ML18239A274

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608854 Amendment No. 2 for Zevacor Molecular to License No. 13-35179-03
ML18239A274
Person / Time
Site: 03038903
Issue date: 08/22/2018
From: Parker B A
NRC/RGN-III
To:
Zevacor Molecular
References
608854
Download: ML18239A274 (7)
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Text

NRCFORM374 U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE PAGE 1 OF 7 PAGES Amendment No. 2 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter I, Parts 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 70 and 71, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose(s) and at the place(s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below. Licensee 1. Zevacor Molecular

2. 14395 Bergen Boulevard Noblesville, IN 46060 In accordance with letter dated 4. Expiration Date: April 30, 2026 May 1----------~,..._--1
5. Docket No.: 030-38903 Reference No.: 3. License No.: 13-35179-03 i; (l amended in its entirety to reacr"'5')

follows: 6. Byproduct, source, and/or special nuclear material 7. Chemical a~rer physical fo~

  • 8. Maxlfflumillmount that Ii may!)~ at any one 9. Authorized use A. Any byproduct material with Atomic Nos. 1 through 83 A. Any er tnl1 Jcense A. (1) For production, possession, or handling of radiochemicals and sealed sources for transfer to persons authorized to receive the licensed material pursuant to the terms and conditions of a specific license issued by the NRC or an Agreement State. (2) Research and development as defined in 10 CFR 30.4. (3) For packaging and distribution of produced radiochemicals and sealed sources to persons authorized to receive licensed materials pursuant to the terms and conditions of a specific license issued by the NRC 1:>r an Agreement State. This should not be distributed as a radiopharmaceutical or radioactive drug.

NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License No. 13-35179-03 Amendment No. 2 Docket or Reference No. 030-38903

6. Byproduct, source, 7. Chemical and/or physical form s. Maximum amount that licensee 9. and/or special nuclear may possess at any one time material Cl'f;' U license C: 1v > B. lndium-111 B. Any 8. 10 cu lotai B. = ,t:~, C. Thallium-201 C. Any C. 7.5 curies total C. D. Lead-202 D. Any D. 90 curies total D. E. Gallium-67 E. Any E. 9.9 curie1tot11 E. F. Gallium-68 F. Any F. 50 curi*a' total F. G. Cobalt-57 G. Any llllliali~r~, total G. H. Cobalt-58 H. Any I Ir Curies total H. I I. Germanium-68 I. Any 1 iQJries M>tal I. J. Zinc-62 J. Any J. 1 QO curies total J. K. Zinc-65 K. Any K: 2000 curies ~-K. L. Copper-62 L. Any t,OO;,c~ total L. WT"" M. Copper-64 M. Any M. 100 curies total M. N. Copper-67 N. Any N. 5 curies total N. 0. Rubidium-81
0. Any 0. 30 curies total 0. P. Rubidium-82 P. Any P. 35 curies total P. Q. Strontium-82 Q. Any Q. 35 curies total Q. R. Strontium-83 R. Any R. 35 curies total R. PAGE 2 OF 7 PAGES Authorized use Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9.A. Same as Item 9 .A. Same as Item 9.A. Same as Item 9.A. Same as Item 9 .A. Same as Item 9.A.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 3 OF 7 PAGES MATERIALS LICENSE SUPPLEMENTARY SHEET License No. 13-35179-03 Amendment No. 2 6. Byproduct, source, 7. Chemical and/or physical form and/or special nuclear material s. Strontium-85

s. Any T. Fluorine-18 T. Any u. Nitrogen-13
u. Any V. Carbon-11 V. Any w. Oxygen-15 W. Any X. Zirconium-89 X. Any \we,w: Y. Europium-154 Y. lncidentall~ctivat&d'P~ucts
z. Scandium-46
z. Incidentally A~ted Products AA. lron-59 AA. Incidentally Activated Pfoduct~ ,} :~> AB. Cobalt-60 AB. Incidentally Activated Products AC. Zinc-65 AC. Incidentally Activated Products AD. Cesium-134 AD. Incidentally Activated Products Docket or Reference No. 030-38903
8. Maximum amount that licensee 9. Authorized use may possess at any one time e~r Ys license S. 35cu s. Same as Item 9.A. ,;-Orsiii T. 300 curies totaf T. Same as Item 9 .A. u. 30 curies total u. Same as Item 9.A. V. 16 curies total V. Same as Item 9.A. w. 1 curietotal
w. Same as Item 9.A. X. Same as Item 9 .A. Y. For possession and storagEi of byproduct materials incidental to radionuclide production.
z. 100 millicuries tot~!~J z. For possession and storage of byproduct materials incidental to radionuclide production.

AA. 1 Otmm~~rieil~tal AA. For possession and storage of '~ j byproduct materials incidental to :/""-,,_ radionuclide production.

AB. 100 millicuries total AB. For possession and storage of byproduct materials incidental to radionuclide production.

AC. 100 millicuries total AC. For possession and storage of byproduct materials incidental to radionuclide production.

AD. 100 millicuries total AD. For possession and storage of byproduct materials incidental to radionuclide production.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 4 OF 7 PAGES MATERIALS LICENSE SUPPLEMENTARY SHEET License No. 13-35179-03 Amendment No. 2 6. Byproduct, source, and/or special nuclear material AE. Europium-152 AF. Manganese-54 AG. Uranium-depleted in Uranium-235 AH. Cesium-137 Al. Cobalt-57 AJ. Barium-133 AK. Germanium-68

7. Chemical and/or physical form AE. Incidentally Activated Pi>~lr' AF. Incidentally A~ed Products AG. Metal AH. Sealed sontCes (lnternatlonttl Isotopes 1,aho, Inc., Model BM06E-37U':)1

\ Al. Sealed sour~ (lnternatl~nal Isotopes ldSQe~11 lnc., Modet BM06E-57)

AJ. Sealed sourcesilnternational odel BM06E-33) 111! i) AK. Sealed sources (lnternation§f'.

Isotopes Idaho, Inc., Model ** BM06E-68)

Docket or Reference No. 030-38903

8. Maximum amount that licensee may possess at any one time R l=ll~ tpis license AE:, ilti'nflwf:,(ri..<)
~ ~, AF. 100 millicuries totl!t" AG. 5000 kllograms total A.H. 0.212 mllllcuries total AJ'° q;~62 f
. "' Alf o~,i1 m1liicuries total "<~ -:;-;, "":)": <' """'",\ "' CONDITIONS
9. Authorized use AE. For possession and storage of byproduct materials incidental to radionuclide production.

AF. For possession and storagEi of byproduct materials incidental to radionuclide production.

AG. Shielding for generators AH. Calibration and checking of the licensee's instruments.

Al. Calibration and checking of the licensee's instruments.

AJ. Calibration and checking of the licensee's instruments.

AK. Calibration and checking of the licensee's instruments.

10. Licensed material may be used or stored only at the licensee's facilities located at 14395 Bergen Boulevard, Noblesville, Indiana, 46060. 11. The Radiation Safety Officer (RSO) for this license is Matthew Trusner.

NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 5 OF 7 PAGES MATERIALS LICENSE SUPPLEMENTARY SHEET License No. 13-35179-03 Docket or Reference No. 030-38903 Amendment No. 2 12. Licensed material shall only be used by, or under the supervision of: Authorized Users Scott Chance, PharmD Maxim Kiselev, Ph.D. John Zehner, R.Ph. 13. This license does not authorize distributroY, pursuanttQ i2. 72 or 3?. 7 4, to pc,rsons exemp~m licensing or to general licensees.

14. A. Sealed sources shall be tested for litkage and/or"~nJaminat registration issued by NRC under 10'tFR 321210 or"bia (I) . . II t int~,vals not to exc ::S.tate }a>'> 8. In the absence of a certificate from a~~sferdr irlijicating registration issued by NRC under 10 32.2'.io"br by an ,;a,tmr~KFstate prior to received from another person shall not ~e*put into use untiltesled and the test res ' .& the intervals specified in the certificate of e within the intervals specified in the certificate of ransfer, a sealed source or detector cell ceived. C. Sealed sources need not be tested if they arei'i~tora,ge and are not being us1i;f~ However, when they are removed from storage for use or transferred to another person, and have not beer:J;Jtist¥~

wit~ln ~~;e<tµlred leak test interval, they shall be tested before use or transfer.

No sealed source shall be stored for a perioa of,mori~tfiail*40 years without being tested for leakage and/or contamination.

D. The leak test shall be capable of detecting the presence of 0.005 microcurie (185 becquerels) of radioactive material on the test sample. If the test reveals the presence of 0.005 microcurie (185 becquerels) or more of removable contamination, a report shall be filed with the U.S. Nuclear Regulatory Commission in accordance with 10 CFR 30.50(c)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations.

E. Tests for leakage and/or contamination, including leak test sample collection and analysis, shall be performed by the licensee or by other persons specifically licensed by the U.S. Nuclear Regulatory Commission or an Agreement State to perform such services.

NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License No. 13-35179-03 Amendment No. 2 Docket or Reference No. 030-38903 PAGE 6 OF 7 PAGES F. Records of leak tests results shall be kept in units of ;~uff lnGU be maintained for three years. 15. Sealed sources or detector cells containing lice+\erial shall not be opel-Jr tources removed from source holders by the licensee, except as specifically authorized.

'"'\ r O ' , 16. The licensee shall conduct a physical inv!P40ry ever;:.six

m. onths, or at other int~.rv. als ai1Pj!.ved by the U.S. Nuclear Regulatory Commission, to account for all sources fl!ig'for devi~;"received and possessed;~nder the ~nse. h* 17. Except fo.r maintaining labeling as ~equiftti by 10 CF.Rt.,,2~

~r 7~: the nclii,~ shall obtdi~u~horization trom. NRC b~fo~e mak~ng any changes m the sealed source, device, jt.JOUrce-d.*.e.v1ceco.n,bn)bi1IIIJliil

  • *t t;;J'tPtJfd alter the deiirJ. pt1on or spec1ficat1ons as md1cated m the respective Registration Certificates iss~ eitherlby the ~o-nt 1 O CFR 32.Z,W or by an Agreement State. 18. The licensee is authorized to hold radioa' ordinary trash provided:

~f~ife ofJess tha~ days for decay-in-storage before disposal in '%5.fc~ ,."'.', A. Before disposal as ordinary trash, the was~I be surveyed at the contain~~~ce with the appropriate survey instrument set on its most sensitive scale and with no interposed sfiilldil"!g.Jo determine that iwJadihactivity cannot be distinguished from background.

All radiation labels shall be removed or obliterated, exceplfor\raqiatioo.11,b!ts::.on materials that are within containers and that will be managed as biomed1cal waste after they have been relets~d ffOm thi licensee.

B. A record of each such disposal permitted under this license condition shall be retained for three years. The record must include the date of disposal, the date on which the byproduct material was placed in storage, .the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.

NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License No. 13-35179-03 Amendment No. 2 Docket or Reference No. 030-38903 PAGE 7 OF 7 PAGES 19. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. This license condition applies only to those procedures that are required to be submitted in SCGRf'<l1tlcfti!A r,Qulations.

The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, rept,~Mtdns, and prol:'eflilr(s

!L\ the licensee's application and correspondence are more restrictive than the regulations.

C, 0 A. Application dated January 25, 2016 (M B. Letter dated April 7, 2016 (ML 16110~) C. letter dated April 19, 2016 (ML 161!620) D. Letter dated May 22, 2018 (Ml 181 552) E. Letter dated July 31, 2018 (ML1822 174) F. letter dated August 22, 2018 (ML 1 m4A483J FOR THE U. S. NUCLEAR REGULATORY COMMISSION Date: AUG 2 2 2018 By: .

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