ML20198J270
| ML20198J270 | |
| Person / Time | |
|---|---|
| Issue date: | 03/07/1997 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-045, AF70-1-45, NUDOCS 9801140087 | |
| Download: ML20198J270 (1) | |
Text
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NUCLEAR REGULATORY COMMISSION WAsHlHQToN. o.C. 20565 4101 Jones File
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- March 7,1997 NG, JR.
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David L. Morrison, Director PTR !
MEMORANDUM TO: :
Office of Nuclear Regulatory Research . . .
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- FROM: Richard L. Bangart, Director '
[/ *? j Office of State Programs /( / tid /s -( gjr
SUBJECT:
PROPOSED RULE: EXEMPT DISTRIBUTION OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)
We have reviewed the subject document and concur. We offer for your consideration the following revisions to the subject section: i IV. Agreement State Compatibility Under the Atomic Eaergy Act, certain regulatory functions are reserved to e the NRC. Among these are the distribution of products to persons exempt from licensing, at discussed in 10 CFR Part 150. Hence, the proposed rula, if adopted would be a Division 4 item of compatibility, with regard to the manufacture and distribution of the capsules (10 CFR Part 32). Due to the need fo'ristionWides consistency,11n the;use of:productsywhich are wide.lv distributed [the] proposed]
rule if adopted;would be a Division 1 item of compatibility with regard to possession and use (10 CFR Part 30). Therefore, the Agreement States will need to make appropriate provisions in their regulations to allow any person to receive capsules containing one microcurie of carbon 14 urea for "in vivo" diagnostic use without need for a license, t
l t 1140087 pg 990109.
1-p MtFR32552 PDR.
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NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 30MH001 s, . . . . . j :
DATED: MAf'CH 7,1997 SIGNED BY: PAUL H. LOHAUS i
ALL AGREEMENT STATES MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATl":N (SP 97 015)
Your attention is invited to the enclosed correspondence which contains:
INCIDENT AND EVENT INFORMATION....... .....
PROGRAM MANAGEMENT INFORMATION.......
TRAINING COURSE INFORMATION..................
TECHNICAL INFORM ATION.............................
OTHER.........................................................XX RULEMAKING PLAN -
10 CFR PARTS 30 & 32 C 14 UREA H. PYLORI DIAGNOSTIC TEST
, Supplementary information: Enclosed for your information is the final rulemaking plan regarding a proposed rule which will allow the exempt distribution of capsules containing one microcurio of C 14 Urea to any person for diagnostic testing. You will recall that a draft of this rulemaking plan, which would have allowed generallicense distribution to any physician, was sent to you for review and comment via All Agreement States letter SP-96107 on October 1,1996. In considering the change from generallicense to exempt distribution, we would appreciate recalving your position on the following two questions within two weeks of the date of this letter:
- 1. What is the position of your State on the NRC's plan not to limit receipt of the drug to physicians, but to rely on FDA and State Boards of Pharmacy to
' decide who should administer the drug? (See page 6 of the final ruiemaking plan)
- 2. = Are there requirements in your State, that are mandated by regulations other than the radiation control program regulations, that might be of concern if
' the capsules are authorized under an exempt distribution license, with a Division 1. level of compatibility for the users? (See page 10 of the final rulemaking plan)
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SP 97- - 2-If you have any questions regarding this correspondence, please contact me or the i individual named below, f POINT OF CONTACT: Lloyd A. Bolling :
TELEPHONE: (301) 415 2327 i FAX: (301)415 3502 INTE!tNET: LAB @NRC. GOV t
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Paul H. Lohaus, Deputy Director !
Office of State Programs
Enclosures:
As stated t'
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Trottier SP 015 -2 Jones /Tse Morris File /Gallagher if you have any questions regarding this correspondence, please contact me or the individual named below. dm POINT OF CONTACT: Lloyd A. 6 'ing TELEPHONE: (301) 415-2327 FAX: (301) 415 3502 INTERNET: LAB @NRC. GOV
'Q1(nalSigned By:
PAUL H. LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated i
Distribution:
EDO RF DIR PF DCD (SP03) RSAOs) E-Mailed S.9roggitis PDR (YESf NO_) RSLOs) 3/10/97 All A/S File FAXED TO STATES: 3/7/97 DOCUMENT T3 receeve NAME: G:\SP97015 o copy of this elocument. Indicate h the tMy , %f C, . Copy without sihhment/encloswa *E* = Copy with attachment /encuswo i *N* = No copy OFFICE OSP OSP.%)u OSP:( y jy RES l OGC DEDR NAME LBolling:nb/gd PLohais([c[ls RBanga,rt ' BMorris i FXCameron HLThompson
,DATE 03/06/97* 03/06/97* 03/07/97* 03/07/9)* 03/07/97*
_ 03 ([197
_ _____ ______-__ ________ __________________________ _ _-