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APR 151985 I&&id40thi FOR:
John C. iloyle, Acting Secretary FRGt:
William J. Dircks Executive Director for Operations SUDJECT:
STAFF REQUIREMENTS - DISCUS 510N OF PROPOSED REV1SIONS TO PART 35, 10:00 A.M., WEDNESDAY, WRCH 20,1935, CG.:MISSIONERS' COWEREt!CE R00f-1, D.C. OFFICE (OPEN TO PiDLIC ATTENDANCE)
This is in response to your r.em,orandum of March 29, 1935 (M350320A) that forwarded the Coc. mission's request for additional information concerning the revision of 10 CFR Part 35, " Medical Use of Gyproduct Material."
In response to the request tnat the stotcaent of considerations include a sumary of NRC's regulatory role as it affects the patient, the staf f proposes to insert the following paragraph on page 3 of SECY 84-185, (the Federal Reqister notica), as the first subdivision under tha heading "GRC'S rMGJLATORY PRGCRAM":
- Policy Recardir.p the Medical Use of Byproduct Faterial in a policy statccent published on Februaryr 9,1979 (44 FR 8242), the NRC noted that it regulates the medical use of byproduct material as necessary to provide for the rediction safety of workers and the general public, regulates the radiation safety of patients wherc justified by the risk to patients, cod ninimizcs its intrusion into ecdical judgments affecting patients and into other aceasitraditionally consitared to bo the practico of tr.edicine.. The NRC'does have the authority to regulato the medicci use of byproduct material to protect the hoolth and safety of patients, but also recognizos that physiciens have the primary responsibility for the protcetion of their patients.
t'F.C regul ations aro predicated on the assumption that properly trained and adequately Infornad physicians will acka decisicas in the best interest of their patients.
This revision retains URC's current balanco between adequeto controls enti evci:'anca of undun interference in medical Jud>r.mnN.
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8509230393 850906
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8 John C. hoyle In response to the request that tha staf f clerify the definition of "ninor chango" by characteriz!ng a representative cross-section of "raince chang.cs"that have required Iicensa cmendrrents in tha y2st, the staf f submitted on analysis or iiccasa tecnc.cnts in a nororandum to sr. Chila frce r.e dated April 3, 1935.
(Signed)Wi!!iam J. Dircks Willicm J. Dircks Executive Director for Operations DISTRIBUTION - 8s0320 NMSS r/f FCML r/f FC Central File NLMcEl roy VLMiller RECunningham JGDavis WJDircks BClausser PPAS/NMSS NMSS 8s0320 DBMausshardt EDO r/f GCunningham Roe.
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