19610 Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices 

VII. Agency Contact 

FOR FURTHER INFORMATION CONTACT: 

Carnisia M. Proctor, U.S. Department of 

Education, 1990 K Street NW., Room 

6038, Washington, DC 20006–8513. 

Telephone: (202) 502–7606 or by email: 

Carnisia.Proctor@ed.gov. 

If you use a TDD or a TTY, call the 

FRS, toll free, at 1–800–877–8339. 

VIII. Other Information 

Accessible Format: Individuals with 

disabilities can obtain this document 

and a copy of the application package in 

an accessible format (e.g., braille, large 

print, audiotape, or compact disc) on 

request to the program contact person 

listed under FOR FURTHER INFORMATION

CONTACT in section VII of this notice. 

Electronic Access to This Document: 

The official version of this document is 

the document published in the Federal 

Register. Free Internet access to the 

official edition of the Federal Register 

and the Code of Federal Regulations is 

available via the Federal Digital System 

at: www.gpo.gov/fdsys. At this site you 

can view this document, as well as all 

other documents of this Department 

published in the Federal Register, in 

text or Adobe Portable Document 

Format (PDF). To use PDF you must 

have Adobe Acrobat Reader, which is 

available free at this site. 

You may also access documents of the 

Department published in the Federal 

Register by using the article search 

feature at www.federalregister.gov. 

Specifically, through the advanced 

search feature at this site, you can limit 

your search to documents published by 

the Department. 

Dated: April 4, 2014. 

Lynn B. Mahaffie, 

Senior Director, Policy Coordination, 

Development, and Accreditation Service, 

delegated the authority to perform the 

functions and duties of the Assistant 

Secretary for Postsecondary Education. 

[FR Doc. 2014–07975 Filed 4–8–14; 8:45 am] 

BILLING CODE 4000–01–P 

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. 

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 Ge68: In the manufacture of calibration 

sources for Positron Emission 

Tomography (PET) scanners used for 

diagnostic medical imaging; and in the 

manufacture of germanium-68/gallium68 (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 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices 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 Ge68 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 Ge68 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 Ge68 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2014–0212; FRL–9908–82] 

Pesticide Experimental Use Permit; 

Receipt of Application, Comment 

Request 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 


TKELLEY on DSK3SPTVN1PROD with NOTICES