			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on December 23, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-97-2338

________________________________________________________________________
__________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Notice of DELTA AIR LINES, INC. (DELTA), filed 12/15/05 to:

Use its route integration authority to integrate its certificate and
exemption authorities and commence new nonstop service between New York
(JFK) and Sao Paulo, Brazil, effective April 1, 2006.  Delta intends to
utilize a portion of its existing allocation of 21 U.S.-Brazil
frequencies to offer nonstop service at New York.  Delta is providing
advance notice consistent with its route integration authority.

At Delta’s request, and with no objection from the carrier
representatives served by Delta, the Department issued a notice
shortening the answer period from December 30, 2005, to December 21.
Continental Airlines, Inc. (Continental) filed an answer on December 21,
objecting to issuance by the Department of a confirming notice without
first evaluating applicable public interest considerations and giving
other carriers an opportunity to apply for the frequencies Delta seeks
to move in the limited entry U.S.-Brazil market.  Continental states
that Delta had stressed the importance of its Atlanta hub gateway in an
earlier proceeding in support of an award to Delta of frequencies to
serve Brazil, and that those considerations would no longer apply if the
frequencies were shifted to New York, where Continental already offers
daily New York-Sao Paolo service at Newark Liberty International
Airport.

On December 22, 2005, Delta replied to Continental’s answer, noting
that, under Department Order 2004-6-25, U.S.-Brazil frequencies may be
used in any city-pair market, and that Delta holds the necessary
economic authority to serve JFK-Sao Paolo, subject only to the advance
notice requirement of its route integration exemption.  Delta also
pointed out that under the route integration conditions applicable here,
the Department will only entertain requests by other carriers for
limited entry route rights that are not then being used by the carrier.
Delta states that it is currently using its 21 allocated Brazil
frequencies.

Applicant rep:   Alexander Van der Bellen<PHONE_NUMBER>    DOT Analyst:
 Esta Rosenberg<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (See Remarks)

The above action was effective when taken: December 23, 2005.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
__________

Remarks:  Upon review of Delta’s December 15, 2005 notice, and the
provisions of Order 2004-6-25, which were  expressly designed to accord
U.S. carriers designated for combination service to Brazil with the type
of flexibility that Delta now seeks to exercise, and the terms of
Delta’s still operative award of route integration authority in the
present Docket, we have determined that no additional authority need be
awarded for Delta to provide its proposed New York-Sao Paolo services.
We have reviewed Continental’s answer and are not persuaded that
further proceedings are necessary.

________________________________________________________________________
__________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; (2) the action
taken was consistent with the public interest; and (3) grant of the
authority would not constitute a major regulatory action under the
Energy Policy and Conservation Act of 1975.  To the extent not granted,
we denied all requests in the referenced Docket.  We may amend, modify,
or revoke the authority granted in this Notice at any time without
hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

 See Notice of Action Taken dated April 24, 2003 (APA renewal pending),
Docket OST-97-2338.

 Delta holds certificate authority to serve between Atlanta, Georgia and
co-terminal points Sao Paulo and Rio de Janeiro, Brazil, under its Route
740 authority, issued by Order 2002-7-31.  Under various certificates
and exemptions, Delta holds authority to offer international services
from New York (JFK).


[Federal Register Volume 74, Number 94 (Monday, May 18, 2009)]
[Notices]
[Pages 23183-23184]
[FR Doc No: E9-11467]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. AC09-86-000, AC09-86-001]

NW Pipeline Co.; Notice of Filing

May 11, 2009.
    Take notice that on April 24, 2009 and May 5, 2009, NW Pipeline Co.
submitted requests for waiver of the requirement to file the FERC Form
No. 6 from January 1, 2008 to February 23, 2008.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 or 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to

become a party must file a notice of intervention or motion to
intervene, as appropriate. Such notices, motions, or protests must be
filed on or before the comment date. On or before the comment date, it
is not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: June 10, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-11467 Filed 5-15-09; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74494-74495]
[DOCID:fr12de06-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-82-000]

Chandeleur Pipe Line Company; Notice of Proposed Changes in FERC
Gas Tariff

December 5, 2006.
    Take notice that on November 30, 2006, Chandeleur Pipe Line Company
(Chandeleur) tendered for filing as part of its FERC Gas Tariff, Second
Revised Volume No. 1, Twentieth Revised Sheet No. 5, to become
effective January 1, 2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention

or protest must serve a copy of that document on the Applicant. Anyone
filing an intervention or protest on or before the intervention or
protest date need not serve motions to intervene or protests on persons
other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21075 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Rules and Regulations]
[Pages 23349-23351]
[FR Doc No: 2018-10491]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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

Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Rules and
Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0667; Product Identifier 2016-SW-053-AD; Amendment
39-19281; AD 2018-10-06]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited
(Bell) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Bell
Model 407 helicopters. This AD requires repetitive inspections of the
tail rotor (TR) driveshaft segment assemblies and a torque check of the
TR adapter retention nuts. This AD was prompted by a report of an in-
flight failure of the TR drive system. The actions of this AD are
intended to detect and correct an unsafe condition on these products.

DATES: This AD is effective June 25, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of June 25, 2018.

ADDRESSES: For service information identified in this final rule,
contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir,
Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(450) 433-0272; or at http://www.bellcustomer.com/files/. You may
review the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0667.

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-2017-
0667; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the Transport Canada AD, any incorporated-by-reference service
information, the economic evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    On July 7, 2017, at 82 FR 31535, the Federal Register published our
notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR
part 39 by adding an AD that would apply to Bell Model 407 helicopters.
The NPRM proposed to require repetitively inspecting each TR driveshaft
segment assembly for rotational and axial play between the adapter and
the TR driveshaft. The NPRM also proposed a one-time verification of
the installation torque of each adapter retention nut. The proposed
requirements were intended to detect a loose TR driveshaft splined
connection, which if not corrected could result in wear in the splines,
failure of the TR drive system, and subsequent loss of directional
control of the helicopter.
    The NPRM was prompted by AD No. CF-2016-21, dated July 7, 2016 (AD
CF-2016-21), issued by Transport Canada, which is the aviation
authority for Canada, to correct an unsafe condition for Bell Model 407
helicopters. Transport Canada advises that a Model 407 helicopter
experienced in-flight failure of the TR drive system, which resulted in
loss of directional control. According to Transport Canada, the splines
connecting the adapter part number (P/N) 406-040-328-105 to the shaft
assembly P/N 407-040-330-107 were ``severely worn and no longer capable
of performing their function.'' The investigation revealed other Model
407 helicopters with the same axial and radial play or looseness of
some splined connections. AD CF-2016-21 states that these parts should
be clamped together with threaded fasteners with no detectable
looseness. Transport Canada advises that undetected looseness at the
splined connection could result in wear of the parts and eventual loss
of directional control of the helicopter.
    For these reasons, AD CF-2016-21 requires a repetitive inspection
of the TR driveshaft assemblies for play and a one-time torque
verification of the TR adapter retention nuts.
    Since the NPRM was issued, the FAA's Aircraft Certification Service
has changed its organization structure. The new structure replaces
product directorates with functional divisions. We have revised some of
the office titles and nomenclature throughout this Final rule to
reflect the new organizational changes. Additional information about
the new structure can be found in the Notice published on July 25, 2017
(82 FR 34564).

Comments

    After our NPRM was published, we received comments from two
commenters.

Request

    Westwind Helicopters questioned the need for the AD. In support, it
stated that the AD inspections are identical to the periodic and
progressive inspections in the Bell maintenance manual and to the one-
time inspection in Bell Alert Service Bulletin (ASB) 407-16-113, dated
February 12, 2016 (ASB 407-16-113). The commenter noted the AD would
result in multiple documentation requirements for operators for the
same maintenance item. The commenter did not request a change to the
AD.
    We partially agree. The commenter is correct that the AD may result
in additional documentation. However, while an operator may incorporate
the procedures described in the Bell maintenance manuals and ASB into
its maintenance program, not all operators are required to do so. In
order for the inspections to become mandatory, and to correct the
unsafe condition

identified in the NPRM, the FAA must issue an AD.
    Bell requested that a statement be added to the AD that
accomplishing the Bell ASB meets the intent of the AD and that no
further action is required.
    We partially agree. Operators may take credit for inspections
previously accomplished in accordance with ASB 407-16-113 under
paragraph (d) of the AD. However, we disagree that no further action is
required because this AD requires repetitive inspections of the TR
driveshaft, whereas ASB 407-16-113 specifies a one-time inspection.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, Transport Canada, its technical
representative, has notified us of the unsafe condition described in
its AD. We are issuing this AD because we evaluated all information
provided by Transport Canada, reviewed the relevant information,
considered the comments received, and determined the unsafe condition
exists and is likely to exist or develop on other helicopters of these
same type designs and that air safety and the public interest require
adopting the AD requirements as proposed.

Related Service Information Under 1 CFR Part 51

    We reviewed ASB 407-16-113, which specifies procedures for
inspecting the TR driveshaft assemblies for noticeable rotational or
axial play between each adapter and TR driveshaft. ASB 407-16-113 also
specifies procedures for performing a torque check of each TR adapter
retention nut on the four TR driveshaft segments.
    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.
    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.

Costs of Compliance

    We estimate this AD affects 667 helicopters of U.S. Registry. We
estimate that operators will incur the following costs in order to
comply with this AD. At an average labor rate of $85 per work-hour,
inspecting the TR driveshaft segments and adapters for play requires
about 1 work-hour, for a cost per helicopter of $85, and a cost of
$56,695 to the U.S. fleet per inspection cycle. Determining the torque
of the four adapter retention nuts requires about 3 work-hours for a
cost per helicopter of $255 and a cost of $170,085 to the U.S. fleet.
    If required, repairing a worn driveshaft adapter would require
about 3 work-hours, and required parts cost about $1,259, for a cost
per helicopter of $1,514.
    Replacing an adapter retention nut requires about 1 work-hour, and
required parts cost are negligible, for a cost of $85 per helicopter
and $56,695 for the U.S. fleet per inspection cycle.

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 helicopters identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (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);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; 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.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 airworthiness
directive (AD):

2018-10-06 Bell Helicopter Textron Canada Limited (Bell): Amendment
39-19281; Docket No. FAA-2017-0667; Product Identifier 2017-SW-053-
AD.

(a) Applicability

    This AD applies to Bell Model 407 helicopters, certificated in
any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a loose tail rotor (TR)
driveshaft splined connection, which if not corrected could result
in wear in the splines, failure of the TR drive system, and
subsequent loss of directional control of the helicopter.

(c) Effective Date

    This AD becomes effective June 25, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    For helicopters with less than 4,000 hours time-in-service
(TIS), within 100 hours TIS, and for helicopters with 4,000 or more
hours TIS, within 50 hours TIS:
    (1) Inspect each TR driveshaft segment assembly for rotational
and axial play between the adapter and the TR driveshaft at the four
positions depicted in Figure 1 of Bell Alert Service Bulletin (ASB)
407-16-113, dated February 12, 2016 (ASB 407-16-113). If there is
any axial or rotational play, remove the adapter from the TR
driveshaft segment assembly and inspect the adapter, washers, and TR
driveshaft for damage. Replace the adapter retention nut and apply a
torque of 30 to 50 inch-pounds (5.7 to 7.9 Nm). Replace any part
with damage or repair the part if the damage is within the maximum
repair damage limitations.
    (2) Determine the torque of each TR adapter retention nut at
each of the four segment assembly positions depicted in Figure 1 of
Bell ASB 407-16-113. If the torque is less than 30 inch-pounds (5.7
Nm), remove the adapter from the TR driveshaft

segment assembly and inspect the adapter, washers, and TR driveshaft
for damage. Replace the adapter retention nut and apply a torque of
30 to 50 inch-pounds (5.7 to 7.9 Nm). Replace any part with damage
or repair the part if the damage is within the maximum repair damage
limitations.
    (3) Repeat the actions specified in paragraph (e)(1) of this AD
at intervals not to exceed 330 hours TIS.

(f) Special Flight Permits

    Special flight permits are prohibited.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
David Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    The subject of this AD is addressed in Transport Canada AD No.
CF-2016-21, dated July 7, 2016. You may view the Transport Canada AD
on the internet at http://www.regulations.gov in Docket No. FAA-
2017-0667.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 6510 Tail Rotor
Drive Shaft.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Bell Alert Service Bulletin 407-16-113, dated February 12,
2016.
    (ii) Reserved.
    (3) For Bell service information identified in this AD, Bell
Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450)
433-0272; or at http://www.bellcustomer.com/files/.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-
321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on May 7, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2018-10491 Filed 5-18-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Page 44480]
[FR Doc No: 2017-20220]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-064, OMB Control No. 3235-0067]

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736

Extension:
    Form S-11

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Form S-11 (17 CFR 239.18) is the registration statement form used
to register securities issued by real estate investment trusts or by
issuers whose business is primarily that of acquiring and holding for
investment interests in real estate under the Securities Act of 1933
(15 U.S.C. 77a et seq.). The information filed with the Commission
permits verification of compliance with securities law requirements and
assures public availability and dissemination of such information.
Information provided is mandatory. We estimate that Form S-11 takes
approximately 779.04 hours per response and is filed by approximately
64 issuers annually. In addition, we estimate that 25% of the 779.04
hours per response (194.76 hours) is prepared by the issuer for an
annual reporting burden of 12,465 hours (194.76 hours per response x 64
responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov .
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: September 19, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-20220 Filed 9-21-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54110-54112]
[FR Doc No: 2018-23422]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0902]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Product Labeling; Medication Guide
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 regulations requiring distribution of
patient labeling, called Medication Guides, for certain products that
pose a serious and significant public health concern.

DATES: Submit either electronic or written comments on the collection
of information by December 26, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0902 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prescription Drug Product
Labeling; Medication Guide Requirements.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and

contact information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Prescription Drug Product Labeling; Medication Guide Requirements

OMB Control Number 0910-0393-Extension

    FDA regulations require the distribution of patient labeling,
called Medication Guides, for certain prescription human drug and
biological products used primarily on an outpatient basis that pose a
serious and significant public health concern. Medication Guides
provide patients the most important information about drug products,
including the drugs' approved uses, contraindications, adverse drug
reactions, and cautions for specific populations. These regulations are
intended to improve the public health by providing information
necessary for patients to use certain medications safely and
effectively.
    The regulations contain the following reporting requirements that
are subject to the PRA:
     21 CFR 208.20--Applicants must submit draft Medication
Guides for FDA approval according to the prescribed content and format.
     21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application
holders must submit changes to Medication Guides as supplements to
their applications to FDA for approval.
     21 CFR 208.24(c)--Each distributor or packer who receives
Medication Guides, or the means to produce Medication Guides, from a
manufacturer under paragraph (b) of this section shall provide those
Medication Guides to each authorized dispenser to whom it ships a drug
product.
     21 CFR 208.24(e)--Each authorized dispenser of a
prescription drug product for which a Medication Guide is required must
provide a Medication Guide directly to each patient when dispensing the
product to the patient or to the patient's agent, unless an exemption
applies under 21 CFR 208.26.
     21 CFR 208.26(a)--Requests may be submitted for an
exemption or a deferral from particular Medication Guide content or
format requirements.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Content and Format of a                       61               1              61             320          19,520
 Medication Guide--Sec.   208.20
Supplements and Other Changes to             155               1             155              72          11,160
 an Approved Application--Sec.
 Sec.   314.70(b)(3)(ii) and
 601.12(f)......................
Exemptions and Deferrals--Sec.                 1               1               1               4               4
 208.26(a)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          30,684
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
        21 CFR section             Number of     disclosures per   Total annual   Average burden    Total hours
                                  respondents      respondent       disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Distributing Medication Guide              191             9,000       1,719,000            1.25       2,148,750
 to Authorized Dispenser--Sec.
   208.24(c)..................

Distributing and Dispensing a           88,736             5,705     506,238,880          * 0.05      25,311,944
 Medication Guide to Patient--
 Sec.   208.24(e).............
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ................  ..............  ..............      27,460,694
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 3 minutes.

    Our estimated annual reporting burden for the information
collection reflects an increase of 51 respondents and responses and a
corresponding overall increase of 4,664 total hours. We attribute this
adjustment to an increase in the number of submissions we received over
the last few years. Based on a review of the information collection
since our last request for OMB approval, we have made no adjustments to
our annual third-party disclosure burden estimate, except for
correction in calculations.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23422 Filed 10-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11806-11808]
[FR Doc No: 2014-04561]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-1065]

Towing Safety Advisory Committee; March 2014 meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal advisory committee meeting.

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

SUMMARY: The Towing Safety Advisory Committee (TSAC) will meet in New
Orleans, Louisiana on March 20, 2014, to review and discuss
recommendations from its subcommittees and to receive briefs listed in
the agenda under SUPPLEMENTARY INFORMATION. The subcommittees will meet
on March 19, 2014, and work on nine assigned tasks listed in the
referenced agenda. All meetings will be open to the public.

DATES: TSAC subcommittees will meet on Wednesday, March 19, 2014, from
7:30 a.m. to 5 p.m. The full TSAC Committee will meet on Thursday,
March 20, 2014, from 7:30 a.m. to 5:30 p.m. These meetings may close
early if the Committee has completed its business. All submitted
written materials, comments, and requests to make oral presentations at
the meetings should reach Lieutenant Commander William A. Nabach,
Alternate Designated Federal officer (ADFO) for TSAC no later than
March 10, 2014. For contact information, please see the FOR FURTHER
INFORMATION CONTACT section below. Any written material submitted by
the public will be distributed to the Committee and become part of the
public record.

ADDRESSES: All meetings will be held at the Wyndham Riverfront New
Orleans Bacchus Conference Room, 701 Convention Center Blvd., New
Orleans, LA 70130.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the individuals listed in the FOR FURTHER INFORMATION CONTACT section,
as soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the committee as listed in the
``Agenda'' section below. Written comments must be submitted no later
than March 10, 2014 and must be identified by Docket No. USCG-2013-1065
and may be submitted by one of the following methods:
     Federal Rulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. (Preferred method to
avoid delays in processing).
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001. We encourage use of
electronic submissions because security screening may delay the
delivery of mail.
     Fax:<PHONE_NUMBER>.
     Hand delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
     To avoid duplication, please use only one of these
methods.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number of this
notice. All comments submitted will be posted without alteration at
http://www.regulations.gov including any personal information provided.
You may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov, insert USCG-
2013-1065 in the Search box, press Enter, and then click on the item
you wish to view.

FOR FURTHER INFORMATION CONTACT: Commander Robert L. Smith Jr.,
Designated Federal Officer (DFO) for TSAC, Commandant (CG-OES-2), U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE. Stop 7509,
Washington, DC 20593-7509; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or
email<EMAIL_ADDRESS>or Lieutenant Commander William A.
Nabach, Alternate Designated Federal Officer (ADFO), TSAC; telephone
(202) 372-1386, fax<PHONE_NUMBER> or email<EMAIL_ADDRESS>
If you have any questions on viewing or submitting material to the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix (Pub. L. 92-
463). TSAC is established in accordance with and operates under the
provisions of the FACA. As stated in 33 U.S.C. 1231a, the Towing Safety
Advisory Committee provides advice and recommendations to the
Department of Homeland Security on matters relating to shallow-draft
inland and coastal waterway navigation and towing safety.

Agenda of Meetings

    The subcommittees will meet on March 19, 2014, from 7:30 a.m. to 5
p.m., to work on their specific task assignments:
    (1) Recommendations Regarding Manning of Inspected Towing Vessels.
    (2) Recommendations to Create Standardized Terminology for the
Towing Industry.
    (3) Recommendations for Evaluating Placement of Structures Adjacent
to or Within the Navigable Channel.
    (4) Recommendations for Designation of Narrow Channels.
    (5) Recommendations for the Maintenance, Repair and Utilization of
Towing Equipment, Lines and Couplings.
    (6) Recommendations Regarding Steel Repair of Inspected Towing
Vessels on Inland Service.
    (7) Recommendations For Mid-Stream Liquefied Natural Gas and
Compressed Natural Gas Refueling of Towing Vessels.
    (8) Recommendations for Improvement of Coast Guard Marine Casualty
Reporting.
    (9) Recommendation to Establish Criteria for Identification of Air
Draft for Towing Vessels and Tows.
    On March 20, 2014, from 7:30 a.m. to 5:30 p.m., TSAC will meet to
receive oral and written reports from its subcommittees on the
following issues:
    (1) Recommendations Regarding Manning of Inspected Towing Vessels.
A progress update will be given.
    (2) Recommendations to Create Standardized Terminology for the
Towing Industry. A final report will be given.
    (3) Recommendations for Evaluating Placement of Structures Adjacent
to or Within the Navigable Channel. A final report will be given.
    (4) Recommendations for Designation of Narrow Channels. A progress
update will be given.
    (5) Recommendations for the Maintenance, Repair and Utilization of
Towing Equipment, Lines and Couplings. A progress update will be given.
    (6) Recommendations Regarding Steel Repair of Inspected Towing
Vessels on Inland Service. A final report will be given.
    (7) Recommendations For Mid-Stream Liquefied Natural Gas and
Compressed Natural Gas Refueling of Towing Vessels. A progress update
will be given.
    (8) Recommendations for Improvement of Coast Guard Marine Casualty
Reporting. A progress update will be given.
    (9) Recommendation to Establish Criteria for Identification of Air
Draft for Towing Vessels and Tows. A progress update will be given.
    There will be a comment period for TSAC and a comment period for
the public after each final report presentation, but before each is
voted on by the Committee. The Committee will review the information
presented on each issue, deliberate on any

recommendations presented in the subcommittees' reports, and formulate
recommendations for the Department's consideration.
    The Committee is scheduled to receive the following briefs:
    (1) National Plan for Safety and Security of Especially Hazardous
Cargo.
    (2) U.S. Army Corps of Engineers Galveston District Set-back
Standard Operating Procedures.
    (3) Carriage of Shale Gas Extraction Wastewater in Bulk.
    A copy of each draft report, presentation and the final agenda will
be available at https://homeport.uscg.mil/tsac.
    An opportunity for oral comments by the public will be provided
during the meeting on March 20, 2014. Speakers are requested to limit
their comments to 3 minutes. Please note that the public oral comment
period may end before the end of the stated meeting times if the
Committee has finished its business. Please contact Lieutenant
Commander William A. Nabach, listed in the FOR FURTHER INFFORMATION
CONTACT section to register as a speaker.

Minutes

    Minutes from the meeting will be available for public review and
copying within 90 days following the close of the meeting and can be
accessed from the Coast Guard Homeport Web site http://homeport.uscg.mil/tsac.

Notice of Future 2014 TSAC Meetings

    To receive automatic email notices of future TSAC meetings in 2014,
go to the online docket, USCG-2013-1065 (http://www.regulations.gov/#!docketDetail;D=USCG-2013-1065), and select the sign-up-for-email-
alerts option. We plan to use the same docket number for all TSAC
meeting notices in 2014, so when the next meeting notice is published
you will receive an email alert from www.regulations.gov when the
notice appears in this docket.

    Dated: February 25, 2014.
J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2014-04561 Filed 2-28-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10318-10320]
[FR Doc No: 2023-03425]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OGC-2023-0084; FRL-10668-01-OGC]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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

SUMMARY: In accordance with the Clean Air Act, as amended (CAA or the
Act), notice is given of a proposed consent decree in Environmental
Integrity Project and Sierra Club v. Regan, No. 1:22-cv-3063 (D.D.C.).
On October 10, 2022, Plaintiffs Environmental Integrity Project and
Sierra Club filed a complaint in the United States District Court for
the District of Columbia. Plaintiffs alleged that the Environmental
Protection Agency (EPA or the Agency) failed to perform certain non-
discretionary duties in accordance with the Act to take final action
with respect to a state implementation plan (SIP) revision submitted by
the Texas Commission on Environmental Quality (TCEQ). The proposed
consent decree would establish a deadline for EPA to sign a notice of
final rulemaking.

DATES: Written comments on the proposed consent decree must be received
by March 20, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OGC-2023-0084, online at https://www.regulations.gov (EPA's preferred
method). Follow the online instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
number for this action. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Additional Information
about Commenting on the Proposed Consent Decree'' heading under the
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pettit, Air and Radiation
Law Office, Office of General Counsel, U.S. Environmental Protection
Agency; telephone<PHONE_NUMBER>; email address
pettit.elizabet[email protected].

SUPPLEMENTARY INFORMATION:

I. Obtaining a Copy of the Proposed Consent Decree

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2023-0084) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC.
The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    The electronic version of the public docket for this action
contains a copy of the proposed consent decree, and is available
through https://www.regulations.gov. You may use https://www.regulations.gov to submit or view public comments, access the index
listing of the contents of the official public docket, and access those
documents in the public docket that are available electronically. Once
in the system, key in the appropriate docket identification number then
select ``search.''

II. Additional Information About the Proposed Consent Decree

    The proposed consent decree would establish a deadline for EPA to
take action pursuant to CAA section 110(k) on a SIP revision submitted
by TECQ on August 20, 2020. To address EPA's 2015 startup, shutdown,
and malfunction policy, the SIP revision purports to establish
federally enforceable SIP requirements for the control of particulate
matter emissions from eight coal-fired power plants located in Texas
during periods of planned maintenance, startup, and shutdown.\1\ The
proposed consent decree would require EPA to sign a notice of final
rulemaking by October 1, 2024.
---------------------------------------------------------------------------

    \1\ On June 12, 2015, the EPA finalized ``State Implementation
Plans: Response to Petition for Rulemaking; Restatement and Update
of EPA's SSM Policy Applicable to SIPs; Findings of Substantial
Inadequacy; and SIP Calls to Amend Provisions Applying to Excess
Emissions During Periods of Startup, Shutdown and Malfunction'' (80
FR 33839, June 12, 2015).
---------------------------------------------------------------------------

    In accordance with section 113(g) of the CAA, for a period of
thirty (30) days following the date of publication of this document,
the Agency will accept written comments relating to the proposed
consent decree. EPA or the Department of Justice may withdraw or
withhold consent to the proposed consent decree if the comments
disclose facts or considerations that indicate that such consent is
inappropriate, improper, inadequate, or inconsistent with the
requirements of the Act.

III. Additional Information About Commenting on the Proposed Consent
Decree

    Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2023-
0084, via https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from this docket. EPA may publish any comment
received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information
identified as CBI, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section of this document. Note that written
comments containing CBI and submitted by mail may be delayed and
deliveries or couriers will be received by scheduled appointment only.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment. This ensures that you
can be identified as the submitter of the comment and allows EPA to
contact you in case EPA cannot read your comment due to technical
difficulties or needs further information on the substance of your
comment. Any identifying or contact information provided in the body of
a comment will be included as part of the comment that is placed in the
official public docket and made available in EPA's electronic public
docket. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.
    Use of the https://www.regulations.gov website to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
    Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be

marked ``late.'' EPA is not required to consider these late comments.

Gautam Srinivasan,
Associate General Counsel.
[FR Doc. 2023-03425 Filed 2-16-23; 8:45 am]
BILLING CODE 6560-50-P


                 United States Environmental Protection Agency
                    Docket Index for EPA-R09-OAR-2018-0413

                        Notice of Proposed Rulemaking
Revisions to California State Implementation Plan; South Coast Air Quality Management District; Stationary Source Permits

                                 July 18, 2018
 Note: Copies of the Federal Register (FR) notices listed in Section C are publicly accessible at http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR.

Document Number
Document Name
A.1
SIP submittal package from the California Air Resources Board; Dated May 8, 2017
A.2
SCAQMD Amended Rule 1325 Adoption documents
A.3
SCAQMD Amended Rule 1325  -  Federal PM2.5 New Source Review Program (Clean Version); Adopted November 4, 2016
A.4
SCAQMD Amended Rule 1325  -  Federal PM2.5 New Source Review Program (Strike-out Version); Adopted November 4, 2016
A.5
SCAQMD Staff Report for Amended Rule 1325; Dated October 13, 2016

Document Number
Document Name
B.1
SIP Submittal Completeness Letter (Matthew J. Lakin,
EPA Region 9 Letter to Richard W. Corey, CARB); Dated November 1, 2017
B.2
SIP Approved SCAQMD Rule 1325  -  Federal PM2.5 New Source Review Program: Adopted December 5, 2014
B.3
TSD for NPRM for SCAQMD Rule 1325: Dated February 13, 2015
B.4
EPA Letter to SCAQMD requesting Commitment Letter; Dated May 10, 2018
B.5
SCAQMD Commitment Letter; Dated June 26, 2018
B.6
CARB Commitment Letter: Dated July 16, 2018

Document Number
Federal Register Citation & Date
C.1
 80 FR 24821, May 1, 2015
C.2
 81 FR 1514, Jan. 13, 2016
C.3
 81 FR 58010, August 24, 2016


[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)]
[Notices]
[Pages 12822-12823]
[FR Doc No: 2015-05523]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-1315 (formerly 1999-D-0296)]

Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Prescription Drug User Fee Act Products;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Formal
Meetings Between the FDA and Sponsors or Applicants of Prescription
Drug User Fee Act (PDUFA) Products.'' This draft guidance provides
recommendations to industry on formal meetings between FDA and sponsors
or applicants relating to the development and review of drug or
biological products (``products''). This draft guidance revises the
guidance for industry entitled ``Formal Meetings Between the FDA and
Sponsors or Applicants'' published May 19, 2009.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 9, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-
0002, or the Office of Communication, Outreach, and Development, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rachel E. Hartford, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-0319; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products.'' This draft guidance provides recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of products regulated by the
Center for Drug Evaluation and Research and the Center for Biologics
Evaluation and Research. This draft guidance does not apply to
abbreviated new drug applications, applications for biosimilar
biological products, or submissions for medical devices. For the
purposes of this draft guidance, ``formal meeting'' includes any
meeting that is requested by a sponsor or applicant following the
request procedures provided in this guidance and includes meetings
conducted in any format (i.e., face to face, teleconference,
videoconference, or written response).
    This draft guidance discusses the principles of good meeting
management practices and describes standardized procedures for
requesting, preparing for, scheduling, conducting, and documenting such
formal meetings. The general principles in this draft guidance may be
extended to other nonapplication-related meetings with external
constituents, insofar as this is possible.
    This draft guidance revises the guidance for industry entitled
``Formal Meetings Between the FDA and Sponsors or Applicants''
published May 19, 2009. This draft guidance is being

updated in accordance with the Meeting Management Goals section of the
PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years
2013 through 2017. Significant changes from the 2009 guidance include:

 Addition of the written response meeting format for pre-
investigational new drug application and Type C meetings
 Designation of a post-action meeting requested within 3 months
after an FDA regulatory action other than approval as a Type A meeting
 Designation of a post-action meeting requested 3 or more
months after an FDA regulatory action other than approval as a Type B
meeting
 Designation of a meeting regarding risk evaluation and
mitigation strategies or postmarketing requirements that occur outside
the context of the review of a marketing application as a Type B
meeting
 Inclusion of a meeting package in Type A meeting requests
 Designation of meetings to discuss the overall development
program for products granted breakthrough therapy designation status as
a Type B meeting

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on formal
meetings between FDA and sponsors or applicants of PDUFA products. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that 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 referred to in the guidance
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants''
have been approved under OMB control number 0910-0429. The collections
of information for Form FDA 1571 and end-of-phase 2 meetings have been
approved under OMB control number 0910-0014, and collections of
information for Form FDA 356h have been approved under OMB control
number 0910-0338.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: March 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05523 Filed 3-10-15; 8:45 am]
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[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Page 5562]
[FR Doc No: 2017-00930]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Notice of Revocation of Market-Based Rate Tariff

------------------------------------------------------------------------
                                                     Docket Nos.
------------------------------------------------------------------------
Electric Quarterly Reports.................  ER02-2001-020
Bargain Energy, LLC........................  ER14-1343-001
CES Placerita, Incorporated................  ER14-57-000
DES Wholesale, LLC.........................  ER12-1770-001
DownEast Power Company, LLC................  ER10-1304-002
Escanaba Green Energy, LLC.................  ER12-2307-001
LVI Power, LLC.............................  ER12-2484-000
Madstone Energy Corp.......................  ER11-4482-000
NiGen, LLC.................................  ER15-567-001
R&R Energy, Inc............................  ER11-4711-002
Tall Bear Group, LLC.......................  ER12-2374-000
------------------------------------------------------------------------

    On October 27, 2016, the Commission issued an order announcing its
intent to revoke the market-based rate authority of the public
utilities listed in the caption of that order, which had failed to file
their required Electric Quarterly Reports.\1\ The Commission directed
those public utilities to file the required Electric Quarterly Reports
within 15 days of the date of issuance of the order or face revocation
of their authority to sell power at market-based rates and termination
of their electric market-based rate tariffs.\2\
---------------------------------------------------------------------------

    \1\ Electric Quarterly Reports, 157 FERC 61,058 (2016) (October
27 Order).
    \2\ Id. at Ordering Paragraph A.
---------------------------------------------------------------------------

    The time period for compliance with the October 27 Order has
elapsed. The above-captioned companies failed to file their delinquent
Electric Quarterly Reports. The Commission hereby revokes the market-
based rate authority and terminates the electric market-based rate
tariff of each of the companies who are named in the caption of this
order.

    Dated: January 9, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-00930 Filed 1-17-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Notices]
[Pages 14327-14328]
[FR Doc No: 2014-05449]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-19]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 2, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0874 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Keira Jones<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 7, 2014.
Lirio Liu,
Director, Office of Rulemaking.
PETITION FOR EXEMPTION
Docket No.: FAA-2013-0874
Petitioner: Hyannis Air Service d.b.a. Cape Air/Nantucket Airlines
Section of 14 CFR Affected: 14 CFR 119.21(a)(4) and 135.243(a)(1)
Description of Relief Sought:
    Hyannis Air Service, Inc. d.b.a Cape Air/Nantucket Airlines
requests relief from the requirements of Sec.  135.243(a)(1)

requiring a Pilot in Command of Cape Air's part 135 commuter operation
to possess an Airline Transport Pilot (ATP) certificate. Cape Air
requests relief for its part 135 Scheduled Commuter Pilots be allowed
to exercise their commercial pilot certificates with multi engine and
instrument ratings in the course of their duties as captains for Cape
Air. Cape Air would use current ATP Training Standards; ATP
Aeronautical Experience requirements per Sec.  61.159, ATP Practical
Training Standards.

[FR Doc. 2014-05449 Filed 3-12-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 3, 2010 (Volume 75, Number 22)]
[Rules and Regulations]
[Page 5514-5515]
[DOCID:fr03fe10-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2009-0771; FRL-9108-7]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correcting amendment.

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

SUMMARY: This document corrects an error in the amendatory instruction
in a November 20, 2009 final rule pertaining to the Indiana State
Implementation Plan (SIP) revision updating the definition of
``References to the Code of Federal Regulations,'' to refer to the 2008
edition. The amendatory instruction in that rulemaking conflicts with
the actual amendment language. EPA, therefore, is correcting the
erroneous amendatory instructions.

DATES: Effective Date: This final rule is effective on February 3,
2010.

FOR FURTHER INFORMATION CONTACT: Christos Panos, Environmental
Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA published a final rule document on
November 20, 2009, (74 FR 60197) approving Indiana's request to revise
the Indiana SIP by updating the definition of ``References to the Code
of Federal Regulations,'' to refer to the 2008 edition. In this
approval EPA erroneously identified the paragraph being added to 40 CFR
52.770. The amendatory instruction in that rulemaking conflicts with
the actual amendment language. The amendatory language says to add
paragraph (c)(192), but the actual language being added is for
paragraph (c)(191). Therefore, the amendatory instruction should have
referred to paragraph (c)(191).

Correction

    In the final rule published in the Federal Register on November 20,
2009, (74 FR 60197), on page 60199, second column, in amendatory
instruction 2, in the second line, ``* * * adding paragraph (c)(192) *
* *'' should have read: ``* * * adding paragraph (c)(191) * * *''.
    Section 553 of the Administrative Procedure Act, 5 U.S.C.
553(b)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. We have determined that
there is good cause for making today's rule final without prior
proposal and opportunity for comment because we are merely correcting
an incorrect citation in a previous action. Thus, notice and public
procedure are unnecessary. We find that this constitutes good cause
under 5 U.S.C. 553(b)(B).

Statutory and Executive Order Reviews

    Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993),
this action is not a ``significant regulatory action'' and is therefore
not subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'', 66 FR 28355 (May 22, 2001). Because the
agency has made a ``good cause'' finding that this action is not
subject to notice-and-comment requirements under the Administrative
Procedures Act or any other statute as indicated in the Supplementary
Information section, above, it is not subject to the regulatory
flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) or to sections 202 and 205 of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in sections 203 and
204 of UMRA. This rule also does not have a substantial direct effect
on one or more Indian tribes, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes, as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor
will it have substantial direct effects 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
governments, as specified by Executive Order 13132 (64 FR 43255, August
10, 1999). This rule also is not subject to Executive Order 13045 (62
FR 19885, April 23, 1997), because it is not economically significant.
    This technical correction action does not involve technical
standards; thus the requirements of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do
not apply. The rule also does not involve special consideration of
environmental justice related issues as required by Executive Order
12898 (59 FR 7629, February 16, 1994). In issuing this rule, EPA has
taken the necessary steps to eliminate drafting errors and ambiguity,
minimize potential litigation, and provide a clear legal standard for
affected conduct, as required by section 3 of Executive Order 12988 (61
FR 4729, February 7, 1996). EPA has complied with Executive Order 12630
(53 FR 8859, March 15, 1998) by examining the takings implications of
the rule in accordance with the ``Attorney General's Supplemental
Guidelines for the Evaluation of Risk and Avoidance of Unanticipated
Takings'' issued under the executive order. This rule does not impose
an information collection burden under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.)
    The Congressional Review Act (5 U.S.C. 801 et seq.), as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
determination must be supported by a brief statement. 5 U.S.C. 808(2).
As stated previously, EPA had made such a good cause finding, including
the reasons therefore, and established an effective date of February 3,
2010. EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This correction to 40 CFR 52 for
Indiana is not a ``major rule'' as defined by 5 U.S.C. 804(2).

    Dated: January 22, 2010.
Walter W. Kovalick, Jr.,
Acting Regional Administrator, Region 5.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart P--Indiana

Sec.  52.770  [Amended]

0
2. Section 52.770 is amended by redesignating paragraph (c)(192) as
paragraph (c)(191).

[FR Doc. 2010-2248 Filed 2-2-10; 8:45 am]
BILLING CODE 6560-50-P