ML20236U309

Recommends That NMSS Proceed W/New Rulemaking, QA & Penalties for Negligence. Draft Regulatory Agenda Entry Addressing Issue Encl.W/O Stated Encl

ML20236U309
Person / Time
Issue date:	08/08/1986
From:	Jennifer Davis NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
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References
FRN-52FR36942, RULE-PR-35 AC65-1-060, AC65-1-60, NUDOCS 8712020428
Download: ML20236U309 (1)

Text

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'" DISTRIBI) TION - NMSS 860387 (Partial Response)

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, VLMiller RECunningham DBMausshardt ~ JGDavis BClausser CCudd s cono q MEMORANDUM FOR: Victor Stello, Jr.

Executive Director for Operations FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards

SUBJECT:

HEW RULEMAKING: " QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" (NMSS 860387 Partial Response)

On April 14, 1986, the Commission directed the staff to submit a rulemaking package to provide the authority to require independent verification of therapy doses and penalize medical licensees for negligence. The purpose of the enclosed paper is to request permission to initiate a new rulemaking project entitled " Quality Assurance and Penalties for Negligence" to implement the Commission's requirement. The objective of the rule is to reduce the chance of therapy misadministration. The rule would require medical therapy licensees to implement quality assurance programs, and would define and establish penalties for negligence. The Commission directed that the staff prepara this rulemaking (see Enclosure 2 of the draf t Commission Paper).

The attached Draft Regulatory Agenda Entry addresses the issue, need for rulemaking, regulatory alternatives, proposed resolution, effects, and NRC resources and scheduling. These matters are discussed in greater depth in Enclosure 4, " Regulatory Analysis," and Enclosure 8. " Corollary Issues," of the draft Commission Paper.

Based on the findings of the screening process used in this Office, I have made a determination that the preliminary judgmonts made by the staff regarding the issue, need for rulemaking, as directed by the Commission, regulatory alternatives, proposed resolution, effects, and NRC resources and scheduling are founded in accordance with the Commission's instructions.

I recommend that this Office proceed with this rulemaking.

M John Pa. Davis John G. Davis, Director

~ Office of Nuclear Material Safety and Safeguards

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Enclosures:

1. Draft Regulatory Agenda Entry

2. Draft Comission Paper

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