NRC/Nuclear Pharmacy and Radiopharmaceutical Manufacturer IndustryPublic Workshop on the Public Comments on Draft Regulatory Guides DG-0006 and DG-0007

概要

The U.S. Nuclear Regulatory Commission will be holding a public meeting to discuss the public comments received on two draft regulatory guides: Draft Regulatory Guide DG-0006, ``Guide for the Preparation of Applications for Commercial Nuclear Pharmacy Licenses,'' and Draft Regulatory Guide DG-0007, ``Guide for the Preparation of Applications for Licenses to Authorize Distribution of Various Items to Commercial Nuclear Pharmacies and Medical Use Licensees.'' These documents provide guidance to individuals applying for commercial nuclear pharmacy and radiopharmaceutical manufacturer distribution licenses. Representatives of these categories of licensees have been invited to discuss the public comments on the draft guides and the staff's proposed resolutions of the comments, as well as alternative solutions presented at the meeting. (Draft Regulatory Guide DG-0007 also includes guidance for sealed source and device manufacturers, but since this guidance was not changed, it will not be discussed at this meeting.) The workshop will be held at NRC Headquarters in Rockville, MD.