ML20202F312
| ML20202F312 | |
| Person / Time | |
|---|---|
| Issue date: | 02/09/1978 |
| From: | Kelley J NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Bradford P, Gilinsky V, Hendrie J, Kennedy R, The Chairman NRC COMMISSION (OCM) |
| References | |
| SECY-78-068-C, SECY-78-069-C, SECY-78-070-C, SECY-78-68-C, SECY-78-69-C, SECY-78-70-C, NUDOCS 9902040021 | |
| Download: ML20202F312 (2) | |
Text
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,th" %ugo UN1'! ED STAT::S f'
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q~,...n y February 9, 1978
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l MEMORANDUM F0H:
Chairman Hendr$e Commissioner Cilincl:y Commissioner Kennedy
. Commissioner Bradford PROM:
times L.
Kelley eputy General Counsel
SUBJECT:
OGC COMMENTS OH --
SECY-78-68:
HRC Regulation of the Medical Uses of By-Product Material SECY-78-69:
Proposed Amendments to 10 CPR Part 35 to Change Conditions of Special Licenses for Certain Croups of Medical Uses of By-Product Material SECY-78-70:
Proposed Amendments of 10 CFR Part 35 to Require Reporting of Misadministrations of By-Product Material SECY-78-68 OGC concurs.
We expect that the Final Policy Statement will be sent to the Commission for review before it is published.
As we commented at the draft stage of the paper, our only other comments are suggested editorial changes which we can l
provide to the staff.
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OGC concurs.
In our view, NRC is deferring to FDA for cer-tain classes of material where the danger to the patient is lower than in other classes.
This should avoid a needless l
overlap betueen agencies without any apparent adverse effect j
on the oublic health and safety.
Background on the develop-ing role of the FDA in thic area in found in the proposed policy statement (SECY-78-68).
I
Contact:
ilark E.
Chopko, 000 631;-lh05
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SS 9902040021 780209 COMMS NRCC PDR CORRESPONDENCE PDR
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The Commission Febr y,
1978
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SECY-78-70 OGC. concurs, with one reservat4 1.
The staff recommends that only HRC and the referring physi-cian be informed of a misadministration.
The patient is i
not informed by the licensee, but nay be by his referring physician.
We want to raise for the Commissioners the possibility of adopting a stronger method for providing misadministration information to the patient.
We believe 1
that part of the NRC responsibilit y for the protection of the public includes providing information to the affected i
patient where appropriate.
However, we note that an abso-lute rule mandating that the information be provided to the patient by the licensee in every instance ignores the possibility of a medical judgment that a patient should not know of the incident, because such knowledge would be detri-mental to his physical or psychological condition.
The Commission may want to adopt a requirement that the patient be informed either by the licensee or by the referring physician of a maj or misadministration except when the referring physician decides that it is detrimental to the patient's interest.
This requirement is in addition to informing the NRC and the referring physician and similar to the preference of OELD.
While the practical effect of this provision may be indistinguishable from the alternative i
proposed in SECY-78-70 that only MRC and the referring physi-clan be informed, we recommend that the Commission give it consideration as a possible means to strengthen protections of the patient.
i cc:
K. Pedersen, OPE (2)
SECY (2)
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