ML20198K567
| ML20198K567 | |
| Person / Time | |
|---|---|
| Issue date: | 12/01/1997 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Gingrich N, Gore A, Murphy R GENERAL ACCOUNTING OFFICE, HOUSE OF REP., SPEAKER OF THE HOUSE, SENATE, PRESIDENT OF THE SENATE |
| Shared Package | |
| ML20198K526 | List: |
| References | |
| FRN-62FR63634, RULE-PR-30, RULE-PR-32 AF70-2-003, AF70-2-3, NUDOCS 9801150041 | |
| Download: ML20198K567 (3) | |
Text
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- The H$norable'Al Gore I
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President of the United
- States' Senate :
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/ T Washington, DC. 20510. :
Dear Mr. President:
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Purs" ant to Subtitle E of the Small Business Regulatory Enforcement Falmess Act of 1996,5.-
U.S.0; 80.1, the Nuclear Regulatory Commission (NRC) is submitting a final rule regarding' distribution of a radioactive drug containing one raicrocurie of carbon-14 urea to any person forl
- 1"in vivo" diagnostic use for humans. The purpose of this diagnostic test is to detect the-
, presence.of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The final rule 1
makes the drug more widely available,- and reduces costs to patients, insurers, and health care; industry.LThe distribution of the drug'in' capsule form presents a minimal radiation. risk and, therefore, regulatory control of the drug for radiation safety is.not necessary. This actiw is !
, being taken in response to a petition fot tulemaking (PRM-35-12) submitted by Tri-Med -
. Specialties, Inc. -
t We have duermined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). -We have confirmed this determination with the Office of Management and Budget.
. Enclosed is a copy of the final rulc that is being transmitted to the Office.of the Federal Register
- for publication. Also enclosed is a copy of the Regulatory Anslysis for the final rule. The 1
4 Regulatory Flexibility Certification is included in the final rule.
Sincerely, s
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
Final Rule Regulatory Analysis-DISTRIBUTION RPHEB R/F 4
~ RES File
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- see previous ccocurrence Document name: o:\\tse\\c14fr-sl,wpd -
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i LDic mb K b'19971 hk iThe Honorable Newt Gingrich;
-._ Speaker of the United States :
' HUJss of Representatives -
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. Washington, DC 20515; i Dear Mr. Speaker;
' i Pursuant to Subtitle'E of the Small Business Regulatory Enforcement Faimss Act of 1996,5
. U.S.C. 801, the Nuclear Regulatory Comrnission (NRC) is wbmitting a Gnal rule regarding -._.
Edistribution of a radioactive drug containing one microcurie ~of carbon 14 uros to any person for -
1"in vivo" diagnostic use for humans. The' purpose of this diagnostic test is to detect the-:
_ i
- presence of the bacterium Helicobacter pylori (H.' pylori), a cause of peptic ulcers. The final rule :
makes ine drug more widely_ available, and reduces costs to patients, insarers, and health care industry. The distribution of ine drug in capsule form presents a minimal radiation risk and,-
H I therefore',- regulatory control of the drug for radiation safety is 'not necessary. THs action is ibeing taken in response to a petition for ruiemaking (PRM-35-12) submitted by Tri-Med :
Specialties, Inc.
We have determined that this rule is not a "mf or rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.
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Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register-
? for publication Also enclosed is a copy of the Regulatory Analysis for the final rule. The 4
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- Regulatory Flexibility Certification is included in the final rule.
Sincerely, Original signed by DKRathbun Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
Final Rule Regulatory An:.vsis G
DISTRIBUTION:
V RPHEB R/F RES File g
OC R/F L*see previous concurrence -
Document name: o:\\tse\\c14fr-sl.wpd -
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ATse'
~CATrottier
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MKnapp*
D un DATE' i8/1/97 8/5/97-8/12/97 8/
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OFFICIAL-RECORD COPY RES#3A-3 S-4 f
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D comber 1, 1997 Mr. Robert r'. Murphy
{pp General Counsel General Accounting Office Room 7175 441 G. St., NW Washington, DC 20548
Dear Mr,
Murphy:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Faimess Act of 1996,5 U.S.C. 801, the Nuclear Regulatory Commission (NRL) is subnitting a final rule regarding distribution of a radioactive drug containing one microcurist of carbon 14 urea to any person for "in vivo" diagnostic use Ior humans. The purpose of this diagnostic test is to detect the sence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The final rule makes the drug more widely available, and reduces costs to patients, insurers, and health care industry. The distribution of the drug in capsule form presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. This action is being taken in response to a petition for rulemaking (PRM 3512) submitted by Tri-Med Specialties, Inc.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule that is being transmitted to the Office of the Federe! r.egister for publication. Also enclosed is a copy of the Regulatory Analysis for the final rule. ':,e Regulatory Flexibility Certification is included in the final rule.
Sincerely, original signed by DKRathbun Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
Final Rule Regulatory Analysis DISTRIBUTION:
RPHEB R/F RES File OC R/F
- see previous concurrence DOCUMENT NAME: 0:\\tse\\c14fr-sl um.m,,-.,
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OFFICE:
DRA/RPHEB DRA/RPHEB D/DRA/RES D/RES D/06M NAME:
ATse:nb*
CTrottier*
JMurphy*
MKnapp*
D un DATE:
8/1/97 l 8/ 5 /97 8/12 /97 8/
/97
/8tl /97 OFFICIAL RECORD COPY