ML20151B288
| ML20151B288 | |
| Person / Time | |
|---|---|
| Issue date: | 04/01/1988 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| FRN-55FR1439, REF-10CFR9.7 AC65-1-122, M880322B, NUDOCS 8804080133 | |
| Download: ML20151B288 (2) | |
Text
IN RESPONSE, PLEASE REFER TO:
M880322B
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UNITED STATES NUCLEAR REGULATORY COMMISSION
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April 1, 1988 CFFICE OF THE SECRETARY MEMORANDUM FOR:
Victor Stello, Jr.
Executive Director for Up yations FRO!!:
Samuel J. Chilk,Sec.zeto}
$g STAFFREQUIREMENTS-BRI(FI'jGONSTATUSOF t
SUBJECT:
PROPOSED RULEMAKINO ON BAbIC QA IN RADIATION 2:00 P.M.,
THERAPY ANL BELATED SCTIVITIES, TUESDAY, 11AQ.Cb 23, 19?8. COMMISSIONERS'-
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CONFERENCE ROOM, D C, OFF! ICE (OPEN TO PUBLIC ATTENDANCE)
The Commission was briefed Prf t e.C.af f on the status and h
public comments of rilcreaxing ef forts dor both basic and comprehensive quality assur,nce fequirementy dor aidical uses s
of radioisotopes.
The Commission madri the follcsing teque6tes The staff should communicate with staten, interested parties, and health cara communities :o $0entify oppor-tunities for ccorfrouion to foster laproved programs for the medical use of isotoper.
ste? s to obtain C
The staff should contact the Agreement any available data on medical misadministrations to supplement NRC's data base.
The staff should arrange for the Oemmission to be briefed by the NRC's Medical Advisory Committee and represertative professional societies on positive it/,ps that can be taktn l
to improve quality assurance for medical use of isotopes.
(Subsequent to the meeting, the Commise;on spheduled a meeting with the MRC's Medical Advisorv Cntmaittea and 1988.1 representative professional societies dar' April 7c l
i G804000133 000401 PDR 10CFR ppg PT9.7 l
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T i The staff should submit for Commission consideration an options paper on ensuring quality in the medical appli-cation of byproduct materials.
The options should include performance based quality assurance requirements containing specific elements necessary for implementation.
(Option 2, as presented in the briefing material.)
(EDO)
(SECY Suspense:
TBD)
Commissioner Bernthal requested the staff to provide the basis for staff's determination that some fraction of misadmini-strations reported as abnormal occurrences could likely result in adverse health effects.
He also expressed concern as to whether the threshold implied by such a determination comports with that used elsewhere by the Commission to determine adverse health effects.
(EDO)
(SECY Suspense:
4/22/88) cc:
Chairman Zech Commissioner Roberts Commissioner Bernthal Commisslorer Carr Commissioner Rogers OGv (H Street)
GPA PDR - Advance DCS - 016 Phillips t
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