ML20198J978
| ML20198J978 | |
| Person / Time | |
|---|---|
| Issue date: | 08/23/1996 |
| From: | Abbott C NRC OFFICE OF THE CONTROLLER |
| To: | Steve Jones NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-071, AF70-1-71, NUDOCS 9801140277 | |
| Download: ML20198J978 (2) | |
Text
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August 23,1996 !
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NOTE TO: . Sam Jones, Task Leader, RES FROM: Carol Abbott, OCOBA/PAB b .tZ$5.., ((
SUBJECT:
RULEMAKING PLAN: MEDICAL USE OF CAPSULES CONTAINING ONE MICROCURIE OF CARBON 14 (PRM-35-12) l
As reques6d in David Morrison's August 14,1996 memo, OC has reviewed the subject rulemaking plan to issue a direct final rule amending 10 CFR Part 35 (adding Subpart D) to
' allow all physicians to receive and use capsules containing one microcurie of carbon-14 for medical use without an NRC Part 35 license. Our review of the current NRC budget shows that resources are available to proceed with the rulemaking and, because no additional resources are required by NRC to implement the rule, OC finds that tt'oro are no resource-related issues ;,
associated with this rulemaking. Therefore, OC grants concurrence and recommends that the i Resourons section (on page 7 of the Rulemaking Plan) be revised as follows:
i Resources i
[ Resources to complete and implement this rule are included in the current budget.
N cc:
P.Rabideau OC/DDA J. Evans OC/DBA D.Corley OC/DBA/PAB ,
P.Wolfe OC/DBA/PAB '
R.Albright OC/DBA/ BOPS
. D. Howe, NMSS OC Action iter.1: 96-151-DBA Action item: 96194. -
L PAB Action item: 6-194 DBA File: NML-1.1 =
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Basis for the recommendation for a direct final rule:
(1) The direct final rule (versus a proposed rule / final rule) is the most expedient means for NRC to grant the petition. The product could be aos. roved by the Food and Drug Administration (FDA) by the end of this year. If this is so, only proceeding with a direct final rule could permit use of the tapsules by any physician concurrent with FDA approval. The proposed rule / final rule approach would avid.about six months to the rulemaking schedule, with concomitant loss of the benefits to be provided though this rulemaking.
(2) The two opposing cornents received in response to the " Notice of receipt of petition for rulemaking" will be addressed in the direct final rule.
(3) In ace ndance with usual procedures, the staff will prepare a companion proposed rule, to be published at the same time as the direct final rule, in the event any significant opposing comments are received.
Aareement State Imolementation This action would not affect the Agreement States because the current Subpart D (i.e., il 35.100 and 35.120) is not an item of compatibility.
-Therefore,-the new section, 6 35.110, would not be an item of compatibility.
Suooortina Documents A regulatory analysis and an environmental assessment will be provided fer this rulemaking.
Resources lume L w+lth A Jhe-estimated-staff reseveces %w are for-the-rulemaiting U4GJAult -FTE;-mL we.lM m w umt-,1 h lead Office Staff and Staff from Sunoortina Offices hapfg Lead Office (RES) - Sam Jones NMSS - Donna Beth Howe OGC - Marjorie Rothschild OSP - Lloyd Bolling ADM - Mike Lesar Steerino Groups /Workino Group There is no need for a steering group for this rulemaking. The Working Group is identified above.
Enhanced Public Particioation This rulemaking will be placed on the electronic bulletin board at FedWorld and will also be published in the Federal Reatster.
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