[Federal Register Volume 79, Number 169 (Tuesday, September 2, 2014)]
[Notices]
[Pages 51985-51986]
From the Federal Register Online via the Government Publishing 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