ML20206U207

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Refers to 981204 Metorex Request for Amend to Registry NR-701-D-101-B & NRC Distribution License Which Described Mods Made to Ssps & Heps Probes.Informs That Actions Should Be Reviewed by NMSS Before Being Forwarded to Region I
ML20206U207
Person / Time
Issue date: 12/22/1998
From: Blough A
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To: Cool D
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20206U187 List:
References
SSD, NUDOCS 9905250103
Download: ML20206U207 (3)


Text

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475 ALLENDALE ROAD g*..,*,o KING oF PRUSSIA, PENNSYLVANIA 19406-1415 2A ,h December 22, 1998 MEMORANDUM FOR: Donald A. Cool, Director f Division of Industrial and Medical Nuclear Safety, NMSS FROM: A. Randolph Blough, Director -

Division of Nuclear Materials Safety, Rl

SUBJECT:

METOREX REQUEST TO AMEND REGISTRY NR-701-D-101-B In a letter dated December 4,1998, Metorex requested an amendment to Registry NR-701-D-101-B and their NRC distribution License. The letter describes changes which affect the SSPS and HEPS probes, which the licensee modified by adding a 50 kBq cadmium-109 source to the SSPS probe, modified the HEPS probe by adding a flow cell and made changes to the source holder and shutter mechanism, and supplied the HEPS probes to one company that incorporated it into an online analyzer with a flow cell of their own design.

These changes had not been reviewed and approved by the NRC prior to being implemented and distributed to customers.

Motorex contacted NRC Region I, by telephone, as soon as it realized that changes to its devices had occurred in order to obtain advice on what action it should take. Region I informed the licensee to contact the Materials Safety Branch, NMSS for instructions to obtain an evaluation of the changes. The licensee contacted John Lubinski and was told to forward its request to NRC Region I for processing and evaluation. The licensee sent its ,

request to the Region in a letter dated December 4,1998. l It is our view that this type of action should be initially received, processed and evaluated by NMSS/lMNS prior to being forwarded to Region I. Accordingly, we have voided the licensee's request to amend its distribution license, and plan to wait until the registry is changed before considering an amendment request from the licensee. It is our understanding, based on a discussion with the licensee, that Metorex is not distributing i these modified devices at this time, i

Please provide a copy of the amended registry sheet to Region I when your action is complete. l

Attachment:

Letter dated December 4,1998

Contact:

Judith A. Joustra (610)337-5355 i

l 9905250103 990521 PDR RC *

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_a PAGE1 NRC FORM 567 U. S. NUCt. EAR REGULATORY COMMISSION (683)

REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all related letters /applicatens and drawings to: The Seeled Source Safety Sec%n, ATTN: Chef, OWFN Mail Stop 6 H3. Change the License Tracking System milestone to 19 and assign to reviewer code I-5.

NOTE: Retain a copy of this request with the application and buckground files.

MQUESTER REGION / LOCATION:

Mg%[6k ]I il U111 IV RV R HQ U LFDCB TELEPHONE NUMBER ' DATE TYPE OF ACTION REQUESTED (Check as appropriate)

APPUCANT'S NAME ,___

/ 9 9 um Pmrasw MCJL CONTROL NUMBER (S)

SOURCE REVIEW DEVICE REVIEW AMENDMENT OF

=g-Ax 8 33 e29-303H'O- DDC, LETTER /APPUCATON DATE LCENSE NUMBER (S) CUSTOM REVIEW M[ #[O/-h-/O/-b M-4-92 c w McNTS fKINCE TDn) L K.0SS /L.QAUS COK. fMH TE C. G AJTell.

g>5o peiL.u r>s Bau EvMD EM /J6, N7 oS/o / 3 FOR SSSS USE ONL_Y EVIEWER UMBERS /IJf M VJ / /K> IQ NUMBER ASSGNED F D Jo 3Df 5, $L.P5 PRbEES _[j DATE RECEIVED DATE ASSGNED DATE TO FEES

/-4-99 /- + 99 '

TYPE OF ACTION (Indicate the number of sech type)

)(l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (98)

NEW NEW NEW NEW AMENDMENT f AMENDMENT _

AMENDMENT _

AMENDMENT I LICENSING ACTION REQUIRED IF KNOWN -

E EQU D

) OTHER (Specity)

EW RS EA)OfNc- l%EG7IS7Ty (~G 957X161T-NUMBER OF /OA) OF 5595 /h>o HEF5 P/2c8ES ,

DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY l NAME CHANGE ADDRESS CHANGE j NEW REGISTRATION - ] PRODUCT INACTIVE -

ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY

_ /N ] 9A U 9B 9C 9D i GMOUNT CEIVED A CHECK NUMBER , MATANN UPDATED

( cib1 hh f 'jc/ } h d[ AS REQUIRED MTE OF

/, y LM

' 35M _] MATSYS UPDATED AS REQUIRED AFQHOVED BY DATE RETURN DATE D

COMMENTS 70C FORM b67 (5 93)

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