Permit Revisions to Existing RadioGenix Sample Clauses

Permit Revisions to Existing RadioGenix. ® System Radiation Safety Programs to Conform to Future Changes in Licensing Guidance and Safety Recommendations from the Manufacturer. Requesting authorization in accordance with the following guidance will permit a licensee to make certain changes under 10 CFR 35.26, “Radiation protection program changes,” to the RadioGenix® System safety program that might otherwise require a license amendment. This authorization may also be used by the commercial nuclear pharmacy to make limited changes to the radiation safety program without needing to submit a license amendment. The above licensing guidance and safety recommendations from the manufacturer may be revised as additional experience is gained regarding medical use of the RadioGenix® System by the regulator and manufacturer. A medical use or commercial nuclear pharmacy licensee already authorized to use the RadioGenix® System and committed by license condition to follow the provisions in the guidance and Operators Guide existing at the time of the commitment must apply for and receive an amendment to its license prior to making changes to conform to the revised guidance and additional radiation safety recommendations. An applicant initially applying for authorization for medical or commercial nuclear pharmacy use of the RadioGenix® System (or a licensee applying later for an amendment to conform to revisions in this guidance) may request authorization to allow future changes to its radiation safety program, provided the following conditions are met:
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Related to Permit Revisions to Existing RadioGenix

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