ML20148H613
| ML20148H613 | |
| Person / Time | |
|---|---|
| Issue date: | 05/19/1997 |
| From: | Dicus G NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20148H596 | List: |
| References | |
| FRN-62FR32552 AF70-1-011, AF70-1-11, SECY-97-090-C, SECY-97-90-C, NUDOCS 9706100459 | |
| Download: ML20148H613 (2) | |
Text
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l NOTATION VOTE RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER DICUS
SUBJECT:
SECY-97-090 - PROPOSED RULE: EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)
Disapproved Abstain l Approved X
'Not-Participating Request Discussion i
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COMMENTS: One edit, attached , i i
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Release Vote / XX / MA /9 . / 99)
DATE' I
. Withhold Vote / __ /
i Entered on "AS" Yes X No l l
i 9706100459 970530 PDR COMMS NRCC CORRESPONDENCE PDR u
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s person desiring to use the capsules for human research would still be required to submit an application for a specific license under Part 35 in order to protect human subjects.
1 The phrase "in vivo diagnostic use" is being used in 5 30.21 instead of " medical use" for two reasons. First, the term " medical use" has a specific meaning and is defined in 5 35.2 to mean "the intentional internal or external administration m yproduct mate ial or the radiation therefrom to patients or human research subjects under the supervision of an authorized user." This term would be inappropriate because: ,
(1) " Medical use" limits administration to authorized users; use of this drug would not be so limited; and (2) " Medical use" includes the administration of the drug to a human research subject, which would be prohibited by this rulemaking. l Effects of the Proposed Amendments i
f The effect of these proposed amendments would be to make the drug available to any person, for "in vivo" diagnostic use, without need for an NRC or Agreement State license. Because the receipt and use of the drug would be exempt from NRC licensing, Agreement States would need to make appropriate provisions in their regulations to recognize the exempt distribution of the drug, for "in vivo" diagnostic use. Thus, after the manuf acture and distribution of the drug, the NRC and the Agreement States would not regulate the use of the drug as long as its use was for "in vivo" diagnostic use. This i tate regulations, primary-care physicians would g means that, under NRC and Agreement not need to be " authorized users" in order to administer the drug, and would not 1
i necessarily need to refer their patients to nuclear medicine physicians. This should result l
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