ML20198L477
| ML20198L477 | |
| Person / Time | |
|---|---|
| Issue date: | 09/03/1997 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Knapp M NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20198K526 | List: |
| References | |
| FRN-62FR63634, RULE-PR-30, RULE-PR-32 AF70-2-017, AF70-2-17, NUDOCS 9801160040 | |
| Download: ML20198L477 (4) | |
Text
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UNITED STATES NUCLEAR REGULATORY COMMISSION
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MEMORANDUM TO: Malcolm R. Knapp, Acting Director l
Office of Nuclear Regulatory Research FROM: Richard L. Bangart, Director .
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Office of State Programs FINAL RULE: EXEMPT DISTRIBUTION OF A RADIOAC E SUDJECT: ,
DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA 49 ARTS 30 AND 32) ,
We have evaluated the package distributed for review and concur subject to incorporation of comments noted as markups on pages 18 and 19, attached. The OSP staff contact for this review is Lloyd Bolling. He can be contacted at 415 2327 or by e mail address LAB.
Attachment:
As stated cc: A. Tse, RES
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This peregraph establishes that persons exempt from licensing would be prohibited from l
using the drug for resaarch involving humans subjects. A specific Part 35 license would 's needed to use the drug in any research involving human subjects in order to ensure the protection the rights of the human subjects.
Paraorsch fe)
This paragraph specifies that a specific license is needed to manufacture, prepare, process, produce, package, ropackage or transfer such capsules for commerclat distribution.
Parnaraoh (d)
This paragraph declares that the regulations do not relieve end users from complying with applicable FDA, other Federal, or State requirements goveming the receipt, administration, an k t
r use of drugs, f% G$0.-
V. Agreement State Compatibility 5 Under the Atomic Energy Act, certain regulatory functions a reserved to the NRC.
Among these are the distribution of products,to persons exempt fro licensing, as discussed in 10 CFR Part 150. Hence, amendments related to the manufacture a d commercial distribution of the capsules (10 CFR Part 32)is a Lwiston 4 item of compatibili . However, amendments related to possession and use (10 CFR Part 30) is a Division 1 item of compatibility because of the nood for nationwide consistency in the use of prrducts which are widely distrib ed. M r regulations to Therefore, the Agreement States will need to make appropriate provisions in th' k pr*
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allow any person to receive capsules containing ons microcurie o m diagnostic use without need for a license.@,: SC :..e q:d ".: ^.;=
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I VI, Finding of No Significant EnvironmentalImpact: Availability The Commission has determined under the National Environmen amended, and the Commission's regulatlo a M Subpar 1 A of 10 CF amendments is not a major Federal action significantly affecting the quali environment; therefore, an environmentalimpact statement is not req establishes requirements for the manufacture and commercial distribu caps'utes to persons exempt from licensing and establisnes reg receive the capsules without an NRC license. The Commission f bel component of this drug presents no significant radiation d risk and the "in vivo" d!sgnostic use of the capsules for radiation safety is n
! li that this final rule will not cause tny significant increase in radiation ex I
radiation release to the environment beyond the exposures or r I
the carbon 14 capsules under the current regulations. Also,it is expe non radiologicalimpacts. One public comment on the draft environm j
received (See Comment 9 under the heading
- Proposed Rulo, Pub o
Responses *),
The environmental assessment and finding of no significantimpact o i-determination is based is available forinspection at the NRC Public Street NW,(Lower Level), Washington, DC. Single copies of the e
' the finding of no significantimpact are available from Dr. Amnony N. T 19
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.The Commissioners 4 l s
L Concurren:2 #sge for Commission Paper Relating to '
Dental of Petition for Rulemaking (PRM 5043) -
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r i RECORD NOTE: A conv of this Denial of Petition was sent to CRGed. OC and IG for information on ,
, 5 DOCUMENT NAME: 0;\jamgochtslodideWtass2.wpd 'See previous conc. ,
To roceive a copy of this document, Indicate in the box 'C" = copy without attachment / enclosure, *B" = copy with t rttachment/ enclosure, "N" = No copy ,
OFFICE: RPHEB/DRA RPHEB/DRA D/DRA/RES D/RES
' JMurphy* MKnapp NAME: MJcmoochlan*;nb CTrottier*
DATE: 7/17/97 7/24/97 8/15/97 8/ /97 -
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OFFICE: D/NMSS D/AEOD D/NRR D/OE [
NAME: CPaperiello TMartin 8 Collins JLieberman DATE: 8/ /97 8/ /97 8/ /97 & /97 ummmmumune ummunummuuammuuuuumaumummuumuseuumuumn usuuummuuuuuuuummum muumm OFFICE: D/OSP [r7/ OGC D/RDB/ADM CARM8/lRM NAME: ,RBangart WOlmstead DMeyer BShelton
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OFFICIAL RECORD COPY RES FILE CODE NO.:
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RPHEB/rf Central File, EDO R/F CAGallagher, BMMorris, DMendiola, LBRiani .'
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