ML20198K065
| ML20198K065 | |
| Person / Time | |
|---|---|
| Issue date: | 04/11/1996 |
| From: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-080, AF70-1-80, NUDOCS 9801140310 | |
| Download: ML20198K065 (1) | |
Text
-- - - . . . - --
f9F 7o-l April 11, 1996 3k .
MEMORANDUH T0: James M. Taylor, Executive Director for Operations FROM: David L. Morrison, Director /s/ Joseph A. Hurphy for Office of Nuclear Regulatory Research
SUBJECT:
INITIATION OF A RULEMAKING PLAN ON CARBON-14 FOR IN VIVO DIAGNOSTIC TESTING, 10 CFR PART 35 (PRM-35-12)
In accordance with the rulemaking procedures specified in.llanagement Directive 6.3, RES intends to develop a rulemakin9 plan to amend 10 CFR Part 35.
This rulemaking is in response to a petition filed by Tri Med Specialties,
> Inc. The petitioner requests that NRC amend its regulations to permit pharmaceutical manufacturers to distribute capsules containing carbon-14 to '
any physician for administr6 tion to humans for in vivo diagnostic testing.
.Under the current regulations, these capsules may be distributed only to physicians who are authorized users (i.e., physicians who meet training
- requireents specified in 10 CFR Part 35).
Notice of receipt of the petition was published for pubisc comment in the Federal Reaister on December 2, 1994 (59 FR 61831). A total of 314 public comment letters (312 supporting and 2 opposing) were received. The two letters _ opposing the petition made the following two poirts:-(1) the product should not receive an exempt status because the uncontrolled distribution and application of this product could lead to significant risk to the public and (2) medical uses should be restricted to short-lived isotopes because of disposal problems presented by long-lived isotopes.
A RES contractor, ICF/SAIC, was tasked to assess the sai'ety implications of the petition. Recently, we received a draft report from ICF/SAIC, and, based on the conclusions of the report along with-the comments received, we believe that the petition should be granted. Accordingly, we are developing a rulema'<ing plan to amend 10 CFR Part 35 to allow any physician to receive and use this product for human use. We will be submitting a rulemaking plan for your apprcval as soon as it is developed.
Djity_)'o ut iojl:
JEGlenn/RPHEB rf STreby, OGC File Center CPaperiello, NMSS FACostanzi MKnapp, HMSS LRiani DCool, NMSS ATse FCombs, NHSS SFeld HPollycove, NHSS JMate LCamper, HMSS DOCUMENT NAME: 9:\ jones \trirule.tse-
- See previous conc.
- !!,*dfiMILM ,"W'T4"* '"" " * *" " ~ "" """"' '""'*"~ '"""' * * "" ""'
Off: DRA/RPHEB ' DRA/RES DRA/RES Df0R//RES D/RfJr r Name: SJones*- ABeranek* JGlenn* t hr1s khh
~
Date: 4/5/96' 4/5/96 4/5/96 b/10 /96 4/ fp /96 Dist: Yes/No sYes/No-Yes/No Yes/No
- b/No
% 10 N M
- - , _ 030