ML20006B565

Ack Receipt of Transmitting Constituent R Clark Ltr in Support of Petition for Rulemaking PRM-35-9.NRC Currently Reexamining Regulations Governing Use of Radiopharms in Nuclear Medicine & Will Consult W/Fda

ML20006B565
Person / Time
Issue date:	01/11/1990
From:	Rathbun D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA)
To:	Byran R SENATE
References
RULE-PRM-35-9 CCS, NUDOCS 9002050078
Download: ML20006B565 (2)

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UNITO STATES 1

NUCLEAR REGULATORY COMMISSION

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January 11, 1990 The Honorable Richard H. Brye.n United Statas Senate p

Washington, D. C.

20510

Dear Senator Bryan:

This is to acknowledge receipt of yNr letter dated December 7,1989, j

transmitting correspondence from your constituent, Dr. Robert Clark.

in support of a petition for rulmmking to ravite 10 CFR 35 degulations.

'I The petition for rulemaking was submitted to the Nuclear Regulatory Commission (NRC) by the American College of Nuclear Physicians _ and the Society of Nuclear Medicir.e. The petitioners requested that the.NRC modify current regulations to allow:

(a)theuseofradiopharmeeuticals i;

for therapeutic indications not listed in the package insert (diagnostic j

indications _ are not restricted by current regulations), (b) deviations from the manufacturer's instructions in preparing radiopharmaceuticals, and (c) compounding radiopharmaceuticals from reagent chemicals.

The NRC published a Federal Register notice (54 FR 38239, September 15, 1989), announcing mceipt of the petition and providing a 90-day public comment period. We have received more than 400 consnent letters.

in light of the information submitted by the-petitioners and the commenters, the~ NRC is currently reexamining'its regulations governing the use of radiopharmaceuticals in nuclear medicine.- The issues raised will be addressed in a rulemaking proceeding specifically designed to resolve the petition. During this rulemaking process, the NRC will consult with the Food and Drug Administration, which approves the package insarts and-l the manufacturer's instructions, and the State Boards of pharmacy and j

invite their views regarding the resolution of this-petition.

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I want to assure you that the comments of your constituent will be.

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considered along with the othwes in reexamining our regulations. However, it would be premature to predict the outcome of. the reexamination before completion of the rulemaking proceeding.

I I trust this information is responsive to your request.

L Sincerely, I

M Fuli TQ7 Dennis K. Rathbun, Director' Scil SCAy Congressional Affairs Office of Goveramental and L

Public Affairs l

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Letter also verbally approved by Jim Blaha and Mike Weber (per Dennis Rathbun/Betsy Keeling) prv /-//- 90 l

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WASHINGTON,00 20810 December 7,'1989 Chairman Lando sceh, Jr.

Nuclear-Regulatory Commission Wash $.ngton, DC 20555 Dear Chairman zoch

. Please find enclosed a copy of a letter sent to the Nuclear Regulatory Commission by one of my constituents, Dr. Robert ~

Clark.

As you can see, Dr. Clark is concerned with the Commission's rugulations regarditig nuclear medicine.

Pleasa provide me information regarding this issue.

In particular, I would appreciate information regarding the pstition of the Society of Nuclear Medicine Dr. Clark mentions in his letter.

Thank you for.your consideration of this matter.

Sin eraly, fl+

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WASHINGTON DC 20810 i

December 7, 1989 t

i Chairman Lando Zech, Jr.

l Nuclear Regulatory Com:nission Washington, DC 20$55

Dear Chairman tech:

4 Please find enclosed a copy of a letter sent to the Nuclear Regulatory Commission by one of my constituents, Dr. Robert i

Clark.

As you can see, Dr. Clark is concerned with the Commission's regulations regarding nuclear medicine.

Please provide me information regarding this issue.

In particular, I would appreciate information regarding the petition of the Society of Nuclear Medicine Dr. Clark mentions in his i

letter.

Thank you for your consideration of this matter, i

Sin erely, L

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U ited Stat Sen'ator RHB/jb i

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1 ROBE RT W. CL ARK. M.D., L.T.D.

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3121 S. Maryland Parkway. Suite 504 Las Vegas Nevada 89109 INTERNAL MEDICINE NUCLEAR MEDICINB ENDOCRINOLOGY & METABOLISM MEDICAL DIRECTOR DIPLOMATE Nevada Nucleet Madisine Leberstery American board Of internal Medicme pyggg FELLOW American Board of Neslear Madisine Amencan Colley Of Physicians gggggg

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N +fd Amer.can College of Weslear Physistmas SectetSr. o: the Commiss!on U.S. Nuclear Pegu atory Commission Docreting anc Serv!ce Branch. Docket ePRM-35-9 Wasn.neton. D.C 20555 Dehr Mr..5ecretu y.

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'ng tc you to request that the Amerlean Col!ege et live es: Pn ysi c i an s. Soc i e t y of Nuclear Mecicine petition for Puiemaring oe i v.p i eme n t e c.

I na"e Deen practicing.uclear mealcine for 25 years.

I ran the nucient mecicine cepartment at Southern Nevaca Memorial Hospital (now Un!.erstty Mealcal Center) here in Las Vegas +or two years anc openeo the rirst inoepencent nuclear mealcine lacoratory licensea by the State of Nevaca i t.

1973 which I continue to own, run. aria operste.

The ru.es vn;ch nave oeen implementec by the Nuclear Pegulatory Cc'.r. ss i c r anc suosequer.tly acopted Dy the State of Nevaca cu r : ~.g tne perioc of time that my fees for my clinical services have :ncreasea 1504 from 1973 thru 1989 have increasec the cost of rnato;sotcpes in excess of 1000A wi th no acol t ional oenet i ts to the patients hna with no acultional prof its to the suppliers.

' lou r increasing rules. requ i rements, regu l at iones wh i ch are prcposec. furtner tnreaten to both limit the access of patients to qunilty nuciear mealcine services anc continue to increase the costs.

For tnis reason. I am requesting that the petition oy the Society ot !!ucle ar Meciclne De implementea to prevent tut ther incressec costs anc ceterioration of care to patients.

Jcur conssceration of this woula De greatly appreclateo.

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