ML20198H571

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Forwards Documents & Index for Regulatory History File of Proposed Rule Entitled, Exempt Distribution of Radioactive Drug Containing One Microcurie of Carbon-14 Urea, 10CFR30 & 32
ML20198H571
Person / Time
Issue date: 01/09/1998
From: Tse A
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
NRC (Affiliation Not Assigned)
Shared Package
ML20013E023 List:
References
FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-001, AF70-1-1, NUDOCS 9801130343
Download: ML20198H571 (5)


Text

_ _ _ _ _ - _ ____-___

. f- k UNITED STATES j,

j NUCLEAR REGULATORY COMMISSION WASHINGTON D.C. 2060H001

%*****/ January 9,1998 AF70-1 MEMORANDUM TO: Nuclear Document System (NUDOCS), Mail Stop OWFN-F'1-17 Information and Records Management Branch Office of Chief infor ation Officer

' FROM: Anthony N. Tse Radiation Protection and Health Effects Branch Division of Regulatory Applications

. Office of Nuclear Regulatory Research

SUBJECT:

PROPOSED RULE (10 CFR PARTS 30 AND 32) ON MEDICAL USE OF BYPRODUCT MATERIAL -INDEX AND DOCUMENTS FOR REGULATORY HISTORY Attached are an index and the documents for a regulatory history 6le of a proposed rule. This proposed rule, entitled " Exempt Distribution of a Radioactive Drug Containing One Microcurie of 1 Carbon-14 Urea," was published on June 16,1997 (62 FR 32552).

All documents contained in this regulatory history file can be made available to the public y? document room. Thus, each document is marked "PDR"in the upper right-hand comer of the front page, if you have any questions, please call me at 415-6233.

Attachments:

1. Index
2. Documents

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ATTACHMENT 1 9

AF70 INDEX- REGULATORY HISTORY -

Proposed Rule Entitled " Exempt Distribution of a Radioactive Drug Containing One Microcurie of Cart >on 14 Uros*

DATE -FROM To- SUBJECT L 08/06/97 Dart >uckle B3helton OMB approval of inf. coll. requirements :

06/16/97 FR notice Proposed rule (62 FR 32552) 06/16/97 (Associated with final rule) Regulatory analysis 06/16/97 (Associated with final rule) Environmental assessment 06/13/97 - DRathbun Congr committees Forwarding the proposed rule-06/12/97 ' (Associated with proposed rule) Public announcement

-06/05/97 ALevin '

OMB Paperwork Reduction Act S Jbmission 06/04/97 -- CTrottier DMeyer Forwarding proposed rule for publication 05/30/97- JHoyle _

LJCallan - SRM (including Commission voting sheets) 05/20/97- - LaCallan- Rep. DBurton Responding to inquiry -

- 05/19/97 - l SHoffman HThompson, Jr. C-14 uros received FDA approval 05/02/97- DMeyer SJones _ Comments on FR notice 04/28/97- - LJCallan' Commissioners SECY-97-090.

04/18/97__ DButton HThompson, Jr. Expressing ec icems 04/17/97- DMorrison LJCallan Proposed rule for signature 04/17/97 : STreby OGC - No legal objection (on conc sheet) 04/08/97 D BSmith LBolling Responding to PLohaus' ltr dated 3/7/97

.04/04/971 BMorris WFry (petitioner) Responding to petitioner's concem

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~04/04/97 - AZeitoun JMate Safety report for the use of C-14 urea

'04/03/97 AZeitoun JMate Env. assess, for the use of C 14 urea 04/01/97 'CTrottier BShelton OMB package 04/01/97 : TFrazee- L3olling Responding to OSP letter of 03/07/97 03/26/97 RRatliff PLohaus- (same as above) 03/25/97i KWangler_ LBolling Additionai comments 03/24/97 KWangler . LBolling Responding to OSP letter of 03/07/97 03/24/97 ' CPaperiello - DMorrison NMSS conc .

03/21/97 > DTem PLohaus. Responding to OSP letter of 03/07/97

- 03/21/97 ~ MHibbs PLohavs (same as above)

.03/20!97: : JVicki LBolling . (same as above) 03/20/97 . BShelton . ATse- IRM comments 03/17/07 WSinclair .PLohaus Responding to OSP letter of 03/07/97 -

40217/97 - RFietcher PLohaus (same as above) 03/14/97 SCollins PLohaus. (same as above) 03/13/971 MMobley PLohaus- (same as above)

-03/13/97- DMeyer .  : DMorrison ADM conc & markup -

L 03/12/97- i THeavey ;SJones_ OCFO conc

-03/11/97 DFlater _ - LBolling Responding to OSP letter of 03/07/97

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e ' 03/11/97 - HBell - DMorrison - No comments

03/07/97_-_ ~ RBangart DMorrison OSP conc ,

03/07/97 PLohaus' AN Agreement States' Forwarding final rulemaking plan  :

03/05/97 JLieberman SJones OE conc 03/05/97 CTrottier ATse . SHoffman requesting a ltr on delay j 1 03/03/97L JHoyle LJCallen SRM approving Rulemaking Plan - t I '

- 02/26/97_ DMorrison Office Directors Office conc request - Proposed rule 02/07/97; HThompson Commissioners Final rulemaking plan 2

01/30/97--- DMcrrison - HThompson Final rulemaking plan -

,_ _ 12/06/96- MDibbles LBolling Comments on draft rulemaking plan-l 10/29/96 THill _ LBolling - (same as above) 10/10/96 T ortci9er PLohaus (same as above) 10/24/96 CJones LBolling (same as above)

.10/23/96 BSpill 3

TFrazee (same as above)

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-10/22/96 TFrazee . LBolling (same as above)-

, 10/21/96 JJacobi. LBolling (same as above)

- 10/17/96 : JDavidson LBolling (same as above) .

10/14/96 RAldrich LBolling (same as above)

10/10/96 JTaylor Senator CRobb Responding to inquiry i 10/04/96 VJeffs LBolling (same as abve) l 10/02/96_ JTaylor Commissioners Draft rulemaking plan 09/30/96 DMorrison JTaylor Draft rulemaking plan -

u - 09/30/96 DMorrison- RBangart Agreement State input on draft plan

[ 09/25/96 JTaylor Rep. DBurton Responding to inquiry

09/20/96 STrsby DMorrison OGC- No legal objection 1 09/20/96 RBangart OSP conc on rule plan (on sign sheet)

- 09/19/96 ;CPaperiello DMorrison NMSS conc

, 09/03/96- DBurton JTaylor - Requesting assistance on Tri-Med

08/27/96 JLieberman DMorrison OE conc 08/23/96 -CAbbott SJones OC conc

!. 08/20/96 DMeyer DMorrison ADM conc 08/19/96 - CRobb DRathbun Requesting assistance on Tri-Med 08/14/96 DMorrison Office Directors Requesting conc on rulemaking plan 05/30/96- AZeitoun: SJones Transmitting reports:

Environmental assessment

Safety report -

Analysis of costs and benefits-

-05/10/96 LCamper -JGlenn _ Comments on draft safety report, etc. .

05/09/96 SWyngarden JMate Revised Analysis of costs and benefits 04/11/96' DMorrison - JTaylor ' Initiation of a rulemaking plan -

03/29/96 SWyngarden JMate Transmitting draft reports:

J Safety report.

Environmental assessment-

_ Analysis of costs and benefits-

.  : 02/22/96 - JTaylor Rep JMeyers Responding to inquiry

- 01/16/96. JMeyers ISelin Expressing concems 11/22/95 JTaylor Rep. DBurton Responding to inquiry

. . 11/17/95? BSiegel DCool Minutes of ACMUI meeting (10/18-19,1995)

10/19/95_ _ DBurton ~ JPiccone Requesting serious consideration 04/12/95 E MLesar . SJones PRM-35-12 docket file e

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3 01/30/95 JTaylor Rep. DBurton

- Responding to inquiry 01/05/95 DBurton ISelin Requesting NRC to adopt the petition 12/19/94 FR notice Correction on benefits (59 FR 65280) 12/02/94 FR notice Filing of petition (59 FR 61831) 11/30/94 WFry Secretary of the Comm Benefits of the test 11/02/94 EBeckjord PNorry Fast-track determination 08/23/94 WFry Reg. Publ. Branch Submitting a petition for rulemaking 4

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ATTACHMENT 2 AF70 - 1 i

DOCUMENTS FOR POR 1

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