ML20236J293
| ML20236J293 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20236J272 | List: |
| References | |
| REF-10CFR9.7 SECY-98-054-C, SECY-98-54-C, NUDOCS 9807080123 | |
| Download: ML20236J293 (2) | |
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FROM CHAI RMAN 3014151757 (mon) 4.13'96 17: 24/ST.17:10/No.4260016673 P 7 l
tLO T A T I O N VOTE k '
l BESPONSE SHEET TO: -John C. Hoyle, Secretary j
' FROM: CHAIRMAN JACKSON I
SUBJECT:
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SECY-98-054 - COMM4SSION RESOLUTION OF i SIGNIFICANT ISSUES ASSOCIATED WITH THE REVISION !
OF 10 CFR PARY 35, " MEDICAL USES OF BYPRODUCT '
MATERIAL" Approved
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X Disapproved X Abstain Not Participating Request Discussion COMMENTS:
S$e attached conwnents.
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R;lesse Vote /1/ April IL 1998 f s
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Withhofd Vote / /
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. Entered en ".AS" Yes X No 7
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Chairman Jackson's comments on SECY 98-054 l Regarding Patient Notification, I approve alternative 1, to require that the licensee notify the l NRC, the referring physician, and the patient, unless the referring physician informs the licensee that he or she will inform the individual who received the misadministration (medical event), or that based on his or her medical judgement, telling the individual would be harmful.
Regarding identification of precursor events, I disapprove the staff's recommended attemative 2 and recommend alternative 3. The existing regulations contain sufficient requirements for licensees to identify and report these " precursors events." There does seem to exist a lack of i clarity on the part of the NRC staff and the licensees regarding the applicability of these regulations to materials licensees; therefore, the staff's suggested use of an Information Notice to licensees regarding the applicability of the existing reporting requirements to their respective programs is appropnate. However, I note from a review of past Generic Communications that an Information Notice regarding these requirements has been previously issued with limited success. Therefore, in adoition to the issuance of the Information Notice, the staff should re-inforce the need for compliance with these requirements in its inspection and enforcement activities related to materials licensees.
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