ML20045B319
| ML20045B319 | |
| Person / Time | |
|---|---|
| Issue date: | 03/30/1993 |
| From: | Rogers K NRC COMMISSION (OCM) |
| To: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| NUDOCS 9306170186 | |
| Download: ML20045B319 (1) | |
Text
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RELEASED TO THE PDR NOTATION VOTE; g/n/9 3 gL e
'de idais RESPONSE SHEET T0:
SAMUEL J. CHILK, SECRETARY OF THE C0 MISSION FROM:
C0144ISSIONER R0GERS
SUBJECT:
SECY-93-050 - PROPOSED AMENDMENTS ON PREPARATION, TRANSFER, AND USE OF BYPRODUCT MATERIAL FOR MEDICAL USE smm r APPROVED " " "u DISAPPROVED ABSTAIN
~
NOT PARTICIPATING REQUEST DISCUSSION C0!41ENTS:
1.
The format of Table 1 on page 10 of Enclosure 1 is an effective way of summarizing the main points of the ACNP-SNM petition and the NRC's response to those points.
- However, several of the entries which describe NRC responses speak of permitting " greater discretion," but do not describe the nature of the discretion, and therefore do not respond directly to the points raised by the petition.
The staff should revise the table to be more clearly responsive to the petition before publishing the proposed rule in the Federal Recister.
2.
The proposed rule would define " patient" in Part 35 so as to include an individual serving as a research subject.
I believe that this could be a potential source of confusion and suggest that the term " patient" be used only in the conventional way and that research subjects be referred to as such in the proposed rule.
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