Alliance HealthCare Amend the radioactive materials ...

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100 Ou)"\'i"\\" eireI<-. Suile -100 [3cac h, C:\ 92660 r 800.544.3215 F 949.242.5397 \\ ices- lIs . com ,\ ugUSI 15. 20 13 ;-\uc1ear Re gulalo'y Commi ssion 612 E. Lam"r Blvd .. Suite -l00 Arlington. rx 760 II RIO: license number 50-2321 -1- 0 I Dear Si r/Madam. PUBUC IJ Immedlale Relea .. IJ Normal Release NON-PUBUC IJ A.3 Sensltlve.socurfly Relaled IJ A.7 Sensitive Internal IJ 0Iher:. ____ _ I,'.]G 19 2013 DNMS ____ Date: ___ _ I'ka c alllcndthe Radioactive license lor Diagnostic l lcalth Cent.::r of Anchorage, a o\\TIcd subsidiary of Alliance J k althCare Scrvi c<.: s. Inc . 10 change th t: Radiati on Ollieer to John \\' ood . Mr. Wood appears as RSO on California license number 6&38- 17. A copy of the li cense and limd: n:nr\, al kttt 'r an: I r) ou have any questi ons please contac t: Michal 'i Culley CO'lXlrate Rad iat ion Ofl i <:c r i\ 11 ianee HealthC are Sel "\' ices 9711-852 -3527 email: i,lnc. ri [ n:lJ!J.n,g"cOI1) PUBUC IJ Immediate Re lease I!I" Normal Release NON·PUBLIC IJ A.3 Sensltive.securfly Relaled IJ A.7 Sensitive Internal IJ Other: .--.,..-____ _ Rftiewlr: f0 Date : O't/Uk3 11 5 815 81

Transcript of Alliance HealthCare Amend the radioactive materials ...

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,\ ugUSI 15. 2013

;-\uc1ear Regulalo'y Commission 612 E. Lam"r Blvd .. Suite -l00 Arlington. rx 760 II

RIO: license number 50-2321-1-0 I

Dear Si r/Madam.

PUBUC IJ Immedlale Relea .. IJ Normal Release

NON-PUBUC IJ A.3 Sensltlve.socurfly Relaled IJ A.7 Sensitive Internal IJ 0Iher:. ____ _

RECEIV~D

I,'.]G 19 2013

DNMS

~. ____ Date: ___ _

I'ka c alllcndthe Radioactive Material~ license lor Diagnostic l lcalth Cent.::r o f Anchorage, a \\holl~ o\\TIcd subsid iary of Alliance J k althCare Scrvic<.:s. Inc. 10 change tht: Radiation Sat~ly Ollieer to John \\' ood. Mr. Wood appea rs as RSO on California license number 6&38- 17. A copy of the license and limd : n:nr\, al kttt'r an: attw.: h('~ll.

I r) ou have any questions please contact:

lju~fi7 Michal' i Culley CO'lXlrate Rad iat ion Sakt~ Ofli<:cr i\ 11 ianee HealthC are Sel"\'ices 9711-852-35 27 email: ID~It1I~. 1l11 i,lnc.ri [n:lJ!J.n,g"cOI1)

PUBUC IJ Immediate Release I!I"Normal Release

NON·PUBLIC IJ A.3 Sensltive.securfly Relaled IJ A.7 Sensitive Internal IJ Other:.--.,..-____ _

Rftiewlr: f0 Date: O't/Uk3

11 5 815 8 1

State of California-Health and Human Services Agency California Department of Pub lic Health

Page 1 of 7 pages RADIOACTIVE MATERIAL LICENSE

Pursuan t to the California Code of Regulations, Division 1, Title 17, C/lapter 5, Subchapter 4, Group 2, Licensing of Radioactive Materia l, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing tile licensee to receive, usc, p ossess, transfer, or dispose of radioa ctive material listed below; and to use such radioactive material for the purpose(s) and at the place(s) designated below. This license is subject to all applicable rules, regulations, and orders of the California Department of Public Health now or hereafter in effect and to any standard or specific condition specified;n this license.

1. Licensee: RCOA Imaging Services, Inc. 3. License Number:

6838-17 Amendment Number : 20

2. Address· 161 10 Jog Road, Suite 200 Delray !:leach, FL 3]446

Atlontion: J oh n R. Wood, CN MT Radiati on Safety Officer

4. Expiration date:

February 15,2011

5. Inspection agency: Radiologic Health Branch North

(3)

In response to the letter, with attachments, dated April 2, 21H2, signed by John Wood, Radiation Safety Officer lind Allen D. McGee, President and CEO, License Number 6838-17 is hereby amended as follows:

6. Nuclide 7. Form 8. Possession Limi t A. Any radioactive material permitted A. Any A. The possess ion limit not to

by 10 CFR 35.200. Excluding Xenon exceed 2.35 Ci.

B. B. B. J. Any radionuclide with atomic J. Sealed, solid or liquid J. Total not to exceed 50 lOCi.

num bers 3-83 . sources manufactured in Each source not to exceed accordance with a specific 10mCi. license issued by the Un ited States Nuclear Regulatory Commission, an Agreement State or a Licensing State.

2. Fluorine-IS 2. Any 2. Total not to exceed 25 mC i.

9. Authorized Use

A. Any imaging and local ization study permitted by 10 c rR 35.200.

B. 1-2. Marker and ca li bration sources.

UCFNSE COND1110NS

10. Rad ioacti ve material shall be used only at the follow ing locations:

(a) Human use :

(I) CI in ics and hospitals as temporary job sites not under exclusi ve federal jurisdiction provided that the namc, address, activity status and responsible authorized lIscr(s) for each site are identified on the licensee's in ternal tracking database.

(2) Mobile PETICT Coach (Y IN I LH 142UI1751 014272) (3) Mobile PETICTCoach (Y IN ILHI 42 UH 74101]IH4) (4) Mob ile PETICT Coach (Y IN I S9FS482061182939) (5) Mobi le PETICTCoach (YIN ILl I142U]-1251013983) (6) The Licensee is authorized to use a van nol listed on Ihis license and not under exclusive federal

jurisdiction provided that the Department is nOI{fied in writing within 60 days 0/ use.

State ot California· Health and Human Services Agency

RADIOACTIVE MATERIAL LICENSE

(b) Nonhuman usc only:

Californ ia Department of Public Health

Page 2 of 7 pages

License Number: 6838·17

Amendment Number: 20

(I) Mobile Coach base sile located at Sutter Regional Med ical Foundation, 2700 Low Court, Fairfield, CA. (Storage Only).

11. Th is license is subject to an annual fee for sources of radioactive material authorized to be possessed at anyone time as specified in Items 6, 7, 8 and 9 of this license. The annual fee for thi s license is required by and computed in accordance with Titlc 17, Cal ifornia Code of Regulations, Sections 30230-30232 and is also subject to an annual cost-of-living adjustment pursuant to Section 100425 of the California Health and Safety Code.

12. (a) The individuals named below are authorized the specific uses of radioactive material described in Items 6, 7, 8, and 9 of this license as fo llows:

( I ) Eric s. naill, M.D. 35.200 and 9.B.I.-2.

(2) Barry Englestad, M.D. 35.200 and 9.B.I.-2.

(3 ) Jimmy D. Cardoza, M.D. 35.200 and 9.B.I.-2.

(4) Alan T. Miyamoto, M.D. 35.200 and 9.B.I.-2.

(5 ) James C. Wu, M.D. 35.200 and 9.13.1.-2.

(6) Kaveh Soleimanpour, M.D. 35.200 and 9.B.I.-2.

(7) Sunil N. Gandhi, M.D. 35.200 and 9.13.1.-2.

(8) Ying rung, M.D. 35.200 and 9.13.1.-2.

(9) Annie P. Lai, M.D. 35.200 and 9.13.1.-2.

(10) Phillip Wong, M.D. 35.200 and 9.13.1.-2.

(I I) Soph ia Kung, M.D. 35.200 and 9.B.I.-2.

(12) Susan H. Cha, M.D. 35.200 and 9.B.I.-2.

(13) Eric A, Dovichi, M,D, 35.200 and 9.B.1.-2.

(b) Radioactive material may be used by the follow ing individuals for physical measurements only:

( I) John Wood, CNMT

(2) Terre L. Stevens, CNMT

(3) Kipley Parrish , CNMT

(4) Lawrence A. Abrams, CNMT

(5) Sherry 1.. Leinen, CNMT

(6) Chri stina Z. Darwin, CNMT

(7) Vivian Lau, CNMT

(8) Sybil Rappaport, CNMT

State of California-Health and Human Servicos Agency

RADIOACTIVE MATERIAL LICENSE

California Department of Public Health

,

Page 3 of 7 pages

License Number: §.83 8-17

Amendment Number: 20

13. Except as specifically provided otherwise by this license, the liccnsee shall possess and use radioactive material described in Items 6, 7, 8 and 9 of this license in accordance with the statements, representations, and procedures contained in the documents listed be low. The Dcpartment's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

(a) The application dated September 13, 2000, supplemented by the lettcrs dated November 2, 2000, J)ecember 5, 2000, and January 8, 2001, all with attachments, and all signed by Lee Ann I'armer, Operations Manager, and the letter datcd February 9, 200 I, signed by Stephen N. Kitts, Director, Quality Control.

(b) The letter, with attachments, dated March 21, 2002, signed by Steve Kitts, Director of Quality Control, regarding the addition ofa second mobi le van coach.

(c) The letters, both with attachments, both dated March 25, 2003, both signed by Steve Kitts, Director, Quality Control, and John Wood, Radiation Safety Officer, rcgarding the removal of the 1355 Linda Vista Drive, San Marcos, CA. use locat ion.

(d) The lettcr dated January 9, 2004, signed by Steve Kitts, Director, Quality Control, and John Wood, Rad iation Safety Officer, and the lettcr dated February 20, 2004, signed by John Wood, Radiation Safety Officer, rcgard ing the addition ofa mob ile PET coach.

(e) The leller, with attachments, dated March 18, 2004, signed by Steve Kitts, Director of Quality Control, John Wood, CNMT, Radiation Safety om eel', regard ing the removal of two mobile PET coaches.

(I) The letter, with attachments, dated May 9, 2005, signed by Steve Kitts, Director of Quality Control, regarding the new PETICT Coach and the 18'" and Highway 53, base site.

(g) The letters, both with attachments, dated February 28, 2005, and August 2, 2005, both signed by John Wood, CNMT, Radiation Safety Omeer, regarding the decommissioning and release for un restricted use of the 1537 E. McFadden Ave., Unit G, Santa Ana, use location and mobile PET coach YIN # I I ,H I 42UH6Y I 0 I 1058.

(h) The letters, both with attaehmcnts, dated March 9, 2007, and June 28, 2007, both signed by Lee Ann Farmer, Director of Regulatory Compliance and Operations Manager, and the electronic com munications sent August 2, 2007, from John Wood, CNMT, Radiation Safety Officer, regarding new mobile PET coaches YIN numbers ILHI42UH241013478 and IS9FS482061 182939.

(i) The letter, with attachments, dated April 2, 2008, signed by Lee Ann Fanner, Director of Regulatory Compliance and Operations Manager, modified by the application, with attachments, dated June 18, 2008, signed by Donald C. Mcder, Chief Operating Officer and supplemented by the letter, with attachments, dated, July 30, 2008, signed by Lee Ann Farmcr, Director of Regulatory Compliance and Operations Manager, Eastern Region, regarding an increase to possess ion limits, and the addition or Human-Use M obile Provider services with associated procedures and commitments. Locum Tenens req uest is not authorized.

U) The letter, dated March 18, 2009, signed by Lee Ann Farmer, Director of Regulatory Compliance and Operations Manager, and John Wood, Rad iation Safety Officer, regarding the commitment to limi t the human administration of l od in e~ 1 31 to 30 microcurie::; or less and lodine-123 to 3 millicuries or less.

(k) The letter datcd July 29, 2009, signed by Lee Ann Fanner, Director Regulatory Compliance and Operations Manager, and John Wood, Radiat ion Safety Omcer, regarding the addition of a mobile PETICT Coach VIN number ILH142UH25J013983.

State of California-Health and Human Services Agency

RADIOACTIVE MATERIAL LICENSE

California Department of Public Health

Page 4 of 7 pages

license Number: 6838-17

Amendmenl Number: 20

(I) The letter, with attachments, dated March 15, 20 I 0, signed by Lee Ann Farmer, RT, Director of Regulatory Compliance and Operations Manager and John Wood, Radiation Safety Officer, and the lettei', with attachments, dated January 5, 201 1, signed by Kevin Kilroy, CFO, and John Wood, Radiation Safety Officer, regarding the add it ion of a Cardiogen-82 Generator, the correction of a mobile PET/CT coach 's VIN number and the approval for the Licensee to use a van not listed on th is license and not under exclusive federal jurisdiction prov ided that lhe Department is notified in writing within 60 days of use along with procedures and commitments.

(m) The letter, with attachments, dated May 6, 2011, signed by Kevin Kilroy, Chief Financial Officer and John Wood, CNMT, Rad iation Safety Officer, regarding the move to a new mobile coach base si te located at Sutter Regional Med ical Foundation, 2700 Low Cou rt, Fairfield, CA.

(n) The letter dated September 6, 20J I, signed by Kevin Kilroy, Chief Financ ial Officer, and John Wood, Radiation Salety Ofticer, rcgarding the commitment to follow su rvey procedurcs in NRC NUREG 1556, Volume 9, Revision 2, Appendix R.

(0) The letter, with attachments, dated November 29, 2011, signed by Allan McGee, President and CEO and John Wood, Radiation Safety Officcr, regarding the authorization for signature authority for Co llcen L. Sevigny, Eastern Operations Manager, for this license.

14. The Radiation Safety Officer in this program shall be John Wood, CNMT.

15. Scaled sou rces possessed under this license shall be tested for leakage andlor contamination as required by Title 17, California Code of Regulations, Section 30275 (c).

16. In lieu of the leak test intervals required by California Code of Regu lations, Title 17, Section 30275 (e), sealed sources can be tested for Jeakagl.:: and/or contamination at longer intervals when they are specified in a certificate of registration issued by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licens ing State. When a longer interval stipulated in a certificate of registration is used, the certi ficate must be maintained on file and avai lable for inspection [or as long as the associated leak test records are retained.

17. Quantitative analytical assays for the purpose of tests for leakage andlor contamination of sealed sources shall be performed only by persons specifically authorized to perform that service.

18. The following individuals arc authorized to collect wipe test samples of scaled sources possessed under this license using leak test kits acceptable to the California DepaJtment of Public Health .

(a) The Radiati on Safety Officcr (b) Qualified individuals designated in writing by the Radiation Safcty Officer

19. The licensee shall conduct a physical inventory every six months to account for all sealed sources and/or devices received and possessed under the license. Records of the inventories shall be maintained for inspection, and may be disposed of fo llowing Department inspection.

20. Where users or their assi stants are engaged ill elution of from generators, the exposure to the fingers or hands shall be monitored as requ ired by Title 10, Code of Federal Regulations, Part 20, Section 20.1502 Cal.

21. The licensee is authorized to hold radioactive materials with a physical half-l ife of less tlian 65 days for decay in storagt: before disposal in ordinary trash provided:

(a) Radioactive waste to be disposed of in this manner shall be held for decay in storage for at leasl I 0 half~lives.

State of Cal ifornia-Health and Human Services Agency

RADIOACTIVE MATERIAL LICENSE

California Department of Public Health

Page 5 of 7 pages

license Number: 6838- 17

Amendment Number: 20

(b) Before disposal as normal waste, rad ioactive waste shall be surveycd to determine that its radioact ivity cannot be distinguished from background. All radiation labels shall be removed or obliterated .

(c) Records shall be ma intained of the disposal of licensed materials made by decay in storage. These records shall be sufficient to demonstrate compliance with th is license condition and shall be retained for 3 ycars after the record is made.

(d) Generator columns shall bc segregated so that thcy may be monitored separately to ensure decay to background levcls prior to disposal.

22. Nuclear medicinc tcchnology procedures sha ll be performed by nuclear med icine technologists pursuant to Title 17, California Code of Regulations, Subchapter 4.6. Such procedures shall be performed under the supervision of authorized user physicians on this license who meet the criteria specificd in Scction 30510. Ceri ificates or special permits issued pursuant to Subchapter 4.6 shall be prominently displayed at the fac il ity(ies) authorized on th is license.

23. Release of patients contalllltlg radioactive materials or implants containing radioactive materials shall be in accordance with 10 CrR 35.75 (1-1-08 Edition).

24. Each human use of radioactive mater ial performed under this license shall inc lude the followi ng responsibilities by a physician listed in Condition 12 of this license:

(a) Determination that the procedure to be used is appropriate to the patient, based on knowledge of the patient's condition.

(b) Assuring that the appropriate radiopharmaceutical and other pharmaceutical are prescribed.

(c) Assuring thc safety of the patient and the public in both the conduct of the exam and maintaining radiation hea lth and safety.

(I) Assu ring technologist certification and training (2) Camcra and dose ca librator quality control (3) Superv ision of actual procedure (4) Preparation of reports (5) Interact ions with technulogist, patient, and referring physicians (6) ' Maintain records of admi nister activity (7) Supervise area surveys (8) Maintain records of procedures (9) Confirm that the procedure has been satisfactorily completed

(d) The intcrpretation of the diagnost ic data and communication of the resuits to the referr ing physicians in a timely and effective way.

25. The licensee shall maintain avai lable for inspection a record ofhumatlllse ofradioaclive material under this license. For each such lise, thc record shall include the following inforl11Cltion:

(a) The name of the responsible physician. (The responsib le physician must be an authorized user in Condition 12 of this license).

(b) The name of the referring physician.

State of California-Health and Human Services Agency

RADIOACTIVE MATERIAL LICENSE

(c) The kind, amount, and supplier of the radiopharm aceutical used .

(d) Thc proced ure, date performed, and if applicable, location of pcrformance.

California Department of Public Health

Page 6 of 7 pages

license Number: 6838-1 7

Amendment Number: 20

(c) A copy of the written diagnostic information suppl ied to the referring physician by the responsible physician.

26. When engaged in provid ing mobile nuclear medica! services to non-l icensed customers. the licensee shall retain all responsibilities for the use of radioactive materia! authorized by this license.

27. The licensee shal l provide mobile services only to those fac ili ties ident ified as use locations in Condit ion 10 of the mobile license.

28. Production or processing of radiopharmaceuticals for the purposc of commcrcial distribution to other licensees is no! authorized by th is license.

29. For a period not to excecd 60 days in any calendar ycar, a physician is authorized to usc licensed materials for human usc under the terms of this license, prov ided the physician:

(a) Has the prior written permission of the Licensec's Executive Management and its Radiation Safety Officer.

(b) Is specifically named as an authorized user on a cu rrent and valid U.S. Nuclear Regulatory Commission, an Agreement State or a Licensi ng State license authorizing human use.

(c) Performs only those proccdures for wh ich the physician is specifically authorized by the U.S. Nuclcar Regulatory Commiss ion, Agreement State or a Liccnsing Statc liccnsc.

The liccnsce shall maintain for inspection copies of the writ tcn permission specified in (a) above and the license(s) speci fied in (b) and (c) above. These records shall be maintaincd for five years from the time the li censee grants its permission under (a) above.

30. In addition to the possession lim its in Item 8, thc lieensce shal l further restrict the possession of licensed material so that at no time will the total quantity of radioactive material possessed requ ire financial surety for decommission ing in accordance with the California Code of Regulations, Title 17, Section 30195.1. A value of 100 microcuries is assigned to Cobalt-57 to supplement lhe Code of Federal Regu lations, Title 10, Part 30, Appendix 13.

31. The licensee will provide the Low Level Rad ioactive Waste (LLRW) reports specified in the California Health and Safety Code section I 15000.1 (il) to the California Dep",1ment of Public lIea lth (CDrB) on an annual basis for both shipped and storcd LLR W. Alternatively, LLR W shipment information lTlay bc provided on a per shi pment basis. LLRW shipment information and annual repol1s shall be mailed to:

Attn: LLR W Tracking Program Californ ia Department of Public Health Radiologic Ilealth Branch MS 7610 P.O. Box 997414 Sacramento, CA 95899-7414

32. At least 30 days prior to vacating any address of use listed ill Condition 10 of this license, the licensee shall provide written notification thereof to the Californ ia Department of Public Health, in H<.:cordanee with T itle 17, Cal iforn ia Code of Regulations, Section 30256 (b).

State of California-Hea lth and Human Services Agency California Department of Public Health

RADIOACTIVE MATERIAL LICENSE

Page 7 of 7 pages

license Number: 6838- 17

Amendment Number: 20

33. A copy orthis license and a copy of all reeords and documents pertainin g to this license shall be maintained available for inspection at 2700 Low CO ll rt, Fairfield, CA.

Date: May 2, 20 J 2

rnia Department of Public Health

By: ~~~----------------------Ra ioJogic Health Branch MS 7610. r.o . Box 997414 Sacramento, CA 95899-7414

I

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State VI (",iif i.I1I?'iealth Jnd 't 'ra~ ?"rvc AgE r,

Califo;'nia Oepartn~ent Of Public Health

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NRC FORM 532 (1-2012)

DATE

U. S. NUCLEAR REGULATORY COMMISSION

08/ 19/2013

NAME AND ADDRESS OF APPLICANT AND/OR LICENSEE

Diagnostic Health Center of Anchorage, LLC a wholly subsidiary of Alliance HealthCare Services Department of Nuclear Medicine ATTN: Shelley L. Becker, Radiation Safety Officer 4100 Lake Otis parkway # I 02 Anchorage, AK 99508

This is to acknowledge the receipt of your:

[Z] LETTER and/or [Z] APPLICATION

LICENSE NUMBER

50-23214-01

MAIL CONTROL NUMBER

581581

LICENSING AND/OR TECHNICAL REVIEWER

ch

DATED: 08/ 1512013

The initial processing, which included an administrative review, has been performed.

[Z] AMENDMENT D TERMINATION D NEW LICENSE D RENEWAL

[{] There were no administrative omissions identified during our initial review.

D This is to acknowledge receipt of your application for renewal of the material(s) license identified above. Your application is deemed timely filed , and accordingly, the license will not expire until final action has been taken by this office.

D Your application for a new NRC license did not include your taxpayer identification number. Please fill out NRC Form 531, located at the following link:

http://www.nrc.gov/read ing-rm/doc-collections/forms/nrc53.LQQf

Send the completed NRC Form 531, by facsimile , to the following number: (301) 415-5387

A copy of your action has been emailedtoourLicenseFeeandAccountsReceivableBranch. in our Headquarters office in Rockville, MD. You will be contacted separately if there is a fee issue involved.

Your application has been assigned the above listed MAIL CONTROL NUMBER. When calling to inquire about this action, please refer to this control number. Your application has been forwarded to a technical reviewer. Please note that the technical review, which is normally completed within 180 days for a renewal application (90 days for all other requests), may identify additional omissions or require additional information. If you have any questions concerning the processing of your application, our contact information is listed below:

NRC FORM 532

(7 i/)O//!J

Region IV U. S. Nuclear Regulatory Commission DNMS/NMSB - B 1600 E. Lamar Boulevard Arlington, TX 76011-4511 (817) 200-1103 or (817) 200-1140

BETWEEN:

Accounts Receivable/Payable and

Regional licensing Branches

[ FOR ARPB USE J INFORMATION FROM WBL

Program Code: 02200 Status Code: Pending Amendment Fee Category: 7C Exp. Date: 11 /30/2014

Fee Comments: Decam Fin Assur Reqd: N

License Fee Worksheet - License Fee Transmittal

A. REGION

1. APPLICATION AITACHED ApplicanULicensee: DIAGNOSTIC HEALTH CENTER OF ANCHORAGE LLC A WHOLLY SUBSIDARY OF ALLIANCE HEALn

Received Date: 08/19/2013

Docket Number: 3020372 Mail Control Number: 581581 License Number: 50-23214-01

Action Type: Amendment

2. FEE AITACHED

Amount:

Check No.:

3. COMMENTS

Signed:

Date:

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

1. Fee Category and Amount

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

Amendment:

Renewal:

License:

3. OTHER

Signed:

Date: