ML20127F125
| ML20127F125 | |
| Person / Time | |
|---|---|
| Issue date: | 10/16/1992 |
| From: | Glenn J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| FRN-57FR48305, RULE-PR-35 NUDOCS 9211090098 | |
| Download: ML20127F125 (5) | |
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liUCLEAR REGULATORY COMMISS103 OCT 26 4
10 CFR Part 35 PUBLIC MEETING ON THE QUAT!TY MANAGEMENT PROGRAM AND MISADMINISTRATIONS RULE:
Meeting Notice AGENCY:
Nuclear Regulatory Commission ACTION:
Notice of meeting and request for comment
SUMMARY
The Nuclear Regulatory Commission (NRC) will convene a meeting with the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) and other professional organizations within the medical community having an interest in the implementation of the Quality Management rogram md Misadministrations Rule (the Rule), to provide an explanation of o
the Rule language and the information collection and reporting requirements-impesed by the Rule.
This will include a discussion of 10 CFR Part 35, Sections 35.2, 35.32, and 35.33; Regulatory Guide 8.33; contractor guidelines for reviewing submitted Quality Management (QM) programs; and the interim inspectien guidance and enforcement policy. Time will be made available for comments and discussion by representatives of other professional organizations participatirg in the meeting.
Following this, the ACNP will describe their Practice Audi? Program and how it might fit into the implementation of the requirements of the Rule, d*
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DATESi The meeting will be held between 8:30 a.m. and 5:30 p.m.,
on November 9,_1992.
ADDRESS: Marriott Airport - Dulles 333 West Service Road Chantilly, Virginia 22021 COMMENTS:
Submit comments to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
FOR FURlHER INFORMATION, CONTACT:
Larry W. Camper, Office of Nuclear Material Safety and Safeguards, MS 6-H-3, U.S. Nuclear-Regulatory Commission, Washington, DC 20555, Telephone (301).504-3417.
SUPPLEMENTARY INFORMATION:
On August 12, 1992, the Commission voted unanimously to override the Office of Management and Budget's (OMB's)-
disapproval of the information collection requirements associated with the Rule.
In:a letter-dated August 14,1992,.tcf James B.; McCrae,L Jr.,- of OMB, James M. Taylor, Executive Director for Operations, NRC, stated'that the.NRC would hold a public workshop'with the medical community and other interested /_
. parties,-to-assure that there is a mutual understanding as to the intent of
.the-Rule, especially1the information collection requirements, and to discuss; effective implementation.
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In addition to the ACNP and-SNM, other profess'ional organizations, such as those representing hospital administrators, physicians, physicists, T
dosimetrists, technologists, and other related professionals that may be affected by the Rule, are being invited and will participate in-a discussion outlining implementation of the rule.
The NRC staff will discuss the definitions and requirements of the Rule with emphasis on clarifying any misunderstandings that may exist with regard to the information recordkeeping and reporting requirements of the Rule.
Inspection guidance in the form of a temporary instruction and interim field notes nas been prepared along with a interim revision to the enforcement policy for the
- Rule, The performance-based inspection program and enforcement policy-will be presented to the meeting participants and comments will be invited for consideration before the staff finalizes the guidance for submission to the Commission. There will be time for questions and answar-throughout the meeting.
The staff, in a letter dated September 8, 1992, informed ACNP that there would be an opportunity during this meeting to discuss ACNP's Practice Audit: Program and its potential utility for satisfying sese or all of the requirements of
-the Rule.
Representatives of ACNP will make this presentation during the-
. afternoon session. ' Additionally, there will be a period;during the.afternocn i-session where other' organizations can make remarks about"similar self-auditing or voluntary quality assurance programs within their respective organizations.
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QUDUCT OF lHE MEET mrg John E. Glenn, Ph.D., will chair the meeting. Dr. Glenn will conduct-the-meeting in a manner that will facilitate the orderly conduct of business.
The O
following procedures apply to public participation in the meeting:
1.
Persons may submit written comments by sending a reproducible copy to the Secretary of the Commission (see " COMMENTS" heading).
Comments must be received by November 4, 1992, to ensure consideration at the meeting.
The -
transcript of the meeting will be kept open until November 16, 1992, for inclusion of written comments.
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2.
Persons who wish to make oral statements should. inform Mr. Camper, in writing, by November 4, 1992.
Statements must pertain to-the topics at hand.
The Chairman will rule on requests to n.ake oral statements. Opportunity for.
members of the public to make oral statements will be based-on the order.in -
which requests are received.
In general, oral statements should be limited to approximately 5 minutes. Oral statements must be supplemented by deta'iled written _ statements, for the record.
Rulings on who may speak, the' order of i
presentation, and time-allotments may be obtained by calling Mr. Camper, (301)-
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504-3417,.'between 9 a.m. and 5 P.M. EST, on November 5, 1992.
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The transcript, minutes of_the meeting, and written comments will be available for inspection, and copying for a fee, at the flRC Public Document Room,2120LStreet,ilW,LowerLevel, Washington,DC20555,(m,orabout I
flovember 23, 1992.
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Seating for the public will be on a first-come, first-served basis.
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John E. Glenn, Chief Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical fluclear Safety Office of fluclear Material Safety IOI992 DATE:
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