Natural Gas Pipelines; Project Cost and Annual Limits, 9697-9698 [2018-04413]
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9697
Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Rules and Regulations
(ii) Reserved.
(3) For service information identified in
this AD, contact Airbus, Airworthiness
Office—EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France;
telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email account.airworth-eas@
airbus.com; internet https://www.airbus.com.
(4) You may view this service information
at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For
information on the availability of this
material at the FAA, call 206–231–3195.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Renton, Washington, on February
22, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2018–04265 Filed 3–6–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
18 CFR Part 157
[Docket No. RM81–19–000]
Natural Gas Pipelines; Project Cost
and Annual Limits
Federal Energy Regulatory
Commission, Energy.
ACTION: Final rule.
AGENCY:
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Effective Date
This final rule is effective March 7,
2018. The provisions of 5 U.S.C. 804
regarding Congressional review of Final
Rules does not apply to the Final Rule
because the rule concerns agency
procedure and practice and will not
substantially affect the rights or
obligations of non-agency parties. The
Final Rule merely updates amounts
published in the Code of Federal
Regulations to reflect the Department of
Commerce’s latest annual determination
of the Gross Domestic Product (GDP)
implicit price deflator, a mathematical
updating required by the Commission’s
existing regulations.
List of Subjects in 18 CFR Part 157
Pursuant to the authority
delegated by the Commission’s
regulations, the Director of the Office of
Energy Projects (OEP) computes and
publishes the project cost and annual
limits for natural gas pipelines blanket
construction certificates for each
calendar year.
DATES: This final rule is effective March
7, 2018 and establishes cost limits
applicable from January 1, 2018 through
December 31, 2018.
FOR FURTHER INFORMATION CONTACT:
Richard W. Fole, Chief, Certificates
Branch 1, Division of Pipeline
Certificates, (202) 502–8955.
SUPPLEMENTARY INFORMATION: Section
157.208(d) of the Commission’s
Regulations provides for project cost
limits applicable to construction,
acquisition, operation and
miscellaneous rearrangement of
facilities (Table I) authorized under the
blanket certificate procedure (Order No.
234, 19 FERC ¶ 61,216). Section
SUMMARY:
157.215(a) specifies the calendar year
dollar limit which may be expended on
underground storage testing and
development (Table II) authorized under
the blanket certificate. Section
157.208(d) requires that the ‘‘limits
specified in Tables I and II shall be
adjusted each calendar year to reflect
the ’GDP implicit price deflator’
published by the Department of
Commerce for the previous calendar
year.’’
Pursuant to § 375.308(x)(1) of the
Commission’s Regulations, the authority
for the publication of such cost limits,
as adjusted for inflation, is delegated to
the Director of the Office of Energy
Projects. The cost limits for calendar
year 2018, as published in Table I of
§ 157.208(d) and Table II of 157.215(a),
are hereby issued.
Administrative practice and
procedure, Natural gas, Reporting and
recordkeeping requirements.
TABLE I TO PART 157
Limit
Year
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
*
*
*
*
3. Table II in § 157.215(a)(5) is revised
to read as follows:
(a) * * *
(5) * * *
TABLE II TO PART 157
Year
1. The authority citation for part 157
continues to read as follows:
■
Authority: 15 U.S.C. 717–717w, 3301–
3432; 42 U.S.C. 7101–7352.
2. Table I in § 157.208(d) is revised to
read as follows:
■
§ 157.208 Construction, acquisition,
operation, replacement, and miscellaneous
rearrangement of facilities.
PO 00000
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Fmt 4700
*
Sfmt 4700
$12,000,000
12,800,000
13,300,000
13,800,000
14,300,000
14,700,000
15,100,000
15,600,000
16,000,000
16,700,000
17,300,000
17,700,000
18,100,000
18,400,000
18,800,000
19,200,000
19,600,000
19,800,000
20,200,000
20,600,000
21,000,000
21,200,000
21,600,000
22,000,000
27,400,000
28,200,000
29,000,000
29,600,000
29,900,000
30,200,000
30,800,000
31,400,000
31,900,000
32,400,000
32,800,000
33,200,000
33,800,000
■
PART 157—[AMENDED]
*
$4,200,000
4,500,000
4,700,000
4,900,000
5,100,000
5,200,000
5,400,000
5,600,000
5,800,000
6,000,000
6,200,000
6,400,000
6,600,000
6,700,000
6,900,000
7,000,000
7,100,000
7,200,000
7,300,000
7,400,000
7,500,000
7,600,000
7,800,000
8,000,000
9,600,000
9,900,000
10,200,000
10,400,000
10,500,000
10,600,000
10,800,000
11,000,000
11,200,000
11,400,000
11,600,000
11,800,000
12,000,000
*
Accordingly, 18 CFR part 157 is
amended as follows:
*
*
(d) * * *
..........
..........
..........
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..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
Prior notice
proj. cost
limit
(Col. 2)
§ 157.215 Underground storage testing
and development.
Issued: February 27, 2018.
Terry L. Turpin,
Director, Office of Energy Projects.
*
Auto. proj.
cost limit
(Col. 1)
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
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......................................
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......................................
......................................
......................................
......................................
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......................................
......................................
07MRR1
Limit
$2,700,000
2,900,000
3,000,000
3,100,000
3,200,000
3,300,000
3,400,000
3,500,000
3,600,000
3,800,000
3,900,000
4,000,000
4,100,000
4,200,000
4,300,000
9698
Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Rules and Regulations
TABLE II TO PART 157—Continued
Year
Limit
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
*
*
*
*
4,400,000
4,500,000
4,550,000
4,650,000
4,750,000
4,850,000
4,900,000
5,000,000
5,100,000
5,250,000
5,400,000
5,550,000
5,600,000
5,700,000
5,750,000
5,850,000
6,000,000
6,100,000
6,200,000
6,300,000
6,400,000
6,500,000
*
[FR Doc. 2018–04413 Filed 3–6–18; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA–2018–N–0387]
Medical Devices; General and Plastic
Surgery Devices; Classification of the
Extracorporeal Shock Wave Device for
Treatment of Chronic Wounds
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the extracorporeal shock
wave device for treatment of chronic
wounds into class II (special controls).
The special controls that apply to the
device type are identified in this order
and will be part of the codified language
for the extracorporeal shock wave
device for treatment of chronic wounds’
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
DATES: This order is effective March 7,
2018. The classification was applicable
on December 28, 2017.
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SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Mehmet Kosoglu, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1572, Silver Spring,
MD 20993–0002, 301–796–6194,
Mehmet.Kosoglu@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
extracorporeal shock wave device for
treatment of chronic wounds as class II
(special controls), which we have
determined will provide a reasonable
assurance of safety and effectiveness. In
addition, we believe this action will
enhance patients’ access to beneficial
innovation, in part by reducing
regulatory burdens by placing the
device into a lower device class than the
automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act to a
predicate device that does not require
premarket approval (see 21 U.S.C.
360c(i)). We determine whether a new
device is substantially equivalent to a
predicate by means of the procedures
for premarket notification under section
510(k) of the FD&C Act and part 807 (21
U.S.C. 360(k) and 21 CFR part 807,
respectively).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 established the first procedure
for De Novo classification (Pub. L. 105–
115). Section 607 of the Food and Drug
Administration Safety and Innovation
Act modified the De Novo application
process by adding a second procedure
(Pub. L. 112–144). A device sponsor
PO 00000
Frm 00016
Fmt 4700
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may utilize either procedure for De
Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA shall classify the
device by written order within 120 days.
The classification will be according to
the criteria under section 513(a)(1) of
the FD&C Act. Although the device was
automatically within class III, the De
Novo classification is considered to be
the initial classification of the device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation, in part by
reducing regulatory burdens. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application in order to market
a substantially equivalent device (see 21
U.S.C. 360c(i), defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On July 25, 2016, Sanuwave, Inc.,
submitted a request for De Novo
classification of the dermaPACE System.
FDA reviewed the request in order to
classify the device under the criteria for
classification set forth in section
513(a)(1) of the FD&C Act.
We classify devices into class II if
general controls by themselves are
insufficient to provide reasonable
assurance of safety and effectiveness,
but there is sufficient information to
establish special controls that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
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]]>Agencies
[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Rules and Regulations]
[Pages 9697-9698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04413]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
18 CFR Part 157
[Docket No. RM81-19-000]
Natural Gas Pipelines; Project Cost and Annual Limits
AGENCY: Federal Energy Regulatory Commission, Energy.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: Pursuant to the authority delegated by the Commission's
regulations, the Director of the Office of Energy Projects (OEP)
computes and publishes the project cost and annual limits for natural
gas pipelines blanket construction certificates for each calendar year.
DATES: This final rule is effective March 7, 2018 and establishes cost
limits applicable from January 1, 2018 through December 31, 2018.
FOR FURTHER INFORMATION CONTACT: Richard W. Fole, Chief, Certificates
Branch 1, Division of Pipeline Certificates, (202) 502-8955.
SUPPLEMENTARY INFORMATION: Section 157.208(d) of the Commission's
Regulations provides for project cost limits applicable to
construction, acquisition, operation and miscellaneous rearrangement of
facilities (Table I) authorized under the blanket certificate procedure
(Order No. 234, 19 FERC ] 61,216). Section 157.215(a) specifies the
calendar year dollar limit which may be expended on underground storage
testing and development (Table II) authorized under the blanket
certificate. Section 157.208(d) requires that the ``limits specified in
Tables I and II shall be adjusted each calendar year to reflect the
'GDP implicit price deflator' published by the Department of Commerce
for the previous calendar year.''
Pursuant to Sec. 375.308(x)(1) of the Commission's Regulations,
the authority for the publication of such cost limits, as adjusted for
inflation, is delegated to the Director of the Office of Energy
Projects. The cost limits for calendar year 2018, as published in Table
I of Sec. 157.208(d) and Table II of 157.215(a), are hereby issued.
Effective Date
This final rule is effective March 7, 2018. The provisions of 5
U.S.C. 804 regarding Congressional review of Final Rules does not apply
to the Final Rule because the rule concerns agency procedure and
practice and will not substantially affect the rights or obligations of
non-agency parties. The Final Rule merely updates amounts published in
the Code of Federal Regulations to reflect the Department of Commerce's
latest annual determination of the Gross Domestic Product (GDP)
implicit price deflator, a mathematical updating required by the
Commission's existing regulations.
List of Subjects in 18 CFR Part 157
Administrative practice and procedure, Natural gas, Reporting and
recordkeeping requirements.
Issued: February 27, 2018.
Terry L. Turpin,
Director, Office of Energy Projects.
Accordingly, 18 CFR part 157 is amended as follows:
PART 157--[AMENDED]
0
1. The authority citation for part 157 continues to read as follows:
Authority: 15 U.S.C. 717-717w, 3301-3432; 42 U.S.C. 7101-7352.
0
2. Table I in Sec. 157.208(d) is revised to read as follows:
Sec. 157.208 Construction, acquisition, operation, replacement, and
miscellaneous rearrangement of facilities.
* * * * *
(d) * * *
Table I to Part 157
------------------------------------------------------------------------
Limit
-------------------------------
Year Auto. proj. Prior notice
cost limit proj. cost
(Col. 1) limit (Col. 2)
------------------------------------------------------------------------
1982.................................... $4,200,000 $12,000,000
1983.................................... 4,500,000 12,800,000
1984.................................... 4,700,000 13,300,000
1985.................................... 4,900,000 13,800,000
1986.................................... 5,100,000 14,300,000
1987.................................... 5,200,000 14,700,000
1988.................................... 5,400,000 15,100,000
1989.................................... 5,600,000 15,600,000
1990.................................... 5,800,000 16,000,000
1991.................................... 6,000,000 16,700,000
1992.................................... 6,200,000 17,300,000
1993.................................... 6,400,000 17,700,000
1994.................................... 6,600,000 18,100,000
1995.................................... 6,700,000 18,400,000
1996.................................... 6,900,000 18,800,000
1997.................................... 7,000,000 19,200,000
1998.................................... 7,100,000 19,600,000
1999.................................... 7,200,000 19,800,000
2000.................................... 7,300,000 20,200,000
2001.................................... 7,400,000 20,600,000
2002.................................... 7,500,000 21,000,000
2003.................................... 7,600,000 21,200,000
2004.................................... 7,800,000 21,600,000
2005.................................... 8,000,000 22,000,000
2006.................................... 9,600,000 27,400,000
2007.................................... 9,900,000 28,200,000
2008.................................... 10,200,000 29,000,000
2009.................................... 10,400,000 29,600,000
2010.................................... 10,500,000 29,900,000
2011.................................... 10,600,000 30,200,000
2012.................................... 10,800,000 30,800,000
2013.................................... 11,000,000 31,400,000
2014.................................... 11,200,000 31,900,000
2015.................................... 11,400,000 32,400,000
2016.................................... 11,600,000 32,800,000
2017.................................... 11,800,000 33,200,000
2018.................................... 12,000,000 33,800,000
------------------------------------------------------------------------
* * * * *
0
3. Table II in Sec. 157.215(a)(5) is revised to read as follows:
Sec. 157.215 Underground storage testing and development.
(a) * * *
(5) * * *
Table II to Part 157
------------------------------------------------------------------------
Year Limit
------------------------------------------------------------------------
1982.................................................... $2,700,000
1983.................................................... 2,900,000
1984.................................................... 3,000,000
1985.................................................... 3,100,000
1986.................................................... 3,200,000
1987.................................................... 3,300,000
1988.................................................... 3,400,000
1989.................................................... 3,500,000
1990.................................................... 3,600,000
1991.................................................... 3,800,000
1992.................................................... 3,900,000
1993.................................................... 4,000,000
1994.................................................... 4,100,000
1995.................................................... 4,200,000
1996.................................................... 4,300,000
[[Page 9698]]
1997.................................................... 4,400,000
1998.................................................... 4,500,000
1999.................................................... 4,550,000
2000.................................................... 4,650,000
2001.................................................... 4,750,000
2002.................................................... 4,850,000
2003.................................................... 4,900,000
2004.................................................... 5,000,000
2005.................................................... 5,100,000
2006.................................................... 5,250,000
2007.................................................... 5,400,000
2008.................................................... 5,550,000
2009.................................................... 5,600,000
2010.................................................... 5,700,000
2011.................................................... 5,750,000
2012.................................................... 5,850,000
2013.................................................... 6,000,000
2014.................................................... 6,100,000
2015.................................................... 6,200,000
2016.................................................... 6,300,000
2017.................................................... 6,400,000
2018.................................................... 6,500,000
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-04413 Filed 3-6-18; 8:45 am]
BILLING CODE 6717-01-P
