Department of Energy April 9, 2014 – Federal Register Recent Federal Regulation Documents

The Isotope Program of the Office of Science of the Department of Energy (Department or DOE) currently produces and distributes the radioisotope germanium-68 (Ge-68). There are two primary uses of the Ge-68: In the manufacture of calibration sources for Positron Emission Tomography (PET) scanners used for diagnostic medical imaging; and in the manufacture of germanium-68/gallium-68 (Ge-68/Ga-68) generators, which provide Ga-68 as a positron source in radiopharmaceuticals used in PET imaging. The Department published in the Federal Register on March 8, 2013, a Notice of Inquiry and Request for Comment on its consideration of withdrawal from commercial production of Ge-68. The Department received numerous comments in response to this Notice of Inquiry, evaluated substantial information provided by one private domestic company seeking the Department's withdrawal, and assessed other information in reaching its conclusion. The Department has determined that Ge-68 is reasonably available from the commercial sector for use in the manufacture of calibration sources but not for use in Ge-68/Ga-68 generators. This Notice of Intent provides the public with notice and seeks any public comment on the Department's intent to withdraw from the production and distribution of Ge-68 used in the manufacture of calibration sources, while maintaining its current position in the production and distribution of Ge-68 for Ge-68/Ga-68 generators. The Department intends to ramp down its sales of Ge-68 to calibration source fabricators and such sales will end completely April 30, 2014. After that date, the Department's customers will be required to sign an end-use statement that the Ge-68 will be used in the fabrication of Ge- 68/Ga-68 generators.