ML20195G803
| ML20195G803 | |
| Person / Time | |
|---|---|
| Issue date: | 10/26/1998 |
| From: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Fye W MARSHFIELD CLINIC, MARSHFIELD, WI |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 NUDOCS 9811230140 | |
| Download: ML20195G803 (1) | |
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% UNITED STATES L.I f 3 NUCLEAR RESULATORY COMMISSION WASHINGTON, D.C. 20665 0001
- October 26, 1998 g
W. Bruce Fye, M.A., M.D., F.A.C.C. g ,_S Medical Director, Marshfield Heart Care ~ gQ 1000 North Oak Avenue
'M I 'O g F l Marchfield, WI 54449 QQ MO
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Dear Dr. Fye:
-(G3ffy35/6) . a 5
- l 1 am responding to your letter to Senator Herb Kohl, dated August 28,1998, iri which you provided comments on proposed changes to the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you supported the use of a " risk-based" approach in' establishing training and experience l
- requirements for cardiologists who use intravascular brachytherapy, which you noted is an investigative procedure. .
The Commission considers the overallissue of training and experience to be one of the most I important issues addressed during the rulemaking. Adequately trained personnel are key to the safe use of radioactive materialin medicine. Therefore, the Commission has proposed that the training and experience criteria for all users of radioactive material be risk-informed and focused on safety. At the same time, however, the Commission recognizes that the proposed rule must be adaptable to the many medical uses of byproduct material, including intravascular brachytherapy. This important issue, among others, was discussed at a Commission public meeting in June 1998. The Commission directed the staff to study the issue further and provide a basis for its current position.
On August 13,1998, the proposed rulemaking was published in the Federal Rgaister, for a 90-day public comment pericd. A series of public meetings was also scheduled during the comment period. The first two meetings took place August 19-20,1998, in San Francisco, California, and September 16 -17,1998, in Kansas City, Missouri. The last meeting was held in Rockville, Maryland, on October 21-22,1998. Details of the public meetings were published in the Federal Reoister on July 24,1998 (63 FR 39763). As noted in the Federal Register notice for these meetings, the Commission, through the facilitator for the meetings, invited participants who represent a broad spectrum of interests that may be affected by the proposed rulemaking.
The American College of Cardiology (ACC) staff has worked with the NRC staff to ensure that the cardiologists' interests are represented at these meetings. Representatives of the ACC and !
the American Society of Nuclear Cardiology were invited to participate in the public meetings. i The Commission plans to carefully evaluate all the public comments in finalizing the training ,
and experience requirements for all users of byproduct material. I l
Sincerelyg i
N N n. { u : m William D. T avers
(
l Executive Director for Operations 9
i l
cc: The Honorable Herb Kohl 9811230140 981026 PDR PR l 20 63FR43516 PDR l 3MID