ML20005F373
| ML20005F373 | |
| Person / Time | |
|---|---|
| Issue date: | 12/28/1989 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Cranston A SENATE |
| Shared Package | |
| ML20005F374 | List: |
| References | |
| RULE-PRM-35-9 CCS, NUDOCS 9001160225 | |
| Download: ML20005F373 (2) | |
Text
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- o UNITED STATES NUCLEAR REGULATORY COMMISSION o
h WASHINGTON, D. C 20666 k
December 28, 1989 The Honorable Alan Cranston United states Senate Washington, DC 20510 Daar Senator Cranston:
Thank you for your letter of November 27, 1989, regarding the cements by I
Dr. Malcolm R. Powell of the University of California at San Francisco on a petition for rulemakirKJ.
As noted in the wu.epcidercie enclosed with your letter, the petition for
[
rulenaking was subnitted to the Nuclear Regulatory Ctmanission (NRC) by the American College of Nuclear Physicians and the Society of Nuclear Medicine.
The petitioners requested that the NRC modify current regulations governing the use of radiopharmaceuticals in nuclear medicine to allow the use of therapeutic radiopharmaceuticals for medical indications not listed in the package insert and pemit deviations from the manufacturer's instructions for eluting generators or preparity reagent kits. Dr. Powell expressed strong support for the petition.
t The NRC published a Federal Register notice (54 IR 38239, September 15, 1989) announcing the receipt of the petition and providing a 90-day public coment period. We have received more than 400 public ocument letters, including Dr. Powell's letter which was enclosed with your letter.
In light of the information subnitted by the petitioners and the cementers, the NRC is currently reexamining its regulations governing the use of radiophamaceuticals in nuclear medicine. The issues raised in the petition and in Dr. Powell's letter will be addr W in a rulemaking proceeding specifically designed to resolve the petition. During the n11emaking process, the NRC will consult with the Food and Drug Administration (PDA) and the State Boards of Pharmacy (SBP) to invite their viws regarding the resolution of this petition.
I want to assure you that Dr. Powell's coments will be considered with the others in raavam Ming our regulations. However, it would be premature for the NRC to predict the autome of the rawa_mination before the ocmpletion of the rulemaking pvcmsiing.
I' I trust that the above information is responsive to your request.
1 Sincerely,
/
i
,kkII&25891226 35-p J,
M. Tay r PDC ecutive Director for Operations
Enclosure:
puu. TEXT ASCll SCAI4(7gSj) 10/17/89 ltr, Powell to NRC qk
2 Distribution:
yd December 28, 1989 EDO r/f TSpeis OGC EDO 4972 BMorris LBolling JTaylor ZRosztoczy VMiller I
frd h M le Alan Cranston J a M tad states Senate SECY 89-1307 PDorm Washington, DC 20510 CA ATse ec W Dear Senator Cranston en NMSS Thank you for your letter of November 27, 1989, regarding the ocenents by Dr. Malcolm R. Powell of the University of California ct San Francisco on a i
petition for rulemaking.
As notad in the cmu-ridens enclosed with your letter, the petition for
]
rulemaking was submitted to the Nuclear Regulatory Comission (NRC) by the American College of Nuclear Physicians and the Society of Nuclear Medicine.
The petitioners requested that the NRC modify current regulations governing j
the use of radiopharmaceuticals in nuclear medicine to allow the use of therapeutic radiophamaceuticals for medical indications not listed in the package insert and permit deviations frcan the manufacturer's instructions for elutirs generators or preparirg reagent kits. Dr. Powell exprammi strong support for the petition.
The NRC published a Federal Register notice (54 FR 38239, September 15, 1989) announcirq the receipt of the petition and providing a 90-day public coment period. We have received more than 400 public coment lettars, including Dr. Powell's letter which was enclosed with your letter.
In light of the information submitted by the petitioners and the ocenenters, the NRC is currently raavaminirg its regulations governing the use of
't radiopharmaceuticals in nuclear medicine. The issues raised in the petition.
and in Dr. Powell's letter will be addrammai in a rulemaking scc-iing t
l specifically designed to resolve the petition. During the rulanaking process, the NRC will consult with the Food and Drug Administration (ITA) and the State i
Boards of Pharmacy (SBP) to invite their views regarding the resolution of
)
l this petition.
I want to assure you that Dr. Powell's ocanments will be considered with the others in :,a===4ning our regulations. However, it would be premature for the NRC to predict the autocane of the raanmination before the ocmpletion of the rulemaking r -:==iing.
c I trust that the above information is responsive to your request.
Sincerely, James M.Tayw, g Original Signed James M. Taylor Dcecutive Director for Operations
Enclosure:
- See previous concurrences, i
10/17/89 ltr, Powell to NRC NMSS OGC GPA CV JGlenn*
SPreby*
VMiller*
DRa JT lor 12/19/89 12/19/89 12/19/89 12Fi/89 12/
/89 OFF: RDB/DRA RDB/DRA DRA/RES DRA/RES RES NAME: ATse/JIblford* SBahadur* ZRocztoczy* BMorris*
TSpeis EBeckjord DATE: 12/19/89 12/19/89 12/20/89 12/20/89 12/ /89 12Q//89
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