2013-05444. Consideration of Withdrawal From Commercial Production and Distribution of the Radioisotope Germanium-68

AGENCY:

Office of Science, Department of Energy.

ACTION:

Notice of Inquiry and Request for Comment.

SUMMARY:

The Department of Energy (DOE) currently produces and distributes the radioisotope germanium-68. DOE is seeking comment and information from the public to assist in its consideration of DOE withdrawal from the commercial production and distribution of germanium-68, based upon private industry expression of interest in and capability to engage in commercial production of germanium-68.

DATES:

Interested persons must submit written comments by April 30, 2013.

ADDRESSES:

Comments may be submitted electronically by emailing to: [e-mail]. Written comments may be addressed to: Dr. Marc Garland, Program Manager, Office of Nuclear Physics, Office of Science, U.S. Department of Energy, Germantown Building, SC-26.2, 1000 Independence Ave. SW., Washington, DC 20585-1290. We note that email submissions will avoid delay associated with security screening of U.S. Postal Service mail.

FOR FURTHER INFORMATION CONTACT:

Dr. Jehanne Gillo, Director, Facilities and Project Management Division, Office of Nuclear Physics, Office of Science, U.S. Department of Energy, Germantown Building, SC-26.2, 1000 Independence Ave. SW., Washington, DC 20585-1290, Tel: [phone].

SUPPLEMENTARY INFORMATION:

It is DOE policy to refrain from competition with private industry in the commercial production and distribution of radioisotopes when those radioisotopes are reasonably available commercially. This policy was announced, and remains in effect, as stated in the Notice published in the Federal Register in 1965, entitled Policies and Procedures for Transfer of Commercial Radioisotope Production and Distribution to Private Industry (“Statement of Policy”), 30 FR 3247 (March 9, 1965).

The Department has been made aware of private industry development of commercial production and distribution of the radioisotope germanium-68. In light of these circumstances, DOE intends to evaluate the capability of private industry to satisfy the market demand for germanium-68, consistent with the guidelines provided in the Statement of Policy, referenced above. In summary, DOE's evaluation will include consideration of: a demonstrable private capability to produce and distribute germanium-68; effective competition in the market for the production and distribution of germanium-68; assurance that private industry will not discontinue production or distribution of germanium-68 in a manner that would adversely impact the public interest; and the germanium-68 will be available at reasonable prices consistent with its intended uses and the prices to be charged will also encourage further research and development. Comments and information from the public received in response to this Notice will be considered in this evaluation.

If the determination is made that germanium-68 is reasonably available from commercial sources and it is appropriate for DOE to withdraw from commercial production and distribution of this radioisotope, DOE will publish in the Federal Register a notice of its intent to withdraw from the market, providing the public with information regarding the basis and timing of withdrawal. Should DOE decide to withdraw from the commercial production and distribution of germanium-68, all existing contracts will be honored.

Issued in Washington, DC, on February 11, 2013.

Jehanne Gillo,

Director, Facilities and Project Management Division, Office of Nuclear Physics, Office of Science.