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[Federal Register Volume 79, Number 169 (Tuesday, September 2, 2014)]
[Notices]
[Pages 51985-51986]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20749]

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DEPARTMENT OF ENERGY

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

AGENCY: Office of Science, Department of Energy.

ACTION: Record of Decision.

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SUMMARY: The Department of Energy (Department or DOE) Isotope Program, 
within the Office of Science, 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 a Notice of Inquiry and Request for 
comment in the Federal Register, on March 8, 2013, concerning 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 available information. The Department 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. The Department published a Notice of Intent and Request for 
comment in the Federal Register, on April 9, 2014, to provide the 
public with notice and seek 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. Three comments in response to this Notice of Intent were 
received and assessed by the Department to conclude the evaluation 
process with this Record of Decision. The Department's decision is to: 
(1) Withdraw from sales of Ge-68 for the purpose of fabricating 
calibration sources, while maintaining production capability in the 
event circumstances change; (2) maintain its current position in the 
production and distribution of Ge-68 for use in the manufacture of Ge-
68/Ga-68 generators; and (3) require the Department's Ge-68 customers 
to sign an end-use statement that the Ge-68 will be used only in the 
fabrication of Ge-68/Ga-68 generators.

FOR FURTHER INFORMATION CONTACT: 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, Tel: 301-903-9576.

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 Federal 
Register notice, 30 FR 3247 (March 9, 1965), entitled ``Policies and 
Procedures for Transfer of Commercial Radioisotope Production and 
Distribution to Private Industry'' (``Statement of Policy''). 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. The Department 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.
    The Department received numerous comments in response to the Notice 
of 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. The Department conducted an evaluation of all 
available information, including all comments received in response to 
the Notice of Inquiry, and subsequently published a Notice of Intent to 
Withdraw from Production and Distribution of the Radioisotope 
Germanium-68 Used for Calibration Sources (``Notice of Intent and 
Request for Comment'') (``NOI'') in the Federal Register, 79 FR 19610 
(April 9, 2014). The NOI announced the Department's intent to withdraw 
from production of Ge-68 for the manufacture of calibration sources, 
but to maintain production and distribution of Ge-68 for Ge-68/Ga-68 
generators. To provide assurance of supply of Ge-68 for calibration 
source purposes, the Department announced that it would maintain 
production capability but not engage in sales to the marketplace. Sales 
of Ge-68 for calibration sources would end by April 30, 2014, and 
thereafter customers would be required to sign an end-use statement 
that the Ge-68 would be used in the fabrication of Ge-68/Ga-68 
generators. The NOI presented the basis for the Department's proposed 
actions and solicited comments regarding those actions.

Evaluation and Determination

    The Department received three comments in response to the NOI, two 
from the general public and one from private industry. The responses 
from the general public were received from a university researcher 
involved in Ga-68 radiopharmaceutical development and a cancer patient 
who benefits from the use of Ga-68 radiopharmaceuticals; both responses 
were in support of the Department's announced intent to maintain 
production for use in Ge-68/Ga-68 generators. Neither commenter 
objected to the Department's withdrawal from the production and 
distribution of Ge-68 used in calibration sources.
    The response received from private industry, Mallinckrodt 
Pharmaceuticals, supported the Department's announced intent to 
withdraw from production of Ge-68 for the manufacture of calibration 
sources, but provided additional information and requested the 
Department reconsider the announced intent to maintain production and 
distribution of Ge-68 for Ge-68/Ga-68

[[Page 51986]]

generators. In summary, Mallinckrodt requested reconsideration on the 
bases that its Ge-68 is qualified for use in Ge-68 generators, and that 
there is effective competition in the market for the supply of Ge-68 
for generators.
    Mallinckrodt provided information indicating that it's Ge-68 is now 
qualified for use in Ge-68/Ga-68 generators, in response to the 
Department's concern expressed in the NOI regarding the lack of 
domestic producers of Ge-68 qualified for use in Ge-68/Ga-68 
generators. The Department acknowledges that Mallinckrodt is now a 
domestic producer of Ge-68 qualified for use in Ge-68/Ga-68 generators.
    In regard to effective competition, Mallinckrodt provided 
information identifying as major Ge-68 suppliers Brookhaven National 
Laboratory (BNL), Los Alamos National Laboratory (LANL) (United 
States), Cyclotron Co. Ltd. (Obninsk, Russia), and iThemba 
Laboratories/NAC (Faure, South Africa), and requested these suppliers 
be considered as constituting effective competition in the supply of 
Ge-68. In the NOI, the Department had stated that, in the absence of a 
Department supply of Ge-68 for the manufacture of generators, 
Mallinckrodt would be the sole domestic source of Ge-68 for generators, 
that a single domestic supplier could be problematic for the U.S. 
market for generators, and that the Department's continued 
participation in that segment of the market as a second domestic 
supplier would serve to reduce the potential for impediments to 
research and development leading to FDA approval of Ga-68 
radiopharmaceuticals. The United States suppliers identified by 
Mallinckrodt--BNL and LANL--are both Department of Energy production 
sites, so if the Department exited the Ge-68 market, Mallinckrodt would 
be the sole domestic supplier of Ge-68. Mallinckrodt correctly noted 
that the Department's policy on withdrawal from radioisotope production 
and distribution may include consideration of foreign producers to 
evaluate effective competition in the market. Even with two potential 
foreign sources of supply, however, the Department concluded that 
insufficient data, and thereby inadequate evidence, exists on the 
capability of these suppliers to provide an adequate supply and 
effective competition in the market to justify the Department's 
withdrawal. Use of Ge-68 in Ge-68/Ga-68 generators, which provide Ga-68 
as a positron source in radiopharmaceuticals used in PET imaging, is a 
relatively new, unique and evolving application of this isotope in a 
critical state of development for cancer research. In consideration of 
the additional information provided on potential suppliers balanced 
against public comments and the critical need and use of Ge-68 in the 
context of Ge-68/Ga-68 generators, the Department affirms its initial 
conclusion that a sole domestic supplier and the uncertain contribution 
of foreign suppliers would not represent effective competition in the 
supply of Ge-68 in support of the Nation's significant interest in the 
research and development of Ga-68 radiopharmaceuticals.
    The Department also affirms its intent that, to help provide 
assurance of supply of Ge-68 for calibration source purposes, DOE will 
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.
    To serve the Nation's interests in the advancement of health care, 
the Department will continue to produce and distribute Ge-68 for use in 
the manufacture of Ge-68/Ga-68 generators until such time as firm data 
exists establishing that there are multiple domestic suppliers capable 
of fully satisfying the needs of the United States market without the 
participation of Department in that market.

    Issued in Washington, DC, on August 21, 2014.
Jehanne Gillo,
Director, Facilities and Project Management Division, Office of Nuclear 
Physics, Office of Science.
[FR Doc. 2014-20749 Filed 8-29-14; 8:45 am]
BILLING CODE 6450-01-P
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