ML20056C036

Discusses New Quality Mgt Program & Misadministration Rule Published 910725 in Vol 56,number 143 of Fr,Effective 920127.Rule Changes Definition of Misadministrations & Reporting Requirements.Forwards Copy of Fr.W/O Encl

ML20056C036
Person / Time
Issue date:	10/08/1991
From:	Pate R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V)
To:	AFFILIATION NOT ASSIGNED
Shared Package
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References
NUDOCS 9111200269
Download: ML20056C036 (2)

Text

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8 NUCLEAR REGULATORY COMMISSION o

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i REGION V.

g 1450 MARIA LANE. SUITE 210 g

WALNUT CREEK, CAUFORNIA 9480H358

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OCT 8 1991 TO:

All Region V Medical Licensees 1

SUBJECT:

REVISIONS TO 10 CFR PART 35 REGARDING QUALITY MANAGEMENT l

PROGRAMS AND MISA0 MINISTRATIONS I

A new Quality Management Program and Misadministration Rule was published on July 25,1991'in Volume 56, No.143 of the Federal Register, copy enclosed.

This rule becomes fully effective on January 27, 1992.

This new rule changes the definition of misadministrations and the associated.

reporting requirements, and requires most medical licenses (refer to 10 CFR 35.32 on enclosed document) to submit Quality Management Programs (QMPs) by January 27, 1992.

It also requires licensees to submit written certifications that the quality management programs have been implemented.

After the QMPs and certifications are submitted, they will be placed in the license file and discussed during any subsequent inspection.

Failure to submit a program and the certification _ by the due date 'will result in' an item of noncompliance or.Other enforcement action.

The programs will be reviewed by members of the licensing staff and incorporated in the licenses when they are renewed.

This letter is being sent to you for informational purposes.

If you have any questions concerning these matters, contact Beth Prange at (510) 975-0250.

Sincerely, i

/

Y o er J. P te, Chief Nuclear Materials and Fuel Fabrication Branch

Enclosure:

Federal Register Notice Vol. 56, No. 143, P. 34104 through 34122 l

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