ML20127A391
| ML20127A391 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1992 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| NUDOCS 9301110273 | |
| Download: ML20127A391 (2) | |
Text
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December 21, 1992
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- .s OF FICE OF THE SECRET ARY MEMORANDUM FOR:
James M. Taylor Executive Director for Op ations FROM:
Samuel J. Chilk, Secreta
SUBJECT:
COMIS-92-026-REVIEWOFkTHQREGULATIONOF THE MEDICAL USE OF BYPRODUCT MATERIAL The recent and most serious therapy misadministration incident in Indiana, Pennsylvania, in addition to other recent events and circumstances, has served to highlight the importance of assuring that NRC's medical licensing program is properly designed and effectively implemented to provide adequate assurance of public health and safety.
1.
The Commission requests that you nominate for Commission approval, a senior NRC manager to perform a management review of the existing medical use regulatory program.
This review should focus on whether our existing programs, including oversight of the Agreement state program, is being effectively implemented.
The review should be coordinated with the management plan (September 8, 1992 Bernero to Taylor memorandum) which is under development, and with any recommendations from the IIT.
The senior manager should identify any recommendations to correct deficiencies in implementation of our existing program.
To complement this implementatfo~n revie U he CommissT$n is
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also interested in an in-depth review of the basic regulatory rules, policies, practices and procedures to-assess whether our current framework for medical use of byproduct material is appropriate to fulfill our statucory responsibilities for public health and safety.
The Commission therefore requests that you propose, for Commission approval, a charter and proposed members for an outside group to conduct such a review.
The group's membership should provide a balanced representation of interested and affected parties including some drawn from the medical licensing community.
The goal of the group is to develop an assessment of the adequacy and appropriateness of the framework, and to identify specific recommendations for Comm ssion review and action.
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In performing tasks one'and two, the senior NRC manager and the review group should solicit the views of'ACMUI.
The Commission asks that you afford both of these efforts a high
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cc:
The Chairman Commissioner Rogers
- 1 Commissioner Curtiss commissioner Remick
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