ML18239A276
| ML18239A276 | |
| Person / Time | |
|---|---|
| Site: | 03038841 |
| Issue date: | 08/22/2018 |
| From: | Parker B A NRC/RGN-III |
| To: | Zevacor Molecular |
| References | |
| 609133 | |
| Download: ML18239A276 (5) | |
Text
NRC FORM374 U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE PAGE 1 OF 5 PAGES Amendment No. 3 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 6. Byproduct, source, and/or special nuclear material A. Any byproduct material with Atomic Nos. 1 through 83 with exceptions
- 8. Molybdenum-99 C. Technetium-99m D. Rubidium-82 E. Strontium-82 F. Strontium-85 G. lndium-111 H. Germanium-68 7, A. B. C. D. E. F. G. H. In accordance with letter dated 4. Expiration Date: December 31, 2025 June t---------~,,.._--1
- 5. Docket No.: 030-38841 Reference No.: Chemical allofcr physical fo~~: , Max1mUm;1mount that liceDUe 9. Authorized use Any lt'lnlfflcurtes per A. For research and development in the d 1 curie total pre-production of radiopharmaceuticals
', ', for testing, validation, and qualification
'<<c > ]. ,> ,' y of FDA regulated drug products for submission of data for drug protocols.
Any B/ *300 curies to~ Q' 8. Same as Item 9.A. Any C. 300 curies totai C. Same as Item 9.A. <:;, ',k Any [!);\ 2 curies total D. Same as Item 9.A. Any E. 2 curies total E. Same as Item 9.A. Any F. 500 millicuries total F. Same as Item 9.A. Any G. 1 curie total G. Same as Item 9.A. Any H. 2 curies total H. Same as Item 9.A.
NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 OF 5 PAGES MATERIALS LICENSE SUPPLEMENTARY SHEET License No. 13-35179-02 Docket or Reference No. 030-38841
- 6. Byproduct, source, and/or special nuclear material I. Gallium-68 J. Cesium-137 K. Cobalt-57 L. Barium-133 Amendment No. 3 7. Chemical and/or physical form I. J. Any Sealed sources Isotopes Idaho, BM06E-37 K. Sealed so Isotopes I BM06E-5 (I nternatf9nal , Inc., Modef L. Sealed so"es (lnternation.}
Isotopes IJemo, lnc.,.,rodeJ,,:'
BM06E*3aui
' 8. Maximum amount that licensee may possess at any one time ii-t:;1 I ,if/llllel*rvis license I. 2 curi t'11!ltJ }\ J. 420 microcuries iOJ "'~ *.Jv:& J1 K. 10.6 millleuries total t;'.>I,~%.
- 9. Authorized use I. Same as Item 9.A. J. For use in calibration and checking of the Hcensee's instruments.
K Same as Item 9.J. L. Same as Item 9.J. 0, the licen~ee'sf!l(c:;il;tieslocated at 1~~ergen Boulevard, Noblesville, lndiam:1, 46060. 10. Licensed material shall be used or stored o 11. The Radiation Safety Officer (RSO) for this licensefs M~hew Trusner. t~~'" 'c(\"' 12. Licensed materials shall be used by, or under the supervision of: Authorized Users Scott D. Chance, PharmD John Zehner, R.Ph. Material and Use All All 13. Licensed material shall not be used in or on humans except as provided otherwise by specific condition of this license.
NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 3 OF 5 PAGES 14. 15. MATERIALS LICENSE SUPPLEMENTARY SHEET License No. 13-35179-02 Amendment No. 3 Docket or Reference No. 030-38841 The !ic~nsee shall not use licensed material in field applic!tio:s
~el! activity is release except as provided otherwise by specific condition of this hcense. ~* r."' ,. ~. H ,,.,. ;I, #f'*'!Ji, f Tu, ,+1t c11w11, TL """' Experimental animals, or the products from e~e,~~~tal animals, that have been administered licensed materials shall not be used for human consumption.
"' .I 16. The licensee shall conduct a physical inyfr,fory every eix months, or at other intervals appr'a,ed by the U.S. Nuclear Regulatory Commission, to account for all sources ~/or devicee re~ived an°'possessed under the f~nse. Records of inventories shall be maintained for three years from the dat~f each inver,f9.1Y, and shall lnclude;tbe' radionucli<E) quantities, manufacturer's name and model numbers, and the date of the inventory~**
- 1-17. Sealed sources containing licensed ma~ shalf fl!!!be o~ttttii:i,*
re~ fro;!'rce holders by the licensee.
- 18. The licensee shall not acquire licensed maflttial in a sealed source,or device unless the~drce or device has been registered with the U.S. Nuclear Regulatory Commission pursuant t~J) 9FR 32.210 or ~quivafentregulation~f~ln Agreement State. . . . ,) 19. A. Sealed sources shall be tested for leakage ;~r c~mtamination at intery.afs exceed the intervals specified in the certificate of registration issued by the U.S. Nuclear Regulatory
~rtln,iS!iQLl}ilnQ.er fflJlFR 32.210 or by an Agreement State. In the absence of a registration certificate, sealed sources shall be tested for'leak~g'e a~a/or contamination at intervals not to exceed six months, or at such other intervals as specified.
B. Notwithstanding Paragraph A of this Condition, sealed sources designed to primarily emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed three months. C. In the absence of a certificate from a transferor indicating that a leak test has been made within the intervals specified in the certificate of registration issued by the U.S. Nuclear Regulatory Commission under 10 CFR 32.210 or by an Agreement State, prior to thei transfer, a sealed source received from another person shall not be put into use until tested and the test results received.
NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License No. 13-35179-02 Amendment No. 3 Docket or Reference No. 030-38841 PAGE 4 OF 5 PAGES D .. Sealed sources need not be tested if they contain only hydroan~ or they contain only a radioactive gas; or the half-life of the isotope is 30 days or less; or they contain not more than 1 OQJn~cf'rielrbfl>@-t,djor gamma-emitting material or not more than 1 O microcuries of alpha-emitting material.
\~ (,1 -,~ E. Sealed sources need not be tested if th~e in storage and are not being used. QJ'(ever, when they are removed from storage for use or transferred to another person, and h~ not been. tested within the require.d leak~i~terval, they shall be tested before use or transfer.
No sealed source shall be $1dJed forap.wiod of more than 10 yf3arawithout1'eing tested for leakage and/or contamination.
' ,c ' ' F. The leak test shall be capable of d~ting the pre,~ of 1$5 becq_ue~~ltJ0.005 micnfS)ries) of radioactive .ma~erial on the test sample. lfthe test reveals the pres*5flce of 18.5 b9'1Lf. re .. 1.s ( .QQ~ mu:rqcuries}
or more:!liremovable contamination, a report shalt be filed with the U.S. Nuclear RegulatlnTCom"llision .. ,t . . JO:CFR 30.SO(c)~.
and the source shall be removed immediately from service and decolGmin~HittePaltecf,o~
i i:fof In accordance
~h Commission regulations. I ' . G. Analysis of leak test samples and/or ~minafio~,,hall J -, . liffl by ;ersons sg\!tefically licensed by the U.S. Nuclear Regulatory Commission or an Agreement State to ~orm such services:
The licensee is auttl&i!ed to collect leak test samples but not perform the analysis.
' H. Records of leak test results shall be kept in units of ~q,~~e~~Af~i~c,9u~f!3) and shall be maintained for three years. ,,-' ' 20. The licensee is authorized to hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal in ordinary trash provided:
A. Before disposal as ordinary trash, the waste shall be surveyed at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to determine that its radioactivity cannot be distinguished from background.
All radiation labels shall be removed or obliterated, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.
NRC FORM 374A MATERIALS LICENSE SUPPLEMENTARY SHEET U.S. NUCLEAR REGULATORY COMMISSION License No. 13-35179-02 Amendment No. 3 Docket or Reference No. 030-38841 PAGE 5 OF 5 PAGES 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 atJt,E\t~ceFt i!l~ete container, and the name of the individual who performed the disposal.
\ ""fA '" 1 UL A '0 *" *~,;,.. 21. Except as specifically provided otherwise
~~~icense, the licensee shall conduct its(fi1o11ram in accordance with the statements, representations, and procedures containe he documents, including any enclosuresfjm:ed below. This license condition applies only to those procedures that are required to be '1),mitted in accordance with the regul,tlons.
TbLu .S. Nuclear Regulatory Commission's regu~at!ons shall govern u~less the stat~nts, reprel!:rttations, and procedures In the licees,e's application and correspondence are more restrictive than the regulations.
'--, * * * ** * "'
- A. Application dated May 27, 2015 (tf-45152A156)
- 8. Letter dated October 16, 2015 (Mt11£R92A§8'l C. Letter dated July 11, 2017 (ML 1719~57) ,,.**.. ,., D. Letter dated July 31, 2018 (re: new R~ (Ml18220B114)
AUG 2 2 2018 Date: ______ _ %,"\!'>, FbR THE U.S. NUCLEAR REGULATORY COMMISSION By: , /Ca Bryan A. Parker Q
- Region Ill