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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
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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
Federal Energy Regulatory
Commission, FERC.
ACTION: Comment request.
AGENCY:
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
SUMMARY:
PO 00000
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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: [email protected].
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
[email protected], 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 [email protected], 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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Federal Register / Vol. 79, No. 169 / Tuesday, September 2, 2014 / Notices
carry out its responsibilities in
implementing the statutory provisions
of Section 203 of the Federal Power Act
(FPA), 16 U.S.C. 824b. Section 203
authorizes the Commission to grant
approval of transactions in which a
public utility disposes of jurisdictional
facilities, merges such facilities with the
facilities owned by another person or
acquires the securities of another public
utility. Under this statute, the
Commission must find that the
proposed transaction will be consistent
with the public interest.
51987
exercised to the detriment of effective
competition and customers, making it
necessary for FERC to review and
approve or disapprove all jurisdictional
mergers, dispositions and acquisitions.
The Commission implements these
filing requirements in the Code of
Federal Regulations (CFR) under 18 CFR
Part 33.
Type of Respondents: Public utilities
subject to the FPA.
Estimate of Annual Burden: 1 The
Commission estimates the annual public
reporting burden for the information
collection as:
Under Section 203 of the FPA, FERC
must review proposed mergers,
acquisitions and dispositions of
jurisdictional facilities by public
utilities, if the value of the facilities
exceeds $10 million, and must approve
these transactions if they are consistent
with the public interest. One of FERC’s
overarching goals is to promote
competition in wholesale power
markets, having determined that
effective competition, as opposed to
traditional forms of price regulation, can
best protect the interests of ratepayers.
Market power, however, can be
FERC–519
[Application under Federal Power Act Section 203]
Number of
respondents
Annual
number of
responses per
respondent
Total number
of responses
Average
burden & cost
per response 2
Total annual
burden hours
& total annual
cost
Cost per
respondent
($)
(1)
(2)
(1)*(2)=(3)
(4)
(3)*(4)=(5)
(5)÷(1)
FERC–519 ...............................................
141
Comments: Comments are invited on:
(1) Whether the collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information will have practical utility;
(2) the accuracy of the agency’s estimate
of the burden and cost of the collection
of information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility
and clarity of the information collection;
and (4) ways to minimize the burden of
the collection of information on those
who are to respond, including the use
of automated collection techniques or
other forms of information technology.
Dated: August 21, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014–20764 Filed 8–29–14; 8:45 am]
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BILLING CODE 6717–01–P
1 The Commission defines burden as the total
time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For
further explanation of what is included in the
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1
141
395
$27,847.5
55,695
$3,926,498
$27,847.5
Take notice that on August 13, 2014
Duke Energy Kentucky, Inc. (DEK) and
Duke Energy Ohio, Inc. (DOE), 139 E.
Fourth Street, Cincinnati, Ohio 45202,
filed in the above referenced dockets
two complimentary applications
pursuant to sections 7(b) and 7(f) of the
Natural Gas Act (NGA). DEK requests
authorization to abandon by sale to
DEO, a segment of existing natural gas
pipeline that extends from Kenton
County, Kentucky to Hamilton County,
Ohio. DEO is concurrently seeking a
determination of a service area within
which DEO may enlarge and extend its
distribution facilities, without further
Commission authorization, all as more
fully set forth in the application which
is on file with the Commission and open
to public inspection. The filing may also
be viewed on the web at http://
www.ferc.gov using the ‘‘eLibrary’’ link.
Enter the docket number excluding the
last three digits in the docket number
field to access the document. For
assistance, please contact FERC Online
Support at FERCOnlineSupport@
ferc.gov or toll free at (866) 208–3676, or
TTY, contact (202) 502–8659.
Any questions concerning this
application may be directed to Chuck
Whitlock, President, Midwest
Commercial Generation and Vice
President, Gas Operations, at (513) 287–
2534 or [email protected], Duke Energy Corporation,
139 East Fourth Street, Cincinnati, OH
45202.
Specifically, the pipeline segment to
be conveyed to DEO (AM–1 River
Crossing) originates at a pipeline valve
in Kenton County, Kentucky, about 400
feet south of the Ohio River, and
extends northward about 0.4 miles,
under the river, to an interconnection
with distribution facilities of DEO at a
pipeline valve in Hamilton County,
Ohio. It is part of DEK’s Line AM–1
natural gas pipeline. DEK states that the
AM–1 River Crossing is used for the sole
purpose of delivering gas to DEO to
serve its own retail customers and retail
customer choice load in Ohio. DEK also
states that its entire retail load that is
served from Line AM–1 is located
upstream of the proposed point of
transfer, so no DEK customer will be
information collection burden, reference 5 Code of
Federal Regulations 1320.3.
2 The estimates for cost per response are derived
using the following formula: Average Burden Hours
per Response * $70.50 per Hour = Average Cost per
Response. The hourly cost figure of $70.50 is the
average FERC employee wage plus benefits. We
assume that respondents earn at a similar rate.
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
[Docket No. CP14–533–000; Docket No.
CP14–534–000]
Duke Energy Kentucky, Inc.; Duke
Energy Ohio, Inc.; Notice of
Applications for Certificate of Public
Convenience and Necessity
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File Type | application/pdf |
File Modified | 2014-08-30 |
File Created | 2014-08-30 |