ML20236J323
| ML20236J323 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/1998 |
| From: | Diaz N 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 9807080133 | |
| Download: ML20236J323 (1) | |
Text
_ _ _ _ _ _ _ _ _ - _ _ - _ _ .
NOT ATIO N VOTE RESPONSE SHEET l TO: John C. Hoyle, Secretary .
i l
FROM: COMMISSIONER DIAZ
SUBJECT:
SECY-98-054 - COMMISSION RESOLUTION OF SIGNIFICANT ISSUES ASSOCIATED WITH THE REVISION l OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" in part Approved x Disapproved x ino.parkbstain
,d. cD.
Not Participating Request Discussion ,
COMMENTS: .
I approve Altemative 1 for the notification of individuals and referring physicians of a medical i event. The Commission should retain the provision in Part 35 to ensure that patients are '
receiving information necessary for making informed decisions regarding their medical care.
I approve Alternative 3 for precursor events. NRC's current regulations and the voluntary database maintained by U.S. Pharmacopeia, as well as FDA information captures the necessary precursor incidents without increasing the regulatory burden on licertsees and NRC as in -
Alternative 1 or 2. Given our scarce resources, the other alternatives are hard to justify.
l l SIGNATURQ I Release Vote / x / 4.4%
t DATE Withhold Vote / /
Entered on "AS" Yes x No
! 9807o8o133 980626 9D PDR CoMMS NRCC CORRESPONDENCE PDR a no ivwee_ __ _ _ _ d