ML20207B059
| ML20207B059 | |
| Person / Time | |
|---|---|
| Issue date: | 06/03/1988 |
| From: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML20205C621 | List: |
| References | |
| FOIA-88-310, TASK-RINV, TASK-SE SECY-88-156, NUDOCS 8806230332 | |
| Download: ML20207B059 (5) | |
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s SECY-88-156 June 3, 1988 (Notation Vote)
For:
The Ccmissioners From:
Victor Stello, Jr.
Executive Director for Operations
Subject:
HEDICAL QUALITY ASSURANCE (QA) RULEttAKING OPTIONS AND RELATED TOPICS
Purpose:
To provide the staff response to Commission requests made during Commission briefings and in Staff Requirements Memoranda (dated 4/1/88 and 4/22/88).
Background:
Two rulemakings on QA in medical use were published for public comment on October 2, 1987:
a Notice of Proposed Rulemaking on basic QA and an Advance Notice of Proposed Rulemaking on comprehensive QA.
The Comission was briefed on the rulemaking by the staff on Haren 22, 1988, and by medical representatives on April 7, 1988.
The Commissien then directed the staff to prepare an options paper providing rulemaking alternatives and to provide further information on specific topics related to QA programs.
Discussion:
RULEMAKING OPTIONS:
A description of rulemaking options is presented below.
The detailed discussions of options, including pros and cons, cost /
benefit analysis, and schedules, are presented in Enclosure 1.
Contact:
Anthony N. Tse, RES 7
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Option 3 - Policy Statement in Place of Rulemaking u
RESFONSE TO OTHER COMMISSION REQUESTS e
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The C6mmiss'ioners 3
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w Coordination:
The Offices of NHSS, AE00, GPA, ARM, and OE have concurred in the recommendations of this paper.
Those Offices have also concurred in the draft final rule on basic QA requirements (Enclosure 2) if the Commission decides to adopt Option 1A.
The Office of the General Counsel has no legal objection to either this paper er the draft final rule.
The Commissioners 4
R commendation:
/g VTetor Stello, Jr. [fo/ Operations Executive Director
Enclosures:
1.
Options for Medical QA Rulemaking 2.
Basic QA Rulemaking Package 3.
Plan for a Pilot Program 4.
Definition of Misadministration 5.
Abnormal Occurrences, Adverse Health Effects, and Medical Misadministrations
5 Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Tuesday, June 21, 1988.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Tuesday, June 14, 1988, with an infor-mation copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners OGC OI OIA GPA REGIONAL IFFICES EDO ACRS ASLBP ASLAP SECY 1
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