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IN RESPONSE, PLEASE
REFER TO: M020219

The Commission was briefed by the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on issues related to the development and implementation of the revised 10 CFR 35 and other issues of concern to the Committee.

The NRC staff should issue for public comment revised draft guidance documents for implementing the revised Part 35, including a stand-alone guide for diagnostic applications. The schedule should allow for resolution of public comment on the guidance document and issuance of the final guidance before the implementation date of the revised 10 CFR 35, which will be six months following publication of the final rule. The inspectors and license reviewers should also be trained to implement the revised final guidance prior to the final rule becoming effective.

The staff should also provide the Commission options for resolving the training and experience concerns raised by the ACMUI members.

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Thursday, February 22, 2007