[Federal Register Volume 78, Number 106 (Monday, June 3, 2013)]
[Proposed Rules]
[Pages 33015-33016]
[FR Doc No: 2013-13109]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0136; Airspace Docket No. 13-ASW-4]

Proposed Amendment of Class D Airspace; Waco, TX, and
Establishment of Class D Airspace; Waco, TSTC-Waco Airport, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class D airspace at Waco, TX, by
separating the Class D airspace at Waco Regional Airport from the Class
D airspace at TSTC-Waco Airport. The FAA is taking this action to
alleviate multiple air traffic controllers handling the same airspace
and for the safety and management of Instrument Flight Rules (IFR)
operations for standard instrument approach procedures at the airport.
The geographic coordinates for Waco Regional Airport also would be
adjusted.

DATES: Comments must be received on or before July 18, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2013-0136/Airspace Docket No. 13-
ASW-4, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2013-0136/
Airspace Docket No. 13-ASW-4.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should

contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to request a
copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking
Distribution System, which describes the application procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by amending Class D airspace at Waco, TX, by
separating the Class D airspace area for Waco Regional Airport from the
Class D airspace area for TSTC-Waco Airport to enhance the management
of IFR operations for standard instrument approach procedures at both
airports. TSTC-Waco Airport would be removed from its current
designation and established under its own designator; Waco, TSTC-Waco
Airport, TX, to accommodate this separation of controlled airspace
surrounding Waco Regional Airport. This would enhance safety by not
having multiple air traffic controllers responsible for the same
airspace. Geographic coordinates would also be updated to coincide with
the FAA's aeronautical database.
    Class D airspace areas are published in Paragraph 5000 of FAA Order
7400.9W, dated August 8, 2012 and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The Class D airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Waco Regional Airport, Waco,
TX.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting Points, dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASW TX D Waco, TX [Amended]

Waco, Waco Regional Airport, TX
    (Lat. 31[deg]36'44'' N., long. 97[deg]13'49'' W.)

    That airspace extending upward from the surface to and including
3,000 feet MSL within a 4.5-mile radius of Waco Regional Airport.
This Class D airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be published in the Airport/
Facility Directory.

ASW TX D Waco, TSTC-Waco Airport, TX [New]

Waco, TSTC-Waco Airport, TX
    (Lat. 31[deg]38'16'' N., long. 97[deg]04'27'' W.)

    That airspace extending upward from the surface to and including
3,000 feet MSL within a 4.4-mile radius of TSTC-Waco Airport,
excluding that airspace within the Waco Regional Airport Class D
airspace area. This Class D airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be published in
the Airport/Facility Directory.

    Issued in Fort Worth, TX on May 22, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-13109 Filed 5-31-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 125 (Monday, June 30, 2014)]
[Rules and Regulations]
[Pages 36657-36658]
[FR Doc No: C1-2014-06954]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 79, 80, 85, 86, 600, 1036, 1037, 1039, 1042, 1048,
1054, 1065, and 1066

[EPA-HQ-OAR-2011-0135; FRL 9906-86-OAR]
RIN 2060-AQ86

Control of Air Pollution From Motor Vehicles: Tier 3 Motor
Vehicle Emission and Fuel Standards

Correction

    In rule document 2014-06954, appearing on pages 23414-23886, in the
issue of Monday, April 28, 2014, make the following corrections:

Sec.  86.113-94  Fuel specifications. [Corrected]

0
On page 23695 make the following correction:
    The first table on page 23695 is corrected as set forth below.

----------------------------------------------------------------------------------------------------------------
                                                                                Reference
           Property                          Unit                          Type 2-D              procedure \1\
----------------------------------------------------------------------------------------------------------------
(i) Cetane Number.............  ..............................  40-50........................  ASTM D613
(ii) Cetane Index.............  ..............................  40-50........................  ASTM D976
(iii) Distillation range:
    (A) IBP...................                                  340-400 (171.1-204.4)........
    (B) 10 pct. point.........                                  400-460 (204.4-237.8)........
    (C) 50 pct. point.........  [deg]F ([deg]C)...............  470-540 (243.3-282.2)........  STM D86
    (D) 90 pct. point.........                                  560-630 (293.3-332.2)........
    (E) EP....................                                  610-690 (321.1-365.6)

(iv) Gravity..................  [deg]API......................  32-37........................  ASTM D4052
(v) Total sulfur..............  ppm...........................  7-15.........................  ASTM D2622
(vi) Hydrocarbon composition:   pct...........................  27...........................  ASTM D5186
 Aromatics, minimum (Remainder
 shall be paraffins,
 naphthenes, and olefins).
(vii) Flashpoint, min.........  [deg]F ([deg]C)...............  130 (54.4)...................  ASTM D93
(viii) Viscosity..............  centistokes...................  2.0-3.2......................  ASTM D445
----------------------------------------------------------------------------------------------------------------
\1\ ASTM procedures are incorporated by reference in Sec.   86.1.

Sec.  1065.845  Response factor determination. [Corrected]

0
On page 23813 make the following correction:
    The table heading for the table titled ``Table 1 of Sec.
1065.845'' is corrected to read as set forth below.

Table 1 of Sec.  1065.845--Default Values for THC FID Response Factor
Relative to Propane on a C1-Equivalent Basis

Sec.  1066.845  AC17 air conditioning efficiency test procedure.
[Corrected]

0
On page 23881 make the following correction:
    The equation in the first column is corrected to read as set forth
below.
[GRAPHIC] [TIFF OMITTED] TR30JN14.057

[FR Doc. C1-2014-06954 Filed 6-27-14; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Proposed Rules]
[Page 12760]
[FR Doc No: 2012-5132]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0369; Airspace Docket No. 11-AEA-07]

Proposed Establishment of Class E Airspace; Wilkes-Barre, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM), withdrawal.

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SUMMARY: A notice of proposed rulemaking published in the Federal
Register on July 1, 2011, establishing Class E airspace at Wilkes-
Barre/Wyoming Valley Airport, Wilkes-Barre, PA, is being withdrawn.
Controlled airspace already exists for area airports under this city
designator. A new proposal amending the existing airspace will be
submitted under a separate rulemaking.

DATES: Effective 0901 UTC March 2, 2012, the proposed rule published
July 1, 2011 (76 FR 38585), is withdrawn.

FOR FURTHER INFORMATION CONTACT: Richard Horrocks, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On July 1, 2011, a NPRM was published in the Federal Register
establishing Class E airspace at Wilkes-Barre, PA, to accommodate new
standard instrument approach procedures for Wilkes-Barre/Wyoming Valley
Airport, Wilkes-Barre, PA (76 FR 38585). Subsequent to publication the
FAA found that Class E airspace extending upward from 700 feet above
the surface currently exists for Wilkes-Barre, PA, with the primary
airport being Wilkes-Barre/Scranton International Airport. To avoid
confusion this proposed rule is being withdrawn and another rulemaking
will be forthcoming adding Wilkes-Barre/Wyoming Valley Airport to the
current city designator, Wilkes-Barre, PA.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Withdrawal

    Accordingly, pursuant to the authority delegated to me, the Notice
of Proposed Rulemaking, as published in the Federal Register of July,
1, 2011 (76 FR 38585) (FR Doc. 2011-16664), is hereby withdrawn.

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    Issued in College Park, Georgia, on February 15, 2012.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2012-5132 Filed 3-1-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13981-13982]
[FR Doc No: 2018-06576]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR18-38-000.
    Applicants: Energy Transfer Fuel, LP.
    Description: Tariff filing per 284.123(b),(e)/: Rate Election of
Energy Transfer Fuel, LP Effective March 16, 2018.
    Filed Date: 3/16/18.
    Accession Number:<PHONE_NUMBER>31.
    Comments/Protests Due: 5 p.m. ET 4/6/18.

    Docket Numbers: RP13-459-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Report Filing: 2017 Penalty Revenue Credit Report.
    Filed Date: 3/19/18.
    Accession Number: 20180319-5130.
    Comments Due: 5 p.m. ET 4/2/18.

    Docket Numbers: RP18-570-000.
    Applicants: Northern Natural Gas Company.
    Description: Petition of Northern Natural Gas Company for Limited
Waiver of Tariff Provisions.
    Filed Date: 3/19/18.
    Accession Number: 20180319-5201.
    Comments Due: 5 p.m. ET 4/2/18.

    Docket Numbers: RP18-571-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(Colorado Bend 46260-4) to be effective 3/21/2018.
    Filed Date: 3/20/18.
    Accession Number: 20180320-5084.

    Comments Due: 5 p.m. ET 4/2/18.

    Docket Numbers: RP18-572-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2018-03-15 MS,
Macquaire, Citadel, CIMA to be effective 4/1/2018.
    Filed Date: 3/20/18.
    Accession Number: 20180320-5183.
    Comments Due: 5 p.m. ET 4/2/18.

    Docket Numbers: RP18-573-000.
    Applicants: LLOG Bluewater Holdings, LLC, Beacon Offshore Energy
Operating, LLC, LLOG Exploration & Production Company, LLC.
    Description: Joint Petition of LLOG Bluewater Holdings, LLC, et al.
for Limited Waiver, et al.
    Filed Date: 3/20/18.
    Accession Number: 20180320-5197.
    Comments Due: 5 p.m. ET 4/2/18.

    Docket Numbers: RP18-574-000.
    Applicants: Elba Express Company, L.L.C.
    Description: Compliance filing Annual Interruptible Revenue
Crediting Report 2018.
    Filed Date: 3/22/18.
    Accession Number: 20180323-5001.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-575-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Sec.  4(d) Rate Filing: Rate Schedule LSS and SS-2
Tracker-Eff. 04/01/2018 to be effective 4/1/2018.
    Filed Date: 3/22/18.
    Accession Number: 20180323-5008.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-576-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Neg Rate Agmt--
Sequent Enegy Management SP100239 to be effective 4/1/2018.
    Filed Date: 3/22/18.
    Accession Number: 20180323-5009.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-577-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(Jera 46437-1) to be effective 3/22/2018.
    Filed Date: 3/22/18.
    Accession Number: 20180322-5001.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-578-000.
    Applicants: Panhandle Eastern Pipe Line Company, LP.
    Description: Compliance filing Flow Through of Cash Out Revenues
filed on 3-21-18.
    Filed Date: 3/22/18.
    Accession Number: 20180322-5002.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-579-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Tracker Filing Effective
May 1, 2018 to be effective 5/1/2018.
    Filed Date: 3/22/18.
    Accession Number: 20180322-5143.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-580-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Tracker 2018 to be
effective 5/1/2018.
    Filed Date: 3/22/18.
    Accession Number: 20180322-5229.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-581-000.
    Applicants: Vector Pipeline L.P.
    Description: Annual Fuel Use Report for 2017 of Vector Pipeline
L.P.
    Filed Date: 3/22/18.
    Accession Number: 20180322-5292.
    Comments Due: 5 p.m. ET 4/3/18.

    Docket Numbers: RP18-582-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Amendments--
BKV to be effective 11/22/2017.
    Filed Date: 3/23/18.
    Accession Number: 20180323-5108.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: RP18-583-000.
    Applicants: High Island Offshore System, L.L.C.
    Description: Sec.  4(d) Rate Filing: NGL Bank Revision to be
effective 12/1/2017.
    Filed Date: 3/23/18.
    Accession Number: 20180323-5136.
    Comments Due: 5 p.m. ET 4/4/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified date(s). Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 26, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-06576 Filed 3-30-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 52 (Friday, March 19, 2021)]
[Notices]
[Page 14893]
[FR Doc No: 2021-05724]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-1375-000]

Diamond Energy ISONE, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Diamond
Energy ISONE, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 5, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: March 15, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-05724 Filed 3-18-21; 8:45 am]
BILLING CODE 6717-01-P


Ecological Incident Statement for Ecological Risk Assessment Problem
Formulation

Fenoxaprop-p-ethyl (PC Code 129092)

and

Fenoxaprop-ethyl (PC Code 128701)

The Agency has received 78 reports of adverse field effects to
non-target plants that have been linked to the use of
fenoxaprop-p-ethyl.  All of these incidents involved damage to a grain
crop (barley, corn, rice, or wheat).  The Agency considered the cause to
be uncertain in 39 cases because more than one herbicide was applied to
the crop.  In the remaining 36 cases, the Agency considers
fenoxaprop-p-ethyl to be the probable cause.  Most of the incidents were
reports of crop damage that occurred following application of the
herbicide directly to the crop, although three incidents occurred from
carryover effects of applications made to another crop in a previous
growing season.  None of the incidents involved damage to crops or other
plants outside the treatment site.  The Agency has received one report
linking fenoxaprop-p-ethyl to adverse field effects to wild animals.  In
1998, approximately 200 fish died in a pond in White County, Illinois
following application of fenoxaprop-p-ethyl, along with two other
herbicides (fluazifop-p-butyl and fomesafen sodium), on a nearby soybean
field.  Because fenoxaprop-p-ethyl is highly toxic to fish and was
applied in close proximity to the pond, the Agency believes that
exposure to this herbicide was a probable cause or contributing factor
to the fish mortality.

The Agency has received no report of adverse field effects to non-target
animals or plants that have been attributed to the use of
fenoxaprop-ethyl.  The Agency also has no incident report from pesticide
registrants concerning fenoxaprop-ethyl contamination of ground or
surface water.

A lack of reported incidents does not necessarily mean that such
incidents have not occurred.  In addition, incident reports for
non-target plants and animals typically provide information on mortality
events only.  Reports for other adverse effects, such as reduced growth
or impaired reproduction, are rarely received.


[Federal Register Volume 88, Number 198 (Monday, October 16, 2023)]
[Notices]
[Pages 71350-71351]
[FR Doc No: 2023-22757]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1922-052]

Ketchikan Public Utilities; Notice of Application Ready for
Environmental Analysis and Soliciting Comments, Recommendations, Terms
and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent Minor License.
    b. Project No.: 1922-052.
    c. Date filed: October 27, 2022.
    d. Applicant: Ketchikan Public Utilities (KPU).
    e. Name of Project: Beaver Falls Hydroelectric Project (project).
    f. Location: On Beaver Falls Creek in Ketchikan Gateway Borough,
Alaska. The project currently occupies 478.4 acres of United States
lands administered by U.S. Forest Service.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Jennifer Holstrom, Senior Project Engineer,
Ketchikan Public Utilities, 1065 Fair Street, Ketchikan, Alaska 99901;
(907) 228-4733; or email at [email protected].
    i. FERC Contact: Golbahar Mirhosseini at
[email protected].
    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
https://ferconline.ferc.gov/QuickComment.aspx. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. All filings must clearly identify the project name and
docket number on the first page: Beaver Falls Hydroelectric Project (P-
1922-052).
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted and is now ready for
environmental analysis.
    l. The existing Beaver Falls Project consists of two developments,
Silvis and Beaver Falls. Beaver Falls Creek first flows into a 300-acre
project reservoir known as Upper Silvis Lake which has approximately
38,000 acre-feet of gross storage capacity and 22,000 acre-feet of
usable capacity and is impounded by Upper Silvis Lake Dam, a 60-foot-
high, 135-foot-long, 22-foot-wide concrete-face, rock-filled dam with a
crest elevation of 1,164 feet msl.\1\ Water passes downstream of Upper
Silvis Lake and dam via two primary methods: (1) via spill over a weir
into an open channel that discharges to Lower Silvis Lake; or (2) via
discharges through the Silvis Powerhouse into Lower Silvis Lake. Both
the spillway weir and the intake to the power tunnel leading to Silvis
powerhouse are located approximately 450 feet south and east of the
dam. The Upper Silvis spillway consists of an ungated concrete-
encapsulated composite rockfill weir with a 54-foot-long and 16-foot
high crest at an elevation of 1,154 feet that passes water into an 800-
foot-long, 20-foot-wide, 8-foot-deep excavated rock spillway channel
leading from Upper Silvis Lake to Lower Silvis Lake. The Upper Silvis
intake consists of a 3-foot by 4-foot manually operated sluice gate
approximately 200 feet downstream of the power tunnel entrance which is
at an invert elevation of 1,050 msl. Water entering the intake passes
through trash racks containing two rack bars 10-inches off center and
spaced 30 feet apart and enters the 980-foot-long underground power
tunnel connecting to a 375-foot-long, 36-inch-diameter steel penstock
that conveys water to a 30 feet by 40 feet by 25-feet-high Silvis
powerhouse. The Silvis powerhouse contains a single Francis-type
turbine with a rated capacity of 2.1 megawatts. Water exiting the
Silvis powerhouse enters a 150-foot-long trapezoidal shaped channel
tailrace that discharges into Lower Silvis Lake. There is also a
penstock bypass gate valve that can be used to bypass the powerhouse
and discharge water from the penstock into the spillway channel that
runs parallel to the penstock and a powerhouse bypass valve that allows
water entering the powerhouse to bypass the turbine and discharge
directly into Lower Silvis Lake. Power from the Silvis powerhouse is
transmitted through a 2,900-foot-long, 5-kilovolt submarine cable
beneath Lower Silvis Lake which connects to a 2,500 Kilovolt-ampere
(kVA), 34.5-4.16 kV transformer located near Lower Silvis Lake Dam.
From the transformer, power is transmitted via a 7,000-foot-long, 34.5-
kilovolt aerial transmission line to the Beaver Falls substation/
switchyard.
---------------------------------------------------------------------------

    \1\ All elevations are in mean sea level (msl). The conversion
to North American Vertical Datum of 1988 (NAVD 88) at the project is
msl minus 8.07 feet.
---------------------------------------------------------------------------

    Water passing downstream of Upper Silvis Lake enters a 67.5-acre
project reservoir known as Lower Silvis Lake which begins the Beaver
Falls development portion of the project. Lower Silvis Lake has a gross
storage capacity of approximately 8,052 acre-feet and usable storage
capacity of 1,600 acre-feet and is impounded by Lower Silvis Dam which
is a 32-foot-high, 140-foot-long concrete-face, rock-filled dam with a
crest elevation of 835 feet. Water either spills over the Lower Silvis
Dam and spillway into Beaver Falls Creek or enters the Lower Silvis
intake structure and power tunnel system. A spillway composed of a
reinforced concrete ungated control weir approximately 3-foot-high,
140-foot-long and 4-foot-wide with a crest elevation of 827 feet
extends from the left abutment of Lower Silvis Lake Dam and discharges
water into Beaver Falls Creek via a 50-foot-wide spillway discharge
channel. Beaver Falls Creek then flows for approximately 0.66-miles to
a 3-foot-high, 40-foot-long concrete Beaver Falls Creek Diversion Dam.
At this point, water can either enter an intake leading to a penstock
that supplies Unit 1 in the Beaver Falls powerhouse, or pass over the
diversion dam spillway and flow an

additional 0.85-mile before discharging into George Inlet. The Beaver
Falls Diversion Dam intake consists of a steel settling box and
concrete shelter house with angled trash racks 81-inches-wide with
1.25-inches clear bar spacing and a manually operated gate that leads
to a 4,170-foot-long above ground steel penstock that conveys water
from the Beaver Falls Creek diversion dam east to the Beaver Falls
powerhouse and supplies Unit 1 in the powerhouse. Rather than spilling
over the Lower Silvis Lake Dam and spillway into Beaver Falls Creek,
water in Lower Silvis Lake can also enter an intake structure located
south of the Lower Silvis Lake Dam. The intake contains a 10-foot by
32-foot steel intake trash rack, with 0.25-inch by 2.5-inch deep bars
spaced 1.75-inches apart. Water from the intake leads to a 3,800-foot-
long underground power tunnel connecting to a 3,610-foot-long above
ground steel penstock that supplies water to Units 3 and 4 in the
powerhouse. A 225-foot-long, 20-inch-diameter ``adit'' (i.e., steel
pipe) taps into the 3,800-foot-long underground power tunnel and can be
used by KPU to divert up to 60 cfs of water from the power tunnel to
supplement flow in Beaver Falls Creek. The adit discharges water into
an open drainage ditch that runs along the Silvis Lakes Trail for
approximately 550 feet and connects to an approximately 50-foot-long
return culvert running under the trail that discharges water into
Beaver Falls Creek just upstream of the Beaver Falls Diversion Dam
described earlier. The project penstocks convey water to a 30 feet by
147 feet by 25-feet-high Beaver Falls powerhouse containing three
horizontal Pelton generating units with a total installed capacity of 5
MW (Units 1, 3 and 4 are operational; Unit 2 is decommissioned).\2\
Water exiting the powerhouse enters a 60-foot-long open tailrace
channel (Units 1 and 2 have separate tailrace channels each 9-feet-wide
while Units 3 and 4 have separate 10-foot-wide channels which merge 30
feet downstream of the powerhouse into a single 20-foot-wide channel).
KPU states there are no transmission lines associated with the Beaver
Falls powerhouse as the powerhouse interconnects to the adjacent Beaver
Falls substation/switchyard, which is also serves as interconnection
point for the Silvis transmission line described earlier. Between both
powerhouses, the Beaver Falls Project generates an average of 45,877
megawatt-hours (MWh) annually.
---------------------------------------------------------------------------

    \2\ The 5 MW total capacity for the Beaver Falls Powerhouse
consists of 1 MW generated from Unit 1, 2 MW generated from Unit 3,
and 2 MW generated from Unit 4. Unit 1 operates at a minimum
hydraulic capacity of 7 cfs and maximum hydraulic capacity of 33
cfs. Unit 3 operates at a minimum hydraulic capacity of 8 cfs and a
maximum hydraulic capacity of 55 cfs. Unit 4 operates at a minimum
hydraulic capacity of 9 cfs and a maximum hydraulic capacity of 56
cfs. Therefore, the minimum capacity of the Beaver Falls Powerhouse
is 7 cfs while the combined maximum hydraulic capacity for the
Beaver Falls powerhouse is 144 cfs.
---------------------------------------------------------------------------

    KPU operates the project in peaking mode utilizing a combination of
river inflow and storage in the reservoirs to meet the power demands of
the City of Ketchikan (particularly in the summer). Upper Silvis Lake
provides the primary storage for the project. KPU proposes to continue
operating the project in peaking mode with no new developments or
modifications to its existing facilities or operation. KPU also
proposes to remove 77 acres of land from the Beaver Falls project
boundary to more closely align with the footprint of its facilities and
maintenance needs. KPU's proposed Beaver Falls project boundary would
include 408.8 acres of land within Tongass National Forest, and
approximately 14.2 acres of Federal lands subject to FPA Section 24,
for a total of 423 acres.
    m. A copy of the application is available for review via the
internet through the Commission's Home Page (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.
At this time, the Commission has suspended access to the Commission's
Public Reference Room. For assistance, contact FERC at
[email protected] or call toll free,<PHONE_NUMBER> or TTY
(202) 502-8659.
    You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    All filings must (1) bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    n. The applicant must file no later than 60 days following the date
of issuance of this notice: (1) a copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification. Please note
that the certification request must comply with 40 CFR 121.5(b),
including documentation that a pre-filing meeting request was submitted
to the certifying authority at least 30 days prior to submitting the
certification request. Please also note that the certification request
must be sent to the certifying authority and to the Commission
concurrently.
    o. Procedural schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Deadline for Filing Comments,               December 2023.
 Recommendations, and Agency Terms and
 Conditions/Prescriptions.
Licensee's Reply to REA Comments..........  January 2024.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.

    Dated: October 10, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-22757 Filed 10-13-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Proposed Rules]
[Pages 46206-46208]
[FR Doc No: 2015-18955]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3224; Directorate Identifier 2015-CE-026-AD]
RIN 2120-AA64

Airworthiness Directives; Schempp-Hirth Flugzeugbau GmbH
Sailplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Schempp-Hirth Flugzeugbau GmbH Models Duo Discus and Duo Discus T
powered sailplanes. This proposed AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as excessive
load on the air brake system. We are issuing this proposed AD to
require actions to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by September 18,
2015.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Schempp-Hirth Flugzeugbau GmbH, Krebenstrasse 25, 73230 Kirchheim/Teck,
Germany; telephone: +49 7021 7298-0; fax: +49 7021 7298-199; email:
<EMAIL_ADDRESS>Internet: http://www.schempp-hirth.com. You may
review this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3224; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-3224;
Directorate Identifier 2015-CE-026-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2015-0139R1, dated July 15, 2015 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Operational experience shows that application of an excessive
load on the air brake system may induce damage to the drive funnels
in the fuselage and to the air brake bellcrank at the root rips of
the wing.
    This condition, if not detected and corrected, could lead to an
uncontrolled actuation of the air brakes (symmetric and asymmetric),
possibly resulting in reduced control of the (powered) sailplane.
    To address this potential unsafe condition, Schempp-Hirth
Flugzeugbau GmbH issued Technical Note (TN) 380-2, 396-17, 868-22
and 890-14 (published as a single document) to provide inspection
instructions.
    Consequently EASA issued AD 2015-0139 to require to repetitive
inspections of the air brake bellcrank, the air brake drive funnels
and the airbrake control system, and replacement of damaged parts.
    Since that AD was issued, it was found that the drawing number
of the reinforced air brake drive funnel was incorrectly stated in
the original issue of the Schempp-Hirth TN. The wrongly referred
drawing S14FB703 refers to an existing part, different from air
brake drive funnel and cannot be installed as a replacement part for
air brake drive funnel. Consequently, Schempp-Hirth Flugzeugbau GmbH
issued Revision 1 of TN 380-2, 396-17, 868-22 and 890-14, hearafter
referenced to as `the revised TN' in this AD.
    For the reasons described above, this AD is revised to require
using the revised TN.

You may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2015-3224.

Related Service Information Under 1 CFR Part 51

    Schempp-Hirth Flugzeugbau GmbH has issued Technical Note No. 380-2/
396-17/868-22/890-14, Revision 1, issued July 13, 2015 (published as a
single document), and Working instruction for Technical Note No. 380-2/
396-17/868-22/890-14, Ausgabe (English translation: Issue) 1, Datum
(English translation: Dated) May 11, 2015. The service information
describes

procedures for inspecting and replacing the airbrake bell crank and the
airbrake drive funnels and inspecting the airbrake control system for
proper clearance and making necessary adjustments. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section of this NPRM.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 31 products of U.S.
registry. We also estimate that it would take about 2 work-hours per
product to comply with the basic inspection requirements of this
proposed AD. The average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $5,270, or $170 per product.
    We estimate that it would take about 4 work-hours per product to
comply with the airbrake bell crank replacement requirement of this
proposed AD. The average labor rate is $85 per work-hour. Required
parts would cost about $500 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $26,040, or $840 per product.
    We estimate that it would take about 4 work-hours per product to
comply with the airbrake drive funnel replacement requirement of this
proposed AD. The average labor rate is $85 per work-hour. Required
parts would cost about $500 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $26,040, or $840 per product
    In addition, we estimate that any necessary follow-on actions to
make any necessary adjustments to the airbrake control system would
take about 2 work-hours for a cost of $170 per product. We have no way
of determining the number of products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Schempp-Hirth Flugzeugbau GmbH: Docket No. FAA-2015-3224;
Directorate Identifier 2015-CE-026-AD.

(a) Comments Due Date

    We must receive comments by September 18, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Schempp-Hirth Flugzeugbau GmbH Model Duo
Discus powered sailplane, serial numbers 1 through 639, and Model
Duo Discus T powered sailplanes, serial numbers 1 through 110 and
112 through 247, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as excessive load
on the air brake system. We are issuing this AD to prevent
uncontrolled actuation of the air brakes (symmetric or asymmetric),
which could result in reduced control.

 (f) Actions and Compliance

    Unless already done, do the actions in paragraph (f)(1) through
(f)(5) of this AD.
    (1) Within 40 days after the effective date of this AD and
repetitively thereafter at intervals not to exceed 100 hours time-
in-service until the terminating replacement action required in
paragraphs (f)(2) and (f)(3) of this AD (as applicable) is done,
inspect the airbrake bell crank, the airbrake drive funnels, and the
airbrake control system.
    (i) Inspect the airbrake bell crank and the airbrake drive
funnels for cracks and damage following Action 1 in Schempp-Hirth
Flugzeugbau GmbH Technical Note No. 380-2/396-17/868-22/890-14,
Revision 1, issued July 13, 2015 (published as a single document).
    (ii) Inspect the airbrake control system for proper clearance
following Paragraph 2.d. of Schempp-Hirth Flugzeugbau GmbH Working
instruction for Technical Note No. 380-2/396-17/868-22/890-14,
Ausgabe (English translation: issue) 1, Datum (English translation:
dated) May 11, 2015.
    (2) If cracks or damage is found on the airbrake bell cranks or
the airbrake drive funnels during any inspection required in
paragraph (f)(1) of this AD, before further flight, replace each
cracked or damaged part

with a reinforced part. Installing a reinforced part terminates the
repetitive inspections required in paragraph (f)(1) of this AD for
that part.
    (i) For replacement of the airbrake bell cranks, follow Picture
2: Reinforced version of airbrake bell crank according to HS 11-
50.016, Revision a or later, in Schempp-Hirth Flugzeugbau GmbH
Working instruction for Technical Note No. 380-2/396-17/868-22/890-
14, Ausgabe (English translation: issue) 1, Datum (English
translation: dated) May 11, 2015.
    (ii) For replacement of the airbrake drive funnels, follow
Picture 5: Airbrake drive funnel in fuselage ``Reinforcement of
airbrake drive funnel according to drawing S14RB703, Revision a, in
Schempp-Hirth Flugzeugbau GmbH Working instruction for Technical
Note No. 380-2/396-17/868-22/890-14, Ausgabe (English translation:
issue) 1, Datum (English translation: dated) May 11, 2015.
    (3) If no cracks or damage were found on the airbrake bell
cranks or the airbrake drive funnels during any inspection required
in paragraph (f)(1) of this AD, within 12 months after the effective
date of this AD, replace each the airbrake bell cranks and airbrake
drive funnels with a reinforced part. These replacements terminate
the repetitive inspections required in paragraph (f)(1) of this AD.
    (i) For replacement of the airbrake bell cranks, follow Picture
2: Reinforced version of airbrake bell crank according to HS 11-
50.016, Revision a or later, in Schempp-Hirth Flugzeugbau GmbH
Working instruction for Technical Note No. 380-2/396-17/868-22/890-
14, Ausgabe (English translation: issue) 1, Datum (English
translation: dated) May 11, 2015.
    (ii) For replacement of the airbrake drive funnels, follow
Picture 5: Airbrake drive funnel in fuselage, ``Reinforcement of
airbrake drive funnel according to drawing S14RB703, Revision a,''
in Schempp-Hirth Flugzeugbau GmbH Working instruction for Technical
Note No. 380-2/396-17/868-22/890-14, Ausgabe (English translation:
issue) 1, Datum (English translation: dated) May 11, 2015.
    (4) If the airbrake control system is found to not have proper
clearance during the inspection required in paragraph (f)(1) of this
AD, before further flight, make all necessary corrective adjustments
following Paragraph 2.d. of Schempp-Hirth Flugzeugbau GmbH Working
instruction for Technical Note No. 380-2/396-17/868-22/890-14,
Ausgabe (English translation: issue) 1, Datum (English translation:
dated) May 11, 2015.
    (5) As of the effective date of this AD, only install an
airbrake bell crank or an airbrake drive funnel that corresponds to
Picture 2: Reinforced version of airbrake bell crank according to HS
11-50.016, Revision a or later, and Picture 5: Airbrake drive funnel
in fuselage, ``Reinforcement of airbrake drive funnel according to
drawing S14RB703, Revision a,'' in Schempp-Hirth Flugzeugbau GmbH
Working instruction for Technical Note No. 380-2/396-17/868-22/890-
14, Ausgabe (English translation: issue) 1, Datum (English
translation: dated) May 11, 2015, as applicable.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2015-0139R1, dated July 15, 2015, for related information. You may
examine the MCAI on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-3224. For service
information related to this AD, contact Schempp-Hirth Flugzeugbau
GmbH, Krebenstrasse 25, 73230 Kirchheim/Teck, Germany; telephone:
+49 7021 7298-0; fax: +49 7021 7298-199; email<EMAIL_ADDRESS>Internet: http://www.schempp-hirth.com. You may review
this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on July 28, 2015.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2015-18955 Filed 8-3-15; 8:45 am]
 BILLING CODE 4910-13-P


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67873
Federal Register/Vol. 73, No. 222 /Monday, November 17, 2008 /Notices
2011; and (4) identifies technical
resources for use by State courts during
the course of the program. This Program
Instruction contains information
collection requirements pursuant to
receiving a grant award that are found
in Public Law 103–66, as amended by
Public Law 105–89, Public Law 107–
133, Public Law 109–239, and Public
Law 109–288. The agency will use the
information received to ensure
compliance with the statute and provide
training and technical assistance to the
grantees.
Respondents: State Courts.
Annual Burden Estimates.
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Application .......................................................................................................
52 1 40 2,080
Annual program report .....................................................................................
52
1
36
1,872
Estimated Total Annual Burden
Hours: 3,952.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
<FONT STYLE="font-size<EMAIL_ADDRESS>All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 12, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–27234 Filed 11–14–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0571]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Compliance With
the Medical Device User Fee and
Modernization Act of 2002, as
Amended: Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices (formerly
‘‘Reprocessed Single-Use Device
Labeling’’)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
reprocessed single-use device labeling.
DATES:
Submit written or electronic
comments on the collection of
information by January 16, 2009.
ADDRESSES:
Submit electronic
comments on the collection of
information to: http://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION:
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60–day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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67874
Federal Register/Vol. 73, No. 222 /Monday, November 17, 2008 /Notices
Compliance With Section 301 of the
Medical Device User Fee and
Modernization Act of 2002, as
Amended: Prominent and Conspicuous
Mark of Manufacturers on Single-Use
Devices (formerly ‘‘Reprocessed Single-
Use Device Labeling’’) (Federal Food,
Drug, and Cosmetic Act, Section 502(u))
(OMB Control Number 0910–0577)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
352), among other things, establishes
requirements that the label or labeling of
a medical device must meet so that it is
not misbranded and subject to
regulatory action. Section 301 of the
Medical Device User Fee and
Modernization Act of 2002 (Public Law
107–250) amended section 502 of the
act to add section 502(u) to require
devices (both new and reprocessed) to
bear prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Thus, the name for this information
collection activity has been changed to
more accurately describe the
information collection content.
Section 2(c) of The Medical Device
User Fee Stabilization Act of 2005
(Public Law 109–43) amends section
502(u) of the act by limiting the
provision to reprocessed single-use
devices (SUDs) and the manufacturers
who reprocess them. Under the
amended provision, if the original SUD
or an attachment to it prominently and
conspicuously bears the name of the
manufacturer, then the reprocessor of
the SUD is required to identify itself by
name, abbreviation, or symbol, in a
prominent and conspicuous manner on
the device or attachment to the device.
If the original SUD does not
prominently and conspicuously bear the
name of the manufacturer, the
manufacturer who reprocesses the SUD
for reuse may identify itself using a
detachable label that is intended to be
affixed to the patient record.
The requirements of section 502(u) of
the act impose a minimal burden on
industry. This section of the act only
requires the manufacturer, packer, or
distributor of a device to include their
name and address on the labeling of a
device. This information is readily
available to the establishment and easily
supplied. From its registration and
premarket submission database, FDA
estimates that there are 10
establishments that distribute
approximately 1,000 reprocessed SUDs.
Each response is anticipated to take 0.1
hours resulting in a total burden to
industry of 100 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN
1
Section of the Act
No. of
Respondents
No. of Responses
per Respondent
Total Annual
Responses
Hours Per
Response
Total Hours
502(u) 10 100 1,000 .1 100
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
http://www.regulations.gov.
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–27178 Filed 11–14–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0111]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SOMATULINE DEPOT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SOMATULINE DEPOT and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES:
Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION:
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product SOMATULINE
DEPOT (lanreotide). SOMATULINE
DEPOT is indicated for the long-term
treatment of acromegalic patients who
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[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Pages 52649-52651]
[FR Doc No: 2017-24586]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2017-N-6289]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Prostatic Artery Embolization Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the prostatic artery embolization device 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 prostatic artery embolization device's 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 November 14, 2017. The classification
was applicable on June 21, 2017.

FOR FURTHER INFORMATION CONTACT: Benjamin Fisher, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G108, Silver Spring, MD 20993-0002, 301-
796-0245, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the prostatic artery embolization
device 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 (21 U.S.C. 360c(f)(2)). 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 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 pre-market approval 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 August 5, 2016, BioSphere Medical, S.A., submitted a request for
De Novo classification of the Embosphere[supreg] Microspheres. FDA
reviewed the request 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 generals 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 has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on June 21, 2017, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 876.5550. We have named
the generic type of device prostatic artery embolization device, and it
is identified as an intravascular implant intended to occlude the
prostatic arteries to prevent blood flow to the targeted area of the
prostate, resulting in a reduction of lower urinary tract symptoms
related to benign prostatic hyperplasia. This does not include
cyanoacrylates and other embolic agents which act by in situ
polymerization or precipitation, or embolization devices used in
neurovascular applications (see 21 CFR 882.5950).
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Prostatic Artery Embolization Device Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf-
                                          life validation, Non-clinical
                                          performance testing, and
                                          Labeling.
Non-target ischemia....................  Clinical data, Non-clinical
                                          performance testing, and
                                          Labeling.
Urinary retention......................  Labeling.
Post-prostatic artery embolization       Labeling.
 syndrome (nausea, vomiting, regional
 pain, non-infectious fever, minor
 hematuria, or hematochezia).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in part 21 CFR part
814, subparts A through E, regarding premarket approval, have been
approved under OMB control number 0910-0231; the collections of

information in part 807, subpart E, regarding premarket notification
submissions, have been approved under OMB control number 0910-0120; and
the collections of information in 21 CFR part 801, regarding labeling,
have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.5550 to subpart F to read as follows:

Sec.  876.5550   Prostatic artery embolization device.

    (a) Identification. A prostatic artery embolization device is an
intravascular implant intended to occlude the prostatic arteries to
prevent blood flow to the targeted area of the prostate, resulting in a
reduction of lower urinary tract symptoms related to benign prostatic
hyperplasia. This does not include cyanoacrylates and other embolic
agents which act by in situ polymerization or precipitation, or
embolization devices used in neurovascular applications (see 21 CFR
882.5950).
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
    (i) Evaluation of suitability for injection through catheters
intended for use in embolization; and
    (ii) Evaluation of the size distribution of the device.
    (3) Performance data must support the sterility and pyrogenicity of
the device.
    (4) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (5) Clinical data must evaluate post-embolization damage due to
non-target embolization under anticipated use conditions.
    (6) The labeling must include:
    (i) Specific instructions on safe device preparation and use;
    (ii) The device shelf life;
    (iii) Data regarding urinary retention; and
    (iv) Data regarding post-prostatic artery embolization syndrome.

    Dated: November 7, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24586 Filed 11-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Notices]
[Pages 38124-38125]
[FR Doc No: 2014-15599]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2014-0051]

Pipeline Safety: Liquefied Natural Gas Facility User Fee Rate
Increase

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of agency action.

-----------------------------------------------------------------------

SUMMARY: This notice is to advise all liquefied natural gas facility
(LNG) operators subject to PHMSA user fee billing of a change in the
LNG user fee rates to align these rates with the actual allocation of
PHMSA resources to LNG program costs. Specifically, the LNG user fee
rates will increase to 5 percent of the total gas program costs. This
percentage represents the approximate ratio between the allocation of
resources to LNG facilities and the total allocation of resources to
all gas facilities. To reduce the financial impact on LNG operators,
PHMSA will implement this increase incrementally over a three-year
period.

DATES: Written comments should be received on or before September 2,
2014.
    Comments: PHMSA invites interested persons to comment on the user
fee assessment process described in this notice. Although the policies
and practices described in this notice are final for purposes of fiscal
year 2014 assessments, any comments received will be considered in
determining whether the fiscal year 2015 and later policies and
practices should be continued or modified. Interested persons should
submit comments to the docket in writing, identifying the title and
docket number of this notice.
    Comments should reference Docket No. PHMSA-2014-0051. Comments may
be submitted in the following ways:
     E-Gov Web site: http://www.regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency. Follow the instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management System, U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590.
    Hand Delivery: DOT Docket Management System, Room W12-140, on the
ground floor of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC between 9:00 a.m. and 5:00 p.m., Monday through Friday,
except Federal holidays.
    Instructions: Identify the docket number at the beginning of your
comments. If you submit your comments by mail, submit two copies. If
you wish to receive confirmation that PHMSA has received your comments,
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.regulations.gov.

    Note: Comments will be posted without changes or edits to http://www.regulations.gov including any personal information provided.
Please see the Privacy Act Statement heading below for additional
information.

Privacy Act Statement

    Anyone may search the electronic form of all comments received for
any of our dockets. You may review DOT's complete Privacy Act Statement
in the Federal Register published April 11, 2000, (65 FR 19476).

FOR FURTHER INFORMATION CONTACT: Roger Little by telephone at 202-366-
4569, by fax at<PHONE_NUMBER>, by email at<EMAIL_ADDRESS>or by
mail at U.S. Department of Transportation, PHMSA, 1200 New Jersey
Avenue SE., PHP-2, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Background

    The Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1986
(Pub. L. 99-272, Sec. 7005) codified at Section 60301 of Title 49,
United States Code, authorizes the assessment and collection of user
fees to fund the pipeline safety activities conducted under Chapter 601
of Title 49. PHMSA assesses each operator of interstate and intrastate
gas transmission pipelines (as defined in 49 CFR Part 192) and
hazardous liquid pipelines carrying crude oil, refined petroleum
products, highly volatile liquids, biofuel, and carbon dioxide (as
defined in 49 CFR Part 195) a share of the total Federal pipeline
safety program costs in proportion to the number of miles of pipeline
for each operator. In accordance with COBRA, PHMSA also assesses user
fees on LNG facilities (as defined in 49 CFR Part 193).

Fee Schedules

    COBRA requires that the Secretary of Transportation establish a
schedule of fees for pipeline usage, bearing a reasonable relationship
to miles of pipeline, volume-miles, revenues, or an appropriate
combination thereof. In particular, the Secretary must take into
account the allocation of Departmental resources in establishing the
schedule. Following consultations with the pipeline industry's major
trade associations, including the American Petroleum Institute, the
American Gas Association, the Interstate Natural Gas Association of
America, and the Association of Oil Pipe Lines on the appropriate basis
for determining fees, the Research and Special Programs Administration
(RSPA), PHMSA's predecessor agency, determined that pipeline mileage
provides the most reasonable basis for determining fees to be paid by
operators of gas transmission lines and hazardous liquid pipeline
facilities.\1\
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    \1\ Pipeline user fee assessments under COBRA were upheld by the
U.S. Supreme Court in Skinner v. Mid-America Pipeline Co., 490 U.S.
212 (1989).
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    On July 16, 1986, RSPA published in the Federal Register a notice
for pipeline safety user fees to describe the agency's implementation
of the requirements set forth in the COBRA Act (51 FR 25782) (the User
Fee Notice). The User Fee Notice adopted pipeline mileage as the fee
basis for natural gas transmission and hazardous liquid pipelines.
Pipeline mileage data for each operator are available from the annual
reports which operators are required to file with PHMSA. Each report
provides the miles of pipeline each operator has at the end of the
calendar year for which the report is filed.
    With respect to the LNG facility portion of the gas program costs,
a fee basis other than mileage was needed. For these facilities, RSPA
determined that storage capacity was the most readily measurable
indicator of usage. The storage capacity of each LNG facility that is
subject to the user fee provisions of the Act was initially based on
those published in a periodic report by the Liquefied Natural Gas
Committee of the American Gas Association. With storage capacity as the
basis, a five step

fee schedule was developed for LNG facilities which provided a means of
relating the fees to usage and resource allocation, taking into account
the wide spread (approximately 900:1) in facility storage capacities.
Since 2010, LNG facility operators have been required to submit an LNG
annual report to PHMSA. PHMSA now uses data from these annual reports
for the LNG facility user fee assessments.
    The ratio of costs apportioned to gas and liquid activities varies
by year, typically ranging between 40/60 and 60/40 gas/liquid. For each
budget year user fee collection, PHMSA estimates the proportion of its
resources for that billing year between natural gas and hazardous
liquid pipeline initiatives and resource requirements costs. The
percentages reflect the allocation of our efforts and resources for the
billing year. For example, in recent years we considered anticipated
program costs for new initiatives that were required by Congressional
and other mandates. In 2011 and 2012, we used a 65 percent gas and 35
percent hazardous liquid split across the total budget. The hazardous
liquid cost portion is offset by annual funding for the Oil Spill
Liability Trust Fund (OSLTF) ($18.547 million for fiscal year 2012). In
fiscal year 2013, the gas/liquid split went to 67/33 partially
resulting from the state grant for gas programs increase in 2013 over
2012 and the fact that the OSLTF did not proportionally cover the same
percent in 2013 (36% of liquid costs) as it did in 2012 (48% of liquid
costs).

Change in LNG Facility User Fee Assessments

    In the 1986 User Fee Notice, RSPA stated that the total LNG user
fee assessment would be ``5 percent of the total gas program costs.''
More specifically, the notice stated:

    Each operator of an LNG facility in service at the beginning of
fiscal year 1986 will to [sic] be assessed a designated share of the
LNG program costs based on the storage capacity of the facility. For
FY-86 these costs are estimated to be approximately 5 percent of the
total gas program costs. This percentage represents the approximate
ratio between the allocation of resources to LNG facilities and the
total allocation of resources to all gas facilities.
    The total user fees for LNG facilities will be calculated as
follows:
    Total LNG user fees equal approximately (105%) (5%) (Total gas
program cost)
    For FY-86 LNG operator assessments will be as follows:
    LNG Facility storage capacity Operator assessment

Less than 10,000 bbl.......................................    $1,250.00
10,000 bbl. but less than 100,000 bbl......................     2,500.00
100,000 bbl. but less than 250,000 bbl.....................     3,750.00
250,000 bbl. but less than 500,000 bbl.....................     5,000.00
500,000 bbl. or more.......................................     7,500.00

    Since the inception of the pipeline user fee billing, PHMSA has
assessed LNG facilities based on the above rate table. The amount of
money collected using this LNG facility fee structure has increased
slightly over the years as more facilities were placed in service, but
the gas program costs have increased at a far greater rate. The LNG
rates have not been adjusted to reflect the increase in gas program
costs since 1986. During the 2014 billing cycle, the LNG facility rate
structure resulted in a collection of $467,500 which is a mere 0.62% of
gas program costs. Five percent of the gas program cost for the 2014
billing cycle would have been $3,774,405.

Notice of LNG Facility Obligation Increase

    In order to ensure that user fees assessed for each type of
pipeline facility have a reasonable relationship to the allocation of
departmental resources and to achieve the 5 percent of total gas
program cost level set forth in the User Fee Notice, PHMSA has
determined that certain changes to the calculation table are necessary.
Specifically, the rate for each of the five tiers in the table will be
updated to arrive at 5 percent of total gas program costs when the
tiers are added together. PHMSA plans to implement the increase in the
LNG facility user fee rates in three equal increments starting in 2015.
In 2015, if the gas program costs remained steady at 2014 levels, the
total LNG industry obligation would increase to $1,256,667; in 2016,
the LNG obligation would increase to $2,513,333; and in 2017, the LNG
obligation would increase to $3,774,405. The actual annual rate for a
particular LNG facility of a given capacity billed each year will
depend on the annual gas program cost and the total number of LNG
facilities. As the LNG rates increase over the three year period, PHMSA
will maintain the current ratio of rates based on storage capacity
reflected in the five tiers. For example, an LNG facility with over
500,000 barrels of storage capacity has a user fee rate that is six
times the rate for a facility with less than 10,000 barrels of storage.
In 2017, when the LNG rates result in a collection of 5 percent of the
gas program cost, an LNG facility with over 500,000 barrels of storage
will still have a rate six times the rate for a facility with less than
10,000 barrels of storage. After 2017, PHMSA plans to continue this
framework for assessing operators of LNG facilities for 5 percent of
the gas program costs. PHMSA has been excluding mobile/temporary LNG
facilities from user fee assessment since these facilities typically
have very low storage volume, and will continue to exclude the mobile/
temporary LNG facilities from user fee assessment.
    Therefore, to account for the increase in total gas program costs
since 1986 and achieve the 5 percent of total gas program cost level
set forth in the User Fee Notice to reflect resource allocation, PHMSA
is notifying LNG facility operators that in 2015, if the gas program
costs remained steady at 2014 levels, the LNG obligation can be
expected to increase to $1,256,667. In 2016, the LNG obligation would
increase to $2,513,333, and in 2017, the LNG obligation would increase
to $3,774,405. LNG operators should expect their individual user fee
assessments to reflect these levels and that the amounts in their user
fee billing statements will continue to be proportional to other LNG
operators of differing capacities depending on the tiers they are in.
Procedures for paying the fees can be found in the annual statement and
include instructions for electronic funds transfer.
    PHMSA invites interested persons to comment on the user fee
assessment process described in this notice. Although the policies and
practices described in this notice are final for purposes of fiscal
year 2014 assessments, any comments received will be considered in
determining whether the fiscal year 2015 and later policies and
practices should be continued or modified. Interested persons should
submit comments to the docket in writing, identifying the title and
docket number of this notice by September 2, 2014.

    Authority: 49 U.S.C. 60301; 49 CFR 1.97.

    Issued in Washington, DC, on June 27, 2014.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2014-15599 Filed 7-2-14; 8:45 am]
BILLING CODE 4910-60-P