ML20133P464

Requests Addl Info Re 850502 Application for Renewal of License SNM-1319,including Info Re Survey Meters & Counting Equipment for Alpha & Neutrons & Outline of Annual Training Lecture Subjs

ML20133P464
Person / Time
Site:	07001342
Issue date:	05/29/1985
From:	Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:	Klingensmith J BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC
Shared Package
ML20133P439	List: ML20133P436 ML20133P445 ML20133P449 ML20133P452 ML20133P458 ML20133P464 ML20133P468 ML20133P476 ML20133P480 ML20133P488 ML20133P497 ML20133P513 ML20133P528 ML20133P532 ML20133P543 ML20133P559 ML20133P562
References
23545, NUDOCS 8511010018
Download: ML20133P464 (2)

Text

__ __ . -- .__ _ _ _ _ .

O 8 o 1

i

, MAY 2 91985 License No. SNM-1319 Docket No. 070-01342 s j Control No. 23545 A

Coratomic, Inc.

ATTN: John R. Klingensmith Patient Records Specialist

]

P.

Indiana,O. Box 4M ,lvnaia Penns' 15701 Gentlemen:

4 This 19 in reference to your application dated May 2,1985 to renew License No. SNM-1319. In crder to(continue our review, we need the following additional information:

1

1. Regarding your survey meters and counting equipment for alpha and l neutrons, please submit the following information for each instrument.

i

^

a. Manufacturers Name and Model No, d

b. Number available

'.c. Sensitivity range

Td. Type of detector

v. Type of radiation detected f ., Method of calibration or determining counting efficiency

. 2. Plea'se submit an outyine of the subjects covered in your annual training l lecture, the length of time involved for each subject, the name of the

! instructor, if other than your radiation safety officer (RS0), and the j training and experience of the instructor if other than your RSO.

1 . .

I 3. Please clarify your rectvery/ return program. Are the nuclear batteries

ever removed from the explanted pacemakers returned to your from the licensed medical institution and placed in a new pacemaker?

4. Please clarify if the inventory /leaktest information given to our inspector during the August 17, 1984, inspection of your facility is the

, total, number of sources you have on hand or does it include the sources which are implanted in patients. We note that this list contained

570 sources.

i

5. Exhibit X for your Model C-100 protocol (July 1,1975), Exhibit X for your Model C-101 protocol (November 1,3 1975), and Exhibit IX of your Model C-101-P protocol (March 2,1983), indicate applications for pacemakerlicenses i

should be sent to the USNRC, Washington, D.C. Please correct these i i l'

1

{ OFFICIAL RECORD COPY 894 - 0001.0.0 i i. 05/73/85 i

i I -

s' 8511010018 850925 REG 1 LIC70 g%

L SNM-1319 PDR I' '

t . _ . - _ . . . , _ . . _ . _ _ _ - _ - , '._ _

O O Coratomic, Inc. 2 exhibits to reflect submission of an application to the Region Office of the NRC which has jurisdiction over the state in which the applicant resides. It is our understanding that you are only manufacturing and transferring the Model C-101-P pacemaker and protocol, if so, it is only necessary to correct the March 2,1983, protocol for the C-101-P pacemaker.

6. It appears from Attachment 1, " Fuel Capsule Assembly Procedure", that you are manufacturing the sealed source that is contained in your pacemakers, please clarify.

We will continue our review upon receipt of this information. Please reply in duplicate to my attention at the Region I office and refer to Mail Control No. 23545.

Sincerely, Origina1 Signed BY:

John E. Glenn Jenny M. Johansen, M.S.

Nuclear Materials Safety Section B Division of Radiation Safety and Safeguards t 4

I t

i.

I 1

RI:DRSS RI:DRSS Johansen/dj lenn 5/;p85 5$[/85

) 0FFICIAL RECORD COPY 894 - 0002.0.0 l 05/23/85

.. . .- .- . - - - . - _.