Energia i regulacje · 04/05/1999

Metabolic Solutions, Inc.; Receipt of Petition for Rulemaking

The Nuclear Regulatory Commission (NRC) has received and requests public comment on a petition for rulemaking dated March 5, 1999, filed by Metabolic Solutions, Inc. (petitioner). The petition has been docketed by the Commission and has been assigned Docket No. PRM- 32-5. The petitioner is requesting that the NRC regulations be amended to extend a regulatory distribution exemption to the petitioner's product, an ``Erythromycin Breath Test.'' That test uses a three- microcurie dose of carbon-14 (C14)-erythromycin to measure the rate of drug metabolism in the human liver. Current NRC regulations permit distribution of radioactive drug capsules that contain one microcurie of C14-urea to persons exempt from licensing. Dose regulations also permit any person exempt from the requirements of a license to use the capsules for diagnostic tests in humans. The petitioner believes that exempting the C14-erythromycin from regulatory control would make the breath test more widely available and reduce the costs of clinical trials without increasing the radiation risk to the public.