ML20128E966

Matls Licensing Package for Jh McKay.Control:117111

ML20128E966
Person / Time
Site:	07003081
Issue date:	10/27/1992
From:	Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
References
117111, NUDOCS 9302110187
Download: ML20128E966 (9)

Text

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( I4RC FORM 3(4 at OF PAGES U.S. NUCLE AR QEGULATOQY COMMIS$10N g j' ( (10;e9)

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q MATERIALS LICENSE ))l' (I i

' Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10,

! Ccde of Federal Regulations, Chapter 1. Parts 30,31,32, 33. 34, 35, 39,40 and 70, and in reliance on statements and representations heretofore l

made by the licensee, a license is hereby issued authorizing the licensee to recene, acquire, pos ess, and tran.ifer byproduct, source, and special

l 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 authorned to recene it in accordance with the reguhitions of the applicable Partist This license shall be deemed to contain the conditions y

specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is suoject to all applicaNe rules, regulations and orders of the buclear g Regulatory Commmion now or hereafter in effect and to any conditions specified below.

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1, John H. McKay 3. Leense number SNM-1997 f

w>g i:.R.R.#5 Stratford, Ontario, Canada NSA 656 4. Expiration date October 31, 1997 -@

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• Docket' No

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070-03081 -

6. Byproduct, source. and/or 7 Chemical and/or physical 8. Mutmum amount that licensee special nuclear material form may possess at any one time under this license g

4lA. Plutonium (principal A. Sealed source A.Onesource,nottoexceedj

'% radionuclide Pu-238) 21G milligrams y t,1

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9. Authorized use p$

If it A. For possession in the United States as a nuclear battery, contained in an implanted  !>!

Medtronic, Inc. Laurens-Alcatel Model 9000 nuclear-powered pacemaker, Serial No. M

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CONDITIONS

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.g k 10. The authorized place of use is anywhere within the United States, including: Alaska, Il4 Hawaii and U.S. Territories and Possessions in the Pacific. P, M-f

11. While visiting the United States, the licensee shall carry on his person at all f' f:  !

times the Medical Alert Card supplied with this license in addition to wearing the identificatien bracelet and carrying the identification cards required by the -

i i Canadian Government.

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q :i, q CONDITIONS (Continued) :P l q :9 l 12. Except as specifically provided otherwise in this license, the licensee shall d -

] conduct its program in accordance with the statements,. representations, and j

} procedures contained in the documents including any enclosures,- listed below. The d i Nuclear Regulatory Commission's regulations shall govern unless the statements, i.j -

4 representations and procedures in the licensee's application and correspondence are A A

q more restrictive than the regulations. 4N j A. Application received September 8, 1992 }

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! For the U.S. Nuclear Regulatory Commission!i.:

fp Original Signed By:  !

Jenny Johansen -

Date 007 2 7 1992 By. lh;l fluclear Materials Safety Branch i.t,i

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OCT 2 71992-License No. SNM-1997 Docket No. 070-03081 Control No. 117111 John II, hicKay-R. R. #5 Stratfon], Ontario, Canada N5A 6S6

Dear Mr. hicKay:

Please find enclosed your NRC material license.

Plese review the enclosed document carefully and be sure that you understand all conditions.

If there are any ermrs or questions, please notify the Region I Material Licensing Section, (215) 337-5093, so that we can pmvide appropdate corrections and answers.

Please be advised that you must conduct your program involving licensed radioactive materials in accordance with the conditions of your NRC license, representations made in your license application, and NRC regulations. In particular, please note the items in the enclosed, " Requirements for Materials Licensees."

Since serious consequences to employees and the public can result from failure to comply __

with NRC requirements, the NRC expects licensees to pay meticulous attention to detail and to achieve the high standard of compliance which the NRC expects of its licensees.

You will be periodically. inspected by .NRC. A fee may be charged for inspections in accordance with 10 CFR Part 170. Failure to conduct your program safely and in-accordance with NRC regulations, license conditions, and representations made in your

-license application and supplemental correspondence with NRC will result in prompt and vigomus enforcement action against yce - This could include issuance of a notice _of violation, or in case of serious violations, an imposition of a civil penalty or an order suspending, modifying or revoking your license as specified in the General Policy and Procedures for NRC Enforcement Actions,10 CFR Part 2, Appendix C.

OFFICIAL RECORD COPY - G:\WPS\MLTR\LSNM1997 - 10/26/92 ML 10

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- John II. McKay - We wish you success in operating a safe and effective licensed program.

Sincerely, Original Sigf.ed Dy:

Jenny Johansen Jenny M. Johansen, Chief L Medical Licensing Section Division of Radiation Safety and Safeguards

Enclosures:

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1. License No. SNM 1997

2. Requirements for Materials Licensees

3. Medical Alert Card i

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DRSS:RI-Dinnitriad (/ nin Johansen j 10/16/9 10/46 /9

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. gy INFORMATION NEEDED FOR PACEJAKER LICENSE q7,l 6 l s _.

NOTE: This information should be received by the U.SF Huclear Regulator ~tegcdyta tw trDCl]_

Commission at least two weeks prior to your triQ to the Urlted Sta Medical 1.icensing Section 0 h h 9

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U.S. Nuclear Regulatory Commission y 1

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Region I e4 b t .,....

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475 Allendale Road ct King of Prussia, Pennsylvania 19406 ,,_

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The following information is submitted in application for a license to possess special nuclear material contained in an implanted nuclear-powered cardiac pacemaker.

I. (a) Applicant's Name d u g A M C k' A /

Address O.R.N 6~

City Mftl15~d L'O C10-7 Country 0',6) n Or) (t/ S 1 4 [D S &

National registry or License No, if any (b) The name, address and telephone number of the hospital , clinic or appropriate authority in your country to be contacted in case of an accident or malfunction of the pacemaker:

Name Y C f a ,2 i /) llc,6 pi Ts) L Address @ g , o w/ M.

o City [ c urli m i G)/0 7 Country, Ufl /J// d d Telephone No. / - ff7 9 - 'ndJJ C o'F S

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11. Pacemaker Identification:

Manufacturer's Name /) 1 E O T/? o /J / 6 Model No. k nuc a u$ tWG h ~T~ n L 0]ODEL O t3 d Serial No. //12 O l} )) it/

Radioactive Material (e.g., Plutonium) Punwuun, Amount of Radioactive Material: milligrams; j. [ Curles 111. I hereby request a license to possess the implanted nuclear-powered cardiac pacemaker as described above during my stay in the United States.

117111 OFMCIAL RECORD COPY An, m 's 0 81m

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(a) / I travel frequently (more than once a year) to the united States.

(b) ~

I will be in the United States from month day . year through .

month day year IV. Travel Itinerary: _.LLEJk<;dt$,_ A/5 t/ d o 't A&' 'I T k -

10HrEni r> <f tozs1 t/nMi a o is fu)/ci nLien1 -

floca n-eis b d sn / e ni cn D -

cwce ' yen t V. Name(s) and address (es) of contact (s) in the untied States:

VI. I will- wear an identification bracelet to be supplied by me which is:

fire resistant and of durable construction, and which is engraved in-English with at least the following information:

1. Who to notify in your country in case of emergency, including telephone numbers to call in the event of an ' accident or difficulty involving the pacemaker.

2. The words " radioactive pacemaker."

, 3. The pacemaker manufacturer's name and model number.

4. The radiation symbol.

5. The name of the bearer.

6. -Identification (spelled out) of the radionuclide contained .in the o pacemaker.

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. VII. In addition to any identity card required in my country, I will carry.on my person-an identity-card provided for my use by-the Nuclear Regulatory Commission.

Sincerely, 1

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]Signatur#) ^

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(Name printed or typed) I N

'O Mr;.s John- McKay'-

' Rural: Route 5 v Stratford, Ontario

- -CANADA NSA 656 - AllG 211932

Dear Mr. McKay:

This refers to my August 19, 1992, telephone conversation with Mrs. McKay in which we discussed your planned trip to the United States. U. S. law requires that a person who' possesses plutonium, the radioactive material used in nuclear-powered pacemakers, must have a license fory t~ hat., material .- In order-for you to obtain the needed license, you should providMthepinformation requested on the enclosed form and send the completed form tof the Nuclear RegulatoryCommission'sRegionIofficeinKingof9'frufsia, Pennsylvania. j Currently, there are no fees associated with this typdi/Afgicense.

inNRC'sRihlonI. office.

Ms.JennyJohansenisinchargeofmedicallicensh'g$ense,or,afteritis If you have any questions about your request for a l issued, the license itself, you may contact Ms. Johanshnhor'h member of her staff at (215) 337-5000.

We usually issue licenses for a period of five-years. This would-allow you to visit the V. S. during that time without having to notify us in advance of your planned visits. As I mentioned to Mrs. McKay, while the license is in-effect, you.will receive mailings from NRC addressed to all NRC licensees.

Most of these mailings will not be applicable to you and you should . simply discard them.

If you have any questions, please feel free to call me at (301) 504-2615.

Sincerely, b

Patr cia C. Vacca, Senior Project Manager Commercial Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS

Enclosure:

Information for. licensing cc w/ enc 1: JJohansen, RI DISTRIBUTION: (w/ enc 1) IMNS Central File _

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'GJackson, OC IMANl[ IMk Ik CC NAME: PVa h MLamhtra JEGlkn- 67dc h ,

. DATE- 08/ j!/ /92 08/ k/92 08/ \ /92-kkfd l

OFFICIAL RECORD COPY G:MCKAY -

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(FOR LFMS USE)

C  : ItlFORMATION FROM LTS

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SeTWEE4:

LICCNSE FEL MANAGEMENT " RANCH, AR1  : P90 GRAM C035: 22161 ANO  : ST ATUS CODE: 3 R EGION AL L IC ENS ING S E C T I C"4 5  : FEE _C AT EGOR Y: , , , , , . . . . . . . , , , , , , , , ,

EXP. DATE: O'

FEE COMMENTS: . . . . . . . . . . . . . . . . . . . . . -

DECOM FIN ASSUR REOD:

LICENSE FEF TRANS9ITTAL A. PEGION

1. APPLICAT10N ATTACHED APPLICANT / LICENSEE: McKAY, JOHN H.

R EC EI V E3 CAir: 920703 30C(tT NO: 70030R1 CONTROL NO.: 117111 LICENSE NO.:

ACTION TYPE: NEW LICENSEE.

2. FEE ATTACHE 3 AMOUNT: . .....

CHECA tC . : ./. .....

3. COMMENTS

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B. L! CENSE "EE MANAGEMNT 3 RANCH (CHECK WHEN MILESTONE 03 IS ENTERED /4./)

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-2. CORRICT FEE PAID. APPLICATION MAY.OE PROCESSED FOR: f _ ff f 33I e y'v?, y E r I y- A#// y

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