ML20236T476
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%,*. ,****/ SEP 22 BB7 MEMORANDUM FOR: David Meyer, Chief Rules and Procedures' Branch FROM: Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
PUBLICATION OF FEDERAL REGISTER NOTICES Please arrange for publication of the enclosed notices " Comprehensive Quality Assurance in Medical Use and Standard of Care" for a 90-day comment period, and " Basic. Quality Assurance in Radiation Therapy" for a 60-day comment period. Both notices should be published within one issue of the Federal Register. Courtesy copies should be mailed'to. licensees in Program Codes 02110, 02120, 02121, 02200, 02201, 02209, 0227.0, 02220, 02300, 02500, l 02510, 02511,.02512, and 02513.
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- kua j rh/jw py These notices have been revised to reflect Commission comments.. An annotated L. Staff Requirements Memorandum is enclosed showing where changes were made.
Congressional letters and a draft public announcement letter are also enclosed.
^1/1 H$ L. Thompson rector 0fceofNuclearMat/,Jral Safety and Safeguarns
Enclosures:
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F 1-i 3712010278 871201 PDR PR j 35 52FR36942 ,P,DR
,i DRAFT PUBLIC AFFAIRS NOTICE l
l Today the Nuclear Regulatory Commission published in the Federal Register two notices on quality assurance in the medical use of byproduct material. l Based on analyses of several misadministration events over the years, the 1 NRC believes that additional regulatory oversight is needed to reduce the chance of misadministration and provide for better patient safety. The NRC has devel- 1 oped a two-pronged approach to this problem. First, the agency will publish a basic quality assurance rule that would impose additional quality assurance requirements on licensees that use materials that pose a clear potential for )
hazard to the patient. This action would affect licensees that offer radiation therapy services or that use potentially hazardous diagnostic radiopharmaceuticals. f
~Second, the agency will, at the same time, request public comment on how the NRC should implement a comprehensive quality assurance program requirement that would ]
apply to all licensees authorized to provide any type of medical use service.
l The NRC has provided a 60-day public comment period on the basic rule and a j i
90-day public comment period on the advance notice. Copies of the notices were I mailed to affected NRC licensees and other individuals.
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SEP 22 5
' MEMORANDUM FOR: David Meyer, Chief-Rules and Procedures Branch FROM: Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
PUBLICATION OF FEDERAL REGISTER NOTICES Please' arrange for publication of the enclosed notices'" Comprehensive Quality Assurance in Medical Use and Standard of Care" for a 90-day comment period, and " Basic Quality Assurance in Radiation Therapy" for a 60-day .]
comment period. Both notices should be published within one issue of the i j
Federal Register. Courtesy copies should be mailed to licensees in Program L Codes 02110, 02120, 02121, 02200, 02201, 02209,-02210, 02220, 02300, 02500, .
02510, 02511, 02512, and 02513. .I L
These notices have been revised to reflect Commission comments. An annotated i Staff Requirements Memorandum is enclosed showing where changes were made.
Congressional letters and a draft public announcement letter are also enclosed.
L g ped) Mh L NUF"5 Hugh L. Thompson, Jr., Director Office of Nuclear Material ;
Safety and Safeguards
Enclosures:
As stated DISTRIBUTION: ,
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i SEE PREVIOUS CONCURRENCE
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NAME:NMcElroy/cv :VMiller :GS'oblom : nningifsm ~ :RBernero:HTo(mpson DATE:9/18/87 :9/18/87 :9/ 67 :9/N/87 :9/)t/87 :9/1 /87 1
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