vol. 9, Rev: 2

APPENDlXC

AND

"Checkbos'to indicatematerial

included in.ppUcation

Table C.3 Items 7 through 11 on NRC Form 313: Training & Experience, Facilities& Equipment, Radiation Protection Progratrl, and Waste Disposal.. . "

(Check all applicable rows andfill in details and attach a copy of the checklist to the application orprovide information separately.) .' , '

u _................ • _••••• _ ~_._ h H _. • h U •••

. SUlgested ResponseItem Numberand Title

Item 7; RadiationSafety OfficerName: o.A-rJM'I L .OA"'~'UO

For an individual previously identified as an RSO on an NRC orAgreement State license or permit:

Previous license nmnber (if issued by the NRC), or a copy of a license (ifissued by an Agreement State), or a copy of a permit (if issued by an NRCmaster materials licensee) on which the individual was specifically named

..!.l-::~1.1.!.~:::.~.I.+-as_th_e_RS_O_. -+ _ ..For an individual qualifying under 10 CFR 35.57(a)(3):

Documentation that the individual was:• the RSO for only the medical uses of accelerator-produced radioactive

material Drdiscrete sources ofRa-226 included in the definition ofbyproduct material as a result of the EPAct;

• the RSO for the medical uses of these materials before or during the..............................._.._. effective period of NRC's waiver of August 31, 2005.

For an individual qualifying under 10 CFR 35.50(a):

Copy of certification by a specialty board whose certification process has abeen recognized'? by NRC or an Agreement State under 10 CFR 35.50(a).

AND................... ~ _............. . _ n........................... . _ _..u .Description of the training and experience specified in 10 CFR 35.S0(e) ademonstrating that the proposed RSO is qualified by training in radiationsafety, regulatory issues, and emergency procedures as applicable to thetypes of use for which the applicant seeks approval of an individual toserve as RSO.

Written attestation, signed by a preceptor RSO, that the individual has asatisfactorily completed training in and experience required forcertification, as weU as training in radiation safety, regulatory issues, andemergency procedures for the types of use for which the licensee seeksapproval, and has achieved a level of radiation safety knowledge sufficientto function independently as an RSO.

AND

If applicable, description of recent related continuing education andexperience as required by 10 CFR 35.59 ....................................... ...._-'-----------"--------------_ _ .

a

l«The names of board certifications that have been recognized by the NRC or an Agreement State areposted on the NRC's Web site http://www,nrc.gov/materials/lDjaulmed-use-toolkit,htmJ ..

C-9 NUREG -1556, Vol. 9, Rev, 2

APPENDlXC

Table C:3 Item$ 7 through 11 on NRC Form 313: Training & experience, Facllltle$& Equipment, Radiation Protection Program. and Waste Disposal

(Check all applicable ~ows andfill in details and attach a copy 0/ tlte checklist to the application or. provide in/ormation separately.)

Item Numberand'Titie'

."

Su"este~ Response

Item 7: Authorized For an individual previously identified as an AU on an NRC or AgreementUsers for medical State license or permit: .uses: '

......................................t------------------------t .

A preceptor attestation, if required (e.g., attestation is required to meet therequirements in 10 CFR 35.396, 35.390(b)(I)(iiXG), or 35.690(c» .......................................f-.....:...-------;..._-..;...;.::._;";,,,..;.;...;.;._--..;...;;---+ ..-- ..

Documentation that the physician, podiatrist, or dentist:.• used only accelerator-produced radioactive materials, or discrete

sources of Ra-226, or both, for medical uses before or during theeffective period of NRC's waiver of August 31, 2005;. and

• used these materials for the same medical uses requested .•••• u " ..u~u _........ • u .

For an individual qualifying under J0 CFR Part 35. Subparts D. E. F. G.and/or H. who is board-certified:

Name(s), (includinglicense numberauthorizing practiceof medicine,podiatry, ordentistry if notprovided previouslyor in attachment);Requested uses foreach individual

Description of the additional'training and experience to <klJlQnstrate the aAU is also qualified for the new medical uses requested (e.g., training andexperience needed to meet the requirements in 10 CFR 35.290 (b), 35.396,35.390(bXl)(ii)(G), or 35.690(\=».

Copy of the certification(s) by a specialty board(s) whose certification aprocess has been recognized'! by the NRC under 10 CFR Part 35,Subpart D, E, F, G, or H, as applicable to the use requested.

Previous license number (if issued by the NRC), or a copy of the license(if issued by an Agreement State), or a copy of a permit issued by an NRCmaster materials licensee, or a copy of a permit issued by an NRC or'Agreement State broad-scope licensee, or a copy of a permit issued by anNRC Master Materials License broad-scope permittee on which thephysician, dentist, or podiatrist was specifically named as an AU for theuses requested.

For an AU requesting authorization/or an additional medical use:

AND

For an individual qualifying under 10 CFR 35,57(b)(3):

AND

Cbeckboxto indicatematerial

included inapplication

a

12Thenames ofboard certifications that have been recognized by the NRC or an Agreement State areposted on the NRC's Web site http://www.nrc.20v/materialslmiaulmed-use-toolkit.html.~G - 1556, Vol. 9, Rev. 2 C-12

Jb576624

• Item 7: Names for Authorized User Additions for 35.300James Neeley, MDAlan Wray, MDJohn J. Strobel, MDJames B. Harris, MDJames F. Schmutz, MDMichael C. Biddulph, MDDavid R. Warden, III, MDSteven D. Smith, MDR. Douglas Greally, MDMichael T. Callaghan, MDCalvin McAllister, MDPeter L. Vance, MDSteven J. Todd, MDNeil Clinger, MDRichard M. Penney, MDChristopher O. Harker, MD

See attached License: # 11-27346-0 1

Licensed material shall be used only at the facilities located at Teton Nuclear Medicine, 2001 S.Woodruff, Suite #20, Idaho Falls, ID 83404.

Attachment

Dec 20 2011 9:16AM, . PRINTELLIGENT LOGISTICS 801. 973 7090

Amendment No. 28

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 of 4

MATERIALS LICENSESUPPLEMENTARY SHEET

Docket or Reference Number030-32290

6. Byproduct, source, and/or special 7. Chemical and/or 1'\".......;1"21nuclear material

8. Maximum amount that fi.may possess at anyoneunder this license

9.

E. Gadolinium-153 E. (North AmericanModel 3601 or Du Pont

Company

E. 300 millicuries ~housing, totalpossession 1,2lmillicuries

A.B.C.D.E.

I-'0. Licensed material maw used

Idaho Falls, Idaho.

11. The Radiation Safety ~r

12.

A.

Authorized Users

James Neeley, M.D. 100; 35.200; 35.300; Gadolinium-153 for patiention correction

James P. Edlin, M.D. 100; 35.200; 35.300; Gadolinium-153 for patientn correction

John D. Chambers, Jr., M.D.

John J. Strobel, M.D. 100; 35.200; 35.300; Gadolinium-153 for patientcorrection

J 2011 9: 17AM PRINTELLIGENT LOGISTICS 801. 973 7090

MATERIALS LICENSESUPPLEMENTARY SHEET 030-32290

Amendment No. 28

Authorized Users

James Schmutz, M. D.

Michael C. Biddulph, M.D.

t .- Michael T. Callaghan, M.D. ~ ~

~\,.- .

CalvinMcAllister,M.D~"

,David R. warden~.D ..,._Douglas U. Bla~.D.

Steven D. Smi1b.D.(/l

#J Peter Lead vancP1.D.\1)

Thomas J. Maley,~~

~ ~Steven J. Todd, M.D. /)

Allan Wray, M.D.

t Neil Clinger, M.D.

• Richard M. Penney, M.D.

Christopher O. Harker, M.D.

Material and Use

35.100; 35.200; Gadolinium-153 for patient attenuaticorrection

35.100; 35.200; 35.300; Gadolinium-153 for patientattenuation correction

Gadolinium-1S3 for patient attenuati.

on <..300; 35.400; G~~m-153. for patient ettenuatk

ction 0for patient attenuatic

153 for p~nt attenuation corree

administ~n of sodium iodide I", .. ""......9 attiFltJation correction

....,.In>nn. J'ljJMldIin um-S for patient attenuaticlldhltiliifih.. 0

15~atient attenuation corree

35.400 .~

~1.LLI\.ldlllO. 2~' 35.300

100; 35.200; oral administration of sodium iodide I·33 millicuries

100; 35.200; oral administration of sodium iodide 1-

11576624