Federal Register / Vol. 79, No. 169 / Tuesday, September 2, 2014 / Notices 51985 

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. 

Authority: 20 U.S.C. 101c. 

Ted Mitchell, 

Under Secretary, U.S. Department of 

Education. 

[FR Doc. 2014–20870 Filed 8–29–14; 8:45 am] 

BILLING CODE 4000–01–P 

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. 

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 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 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 Ge68/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 

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51986 Federal Register / Vol. 79, No. 169 / Tuesday, September 2, 2014 / Notices 

generators. In summary, Mallinckrodt 

requested reconsideration on the bases 

that its Ge-68 is qualified for use in Ge68 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 Ge68 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 Ge68/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 

DEPARTMENT OF ENERGY 

Federal Energy Regulatory 

Commission 

[Docket No. IC14–14–000] 

Commission Information Collection 

Activities (FERC–519); Comment 

Request 

AGENCY: Federal Energy Regulatory 

Commission, FERC. 

ACTION: Comment request. 

SUMMARY: In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, 44 U.S.C. 

3507(a)(1)(D), the Federal Energy 

Regulatory Commission (Commission or 

FERC) is submitting its information 

collection FERC–519 (Application 

under Federal Power Act Section 203) to 

the Office of Management and Budget 

(OMB) for review of the information 

collection requirements. Any interested 

person may file comments directly with 

OMB and should address a copy of 

those comments to the Commission as 

explained below. The Commission 

previously issued a Notice in the 

Federal Register (79 FR 30598, 5/28/

2014) requesting public comments. The 

Commission received no comments on 

the FERC–519 and is making this 

notation in its submittal to OMB. 

DATES: Comments on the collection of 

information are due by October 2, 2014. 

ADDRESSES: Comments filed with OMB, 

identified by the OMB Control No. 

1902–0082, should be sent via email to 

the Office of Information and Regulatory 

Affairs: oira_submission@omb.gov. 

Attention: Federal Energy Regulatory 

Commission Desk Officer. The Desk 

Officer may also be reached via 

telephone at 202–395–4718. 

A copy of the comments should also 

be sent to the Commission, in Docket 

No. IC14–14–000, by either of the 

following methods: 

• eFiling at Commission’s Web site: 

http://www.ferc.gov/docs-filing/

efiling.asp. 

• Mail/Hand Delivery/Courier: 

Federal Energy Regulatory Commission, 

Secretary of the Commission, 888 First 

Street NE., Washington, DC 20426. 

Instructions: All submissions must be 

formatted and filed in accordance with 

submission guidelines at: http://

www.ferc.gov/help/submissionguide.asp. For user assistance contact 

FERC Online Support by email at 

ferconlinesupport@ferc.gov, or by phone 

at: (866) 208–3676 (toll-free), or (202) 

502–8659 for TTY. 

Docket: Users interested in receiving 

automatic notification of activity in this 

docket or in viewing/downloading 

comments and issuances in this docket 

may do so at http://www.ferc.gov/docsfiling/docs-filing.asp. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Brown may be reached by email 

at DataClearance@FERC.gov, by 

telephone at (202) 502–8663, and by fax 

at (202) 273–0873. 

SUPPLEMENTARY INFORMATION: 

Title: FERC–519, Application under 

Federal Power Act Section 203. 

OMB Control No.: 1902–0082. 

Type of Request: Three-year extension 

of the FERC–519 information collection 

requirements with no changes to the 

reporting requirements. 

Abstract: The FERC–519 (Application 

under Federal Power Act Section 203) is 

necessary to enable the Commission to 

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