Notice of Intent To Withdraw From Production and Distribution of the Radioisotope Germanium-68 Used for Calibration Sources, 19610-19611 [2014-07865]

Agencies

• DEPARTMENT OF ENERGY

[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19610-19611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07865]


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DEPARTMENT OF ENERGY


Notice of Intent To Withdraw From Production and Distribution of 
the Radioisotope Germanium-68 Used for Calibration Sources

AGENCY: Office of Science, Department of Energy.

ACTION: Notice of intent and request for comment.

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SUMMARY: 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.

DATES: Interested persons must submit written comments by May 9, 2014.

ADDRESSES: Comments may be submitted by mail 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, or electronically by email to: 
marc.garland@science.doe.gov. 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, Tel: 301-903-1455.

SUPPLEMENTARY INFORMATION: It is the Department's 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 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 Statement of Policy provides criteria and guidance 
on withdrawal from the market and states that when the Department 
determines to voluntarily withdraw from the commercial production and 
distribution of particular radioisotopes, it will publish a notice of 
such intent for public comment.

Background

    The Department currently produces and distributes the radioisotope 
Ge-68. Recently, it was made aware of domestic private industry 
development of commercial production and distribution of this 
radioisotope in the United States, in addition to the distribution in 
the United States of the radioisotope produced by foreign entities. In 
light of these circumstances, a Notice of Inquiry and Request for 
Comment entitled Consideration of Withdrawal from Commercial Production 
and Distribution of the Radioisotope Germanium-68 (``Notice of 
Inquiry'') was published in the Federal Register (78 FR 15009, March 8, 
2013) announcing the Department's intent to conduct an evaluation and 
to request comments and information from the public for consideration 
in the evaluation. In summary, the Department's evaluation included 
consideration of: A demonstrable private capability to produce and 
distribute Ge-68; effective competition in the market for the 
production and distribution of Ge-68; assurance that private industry 
will not discontinue production or distribution of Ge-68 in a manner 
that would adversely impact the public interest; the Ge-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; and comments and information from the public received in 
response to the Notice and Departmental inquiries.

Evaluation and Determination

    The Department received numerous comments in response to the Notice 
of

[[Page 19611]]

Inquiry from private citizens affected by the use of Ge-68 in Ge-68/Ga-
68 generators critical in medical imaging for certain cancers, and from 
some private companies involved in the manufacture of products for 
medical purposes. Responses from commenters focused on concerns such as 
pricing, monopolies, and discontinuation of isotope availability in the 
event of foreign or domestic supply disruption. A private U.S. company, 
Mallinckrodt Pharmaceuticals Inc., supplied a substantial amount of 
information in support of the Department's withdrawal from commercial 
production and distribution of Ge-68. The concerns and interests 
expressed by private citizens and affected industry are precisely those 
which comprise the factors the Department has evaluated to ensure there 
would be no adverse impacts in the event of DOE withdrawal from 
production.
    While DOE is currently the only domestic producer of Ge-68, there 
are foreign producers of Ge-68 that distribute the radioisotope in the 
U.S. through U.S. distributors. Mallinckrodt has an existing facility 
in the U.S. that currently produces radioisotopes, with the capability 
to produce Ge-68 for domestic distribution. The information supplied by 
Mallinckrodt indicates it has a long history as a strong market 
participant in the production and sales of radioisotopes. Further, 
Mallinckrodt was judged to have the facilities, expertise, and 
management and financial resources necessary to produce sufficient 
quantities of Ge-68 to meet domestic demand. Production and 
distribution of radioisotopes is the core of the Mallinckrodt's 
business and Ge-68 is the latest product that they have developed to 
generate near-term sales and capture a share of a long-term growth 
market. Mallinckrodt has demonstrated capability to commercially 
produce Ge-68.
    The Department has determined that there is sufficient evidence to 
conclude that, upon the Department's withdrawal from the production and 
distribution of Ge-68, Mallinckrodt would continue production of Ge-68, 
based upon the investments it's made in developing production 
capability, the fact that it has built a worldwide capability to engage 
in isotope production and distribution, and that such activities are at 
the core of their business. The Department has further concluded that 
if it were to withdraw from the market, Mallinckrodt would establish 
the price for the Ge-68 isotope on a fair and reasonable basis and 
within a range of the prices the Department currently charges. While 
Mallinckrodt did not explicitly state the price it would charge, its 
intention to maintain pricing consistent with the market suggests that 
there would not be catastrophic price changes if the Department 
withdraws from the market. With multiple private sector suppliers, 
pricing more likely than not would be controlled by market forces 
obviating the need for any Department mandate.
    In light of the information provided by Mallinckrodt, input from 
private industry, and other information available to the Department, 
the Department intends to withdraw from the market for Ge-68 for the 
manufacture of PET calibration sources. The Department has concluded 
that Mallinckrodt has the capability and intent to meet market demand, 
and because there are multiple suppliers of Ge-68 suitable for use in 
the manufacturing of PET calibration sources (as well as multiple 
companies engaging in source fabrication), the Department has further 
concluded that the demand for the Ge-68 for calibration source 
manufacturing will be met and maintained at reasonable market-based 
pricing.
    The Department has concluded that it will not withdraw from the 
market for Ge-68 for the manufacture of generators, however, because it 
has determined that there are no suppliers of bulk Ge-68 qualified for 
use in Ge-68/Ga-68 generators. This issue involves several concerns. 
First, if the Department were to exit the market, it appears that there 
would be no domestic producers of Ge-68 presently qualified for use in 
Ge-68/Ga-68 generators. These generators provide Ga-68 which is 
incorporated as a positron source in radiopharmaceuticals used in PET 
imaging medical applications currently under development. Qualification 
of other Ge-68 suppliers to serve the generator market would take time 
(in addition to potentially lengthy product testing, producers may have 
to change their production processes to provide Ge-68 that can be used 
on a generator for Ga-68 use in humans) and could impact researchers' 
achievement of Food and Drug Administration (FDA) approval for Ga-68-
based medical imaging. Second, there is only one known foreign supplier 
of Ge-68/Ga-68 generators, which the Department does not believe is a 
dependable supply source for the U.S. market. The foreign supplier's 
production data does not provide adequate assurance the U.S. generator 
market would be adequately supplied by foreign suppliers. In the 
absence of a Department supply of Ge-68 for the manufacture of 
generators, Mallinckrodt would be the only immediate domestic source 
for generators, but only when or if the Mallinckrodt develops its own 
generator or its Ge-68 is qualified for use by other generator 
manufacturers. A single foreign supplier represents a risk that one 
domestic company, Mallinckrodt, could be the sole reliable domestic 
supplier of Ge-68 for generators and this could be problematic for the 
U.S. market for generators. If generator manufacturers were able to 
qualify Mallinckrodt's Ge-68 for use in generators, the Department's 
withdrawal from production would provide Mallinckrodt with a monopoly 
position in the marketplace for Ge-68 use in the manufacture of 
generators and other generator manufacturers would eventually be in a 
position of having to buy Ge-68 from their competitor.
    In light of these circumstances, the Department has concluded that 
there is not effective competition in the market for Ge-68 for use in 
Ge-68/Ga-68 generators, and therefore it will continue to serve that 
segment of the Ge-68 market to provide competition. The Department's 
participation in that segment of the market will serve to reduce the 
potential for impediments to research and development leading to FDA 
approval of Ga-68 radiopharmaceuticals.
    To help provide assurance of supply of Ge-68 for calibration source 
purposes, DOE proposes to maintain production capability, but not 
engage in sales to the marketplace, such that production would resume 
in a timely manner if Mallinckrodt and other suppliers are not be able 
to adequately serve the market or if private supplier pricing 
substantially increases and has a negative impact on the development 
and utilization of Ge-68 products.

    Issued in Washington, DC, on April 2, 2014.
Jehanne Gillo,
Director, Facilities and Project Management Division, Office of Nuclear 
Physics, Office of Science.
[FR Doc. 2014-07865 Filed 4-8-14; 8:45 am]
BILLING CODE 6450-01-P