ML20006B545

Ack Receipt of Re Rl Wahl Comments Supporting Petition for Rulemaking to Revise 10CFR35.NRC Currently Reexamining Regulations Governing Use of Radiopharms in Nuclear Medicine to Resolve Issues Raised in Petition

ML20006B545
Person / Time
Issue date:	01/11/1990
From:	Rathbun D NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA)
To:	Levin C SENATE
Shared Package
ML20006B546	List: ML20006B545 ML20006B548
References
RULE-PRM-35-9 CCS, NUDOCS 9002050052
Download: ML20006B545 (2)

Text

~,..

f M 1 i -

. Y p Cao '

Q

/

/

UMTED STATES

)

NUCLEAR REGULATORY COMMISSION-

.o

• E wASHWGTON, D. C 20005 j

..... 'c January 11, 1990 l

1 1

.The Honorable Carl Levin.

United States Senate q

. Washington,'D. C.

20510 1

t

Dear. Senator Levin:

j

>This is to acknowledge receipt of your letter dated December 21 -1989, transmitting co-respondence from your constituent, Dr.- Richard L.

Wahl, in support of a petition for rulemaking to revise 10 CFR 35' l

t

[.

Regulations.

i i

The petition for rulemaking was submitted to the Nuclear Regulatory.

i

r. omission (NRC) by the American College cf Nuclear Physicians 4and the-Society of Nuclear Medicine. The petitioners requested that the NRC- -

7 modify current regulations.to allow:.. (a):the use of radiopharmaceuticals l

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)compoundingradiopharmaceuticalsfromreagentichemicals.

l

,l The NRC publis%d a Federal Register notice (54 FR 38239, September l15, i

1989), announcing receipt of the! petition and providing a.90-day public L

eoment period.

We have received more than'400 comment letters..

In it@t of the'information submitted by the petitioners and'the ll commenters. -the NRC is currently reeye:aning its regulations governing the l

use of radiopharmaceuticals in nuclear medicine. The issues raised will' be addressed in a rulemaking proceeding specifically. designed to.resolvt the petition. During this rulemaking process,'the NRC will consult with t

the Food and Drug Administration, which approves the-package.. inserts-and the manufacturer's instructions, and 'the. State Boards of' Pharmacy :and.

~

invite their views regarding the resolution of thisJpetition.

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

considered along with the others in reexaminingtour regulations..However, l

it would be premature to predict the outcome of the reexamination before-L completion of the rulemaking proceeding.

I. trust this information is responsive to your-request.

/

i Sincerely, l

I 76g7 Dennis K. Rathbun,. Director

'f ASCgSCAN Congressional. Affairs-Office of Governmental and-J Public' Affairs 9002050052 900111 q

1. h9 PDC FULLTEXT ASCll 3CAN

' I 3

I

.y p

0 I'

k.

1

-Q, cogs a0

,.zog e

\\

y;p bp s

.

g ru : g,, WA i t hj',;,{-. -5..%~,$4 Y . Y , sq< v-h..., p_ 3.. j r ,1. . g#y-l ',, N l 49.j..';g, .,7 p,-l V'M

y. 3 w

-) '- 3 7, i:' G5% V, l ',, &_ a l y.. g._ Letter also verbally approved by Jim Blaha and Mike Weber (per Dennis Rathbun/Betsy Keeling) prv /-//-90 .