AEC Licensing of Radioisotopes for Clinical Research
The established policies of the Atomic Energy Commission are embodied in the Federal Register in 10 CFR 30 with which the reader is presumably familiar. The decisions and actions of the Advisory Committee on Medical Uses of Isotopes of the Division of Licensing and Regulation of the AEC contribute to the making of regulations, but it is neither possible nor desirable to attempt to spell out what the position of the Committee will be in a particular case. As a preface let me review briefly some of the history of the Subcommittee on Human Applications of the Isotopes Branch which was the precursor-so to speak-of the present Advisory Committee. The original group (usually dubbed the Subhuman Committee) first met on June 28, 1946, at Oak Ridge. Because the quantities of radioisotopes available were limited, the initial functions of the Subcommittee were, first, to recommend the relative production effort to be devoted to isotopes for therapy and diagnosis; and second, to make recommendations to the Isotopes Branch for the allocation of available materials for clinical use. As the demand for isotopes for medical use increased, production also increased so that allocation as such soon ceased to be an important problem. In 1948 the Subcommittee formulated certain broad objectives and criteria for its role in the authorization process. At this point I wish to make it quite clear that the role of the Subcommittee, and of its product the Advisory Committee, is to appraise applications and to make recommendations with respect to the human use of isotopes for the guidance of the appropriate agencies of the AEC. Authorizations have now been replaced by licenses to possess by-product materials, which are issued by the Division of Licensing and Regulation in accordance with the provisions of 10 CFR 30, and by internal rules, the making of which is a prerogative of the Licensing Division.
KeywordsClinical Research Advisory Committee Body Burden Radiation Injury Atomic Energy Commission
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