ML20198K576
| ML20198K576 | |
| Person / Time | |
|---|---|
| Issue date: | 12/01/1997 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Inhofe J, Schaefer D HOUSE OF REP., SENATE, ENVIRONMENT & PUBLIC WORKS |
| Shared Package | |
| ML20198K526 | List: |
| References | |
| FRN-62FR63634, RULE-PR-30, RULE-PR-32 AF70-2-004, AF70-2-4, NUDOCS 9801150044 | |
| Download: ML20198K576 (2) | |
Text
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a Honorable James M. lnhofe, Chairman
' Subcommittee on Clean Air, Wetlands? -
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s ; Private Property and Nuclear Safetyi . . _
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l Committee on Environment and Public Works :r TUnited States Senate l
l Washingon, DCi20510.1 d
Dear Mr. Chairman:
- j Enclosed for the information of the Subcommittee are copies of a public announcement and a P
- Federal Register notice concoming a final amendment to 10 CFR Parts 30 and 32XThisi l rulemaking is being _taken in response to a petition for rulemaking submitted by Tri-Medi j
. Specialties,; inc. J '
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sThe' Nuclear Regulatory Commission (NRC) is amending its regulations to allow NRC licensees ~l
. to~ distribute a radioactive drug containing one microcurie of carbon-14 urea to any person for -; y j L "in vivo" d; agnostic use. The purpose of this diagnostic test is to detect the presence of the 1 s bacterium Helicobacter pylori (H, pylori), a cause of peptic ulcers. The NRC has ootermined ' l wo
- :S that the radioactive component of such capsules presents an insignificant radiation risk and,~- j therefore. regulahsry control of the drug for radiation safety is not necessary, The manufacture :
4 and distribution of the capsules will continue to require an N9C license. This amendment-
'makes the drug'more widely available, thus reduces cotts tofpatients, insurers, and the health care industry, ;
.1
, Sincerely,' j
- original signed;by DKRatnbun
- Dennis K. Rathbun, Director Office of Congressional Affairs t :
Enclosures:
l
- 1 ~ Public Announcement -
f ,
= 2.- Federal Register Notice
!,' . cc:" Senator Bob Graham Distnbutiorp _ _
w , ;CTrottier/RPHEB rf : !
- File Center 1
NCostanzi4
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300CUMENTJNAME:Lo:Ntse\c14fr-cl .wpd-w... m - ,,.a n r,%,, m twe . . .,%,
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- OFFICE: DRNRPHEB ( DRA/RPHEB2 D/DRA/RES - D/RES D/OCA NAME:' ATse:nb CTsttier '
JMurphy - MKnapp. DRethkn hV/973 DATEii 8/1/97' 8/ - ' /97 - 8/l /07? 8/ /97
- OFFICIAL RF. CORD COPY p64' S '
(RES File Code No.) 3A-3 e t . w w
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4 f>oc mber 1, 1997 ,
The Honorable ban Schaefer, Chairman Subcommittee on Energy and Power pN Committee on Commerce United States House of Representatives ,
Washington, DC _20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a public announcement and a Federal Register notice concerning a final amendment to 10 CFR Parh $3 and 32. This rulemaking is being taken in response to a petition for rutemaking submitted by Tri-Med Specialties, Inc.
The Nuclear Regulatory Commission (NRC) is amending its rt ,;ulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon.14 urea to any person for "in vivo" diagnostic use. The purpose of this diagnostic test is to detect the pres 6nce of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The NRC has determined that the radioactive component of such capsules presents an insignificant radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. The manufacture '
and distribution of the capsules will continue to require an NRC license. This amendment makes the drug more y>idely available, thus reduces costs to patients, insurers, and the health care industry.
Sincerely, original signed by DKRathbun Dennis K. Rathbun, Director i Office of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc: Representative Ralph Hall Difitibulloir CTrottier/RPHEB rf File Center NCostanzl DOCUMENT NAME: 0:,\tse', c14 f r.cl .wpd
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OFFICE: DRA/RPHEB DRA/RPHEB D/DRA/RES D!RES D/OCA _
NAME: ATse;nb CTrottier JMurphy MKnapp DRIfibbri DATE: I 8/1/97 8/ /97 8/ /97 8/ /97 /8/ / /97 OFFidIAL RECORD COPY
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(RES File Code No.) 3A.3 O